Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with a novel idea: injecting beef with ammonia.
The company, Beef Products Inc., had been looking to expand into the hamburger business with a product made from beef that included fatty trimmings the industry once relegated to pet food and cooking oil. The trimmings were particularly susceptible to contamination, but a study commissioned by the company showed that the ammonia process would kill E. coli as well as salmonella.
Officials at the United States Department of Agriculture endorsed the company’s ammonia treatment, and have said it destroys E. coli “to an undetectable level.” They decided it was so effective that in 2007, when the department began routine testing of meat used in hamburger sold to the general public, they exempted Beef Products.
With the U.S.D.A.’s stamp of approval, the company’s processed beef has become a mainstay in America’s hamburgers. McDonald’s, Burger King and other fast-food giants use it as a component in ground beef, as do grocery chains. The federal school lunch program used an estimated 5.5 million pounds of the processed beef last year alone.
FULL STORY: http://www.nytimes.com/2009/12/31/us/31meat.html?_r=1
Thursday, December 31, 2009
Thursday, December 17, 2009
CPSC Renews Crib Warning After Another Death
CPSC Renews Crib Warning After Another Death
All cribs have been recalled but death toll rises to 11
The warning is increasingly urgent. The U.S. Consumer Product Safety Commission is telling parents not to use the recalled Simplicity drip side crib after the report of yet another infant who became trapped and suffocated.
The death toll is now 11, the agency says.
The crib is made by Simplicity Inc. and SFCA of Reading, Pa. The CPSC says the firm has ceased day-to-day operations and presumably has gone out of business.
In September the agency recalled about 600,000 Simplicity drop-side cribs because of an entrapment and suffocation hazard. At the time, two infant deaths had been attributed to the beds.
The recall notice said that, due to sizing problems with the crib's hardware, the drop side can come off the tracks. When the drop side detaches or partially detaches, it creates a hazardous gap, which can lead to infant entrapment and suffocation.
CPSC said it is also is aware of an additional 25 incidents involving the drop side detaching from the crib. To date, CPSC has recalled over 2 million Simplicity drop side cribs due to problems with the crib's plastic hardware.
Read more: http://www.consumeraffairs.com/news04/2009/12/simplicity_cpsc03.html#ixzz0a0ir0eKx
All cribs have been recalled but death toll rises to 11
The warning is increasingly urgent. The U.S. Consumer Product Safety Commission is telling parents not to use the recalled Simplicity drip side crib after the report of yet another infant who became trapped and suffocated.
The death toll is now 11, the agency says.
The crib is made by Simplicity Inc. and SFCA of Reading, Pa. The CPSC says the firm has ceased day-to-day operations and presumably has gone out of business.
In September the agency recalled about 600,000 Simplicity drop-side cribs because of an entrapment and suffocation hazard. At the time, two infant deaths had been attributed to the beds.
The recall notice said that, due to sizing problems with the crib's hardware, the drop side can come off the tracks. When the drop side detaches or partially detaches, it creates a hazardous gap, which can lead to infant entrapment and suffocation.
CPSC said it is also is aware of an additional 25 incidents involving the drop side detaching from the crib. To date, CPSC has recalled over 2 million Simplicity drop side cribs due to problems with the crib's plastic hardware.
Read more: http://www.consumeraffairs.com/news04/2009/12/simplicity_cpsc03.html#ixzz0a0ir0eKx
Test results on formaldehyde in Noodlefish---Hong Kong
Test results on formaldehyde in noodlefish
The Centre for Food Safety (CFS) recently conducted a targeted food surveillance exercise to assess the situation of formaldehyde in noodlefish.
Results showed that one of the 10 samples taken contained formaldehyde at a level of 1,200ppm. The samples had been collected from retail outlets for testing.
"We believe formaldehyde was added as a preservative after the fish were caught, or during transportation or storage," a CFS spokesman said today (December 17).
"At the level of formaldehyde detected in the noodlefish sample, health effects such as abdominal pain and vomiting and kidney problems cannot be ruled out for high consumers," the spokesman said.
"Consumption of noodlefish by the general public with the same detected level as this sample on a long-term basis might have effects on the gastro-intestinal tract. The main health concern of formaldehyde is its cancer-causing potential through exposure via inhalation. According to the World Health Organization, there is not sufficient evidence showing that formaldehyde is carcinogenic through exposure through the oral route."
The CFS called on the trade not to add formaldehyde to fish or other marine products. Under the law, formaldehyde is not permitted for use as a food preservative. Contravention of the law could lead to a maximum fine of $50,000 and six months' imprisonment.
"Regarding the unsatisfactory sample, the CFS issued warning letters to the stall operator concerned asking him to stop selling the affected products. We are tracing the source of the fish in question. We are also collecting sufficient evidence for prosecution," he added.
The CFS also advised the public to take note of the following when buying or cooking marine products (e.g. noodlefish):
* Avoid buying noodlefish that are stiff (formaldehyde could stiffen flesh of fish);* Choose only fish that are fresh and avoid those with an unusual smell;* Wash and cook marine products thoroughly as formaldehyde is water soluble and could dissipate upon heating.
The Centre for Food Safety (CFS) recently conducted a targeted food surveillance exercise to assess the situation of formaldehyde in noodlefish.
Results showed that one of the 10 samples taken contained formaldehyde at a level of 1,200ppm. The samples had been collected from retail outlets for testing.
"We believe formaldehyde was added as a preservative after the fish were caught, or during transportation or storage," a CFS spokesman said today (December 17).
"At the level of formaldehyde detected in the noodlefish sample, health effects such as abdominal pain and vomiting and kidney problems cannot be ruled out for high consumers," the spokesman said.
"Consumption of noodlefish by the general public with the same detected level as this sample on a long-term basis might have effects on the gastro-intestinal tract. The main health concern of formaldehyde is its cancer-causing potential through exposure via inhalation. According to the World Health Organization, there is not sufficient evidence showing that formaldehyde is carcinogenic through exposure through the oral route."
The CFS called on the trade not to add formaldehyde to fish or other marine products. Under the law, formaldehyde is not permitted for use as a food preservative. Contravention of the law could lead to a maximum fine of $50,000 and six months' imprisonment.
"Regarding the unsatisfactory sample, the CFS issued warning letters to the stall operator concerned asking him to stop selling the affected products. We are tracing the source of the fish in question. We are also collecting sufficient evidence for prosecution," he added.
The CFS also advised the public to take note of the following when buying or cooking marine products (e.g. noodlefish):
* Avoid buying noodlefish that are stiff (formaldehyde could stiffen flesh of fish);* Choose only fish that are fresh and avoid those with an unusual smell;* Wash and cook marine products thoroughly as formaldehyde is water soluble and could dissipate upon heating.
Saturday, December 5, 2009
Excelligence Learning Corp. to Pay $25,000 Civil Penalty Due to Violation of Lead Paint Ban
Excelligence Learning Corp. to Pay $25,000 Civil Penalty Due to Violation of Lead Paint Ban
WASHINGTON, D.C.- The U.S. Consumer Product Safety Commission (CPSC) announced today that Excelligence Learning Corp, of Monterey, Calif. DBA Discount School Supply has agreed to pay a $25,000 civil penalty for allegedly violating the federal lead paint ban. The penalty settlement has been provisionally accepted by the Commission.
The settlement resolves CPSC staff allegations that Excelligence imported more than 33,000 units of children’s products that contained lead paint above the 0.06 percent legal limit at different intervals between August 2000 and August 2007. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. As a result of the Consumer Product Safety
Improvement Act of 2008, the regulatory limit was reduced to 0.009 percent on August 14, 2009. These products were recalled in November 2007, December 2007and January 2008.
In agreeing to the settlement, Excelligence denies that it knowingly violated federal law, as alleged by CPSC staff.
WASHINGTON, D.C.- The U.S. Consumer Product Safety Commission (CPSC) announced today that Excelligence Learning Corp, of Monterey, Calif. DBA Discount School Supply has agreed to pay a $25,000 civil penalty for allegedly violating the federal lead paint ban. The penalty settlement has been provisionally accepted by the Commission.
The settlement resolves CPSC staff allegations that Excelligence imported more than 33,000 units of children’s products that contained lead paint above the 0.06 percent legal limit at different intervals between August 2000 and August 2007. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. As a result of the Consumer Product Safety
Improvement Act of 2008, the regulatory limit was reduced to 0.009 percent on August 14, 2009. These products were recalled in November 2007, December 2007and January 2008.
In agreeing to the settlement, Excelligence denies that it knowingly violated federal law, as alleged by CPSC staff.
Thursday, November 26, 2009
Important Information on Changes to Heparin Potency
Important Information on Changes to Heparin Potency
2009-191
OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.
Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals. It is used, for example, as part of kidney dialysis or to prevent blood clots. Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.
Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used. However, there may be specific situations in a hospital setting that will require health care professionals to take this change in heparin potency under consideration, such as procedures where heparin is used as a single dose to achieve an immediate anti-clotting effect. In such procedures, blood monitoring may not necessarily occur.
When administering the drug, health care professionals should be aware of the potential difference in potency between heparin made under the old system and heparin made under the new system.
Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product. As well, following a heparin treatment, patients may notice they are being monitored more than before. This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.
As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time. This is necessary to ensure that there is no heparin shortage and patients can continue to receive treatments as scheduled. Health Canada is currently working with manufacturers to ensure that heparin products using the new standard are clearly identified during this transition.
Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
This document can be found on the Health Canada website.
Patients with questions or concerns about heparin should speak to their health care professional.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or call toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect™ Canada section of the Health Canada website
Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the
Health Canada website.
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
2009-191
OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.
Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals. It is used, for example, as part of kidney dialysis or to prevent blood clots. Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.
Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used. However, there may be specific situations in a hospital setting that will require health care professionals to take this change in heparin potency under consideration, such as procedures where heparin is used as a single dose to achieve an immediate anti-clotting effect. In such procedures, blood monitoring may not necessarily occur.
When administering the drug, health care professionals should be aware of the potential difference in potency between heparin made under the old system and heparin made under the new system.
Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product. As well, following a heparin treatment, patients may notice they are being monitored more than before. This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.
As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time. This is necessary to ensure that there is no heparin shortage and patients can continue to receive treatments as scheduled. Health Canada is currently working with manufacturers to ensure that heparin products using the new standard are clearly identified during this transition.
Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
This document can be found on the Health Canada website.
Patients with questions or concerns about heparin should speak to their health care professional.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or call toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect™ Canada section of the Health Canada website
Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the
Health Canada website.
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Tuesday, November 24, 2009
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.
Media Inquires: Siobhan DeLancey, siobhan.delancey@fda.hhs.gov, 301-796-4668
Consumer Inquires: 1-888-INFO-FDA
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. Sharkco’s History of Violations Prompts FDA to Seek Court Action
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.
“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”
According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.
No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products.
The company produces other seafood products, which are not affected by this action.
Consumer Inquires: 1-888-INFO-FDA
FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. Sharkco’s History of Violations Prompts FDA to Seek Court Action
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.
“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”
According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.
No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products.
The company produces other seafood products, which are not affected by this action.
Monday, November 23, 2009
Press Statement on Corrosion in Homes and Connections to Chinese Drywall
U.S. Consumer Product Safety Commission
November 23, 2009
Press Statement on Corrosion in Homes and
Connections to Chinese Drywall
Results from a major indoor air study of 51 homes are being released today along with
initial reports from two studies of corrosion in homes with Chinese drywall. We now can
show a strong association between homes with the problem drywall and the levels of
hydrogen sulfide in those homes and corrosion of metals in those homes.
By identifying this association, the Interagency Drywall Task Force can now move
forward to develop protocols that will identify homes with this corrosive environment
and can determine the effectiveness of remediation methods. The Task Force continues to
work with Congressional and White House officials to determine the best approaches to
design and fund these identification and remediation efforts to help the families dealing
with this issue.
“We now have the science that enables the Task Force to move ahead to the next phase –
to develop both a screening process and effective remediation methods. Ongoing studies
will examine health and safety effects, but we are now ready to get to work fixing this
problem,” said U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum.
The Studies
The 51 home study contracted by CPSC was done by Environmental Health &
Engineering (EH&E), an internationally known environmental testing firm based in
Massachusetts.
In addition, today two preliminary reports on corrosion safety issues are being released.
The Sandia National Laboratories’ (SNL) Materials and Engineering Center is studying
the long-term electrical safety hazards of conductor metal components. The National
Institute of Standards and Technology (NIST) is studying the corrosion effects on fire
safety components taken from complaint homes.
Findings
EH&E compared 41 “complaint” homes in five states selected from CPSC’s consumer
incident report database, with 10 noncomplaint homes built around the same time in the
same area as the complaint homes. Homes were sampled between July and September
2009.
The EH&E findings are that hydrogen sulfide gas is the essential component that causes
copper and silver sulfide corrosion found in the complaint homes. Other factors,
including air exchange rates, formaldehyde and other air contaminants contribute to the
reported problems.
In ways still to be determined, hydrogen sulfide gas is being created in homes built with
Chinese drywall. Earlier studies found large amounts of elemental sulfur in the Chinese
drywall. CPSC is investigating drywall from other sources that may mimic the problems
found with Chinese drywall. CPSC is meeting with drywall manufacturers and others
who are studying this issue to take their findings into consideration.
EH&E exposed copper and silver test strips, known as coupons, in homes for a period of
about two weeks. The coupons showed significantly higher rates of corrosion in
complaint homes than in the control homes. The dominant species of corrosion on the
coupons was copper sulfide and silver sulfide, as determined by additional laboratory
tests. Visual inspection and evaluation of ground wire corrosion also revealed
statistically significant greater ground wire corrosion in complaint homes compared to
non-complaint homes.
The EH&E study also found that by using hand-held x-ray fluorescence (XRF) and
Fourier Transform Infrared (FTIR) instruments, they were able to detect markers that
could identify Chinese-made dry wall at a sheet-by-sheet level.
While drywall-related corrosion is clearly evident, long term safety effects are still under
investigation. Like the EH&E study, initial reports available today from SNL and NIST
show copper and silver sulfide corrosion on samples of metal taken from homes with
problem drywall. These ongoing investigations will help the CPSC identify the nexus of
problem drywall and long term safety issues.
In addition, the EH&E study found elevated formaldehyde readings in both the control
and complaint homes. This is typical for new, more air-tight homes due to items such as
cabinets and carpets which emit formaldehyde. Both formaldehyde and hydrogen sulfide
are known irritants at sufficiently high levels. The concentrations measured in this study
were below those levels. Investigators believe that the additive or synergistic effects of
these and other compounds in the subject homes could cause irritant effects evident in the
homes.
Next Steps
First, CPSC continues to search for homes exhibiting the corrosion and health effects
under study. In addition to a direct call to consumers, CPSC is contacting governors of all
states, all territories and the District of Columbia, to ensure that all homes with these
problems have been reported to CPSC.
Second, the Interagency Task Force established an Identification and Remediation
Protocol Team of scientists and engineers. This Team will use the results of the EH&E
study and other information to design a cost-effective screening protocol to identify
homes with this problem. Professional air sample testing, and destructive testing of
drywall can carry high costs. The Protocol Team will develop quick, cost-efficient
evaluation methods to identify homes with these problems. The Protocol Team will also
look at remediation protocols, to see what cost-efficiency improvements to current
remediation practices, if any, may be available, and what guidance should be issued on
doing the work safely.
Third, investigations currently underway by Lawrence Berkeley Laboratories, SNL and
NIST and others will continue toward identifying additional information on any possible
long-term health and safety issues.
The Identification and Remediation Protocol Team will use information from the EH&E
study and other information to begin evaluating remediation protocols. Homes that have
undergone remediation are expected to yield valuable information that will be helpful for
homeowners.
The Interagency Task Force is actively talking to Congressional and White House
officials about the best approaches to design and fund both the Identification and
Remediation efforts.
Other Ongoing Efforts
The Interagency Task Force, working with U.S. Customs and Border Protection, is
monitoring imports of possible Chinese drywall. We believe that no new Chinese drywall
has entered the United States in 2009. Owners of known U.S. inventories of Chinese
drywall have been notified of this ongoing investigation. They have indicated that the
drywall boards will not be sold. Further, CPSC has secured the cooperation of the
Chinese Government to help identify the sources and causes of this problem.
CPSC is working with an ASTM committee that has just initiated discussions on the
formulation of a proposed new standard on inspection of drywall for air quality issues.
Recommendations to Affected Homeowners
To date, CPSC has received more than 2000 reports from 32 states, the District of
Columbia and Puerto Rico from consumers and homeowners concerned about problem
drywall in their homes.
Homeowners who believe they may have problem drywall should immediately report to
CPSC by calling 800-638-2772 or logging on to www.CPSC.gov. Hearing- or speechchallenged
individuals may access the phone number through TTY by calling the toll-free
Federal Relay Service at 800-877-8339.
Federal and state health experts suggest these steps to improve indoor air quality and to
reduce exposure to substances that can cause health concerns:
o Open windows as much as possible to let in fresh air.
o Keep the temperature inside homes at the lowest comfortable setting.
o Run the air conditioner or dehumidifier.
o Also, spend as much time outdoors in fresh air as possible.
o Do not smoke, and especially do not smoke indoors. Cigarette smoke contains,
among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to
www.DrywallResponse.gov.
November 23, 2009
Press Statement on Corrosion in Homes and
Connections to Chinese Drywall
Results from a major indoor air study of 51 homes are being released today along with
initial reports from two studies of corrosion in homes with Chinese drywall. We now can
show a strong association between homes with the problem drywall and the levels of
hydrogen sulfide in those homes and corrosion of metals in those homes.
By identifying this association, the Interagency Drywall Task Force can now move
forward to develop protocols that will identify homes with this corrosive environment
and can determine the effectiveness of remediation methods. The Task Force continues to
work with Congressional and White House officials to determine the best approaches to
design and fund these identification and remediation efforts to help the families dealing
with this issue.
“We now have the science that enables the Task Force to move ahead to the next phase –
to develop both a screening process and effective remediation methods. Ongoing studies
will examine health and safety effects, but we are now ready to get to work fixing this
problem,” said U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum.
The Studies
The 51 home study contracted by CPSC was done by Environmental Health &
Engineering (EH&E), an internationally known environmental testing firm based in
Massachusetts.
In addition, today two preliminary reports on corrosion safety issues are being released.
The Sandia National Laboratories’ (SNL) Materials and Engineering Center is studying
the long-term electrical safety hazards of conductor metal components. The National
Institute of Standards and Technology (NIST) is studying the corrosion effects on fire
safety components taken from complaint homes.
Findings
EH&E compared 41 “complaint” homes in five states selected from CPSC’s consumer
incident report database, with 10 noncomplaint homes built around the same time in the
same area as the complaint homes. Homes were sampled between July and September
2009.
The EH&E findings are that hydrogen sulfide gas is the essential component that causes
copper and silver sulfide corrosion found in the complaint homes. Other factors,
including air exchange rates, formaldehyde and other air contaminants contribute to the
reported problems.
In ways still to be determined, hydrogen sulfide gas is being created in homes built with
Chinese drywall. Earlier studies found large amounts of elemental sulfur in the Chinese
drywall. CPSC is investigating drywall from other sources that may mimic the problems
found with Chinese drywall. CPSC is meeting with drywall manufacturers and others
who are studying this issue to take their findings into consideration.
EH&E exposed copper and silver test strips, known as coupons, in homes for a period of
about two weeks. The coupons showed significantly higher rates of corrosion in
complaint homes than in the control homes. The dominant species of corrosion on the
coupons was copper sulfide and silver sulfide, as determined by additional laboratory
tests. Visual inspection and evaluation of ground wire corrosion also revealed
statistically significant greater ground wire corrosion in complaint homes compared to
non-complaint homes.
The EH&E study also found that by using hand-held x-ray fluorescence (XRF) and
Fourier Transform Infrared (FTIR) instruments, they were able to detect markers that
could identify Chinese-made dry wall at a sheet-by-sheet level.
While drywall-related corrosion is clearly evident, long term safety effects are still under
investigation. Like the EH&E study, initial reports available today from SNL and NIST
show copper and silver sulfide corrosion on samples of metal taken from homes with
problem drywall. These ongoing investigations will help the CPSC identify the nexus of
problem drywall and long term safety issues.
In addition, the EH&E study found elevated formaldehyde readings in both the control
and complaint homes. This is typical for new, more air-tight homes due to items such as
cabinets and carpets which emit formaldehyde. Both formaldehyde and hydrogen sulfide
are known irritants at sufficiently high levels. The concentrations measured in this study
were below those levels. Investigators believe that the additive or synergistic effects of
these and other compounds in the subject homes could cause irritant effects evident in the
homes.
Next Steps
First, CPSC continues to search for homes exhibiting the corrosion and health effects
under study. In addition to a direct call to consumers, CPSC is contacting governors of all
states, all territories and the District of Columbia, to ensure that all homes with these
problems have been reported to CPSC.
Second, the Interagency Task Force established an Identification and Remediation
Protocol Team of scientists and engineers. This Team will use the results of the EH&E
study and other information to design a cost-effective screening protocol to identify
homes with this problem. Professional air sample testing, and destructive testing of
drywall can carry high costs. The Protocol Team will develop quick, cost-efficient
evaluation methods to identify homes with these problems. The Protocol Team will also
look at remediation protocols, to see what cost-efficiency improvements to current
remediation practices, if any, may be available, and what guidance should be issued on
doing the work safely.
Third, investigations currently underway by Lawrence Berkeley Laboratories, SNL and
NIST and others will continue toward identifying additional information on any possible
long-term health and safety issues.
The Identification and Remediation Protocol Team will use information from the EH&E
study and other information to begin evaluating remediation protocols. Homes that have
undergone remediation are expected to yield valuable information that will be helpful for
homeowners.
The Interagency Task Force is actively talking to Congressional and White House
officials about the best approaches to design and fund both the Identification and
Remediation efforts.
Other Ongoing Efforts
The Interagency Task Force, working with U.S. Customs and Border Protection, is
monitoring imports of possible Chinese drywall. We believe that no new Chinese drywall
has entered the United States in 2009. Owners of known U.S. inventories of Chinese
drywall have been notified of this ongoing investigation. They have indicated that the
drywall boards will not be sold. Further, CPSC has secured the cooperation of the
Chinese Government to help identify the sources and causes of this problem.
CPSC is working with an ASTM committee that has just initiated discussions on the
formulation of a proposed new standard on inspection of drywall for air quality issues.
Recommendations to Affected Homeowners
To date, CPSC has received more than 2000 reports from 32 states, the District of
Columbia and Puerto Rico from consumers and homeowners concerned about problem
drywall in their homes.
Homeowners who believe they may have problem drywall should immediately report to
CPSC by calling 800-638-2772 or logging on to www.CPSC.gov. Hearing- or speechchallenged
individuals may access the phone number through TTY by calling the toll-free
Federal Relay Service at 800-877-8339.
Federal and state health experts suggest these steps to improve indoor air quality and to
reduce exposure to substances that can cause health concerns:
o Open windows as much as possible to let in fresh air.
o Keep the temperature inside homes at the lowest comfortable setting.
o Run the air conditioner or dehumidifier.
o Also, spend as much time outdoors in fresh air as possible.
o Do not smoke, and especially do not smoke indoors. Cigarette smoke contains,
among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to
www.DrywallResponse.gov.
Thursday, November 19, 2009
FDA Takes Action Against Maryland Veal Calf Dealer, Sold animals for human consumption that contained illegal drug residues
Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against Maryland Veal Calf Dealer
Man allegedly sold animals for human consumption that contained illegal drug residues
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an “extralabel” manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.
Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle’s veal calves sampled by the U.S. Department of Agriculture.
Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia.
It also is indicated for the control of inflammation in endotoxemia.
The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.
Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr.
Nickle’s operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.
Consumer Inquiries: 888-INFO-FDA
FDA Takes Action Against Maryland Veal Calf Dealer
Man allegedly sold animals for human consumption that contained illegal drug residues
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an “extralabel” manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.
Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle’s veal calves sampled by the U.S. Department of Agriculture.
Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia.
It also is indicated for the control of inflammation in endotoxemia.
The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.
Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr.
Nickle’s operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.
Thursday, November 5, 2009
Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online
Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online
2009-179
OTTAWA - Health Canada and the Competition Bureau are advising Canadians not to purchase unauthorized products that claim to fight or prevent the H1N1 flu virus, from the Internet or other sources. Health Canada is working with the Competition Bureau and the Royal Canadian Mounted Police (RCMP) to address unauthorized products, including those with fraudulent claims to treat or prevent the H1N1 flu virus.
There are only three products authorized by Health Canada that should be used against the H1N1 flu virus: the H1N1 vaccine Arepanrix, and the antiviral drugs Tamiflu (oseltamivir) and Relenza (zanamivir). In addition, the distribution of 200,000 doses of unadjuvanted H1N1 vaccine Panvax from Australia has been authorized for use in pregnant women. Antivirals should only be purchased with a prescription from a health care practitioner who has examined the patient. The vaccines should be administered by a qualified health care practitioner, and are not available for sale to the public.
While there are legitimate Canadian Internet pharmacies, consumers should be aware of the risks associated with buying drugs online. For more information on the subject, Health Canada has published an It's Your Health article on Buying Drugs over the Internet. Health Canada will continue to monitor the Internet and to take action against Canadian Web sites selling unauthorized products for the treatment or prevention of the H1N1 flu virus, or any other health condition.
Combating health fraud also remains a priority for the Competition Bureau, a law enforcement agency that regularly monitors the Internet and takes enforcement action against false and misleading advertising. For information on the Bureau's activities in the area of health fraud, please visit: www.competitionbureau.gc.ca/healthfraud.
Health Canada and the Competition Bureau would also like to share the following advice with Canadians to avoid becoming victims of health fraud:
Beware of ads that "promise too much." Think twice before buying a product that claims it can "do it all." Steer clear of a product that claims to be a "scientific breakthrough." Don't be swayed by a questionable "success story" or so-called "patient testimonial." Consult your health care practitioner before trying any new treatment. Taking unapproved or counterfeit drugs could pose serious risks to health. These products may contain ingredients not listed on the label or dangerous additives, and could cause serious side effects. Authorized health products will display either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.* This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Canadians are encouraged to stay informed on the H1N1 flu virus by visiting the Public Health Agency of Canada's website, or calling the toll-free public information line at 1-800-454-8302.
Canadians with questions or complaints about counterfeit drugs and/or drugs purchased over the Internet can call Health Canada's toll-free line at 1-800-267-9675.
The Competition Bureau urges Canadians who come across a Web site promoting a treatment or cure that seems too good to be true, to call toll free (1-800-348-5358) or go to www.competitionbureau.gc.ca/info.
Health Canada issued an advisory about the online purchase of Tamiflu in December 2005.
* The manufacturer of Arepanrix has been exempted from the DIN labelling requirement to
avoid delays in the labelling and delivery of the vaccine.
Media Enquiries:Health Canada(613) 957-2983
Competition Bureau(819) 953-4257
Public Enquiries (Health Canada):(613) 957-29911-866 225-0709
Public Enquiries (Competition Bureau):1-800-348-5358
2009-179
OTTAWA - Health Canada and the Competition Bureau are advising Canadians not to purchase unauthorized products that claim to fight or prevent the H1N1 flu virus, from the Internet or other sources. Health Canada is working with the Competition Bureau and the Royal Canadian Mounted Police (RCMP) to address unauthorized products, including those with fraudulent claims to treat or prevent the H1N1 flu virus.
There are only three products authorized by Health Canada that should be used against the H1N1 flu virus: the H1N1 vaccine Arepanrix, and the antiviral drugs Tamiflu (oseltamivir) and Relenza (zanamivir). In addition, the distribution of 200,000 doses of unadjuvanted H1N1 vaccine Panvax from Australia has been authorized for use in pregnant women. Antivirals should only be purchased with a prescription from a health care practitioner who has examined the patient. The vaccines should be administered by a qualified health care practitioner, and are not available for sale to the public.
While there are legitimate Canadian Internet pharmacies, consumers should be aware of the risks associated with buying drugs online. For more information on the subject, Health Canada has published an It's Your Health article on Buying Drugs over the Internet. Health Canada will continue to monitor the Internet and to take action against Canadian Web sites selling unauthorized products for the treatment or prevention of the H1N1 flu virus, or any other health condition.
Combating health fraud also remains a priority for the Competition Bureau, a law enforcement agency that regularly monitors the Internet and takes enforcement action against false and misleading advertising. For information on the Bureau's activities in the area of health fraud, please visit: www.competitionbureau.gc.ca/healthfraud.
Health Canada and the Competition Bureau would also like to share the following advice with Canadians to avoid becoming victims of health fraud:
Beware of ads that "promise too much." Think twice before buying a product that claims it can "do it all." Steer clear of a product that claims to be a "scientific breakthrough." Don't be swayed by a questionable "success story" or so-called "patient testimonial." Consult your health care practitioner before trying any new treatment. Taking unapproved or counterfeit drugs could pose serious risks to health. These products may contain ingredients not listed on the label or dangerous additives, and could cause serious side effects. Authorized health products will display either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.* This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.
Canadians are encouraged to stay informed on the H1N1 flu virus by visiting the Public Health Agency of Canada's website, or calling the toll-free public information line at 1-800-454-8302.
Canadians with questions or complaints about counterfeit drugs and/or drugs purchased over the Internet can call Health Canada's toll-free line at 1-800-267-9675.
The Competition Bureau urges Canadians who come across a Web site promoting a treatment or cure that seems too good to be true, to call toll free (1-800-348-5358) or go to www.competitionbureau.gc.ca/info.
Health Canada issued an advisory about the online purchase of Tamiflu in December 2005.
* The manufacturer of Arepanrix has been exempted from the DIN labelling requirement to
avoid delays in the labelling and delivery of the vaccine.
Media Enquiries:Health Canada(613) 957-2983
Competition Bureau(819) 953-4257
Public Enquiries (Health Canada):(613) 957-29911-866 225-0709
Public Enquiries (Competition Bureau):1-800-348-5358
Wednesday, November 4, 2009
The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts
The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts
2009-178
Health Canada and the Canadian Food Inspection Agency are reminding Canadians that raw or undercooked sprouts should not be eaten by children, the elderly, pregnant women or those with weakened immune systems.
Sprouts, such as alfalfa and mung beans, are a popular choice for Canadians as a low-calorie, healthy ingredient for many meals. Onion, radish, mustard and broccoli sprouts, which are not to be confused with the actual plant or vegetable, are also common options.
These foods, however, may carry harmful bacteria such as Salmonella and E. coli O157:H7, which can lead to serious illness.
Fresh produce can sometimes be contaminated with harmful bacteria while in the field or during storage or handling. This is particularly a concern with sprouts. Many outbreaks of Salmonella and E. coli infections have been linked to contaminated sprouts. The largest recent outbreak in Canada was in the fall of 2005, when more than 648 cases of Salmonella were reported in Ontario.
Children, the elderly, pregnant women and those with weakened immune systems are particularly vulnerable to these bacteria and should not eat any raw sprouts at all. They should also avoid eating cooked sprouts unless they can be sure the sprouts have been thoroughly cooked.
Healthy adults who choose to eat sprouts should take precautions to reduce their risk of exposure to sprout-borne bacteria. When purchasing sprouts, always select crisp ones that have been refrigerated and avoid those that appear dark or smell musty. Always use tongs or a glove to place the sprouts in a plastic bag. If possible, when eating in a restaurant, always make sure that the sprouts are fully cooked.
Symptoms from Salmonella usually occur 12 to 36 hours after eating contaminated food while symptoms from E. coli O157:H7 can occur within two to 10 days. Symptoms can include nausea, diarrhea, vomiting, fever and stomach cramps. People who experience these symptoms should contact a doctor immediately. In extreme cases, E. coli O157:H7 can lead to acute kidney failure or even death.
Health Canada and the Canadian Food Inspection Agency continue to work with producers to develop and implement best practices that will reduce the chances of sprouts becoming contaminated. Health Canada's Policy on Managing Health Risks Associated with the Consumption of Sprouted Seeds and Beans was released with this in mind.
More information, including Health Canada's policy on sprouts, can be found on Health Canada's Sprouts Information Page.
Media Enquiries:Health Canada(613) 957-2983
Canadian Food Inspection Agency(613) 773-6600
Public Enquiries:(613) 957-29911-866 225-0709
2009-178
Health Canada and the Canadian Food Inspection Agency are reminding Canadians that raw or undercooked sprouts should not be eaten by children, the elderly, pregnant women or those with weakened immune systems.
Sprouts, such as alfalfa and mung beans, are a popular choice for Canadians as a low-calorie, healthy ingredient for many meals. Onion, radish, mustard and broccoli sprouts, which are not to be confused with the actual plant or vegetable, are also common options.
These foods, however, may carry harmful bacteria such as Salmonella and E. coli O157:H7, which can lead to serious illness.
Fresh produce can sometimes be contaminated with harmful bacteria while in the field or during storage or handling. This is particularly a concern with sprouts. Many outbreaks of Salmonella and E. coli infections have been linked to contaminated sprouts. The largest recent outbreak in Canada was in the fall of 2005, when more than 648 cases of Salmonella were reported in Ontario.
Children, the elderly, pregnant women and those with weakened immune systems are particularly vulnerable to these bacteria and should not eat any raw sprouts at all. They should also avoid eating cooked sprouts unless they can be sure the sprouts have been thoroughly cooked.
Healthy adults who choose to eat sprouts should take precautions to reduce their risk of exposure to sprout-borne bacteria. When purchasing sprouts, always select crisp ones that have been refrigerated and avoid those that appear dark or smell musty. Always use tongs or a glove to place the sprouts in a plastic bag. If possible, when eating in a restaurant, always make sure that the sprouts are fully cooked.
Symptoms from Salmonella usually occur 12 to 36 hours after eating contaminated food while symptoms from E. coli O157:H7 can occur within two to 10 days. Symptoms can include nausea, diarrhea, vomiting, fever and stomach cramps. People who experience these symptoms should contact a doctor immediately. In extreme cases, E. coli O157:H7 can lead to acute kidney failure or even death.
Health Canada and the Canadian Food Inspection Agency continue to work with producers to develop and implement best practices that will reduce the chances of sprouts becoming contaminated. Health Canada's Policy on Managing Health Risks Associated with the Consumption of Sprouted Seeds and Beans was released with this in mind.
More information, including Health Canada's policy on sprouts, can be found on Health Canada's Sprouts Information Page.
Media Enquiries:Health Canada(613) 957-2983
Canadian Food Inspection Agency(613) 773-6600
Public Enquiries:(613) 957-29911-866 225-0709
Friday, October 30, 2009
CPSC/EPA/HUD/CDC/ATSDR Press Statement on Initial Chinese Drywall Studies
CPSC/EPA/HUD/CDC/ATSDR Press Statement on Initial Chinese Drywall Studies
Since the early spring, the federal government has dedicated significant resources to helping families affected by the drywall issue in their homes. The government has been and continues to be committed to providing answers and solutions to these homeowners. The U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA), U.S. Department of Housing and Urban Development (HUD), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substance and Disease Registry (ATSDR), and numerous state departments of health have been working together to investigate and analyze how Chinese made drywall entered into the country, where it was used, what is in it, and what impact it may have on human health and corrosion of electrical and fire safety components.
This is a complicated problem, and we have several studies and other activities underway to help bring the best possible science to bear. The first sets of data released today start to explain differences between Chinese and non-Chinese drywall, but more remains to be learned. We are sharing what we know at this point and are outlining the next steps as we continue to work to answer homeowners’ questions about what is causing the effects reported and observed.
Initial Results of 3 Studies of Chinese and Non-Chinese made drywall
The studies summarized below have discovered certain differences between Chinese and non-Chinese drywall. Further studies must be completed, however, to determine the nexus between the drywall and the reported health and corrosion issues. Preliminarily, the studies show:
1. Elemental and Chemical Testing: Federal scientists analyzed pieces of drywall to discover what chemicals it contains. Some differences were found between the Chinese and non-Chinese drywall. Of the samples tested, the study shows the presence of elemental sulfur in Chinese but not in non-Chinese drywall, and it also shows higher concentrations of strontium in Chinese drywall than in non-Chinese drywall. Testing conducted over the summer by federal and state agency radiation laboratories found no radiation safety risk to families in homes built with manufactured drywall. The strontium found in this drywall does not pose a radiological risk.
2. Chamber Studies: The second set of tests is being conducted by the nationally-respected Lawrence Berkeley National Laboratory (LBL), which is carrying out chamber testing on emissions from samples of Chinese and non-Chinese drywall into the air. These tests are still underway, but we are sharing preliminary findings. Early results show that Chinese drywall emits volatile sulfur compounds at a higher rate than the U.S. made drywall. More tests and analyses are underway at LBL to determine the specific chemical compounds that are being emitted.
3. Indoor Air Studies: In analyzing indoor air results in 10 homes in Florida and Louisiana, federal and Florida Department of Health researchers were looking for hydrogen sulfide, carbon disulfide and carbonyl sulfide, which have been suspected of causing "rotten egg" smells and sulfur-like corrosion of copper and other metals in the homes.
The study found that sulfur gases were either not present or were present in only limited or occasional concentrations inside the homes, and only when outdoor levels of sulfur compounds in the air were elevated.
The indoor air study did lead to a preliminary finding of detectable concentrations of two known irritant compounds, called acetaldehyde and formaldehyde. These irritant compounds were detected in homes both with and without Chinese drywall, and at concentrations that could worsen conditions such as asthma in sensitive populations, when air conditioners were not working or turned off. The levels of formaldehyde were not unusual for new homes and were higher in homes where air conditioners were not working or turned off.
Although formaldehyde was found, when the air conditioning was turned on, it was not at levels that have been found to cause health symptoms.
The initial indoor air studies were conducted on a small and limited sample of homes in Florida and Louisiana to identify and measure contaminants and to inform the development of a federal and state indoor air testing protocol. The studies released today, and the additional study reports scheduled for release next month, once completed, will collectively help to develop a final standard federal and state protocol for testing homes and to identify a nexus between the presence of Chinese drywall and the reported health and corrosive issues.
Next Steps
Although we know more now than we did just a few weeks ago, we are continuing to learn as much as we can in order to respond to homeowners’ concerns with the best scientific information. We expect to have more information to share in late November. At that time, we will have more information from CPSC’s 50-home air sampling project conducted through Environmental Health and Engineering (EH&E), a nationally-respected environmental testing firm based in Massachusetts. The report of our 50-home indoor air study will include additional testing results, including the exposure of small copper and silver metal strips. These strips are being used to help determine if there is a relationship between homes with Chinese drywall and corrosion of metal components in those homes. This study is also looking for certain sulfur gases at lower levels than could be detected in the initial studies.
Also in November, we expect to release a preliminary engineering analysis of potential electrical and fire safety issues related to corrosion.
All of the federal and state partners will continue to work on behalf of the families affected by this Chinese drywall issue. We are committed to providing answers to homeowners. As new information becomes available, we will share it as quickly as possible.
The federal interagency working group is actively talking to Congressional and White House officials to consider legislative and other means of helping families affected by and struggling with this issue.
Recommendations to Affected Homeowners
To date, CPSC has received nearly 1900 reports from 30 states, the District of Columbia and Puerto Rico from consumers and homeowners concerned about problem drywall in their home. Homeowners who believe they may be affected by this issue should immediately report the problem to CPSC by calling 800-638-2772 or logging on to www.CPSC.gov.
Federal and state health experts suggest these steps to improve indoor air quality and to reduce exposure to substances that can cause health concerns:
Open windows as much as possible to let in fresh air.
Keep the temperature inside homes at the lowest comfortable setting.
Run the air conditioner or dehumidifier.
Also, spend as much time outdoors in fresh air as possible.
Do not smoke, and especially do not smoke indoors. Cigarette smoke contains, among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to www.DrywallResponse.gov
Since the early spring, the federal government has dedicated significant resources to helping families affected by the drywall issue in their homes. The government has been and continues to be committed to providing answers and solutions to these homeowners. The U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA), U.S. Department of Housing and Urban Development (HUD), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substance and Disease Registry (ATSDR), and numerous state departments of health have been working together to investigate and analyze how Chinese made drywall entered into the country, where it was used, what is in it, and what impact it may have on human health and corrosion of electrical and fire safety components.
This is a complicated problem, and we have several studies and other activities underway to help bring the best possible science to bear. The first sets of data released today start to explain differences between Chinese and non-Chinese drywall, but more remains to be learned. We are sharing what we know at this point and are outlining the next steps as we continue to work to answer homeowners’ questions about what is causing the effects reported and observed.
Initial Results of 3 Studies of Chinese and Non-Chinese made drywall
The studies summarized below have discovered certain differences between Chinese and non-Chinese drywall. Further studies must be completed, however, to determine the nexus between the drywall and the reported health and corrosion issues. Preliminarily, the studies show:
1. Elemental and Chemical Testing: Federal scientists analyzed pieces of drywall to discover what chemicals it contains. Some differences were found between the Chinese and non-Chinese drywall. Of the samples tested, the study shows the presence of elemental sulfur in Chinese but not in non-Chinese drywall, and it also shows higher concentrations of strontium in Chinese drywall than in non-Chinese drywall. Testing conducted over the summer by federal and state agency radiation laboratories found no radiation safety risk to families in homes built with manufactured drywall. The strontium found in this drywall does not pose a radiological risk.
2. Chamber Studies: The second set of tests is being conducted by the nationally-respected Lawrence Berkeley National Laboratory (LBL), which is carrying out chamber testing on emissions from samples of Chinese and non-Chinese drywall into the air. These tests are still underway, but we are sharing preliminary findings. Early results show that Chinese drywall emits volatile sulfur compounds at a higher rate than the U.S. made drywall. More tests and analyses are underway at LBL to determine the specific chemical compounds that are being emitted.
3. Indoor Air Studies: In analyzing indoor air results in 10 homes in Florida and Louisiana, federal and Florida Department of Health researchers were looking for hydrogen sulfide, carbon disulfide and carbonyl sulfide, which have been suspected of causing "rotten egg" smells and sulfur-like corrosion of copper and other metals in the homes.
The study found that sulfur gases were either not present or were present in only limited or occasional concentrations inside the homes, and only when outdoor levels of sulfur compounds in the air were elevated.
The indoor air study did lead to a preliminary finding of detectable concentrations of two known irritant compounds, called acetaldehyde and formaldehyde. These irritant compounds were detected in homes both with and without Chinese drywall, and at concentrations that could worsen conditions such as asthma in sensitive populations, when air conditioners were not working or turned off. The levels of formaldehyde were not unusual for new homes and were higher in homes where air conditioners were not working or turned off.
Although formaldehyde was found, when the air conditioning was turned on, it was not at levels that have been found to cause health symptoms.
The initial indoor air studies were conducted on a small and limited sample of homes in Florida and Louisiana to identify and measure contaminants and to inform the development of a federal and state indoor air testing protocol. The studies released today, and the additional study reports scheduled for release next month, once completed, will collectively help to develop a final standard federal and state protocol for testing homes and to identify a nexus between the presence of Chinese drywall and the reported health and corrosive issues.
Next Steps
Although we know more now than we did just a few weeks ago, we are continuing to learn as much as we can in order to respond to homeowners’ concerns with the best scientific information. We expect to have more information to share in late November. At that time, we will have more information from CPSC’s 50-home air sampling project conducted through Environmental Health and Engineering (EH&E), a nationally-respected environmental testing firm based in Massachusetts. The report of our 50-home indoor air study will include additional testing results, including the exposure of small copper and silver metal strips. These strips are being used to help determine if there is a relationship between homes with Chinese drywall and corrosion of metal components in those homes. This study is also looking for certain sulfur gases at lower levels than could be detected in the initial studies.
Also in November, we expect to release a preliminary engineering analysis of potential electrical and fire safety issues related to corrosion.
All of the federal and state partners will continue to work on behalf of the families affected by this Chinese drywall issue. We are committed to providing answers to homeowners. As new information becomes available, we will share it as quickly as possible.
The federal interagency working group is actively talking to Congressional and White House officials to consider legislative and other means of helping families affected by and struggling with this issue.
Recommendations to Affected Homeowners
To date, CPSC has received nearly 1900 reports from 30 states, the District of Columbia and Puerto Rico from consumers and homeowners concerned about problem drywall in their home. Homeowners who believe they may be affected by this issue should immediately report the problem to CPSC by calling 800-638-2772 or logging on to www.CPSC.gov.
Federal and state health experts suggest these steps to improve indoor air quality and to reduce exposure to substances that can cause health concerns:
Open windows as much as possible to let in fresh air.
Keep the temperature inside homes at the lowest comfortable setting.
Run the air conditioner or dehumidifier.
Also, spend as much time outdoors in fresh air as possible.
Do not smoke, and especially do not smoke indoors. Cigarette smoke contains, among other contaminants, formaldehyde.
To read the technical research reports or for more information, log on to www.DrywallResponse.gov
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356 WWW.USDOJ.GOV/USAO/MA
E-MAIL: USAMA.MEDIA@USDOJ.GOV
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries.
Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Acting United States Attorney Michael K. Loucks; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division, announced today that STRYKER BIOTECH, LLC, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER were charged in an Indictment with five counts of wire fraud and one count of conspiracy. STRYKER BIOTECH, DAVID ARD and JEFF WHITAKER were also charged with misbranding. In addition, STRYKER BIOTECH and MARK PHILIP were charged with making false statements to the FDA.
The Indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA. In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption (“HDE”).
One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. The Indictment charges that the defendants promoted the use of these devices in a manner that was different from its FDA approved use; namely they promoted a combination of the devices with a bone void filler, called Calstrux, and in furtherance of that promotion provided “recipes” to surgeons, medical technicians and others as to how to mix the OP-1 products with Calstrux. It is alleged that some of these untested “recipes” called for medical personnel to mold the combined product into “cigars,” “tootsie rolls” or “vienna sausages.”
The Indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA. It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
The Indictment also charges that defendants STRYKER BIOTECH, LLC and MARK PHILIP made false statements to the FDA about the number of patients that STRYKER BIOTECH was treating on an annual basis with OP-1 Putty.
If convicted of the wire fraud, conspiracy, misbranding or false statements charges, STRYKER BIOTECH faces fines of the greater of $500,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the wire fraud charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 20 years imprisonment, to be followed by 3 years of supervised release and a fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count. If convicted on the conspiracy charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 5 years imprisonment, to be followed by 3 years of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the misbranding charges, DAVID ARD and JEFF WHITAKER each face up to 3 years imprisonment, to be followed by 1 year of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense on each charge. If convicted on the false statement charge, MARK PHILIP faces up to 5 years imprisonment, to be followed by 3 years supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense.
The case was investigated by the Food & Drug Administration - Office of Criminal Investigations, the Department of Health and Human Services - Office of Inspector General and the Federal Bureau of Investigation. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Loucks’ Health Care Fraud Unit.
The details contained in the Indictment are allegations. The defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
PHONE: (617)748-3356 WWW.USDOJ.GOV/USAO/MA
E-MAIL: USAMA.MEDIA@USDOJ.GOV
STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES
Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries.
Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Acting United States Attorney Michael K. Loucks; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division, announced today that STRYKER BIOTECH, LLC, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER were charged in an Indictment with five counts of wire fraud and one count of conspiracy. STRYKER BIOTECH, DAVID ARD and JEFF WHITAKER were also charged with misbranding. In addition, STRYKER BIOTECH and MARK PHILIP were charged with making false statements to the FDA.
The Indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA. In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption (“HDE”).
One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. The Indictment charges that the defendants promoted the use of these devices in a manner that was different from its FDA approved use; namely they promoted a combination of the devices with a bone void filler, called Calstrux, and in furtherance of that promotion provided “recipes” to surgeons, medical technicians and others as to how to mix the OP-1 products with Calstrux. It is alleged that some of these untested “recipes” called for medical personnel to mold the combined product into “cigars,” “tootsie rolls” or “vienna sausages.”
The Indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA. It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
The Indictment also charges that defendants STRYKER BIOTECH, LLC and MARK PHILIP made false statements to the FDA about the number of patients that STRYKER BIOTECH was treating on an annual basis with OP-1 Putty.
If convicted of the wire fraud, conspiracy, misbranding or false statements charges, STRYKER BIOTECH faces fines of the greater of $500,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the wire fraud charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 20 years imprisonment, to be followed by 3 years of supervised release and a fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count. If convicted on the conspiracy charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 5 years imprisonment, to be followed by 3 years of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count.
If convicted on the misbranding charges, DAVID ARD and JEFF WHITAKER each face up to 3 years imprisonment, to be followed by 1 year of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense on each charge. If convicted on the false statement charge, MARK PHILIP faces up to 5 years imprisonment, to be followed by 3 years supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense.
The case was investigated by the Food & Drug Administration - Office of Criminal Investigations, the Department of Health and Human Services - Office of Inspector General and the Federal Bureau of Investigation. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Loucks’ Health Care Fraud Unit.
The details contained in the Indictment are allegations. The defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:
To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamblehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm
FDA Drug Safety Initiativehttp://www.fda.gov/cder/drugSafety.htm
Consumer Inquiries: 888-INFO-FDA
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:
To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamblehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm
FDA Drug Safety Initiativehttp://www.fda.gov/cder/drugSafety.htm
Wednesday, October 28, 2009
Basic Information on H1N1 Preventative Measures
Seriously....what's a person to do??? Get the shot...don't get theshot.....get the shot.....don't get the shot! Geeze enuf already. So confusing! Who should we believe is telling the truth?
This is great simple information ... Take heed and avoid getting sick.....
Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist),having clinical experience of over 20 years. He has worked ininstitutions like Hinduja Hospital,Bombay Hospital, Saifee Hospital,Tata Memorial, etc.
Presently, he is heading our Nuclear MedicineDepartment and Thyroid clinic at Riddhivinayak Cardiac and CriticalCentre, Malad (W).The following message is given by him; I feel it makes a lot of senseand is important for all to know
The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible not coming intocontact with H1N1 in spite of all precautions.
Contact with H1N1 is not so much of a problem as proliferation is. While you are still healthy and not showing any symptoms of H1N1infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced(instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all officialcommunications).
2. "Hands-off-the-face" approach. Resist all temptations to touch anypart of face until you have washed your hands.
3. *Gargle twice a day with warm salt water (use Listerine if you don'ttrust salt). *H1N1 takes 2-3 days after initial infection in thethroat/nasal cavity to proliferate and show characteristic symptoms.Simple gargling prevents proliferation. In a way, gargling with saltwater has the same effect on a healthy individual that Tamiflu has on aninfected one. Don't underestimate this simple, inexpensive and powerfulpreventative method.
4. Similar to 3 above, *clean your nostrils at least once every daywith warm salt water. Not everybody may be good at using a Neti pot,but blowing the nose hard once a day and swabbing both nostrils withcotton swabs dipped in warm salt water is very effective in bringingdown viral population.*
5. Boost your natural immunity with foods that are rich in Vitamin C.*If you have to supplement with Vitamin C tablets, make sure that italso has Zinc to boost absorption.
6. Drink as much of warm liquids (tea, coffee, etc) as you can.*Drinking warm liquids has the same effect as gargling, but in thereverse direction. They wash off proliferating viruses from the throatinto the stomach where they cannot survive, proliferate or do any harm.
I suggest you pass this on to your entire e-list; you never know who might pay attention to it - and STAY ALIVE because of it
- Neti pots and sinus rinse kits are available at the drug store andrelatively inexpensive under $15.
This is great simple information ... Take heed and avoid getting sick.....
Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist),having clinical experience of over 20 years. He has worked ininstitutions like Hinduja Hospital,Bombay Hospital, Saifee Hospital,Tata Memorial, etc.
Presently, he is heading our Nuclear MedicineDepartment and Thyroid clinic at Riddhivinayak Cardiac and CriticalCentre, Malad (W).The following message is given by him; I feel it makes a lot of senseand is important for all to know
The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible not coming intocontact with H1N1 in spite of all precautions.
Contact with H1N1 is not so much of a problem as proliferation is. While you are still healthy and not showing any symptoms of H1N1infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced(instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all officialcommunications).
2. "Hands-off-the-face" approach. Resist all temptations to touch anypart of face until you have washed your hands.
3. *Gargle twice a day with warm salt water (use Listerine if you don'ttrust salt). *H1N1 takes 2-3 days after initial infection in thethroat/nasal cavity to proliferate and show characteristic symptoms.Simple gargling prevents proliferation. In a way, gargling with saltwater has the same effect on a healthy individual that Tamiflu has on aninfected one. Don't underestimate this simple, inexpensive and powerfulpreventative method.
4. Similar to 3 above, *clean your nostrils at least once every daywith warm salt water. Not everybody may be good at using a Neti pot,but blowing the nose hard once a day and swabbing both nostrils withcotton swabs dipped in warm salt water is very effective in bringingdown viral population.*
5. Boost your natural immunity with foods that are rich in Vitamin C.*If you have to supplement with Vitamin C tablets, make sure that italso has Zinc to boost absorption.
6. Drink as much of warm liquids (tea, coffee, etc) as you can.*Drinking warm liquids has the same effect as gargling, but in thereverse direction. They wash off proliferating viruses from the throatinto the stomach where they cannot survive, proliferate or do any harm.
I suggest you pass this on to your entire e-list; you never know who might pay attention to it - and STAY ALIVE because of it
- Neti pots and sinus rinse kits are available at the drug store andrelatively inexpensive under $15.
Thursday, October 22, 2009
CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll
CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll
WASHINGTON, D.C. - Furthering its commitment to improve the safety of Recreational Off-Highway Vehicles (ROVs) and reduce the number of deaths and serious injuries nationwide, the U.S. Consumer Product Safety Commission voted to publish an advance notice of proposed rulemaking (ANPR) to address safety hazards associated with vehicle ROVs.
CPSC staff’s preliminary evaluations indicated that the vehicles may exhibit inadequate lateral stability, undesirable steering characteristics, and inadequate occupant protection during a rollover crash. The staff reviewed the Recreational Off-Highway Vehicle Association (ROHVA) draft proposed American National Standard for Recreational Off-Highway Vehicles, ANSI/ROHVA 1-200X and found preliminarily that it does not adequately address the deaths and injuries associated with ROV rollovers and collisions.
The ANPR invites written comments from the public regarding the risks of injury associated with ROVs and ways in which these risks could be addressed. Following publication of the ANPR, the public will have 60 days to provide comments to the Commission. Comments can be submitted at www.regulations.gov
WASHINGTON, D.C. - Furthering its commitment to improve the safety of Recreational Off-Highway Vehicles (ROVs) and reduce the number of deaths and serious injuries nationwide, the U.S. Consumer Product Safety Commission voted to publish an advance notice of proposed rulemaking (ANPR) to address safety hazards associated with vehicle ROVs.
CPSC staff’s preliminary evaluations indicated that the vehicles may exhibit inadequate lateral stability, undesirable steering characteristics, and inadequate occupant protection during a rollover crash. The staff reviewed the Recreational Off-Highway Vehicle Association (ROHVA) draft proposed American National Standard for Recreational Off-Highway Vehicles, ANSI/ROHVA 1-200X and found preliminarily that it does not adequately address the deaths and injuries associated with ROV rollovers and collisions.
The ANPR invites written comments from the public regarding the risks of injury associated with ROVs and ways in which these risks could be addressed. Following publication of the ANPR, the public will have 60 days to provide comments to the Commission. Comments can be submitted at www.regulations.gov
Friday, October 16, 2009
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
Media Inquiries: Christopher Kelly, 301-796-4676 christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.
These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.
“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.
Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.
The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.
The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).
Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products
Consumer Inquiries: 888-INFO-FDA
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.
These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.
“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.
Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.
The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.
The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).
Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products
Wednesday, October 14, 2009
2 indicted for sending more than 15,000 misbranded drugs to customers
United States Department of Justice United States Attorney’s Office District of Minnesota
David Anderson, Public Affairs Specialist
(612) 664-5684; cell: (612) 730-2251
WWW.USDOJ.GOV/USAO/MN
2 indicted for sending more than 15,000 misbranded drugs to customers
A federal grand jury has returned an indictment against two Twin Cities men for allegedly releasing more than 15,000 misbranded drugs to customers.
In an indictment filed with the court earlier today, Nicholas David Lundsten, 26, Spring Lake Park, and Patrick James Barron, 29, Fridley, were charged with one count of introduction into interstate commerce of misbranded drugs and one count of importation of non-narcotic Schedule IV controlled substances. The indictment alleges the defendants caused the introduction and delivery of 3,600 pills falsely labeled as Cialis, 1,582 pills falsely labeled as Propetia, 10,419 pills falsely labeled as Viagra; and 340 pills falsely labeled as Levitra. In fact, all of the drugs contained the active pharmaceutical ingredients of the drugs they imitated but were not the authentic product as labeled and were not made by the respective manufacturer. The indictment alleges this occurred from an unknown date through December 2008.
The indictment also alleges the defendants knowingly imported into the United States 39,288 pills purporting to be Xanax, a sedative that contains Alprazolam, a non-narcotic Schedule IV controlled substance, and 27,336 pills purporting to be Phentermine, a weight-loss drug, that contained Sibutramine, another non-narcotic Schedule IV controlled substance, rather than Phentermine.
If convicted, the introduction count carries a maximum penalty of one year in prison, and the importation count carries a maximum penalty of five years in prison. All sentences are determined by a federal district court judge.
This case is the result of an investigation by the U.S. Food and Drug Administration-Office of Criminal Investigation, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection. It is being prosecuted by Assistant U.S. Attorney David J. MacLaughlin.
An indictment is a determination by a grand jury that there is probable cause to believe that offenses have been committed by a defendant. A defendant, of course, is presumed innocent until he or she pleads guilty or is proven guilty at trial.
David Anderson, Public Affairs Specialist
(612) 664-5684; cell: (612) 730-2251
WWW.USDOJ.GOV/USAO/MN
2 indicted for sending more than 15,000 misbranded drugs to customers
A federal grand jury has returned an indictment against two Twin Cities men for allegedly releasing more than 15,000 misbranded drugs to customers.
In an indictment filed with the court earlier today, Nicholas David Lundsten, 26, Spring Lake Park, and Patrick James Barron, 29, Fridley, were charged with one count of introduction into interstate commerce of misbranded drugs and one count of importation of non-narcotic Schedule IV controlled substances. The indictment alleges the defendants caused the introduction and delivery of 3,600 pills falsely labeled as Cialis, 1,582 pills falsely labeled as Propetia, 10,419 pills falsely labeled as Viagra; and 340 pills falsely labeled as Levitra. In fact, all of the drugs contained the active pharmaceutical ingredients of the drugs they imitated but were not the authentic product as labeled and were not made by the respective manufacturer. The indictment alleges this occurred from an unknown date through December 2008.
The indictment also alleges the defendants knowingly imported into the United States 39,288 pills purporting to be Xanax, a sedative that contains Alprazolam, a non-narcotic Schedule IV controlled substance, and 27,336 pills purporting to be Phentermine, a weight-loss drug, that contained Sibutramine, another non-narcotic Schedule IV controlled substance, rather than Phentermine.
If convicted, the introduction count carries a maximum penalty of one year in prison, and the importation count carries a maximum penalty of five years in prison. All sentences are determined by a federal district court judge.
This case is the result of an investigation by the U.S. Food and Drug Administration-Office of Criminal Investigation, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection. It is being prosecuted by Assistant U.S. Attorney David J. MacLaughlin.
An indictment is a determination by a grand jury that there is probable cause to believe that offenses have been committed by a defendant. A defendant, of course, is presumed innocent until he or she pleads guilty or is proven guilty at trial.
Thursday, October 8, 2009
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Media Inquiries: Stephanie Kwisnek, 301-796-4737, Stephanie.Kwisnek@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Company allegedly failed to correct violations
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.
The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.
The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.Consumers can report problems with FDA-regulated products to their district office consumer complaint
coordinator.
Consumer Inquiries: 1-888-INFO-FDA
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Company allegedly failed to correct violations
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.
The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.
The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.Consumers can report problems with FDA-regulated products to their district office consumer complaint
coordinator.
Wednesday, October 7, 2009
Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours
Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours
2009-161
OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.
Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.
The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.
Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.
The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.
Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:
•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)
The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.
Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.
Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
2009-161
OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.
Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.
The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.
Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.
The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.
Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:
•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)
The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.
Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.
Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.
Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Sunday, October 4, 2009
FDA Issues Strategic Plan for Risk Communication
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.
They include:
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
Producing a research agenda for public dissemination
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
Consumer Inquiries: 888-INFO-FDA
FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products
The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.
“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.
They include:
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
Producing a research agenda for public dissemination
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect in some patients
New Heparin to Ship Starting October 8
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information
FDA Alert to Health Care Professionalshttp://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Informationhttp://www.usp.org/hottopics/heparin.html
Information for Consumers: What You Should Know about Changes to Heparinhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184504.htm
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect in some patients
New Heparin to Ship Starting October 8
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information
FDA Alert to Health Care Professionalshttp://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Informationhttp://www.usp.org/hottopics/heparin.html
Information for Consumers: What You Should Know about Changes to Heparinhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184504.htm
Tuesday, September 29, 2009
Consumers Union Opposes USDA Proposal On Salad Safety- Group urges Congress to pass FDA food safety program
Consumers Union Opposes USDA Proposal On Salad Safety
Group urges Congress to pass FDA food safety program
Consumers Union is voicing opposition to a proposed national USDA Leafy Green Marketing Agreement, claiming the pact will fail to adequately improve the safety of raw spinach and other salad ingredients.
"We urgently need improvements in the safety of many kinds of food, from spinach and other leafy greens to peanut butter to imported fish," said Elisa Odabashian, Director of Consumers Union's west coast office. "But this USDA Marketing Agreement approach is the wrong way to go about it.
Consumers Union claims the agreement amounts to industry self-regulation, wrapped up in a USDA package, so consumers think the government is insuring that their food is safe. "But," points out Odabashian, "all the safety standards will be developed by the big food processors and other members of the industry. There will be only one consumer member on their
Administrative Committee, and that consumer member will be chosen by the food processors."
At issue is whether the California Leafy Greens Marketing Agreement, which has set food safety standards for California growers and processors, should be expanded nationally. While the agreement has imposed new safeguards on its participants, it is voluntary.
Read more: http://www.consumeraffairs.com/news04/2009/09/salad_safety.html#ixzz0SSQIElNb
http://www.consumeraffairs.com/news04/2009/09/salad_safety.html
Group urges Congress to pass FDA food safety program
Consumers Union is voicing opposition to a proposed national USDA Leafy Green Marketing Agreement, claiming the pact will fail to adequately improve the safety of raw spinach and other salad ingredients.
"We urgently need improvements in the safety of many kinds of food, from spinach and other leafy greens to peanut butter to imported fish," said Elisa Odabashian, Director of Consumers Union's west coast office. "But this USDA Marketing Agreement approach is the wrong way to go about it.
Consumers Union claims the agreement amounts to industry self-regulation, wrapped up in a USDA package, so consumers think the government is insuring that their food is safe. "But," points out Odabashian, "all the safety standards will be developed by the big food processors and other members of the industry. There will be only one consumer member on their
Administrative Committee, and that consumer member will be chosen by the food processors."
At issue is whether the California Leafy Greens Marketing Agreement, which has set food safety standards for California growers and processors, should be expanded nationally. While the agreement has imposed new safeguards on its participants, it is voluntary.
Read more: http://www.consumeraffairs.com/news04/2009/09/salad_safety.html#ixzz0SSQIElNb
http://www.consumeraffairs.com/news04/2009/09/salad_safety.html
Sunday, September 27, 2009
Prescribers and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension
FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral
SuspensionPrescribers and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.
U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in mg if the dosing dispenser with the drug is in mg.Pharmacists should ensure that the units of measure on the prescription instructionsmatch the dosing device provided with the drug.
If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.
Specific Considerations for Tamiflu Dosing for Children over 1 Year of Age:
Dosing should be prescribed in mg according to information provided in the table below.
Caregivers for children should use the dosing dispenser packaged with the medication, unless otherwise directed by a health care provider.If the dosing dispenser packaged with Tamiflu oral suspension is lost or damaged, or if the prescriber wishes to use volume-based dosing, appropriate dosages in mL are also provided in the table. In these cases the prescriber and pharmacist should ensure that a dosing dispenser, such as an oral syringe calibrated in mL, is given to the patient or caregiver with instructions for use. The dosing dispenser packaged with the product should be discarded.Prescribers should avoid prescribing Tamiflu oral suspension in teaspoons. This can lead to inaccurate dosing. If a prescription is written in teaspoons, the pharmacist should convert the volume to mL and ensure that an appropriate measuring device, such as an oral syringe calibrated in mL, is provided. The dosing dispenser packaged with the product should be discarded.
SuspensionPrescribers and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.
U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in mg if the dosing dispenser with the drug is in mg.Pharmacists should ensure that the units of measure on the prescription instructionsmatch the dosing device provided with the drug.
If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.
Specific Considerations for Tamiflu Dosing for Children over 1 Year of Age:
Dosing should be prescribed in mg according to information provided in the table below.
Caregivers for children should use the dosing dispenser packaged with the medication, unless otherwise directed by a health care provider.If the dosing dispenser packaged with Tamiflu oral suspension is lost or damaged, or if the prescriber wishes to use volume-based dosing, appropriate dosages in mL are also provided in the table. In these cases the prescriber and pharmacist should ensure that a dosing dispenser, such as an oral syringe calibrated in mL, is given to the patient or caregiver with instructions for use. The dosing dispenser packaged with the product should be discarded.Prescribers should avoid prescribing Tamiflu oral suspension in teaspoons. This can lead to inaccurate dosing. If a prescription is written in teaspoons, the pharmacist should convert the volume to mL and ensure that an appropriate measuring device, such as an oral syringe calibrated in mL, is provided. The dosing dispenser packaged with the product should be discarded.
Tuesday, September 22, 2009
Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law
Contact: Kathleen K. Quinn, 301-796-4617, kathleen.quinn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law
The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America.
Smoking is the leading preventable cause of death in America.
The FDA's ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.
"Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA
Commissioner Margaret A. Hamburg, M.D. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation's public health."
Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1
"Flavored cigarettes attract and allure kids into lifetime addiction," said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. "FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."
The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.
The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.
"Youth are twice as likely to report seeing advertising for these flavored products as adults are," said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner.
"Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful."
The FDA encourages consumers to report continuing sales of flavored cigarettes through a special tobacco hotline (1-877-CTP-1373) and Web site (www.fda.gov/flavoredtobacco).
Parents and consumers can learn more about the risks of flavored tobacco products at www.fda.gov/ .
Consumer Inquiries: 888-INFO-FDA
Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law
The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America.
Smoking is the leading preventable cause of death in America.
The FDA's ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.
"Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA
Commissioner Margaret A. Hamburg, M.D. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation's public health."
Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1
"Flavored cigarettes attract and allure kids into lifetime addiction," said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. "FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."
The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.
The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.
"Youth are twice as likely to report seeing advertising for these flavored products as adults are," said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner.
"Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful."
The FDA encourages consumers to report continuing sales of flavored cigarettes through a special tobacco hotline (1-877-CTP-1373) and Web site (www.fda.gov/flavoredtobacco).
Parents and consumers can learn more about the risks of flavored tobacco products at www.fda.gov/ .
CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries
The Tipping Point: CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries
WASHINGTON, D.C. - For young children, the home is a playground, and while many parents childproof to ensure that their home is a safe place, some may not be aware that unsecured TVs, furniture and appliances are hidden hazards lurking in every room. Today, the U.S. Consumer Product Safety Commission (CPSC) is urging parents once again to take simple, low-cost steps to prevent deaths and injuries associated with furniture, TV, and appliance tip-overs.
CPSC staff estimates that in 2006, 16,300 children 5 years old and younger were treated in emergency rooms because of injuries associated with TV, furniture, and appliance tip-overs, and between 2000 and 2006, CPSC staff received reports (pdf) of 134 tip-over related deaths.
Additionally, CPSC staff is aware of at least 30 media reports of tip-over deaths since January 2007 involving this same age group.
“Many parents are unaware of the deadly danger of this hidden hazard. I urge parents to include securing TVs, furniture, and appliances in their childproofing efforts,” said CPSC Chairman Inez Tenenbaum. “Taking a few moments now can prevent a tip-over tragedy later.”
“You may think your home is safe, but everyday things like a television can hurt your child. I was right there and it happened,” said Sylvia Santiago, of West Haven, Connecticut who lost her two-year old daughter in 2008.
Typically, injuries and deaths occur when children climb onto, fall against, or pull themselves up on television stands, shelves, bookcases, dressers, desks, chests, and appliances. In some cases, televisions placed on top of furniture tip over and cause a child to suffer traumatic and sometimes fatal injuries. “The most devastating injuries that we see resulting from furniture tipping on children are injuries to the brain and when a child is trapped under a heavy piece of furniture and suffocates,” said Gary Smith, MD, DrPH, Director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.
Recent revisions to the voluntary safety standards for clothes storage units provide for the inclusion of warning labels and additional hardware to secure the furniture to the floor or wall.
To help prevent tip-over hazards, CPSC offers the following safety tips:
Furniture should be stable on its own. For added security, anchor chests or dressers, TV stands, bookcases and entertainment units to the floor or attach them to a wall.
Place TVs on a sturdy, low-rise base. Avoid flimsy shelves.
Push the TV as far back as possible.
Place electrical cords out of a child’s reach, and teach kids not to play with them.
Keep remote controls and other attractive items off the TV stand so kids won’t be tempted to grab for them and risk knocking the TV over.
Make sure free-standing ranges and stoves are installed with anti-tip brackets.
WASHINGTON, D.C. - For young children, the home is a playground, and while many parents childproof to ensure that their home is a safe place, some may not be aware that unsecured TVs, furniture and appliances are hidden hazards lurking in every room. Today, the U.S. Consumer Product Safety Commission (CPSC) is urging parents once again to take simple, low-cost steps to prevent deaths and injuries associated with furniture, TV, and appliance tip-overs.
CPSC staff estimates that in 2006, 16,300 children 5 years old and younger were treated in emergency rooms because of injuries associated with TV, furniture, and appliance tip-overs, and between 2000 and 2006, CPSC staff received reports (pdf) of 134 tip-over related deaths.
Additionally, CPSC staff is aware of at least 30 media reports of tip-over deaths since January 2007 involving this same age group.
“Many parents are unaware of the deadly danger of this hidden hazard. I urge parents to include securing TVs, furniture, and appliances in their childproofing efforts,” said CPSC Chairman Inez Tenenbaum. “Taking a few moments now can prevent a tip-over tragedy later.”
“You may think your home is safe, but everyday things like a television can hurt your child. I was right there and it happened,” said Sylvia Santiago, of West Haven, Connecticut who lost her two-year old daughter in 2008.
Typically, injuries and deaths occur when children climb onto, fall against, or pull themselves up on television stands, shelves, bookcases, dressers, desks, chests, and appliances. In some cases, televisions placed on top of furniture tip over and cause a child to suffer traumatic and sometimes fatal injuries. “The most devastating injuries that we see resulting from furniture tipping on children are injuries to the brain and when a child is trapped under a heavy piece of furniture and suffocates,” said Gary Smith, MD, DrPH, Director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.
Recent revisions to the voluntary safety standards for clothes storage units provide for the inclusion of warning labels and additional hardware to secure the furniture to the floor or wall.
To help prevent tip-over hazards, CPSC offers the following safety tips:
Furniture should be stable on its own. For added security, anchor chests or dressers, TV stands, bookcases and entertainment units to the floor or attach them to a wall.
Place TVs on a sturdy, low-rise base. Avoid flimsy shelves.
Push the TV as far back as possible.
Place electrical cords out of a child’s reach, and teach kids not to play with them.
Keep remote controls and other attractive items off the TV stand so kids won’t be tempted to grab for them and risk knocking the TV over.
Make sure free-standing ranges and stoves are installed with anti-tip brackets.
Friday, September 18, 2009
Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution
Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution
On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.
The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.
Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:
Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
Lot number 9G04, NDC # 49502-697-29
Lot number 9FD8, NDC # 49502-697-61
Lot number 9FD9, NDC # 49502-697-61
Lot number 9FE1, NDC # 49502-697-61
Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62
Advice for Consumers
Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots above and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.
Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.
Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278.
Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.
Report any information regarding the stolen Dey products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).
On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.
The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.
Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:
Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
Lot number 9G04, NDC # 49502-697-29
Lot number 9FD8, NDC # 49502-697-61
Lot number 9FD9, NDC # 49502-697-61
Lot number 9FE1, NDC # 49502-697-61
Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62
Advice for Consumers
Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots above and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.
Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.
Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278.
Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.
Report any information regarding the stolen Dey products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).
Tuesday, September 8, 2009
Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts
Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Kohl’s Department Stores Inc., of Menomonee Falls, Wis. has agreed to pay a civil penalty of $425,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Kohl’s Department Stores knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In March 2009, CPSC and the sweatshirts’ importer announced a recall of the products.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, Kohl’s Department Stores denies CPSC's allegations that it knowingly violated the law.
In 2008, Kohl’s paid a $35,000 civil penalty for failing to report drawstrings in children’s sweatshirts.
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Kohl’s Department Stores Inc., of Menomonee Falls, Wis. has agreed to pay a civil penalty of $425,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Kohl’s Department Stores knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In March 2009, CPSC and the sweatshirts’ importer announced a recall of the products.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, Kohl’s Department Stores denies CPSC's allegations that it knowingly violated the law.
In 2008, Kohl’s paid a $35,000 civil penalty for failing to report drawstrings in children’s sweatshirts.
Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts
Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Hill Sportswear Inc., of Paramount, Calif. has agreed to pay a civil penalty of $100,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Hill Sportswear knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it manufactured and sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In November 2008, a 3-year-old boy died in Fresno, Calif. when the drawstring on his Hill Sportswear hooded sweatshirt reportedly became stuck on a playground set strangling him. Hill Sportswear and CPSC announced a recall of the sweatshirts in February 2009.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
About 120,000 of these Hill Sportswear sweatshirts were sold at various small retailers in California and Texas from 2003 through December 2008 for approximately $8. Due to the serious nature of this hazard, parents are urged to immediately remove the drawstrings from the sweatshirts or return the garment to either the place of purchase or to Hill Sportswear for a full refund.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Hill Sportswear Inc., of Paramount, Calif. has agreed to pay a civil penalty of $100,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Hill Sportswear knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it manufactured and sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In November 2008, a 3-year-old boy died in Fresno, Calif. when the drawstring on his Hill Sportswear hooded sweatshirt reportedly became stuck on a playground set strangling him. Hill Sportswear and CPSC announced a recall of the sweatshirts in February 2009.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
About 120,000 of these Hill Sportswear sweatshirts were sold at various small retailers in California and Texas from 2003 through December 2008 for approximately $8. Due to the serious nature of this hazard, parents are urged to immediately remove the drawstrings from the sweatshirts or return the garment to either the place of purchase or to Hill Sportswear for a full refund.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.
Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear
Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that two firms, Maran Inc., of North Bergen, N.J. and K.S. Trading Corp., of Moonachie, N.J., have agreed to pay a total of $85,000 in civil penalties. The penalty settlements (Maran and K.S. Trading, pdf), which have been provisionally accepted by the Commission, resolve CPSC staff allegations that the firms knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts or jackets, poses a strangulation hazard to children which can result in serious injury or death. CPSC and the firms announced recalls (Maran and K.S. Trading) of the products.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that two firms, Maran Inc., of North Bergen, N.J. and K.S. Trading Corp., of Moonachie, N.J., have agreed to pay a total of $85,000 in civil penalties. The penalty settlements (Maran and K.S. Trading, pdf), which have been provisionally accepted by the Commission, resolve CPSC staff allegations that the firms knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the neck.
Children’s upper outerwear with drawstrings, including sweatshirts or jackets, poses a strangulation hazard to children which can result in serious injury or death. CPSC and the firms announced recalls (Maran and K.S. Trading) of the products.
CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.
Wednesday, August 26, 2009
CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes
CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes
WASHINGTON, D.C. - The CPSC and Goodman Manufacturing Company, of Houston, TX, are urging consumers who have not yet responded to the previously-announced 1998 recall to do so immediately. After October 1, 2009, the remedy consumers receive will change to be identical to modifications recently announced for a related recall.
The recall included about 10,000 Plexvent and Ultravent HTPV pipe systems attached to certain Goodman mid-efficiency furnaces manufactured from October 1988 to July 1994 (models GUP, GDP, GUPS, GDPS, GUPI, GDPI, GUPX, GDPX, GMP and GMPV for the following brands manufactured by Goodman: Janitrol, GMC, Hamilton Electric, Franklin, Liberty and Sears/Kenmore). The HTPV pipe used for these vents could be susceptible to corrosion, cracking and joint separation, which could result in the release of carbon monoxide (CO) into living areas, posing a danger to consumers. Goodman did not manufacture the HTPV pipe.
The following table describes the different remedies available to consumers with qualifying furnaces that use the two leading brands of HTPV pipe – Plexvent and Ultravent.
Plexvent owners Ultravent owners Valid claims initiated on or before October 1, 2009, with remediation completed and required documentation submitted by January 1, 2010. Will receive a new, professionally-installed venting system free of chargeor a new, high-efficiency Goodman furnace and suitable vent for the manufacturer's price (of just the furnace), with no charge for labor, associated materials or dealer markup. Valid claims initiated after October 1, 2009 A rebate up to $400 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV. A rebate up to $250 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV.
Consumers who register after October 1, 2009 and who choose to repair their systems will be responsible for up-front payment of parts, labor and permits, and will be responsible for arranging to have the work performed.
Consumers should determine whether they have a recalled HTPV pipe system by checking the vent pipes attached to their natural gas furnace. Vent pipes subject to this recall can be identified as follows:
the vent pipes are plastic;
the vent pipes are colored gray or black;
"Plexvent," "Plexvent II" or "Ultravent" is stamped on the vent pipe or printed on stickers placed on pieces used to connect the vent pipes; and
the vent pipes are located on furnaces and the pipes go through the sidewalls of structures.Other plastic vent pipes, such as white PVC, are not included in the recall.
Owners of Goodman furnaces that are vented with HTPV pipe should immediately call Goodman at (800) 394-8084 from 8 a.m. to 4:30 p.m. CT Monday through Friday. CPSC reminds all consumers to have fuel-burning appliances professionally inspected each year to check for cracks or separations in the vents that could allow CO to leak into the home. In addition, CPSC recommends that every home should have at least one CO alarm.
------------------------------------------------------------------------------------------------
Owners of previously recalled Goodman Manufacturing Co. plexvent and ultravent high temperature plastic vent (HTPV) pipe systems for furnaces that pose a risk of carbon monoxide leaks who do not respond by Oct. 1, 2009, will be responsible for up-front payment of parts, labor and permits, as well as for arranging to have the work performed. The recall was initially announced in 1998. Details: by Web at http://www.cpsc.gov
WASHINGTON, D.C. - The CPSC and Goodman Manufacturing Company, of Houston, TX, are urging consumers who have not yet responded to the previously-announced 1998 recall to do so immediately. After October 1, 2009, the remedy consumers receive will change to be identical to modifications recently announced for a related recall.
The recall included about 10,000 Plexvent and Ultravent HTPV pipe systems attached to certain Goodman mid-efficiency furnaces manufactured from October 1988 to July 1994 (models GUP, GDP, GUPS, GDPS, GUPI, GDPI, GUPX, GDPX, GMP and GMPV for the following brands manufactured by Goodman: Janitrol, GMC, Hamilton Electric, Franklin, Liberty and Sears/Kenmore). The HTPV pipe used for these vents could be susceptible to corrosion, cracking and joint separation, which could result in the release of carbon monoxide (CO) into living areas, posing a danger to consumers. Goodman did not manufacture the HTPV pipe.
The following table describes the different remedies available to consumers with qualifying furnaces that use the two leading brands of HTPV pipe – Plexvent and Ultravent.
Plexvent owners Ultravent owners Valid claims initiated on or before October 1, 2009, with remediation completed and required documentation submitted by January 1, 2010. Will receive a new, professionally-installed venting system free of chargeor a new, high-efficiency Goodman furnace and suitable vent for the manufacturer's price (of just the furnace), with no charge for labor, associated materials or dealer markup. Valid claims initiated after October 1, 2009 A rebate up to $400 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV. A rebate up to $250 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV.
Consumers who register after October 1, 2009 and who choose to repair their systems will be responsible for up-front payment of parts, labor and permits, and will be responsible for arranging to have the work performed.
Consumers should determine whether they have a recalled HTPV pipe system by checking the vent pipes attached to their natural gas furnace. Vent pipes subject to this recall can be identified as follows:
the vent pipes are plastic;
the vent pipes are colored gray or black;
"Plexvent," "Plexvent II" or "Ultravent" is stamped on the vent pipe or printed on stickers placed on pieces used to connect the vent pipes; and
the vent pipes are located on furnaces and the pipes go through the sidewalls of structures.Other plastic vent pipes, such as white PVC, are not included in the recall.
Owners of Goodman furnaces that are vented with HTPV pipe should immediately call Goodman at (800) 394-8084 from 8 a.m. to 4:30 p.m. CT Monday through Friday. CPSC reminds all consumers to have fuel-burning appliances professionally inspected each year to check for cracks or separations in the vents that could allow CO to leak into the home. In addition, CPSC recommends that every home should have at least one CO alarm.
------------------------------------------------------------------------------------------------
Owners of previously recalled Goodman Manufacturing Co. plexvent and ultravent high temperature plastic vent (HTPV) pipe systems for furnaces that pose a risk of carbon monoxide leaks who do not respond by Oct. 1, 2009, will be responsible for up-front payment of parts, labor and permits, as well as for arranging to have the work performed. The recall was initially announced in 1998. Details: by Web at http://www.cpsc.gov
Thursday, August 20, 2009
Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults
Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults
2009-137
Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.
This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents. Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.
TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis). They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases. There are currently five prescription TNF blockers authorized in Canada : Enbrel (etancercept) , Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol).
Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers. The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups. As well, the label updates will include other new safety information based on reviews conducted by Health Canada , including the risk of new-onset psoriasis in patients treated with TNF blockers. Health Canada will inform health care professionals and Canadians again once these updates are complete.
The role of TNF blockers in the development of cancer is not known. Health Canada has communicated in the past on the risk of the development of certain types of cancers, including lymphoma, associated with the use of these drugs.
Health Canada recommends that patients should not stop taking their TNF blocker without first speaking to their doctor. Patients should contact their health care professional if they have any concerns about any medicines they are taking.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect ™ Canada Web site
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance Program Health CanadaAL 0701C Ottawa , ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866-225-0709
2009-137
Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.
This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents. Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.
TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis). They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases. There are currently five prescription TNF blockers authorized in Canada : Enbrel (etancercept) , Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol).
Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers. The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups. As well, the label updates will include other new safety information based on reviews conducted by Health Canada , including the risk of new-onset psoriasis in patients treated with TNF blockers. Health Canada will inform health care professionals and Canadians again once these updates are complete.
The role of TNF blockers in the development of cancer is not known. Health Canada has communicated in the past on the risk of the development of certain types of cancers, including lymphoma, associated with the use of these drugs.
Health Canada recommends that patients should not stop taking their TNF blocker without first speaking to their doctor. Patients should contact their health care professional if they have any concerns about any medicines they are taking.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect ™ Canada Web site
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance Program Health CanadaAL 0701C Ottawa , ON K1A 0K9
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866-225-0709
FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products
The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.
The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:Emuprofen (Progressive Emu, Inc.)BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)Ibunex Topical Ibuprofen (Core Products International, Inc.)LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)IB-RELIEF (MEKT LLC)Profen HP (Ridge Medical Products)IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)IBU-RELIEF 12 (Wonder Laboratories)
The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.
The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm
Consumer Inquiries: 888-INFO-FDA
FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products
The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.
The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:Emuprofen (Progressive Emu, Inc.)BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)Ibunex Topical Ibuprofen (Core Products International, Inc.)LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)IB-RELIEF (MEKT LLC)Profen HP (Ridge Medical Products)IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)IBU-RELIEF 12 (Wonder Laboratories)
The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.
The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm
Subscribe to:
Posts (Atom)
