Avoid festive fare food poisoning
Many people will be indulging in festive fare over the coming days and, with this in mind, the Agency would like to remind particular groups of people about the importance of avoiding certain foods in order to minimise the risk of food poisoning, especially listeriosis.
One cause of food poisoning is Listeria monocytogenes, which can lead to listeriosis. Although listeriosis isn’t common, it can be life-threatening in people with reduced immunity.
It usually affects people in vulnerable groups, such as pregnant women and people with weakened immunity, particularly those over 60. People with weakened immunity could include those who’ve had transplants, are taking drugs that weaken the immune system, or who have cancers that affect their immune system, such as leukaemia or lymphoma.
Vulnerable people should avoid soft mould-ripened cheeses, such as Camembert and Brie, blue-veined cheeses and pâté of any type, including vegetable.
Other foods that can sometimes contain listeria include chilled ready-to-eat foods, such as prepacked sandwiches, butter, cooked sliced meats and smoked salmon. Keeping these foods
refrigerated and observing use-by dates are important.
Tuesday, December 23, 2008
Monday, December 22, 2008
FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
Milbank Mills Repeatedly Violated Manufacturing Regulations
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.
FDA has cited the defendants for numerous deviations from cGMP over the last five years. FDA inspected Milbank Mills four times during this period, and found gross deviations from cGMP that resulted in voluntary recalls of medicated animal feeds. Despite repeated warnings from FDA, the defendants have continued to manufacture medicated animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and its regulations.
Medicated animal feeds include specific types and amounts of drugs to prevent disease in food-producing animals, and failure to comply with cGMP requirements when manufacturing such feeds renders the product adulterated (or illegal). Among other cGMP violations, Milbank Mills repeatedly failed to store and handle drugs properly to maintain their effectiveness, did not maintain records of drug inventory and use, and did not adequately test its feed products to ensure that they contained the correct amounts of drugs. In addition, Milbank Mills did not accurately label its medicated feed products or provide adequate directions for their use.
Under the consent decree, failure to comply with the terms could result in civil or criminal penalties. Consumers who may have purchased adulterated feed from Milbank Mills should contact the company directly.
Milbank Mills Repeatedly Violated Manufacturing Regulations
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.
FDA has cited the defendants for numerous deviations from cGMP over the last five years. FDA inspected Milbank Mills four times during this period, and found gross deviations from cGMP that resulted in voluntary recalls of medicated animal feeds. Despite repeated warnings from FDA, the defendants have continued to manufacture medicated animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and its regulations.
Medicated animal feeds include specific types and amounts of drugs to prevent disease in food-producing animals, and failure to comply with cGMP requirements when manufacturing such feeds renders the product adulterated (or illegal). Among other cGMP violations, Milbank Mills repeatedly failed to store and handle drugs properly to maintain their effectiveness, did not maintain records of drug inventory and use, and did not adequately test its feed products to ensure that they contained the correct amounts of drugs. In addition, Milbank Mills did not accurately label its medicated feed products or provide adequate directions for their use.
Under the consent decree, failure to comply with the terms could result in civil or criminal penalties. Consumers who may have purchased adulterated feed from Milbank Mills should contact the company directly.
Update on beef from Northern Ireland
Update on beef from Northern Ireland
The Food Standards Agency is today advising consumers not to be concerned about eating beef from Northern Ireland. Dioxin results from three Northern Irish herds affected by contaminated feed have been received, they exceed permitted limits but the risk to public health remains very low. Any cattle and beef that have been withheld since Tuesday 9 December will not enter the food chain.
This action mirrors the approach of the Republic of Ireland, which announced the trade withdrawal of some meat from the food chain on Friday 19 December, following test results showing dioxin levels above permitted limits present in meat.
The results of dioxin tests for the remaining five herds are still awaited. In the meantime, the cattle and meat from these animals will continue to be held on the relevant farms and at meat processing plants.
Meat processors have informed the Agency that there is no longer any affected meat in the shops, although some may have reached consumers before the notification of this incident. People should not worry as the risk to health from this incident is very low and retailers are not required to take any action to withdraw or recall products. The actual number of cattle farms affected represents less than 0.03% of the total number of cattle farms in Northern Ireland.
Dioxins are chemicals that get into food from the environment and are associated with a range of health effects when there is a long term exposure to them at relatively high levels.
The UK will continue to work with local authorities, the wider enforcement community and European Union member states to protect UK consumers.
The Food Standards Agency is today advising consumers not to be concerned about eating beef from Northern Ireland. Dioxin results from three Northern Irish herds affected by contaminated feed have been received, they exceed permitted limits but the risk to public health remains very low. Any cattle and beef that have been withheld since Tuesday 9 December will not enter the food chain.
This action mirrors the approach of the Republic of Ireland, which announced the trade withdrawal of some meat from the food chain on Friday 19 December, following test results showing dioxin levels above permitted limits present in meat.
The results of dioxin tests for the remaining five herds are still awaited. In the meantime, the cattle and meat from these animals will continue to be held on the relevant farms and at meat processing plants.
Meat processors have informed the Agency that there is no longer any affected meat in the shops, although some may have reached consumers before the notification of this incident. People should not worry as the risk to health from this incident is very low and retailers are not required to take any action to withdraw or recall products. The actual number of cattle farms affected represents less than 0.03% of the total number of cattle farms in Northern Ireland.
Dioxins are chemicals that get into food from the environment and are associated with a range of health effects when there is a long term exposure to them at relatively high levels.
The UK will continue to work with local authorities, the wider enforcement community and European Union member states to protect UK consumers.
Friday, December 19, 2008
FDA Continues To Receive Complaints about Chicken Jerky Products for Dogs and Cautions Consumers
Preliminary Animal Health Notification
FDA Continues To Receive Complaints about Chicken Jerky Products for Dogs and Cautions Consumers
The Food and Drug Administration (FDA) continues to caution consumers of a potential association between the development of illness in dogs and the consumption of chicken jerky products also described as chicken tenders, strips or treats. FDA continues to receive complaints of dogs experiencing illness that their owners or veterinarians associate with consumption of chicken jerky products. The chicken jerky products are imported to the U.S. from China. FDA issued a cautionary warning to consumers in September 2007.
Australian news organizations report the University of Sydney is also investigating an association between illness in dogs and the consumption of chicken jerky in Australia. At least one firm in Australia has recalled their chicken jerky product and the recall notification stated the chicken jerky product was manufactured in China.
FDA believes the continued trend of consumer complaints coupled with the information obtained from Australia warrants an additional reminder and animal health notification.
Chicken jerky products should not be substituted for a balanced diet and are intended to beused occasionally and in small quantities. Owners of small dogs must be especially careful to limit the amount of these products.
FDA, in addition to several veterinary diagnostic laboratories in the U.S, is working to determine why these products are associated with illness in dogs. To date, scientists have not been able to determine a definitive cause for the reported illnesses. FDA has conducted extensive chemical and microbial testing but has not identified any contaminant.
FDA is advising consumers who choose to feed their dogs chicken jerky products to watch their dogs closely for any or all of the following signs which may occur within hours to days of feeding the product: decreased appetite, although some may continue to consume the treats to the exclusion of other foods; decreased activity; vomiting; diarrhea, sometimes with blood; and increased water consumption and/or increased urination. If the dog shows any of these signs, stop feeding the chicken jerky product. Owners should consult their veterinarian if signs are severe or persist for more than 24 hours. Blood tests may indicate kidney failure (increased urea nitrogen and creatinine). Urine tests may indicate Fanconi syndrome (increased glucose).
Although most dogs appear to recover, some reports to the FDA have involved dogs that have died.
The FDA continues to actively investigate the problem. Many of the illnesses reported may be the result of causes other than eating chicken jerky. Veterinarians and consumers alike should report cases of animal illness associated with pet foods to the FDA Consumer Complaint Coordinator http://www.fda.gov/opacom/backgrounders/complain.html in their state.
FDA Continues To Receive Complaints about Chicken Jerky Products for Dogs and Cautions Consumers
The Food and Drug Administration (FDA) continues to caution consumers of a potential association between the development of illness in dogs and the consumption of chicken jerky products also described as chicken tenders, strips or treats. FDA continues to receive complaints of dogs experiencing illness that their owners or veterinarians associate with consumption of chicken jerky products. The chicken jerky products are imported to the U.S. from China. FDA issued a cautionary warning to consumers in September 2007.
Australian news organizations report the University of Sydney is also investigating an association between illness in dogs and the consumption of chicken jerky in Australia. At least one firm in Australia has recalled their chicken jerky product and the recall notification stated the chicken jerky product was manufactured in China.
FDA believes the continued trend of consumer complaints coupled with the information obtained from Australia warrants an additional reminder and animal health notification.
Chicken jerky products should not be substituted for a balanced diet and are intended to beused occasionally and in small quantities. Owners of small dogs must be especially careful to limit the amount of these products.
FDA, in addition to several veterinary diagnostic laboratories in the U.S, is working to determine why these products are associated with illness in dogs. To date, scientists have not been able to determine a definitive cause for the reported illnesses. FDA has conducted extensive chemical and microbial testing but has not identified any contaminant.
FDA is advising consumers who choose to feed their dogs chicken jerky products to watch their dogs closely for any or all of the following signs which may occur within hours to days of feeding the product: decreased appetite, although some may continue to consume the treats to the exclusion of other foods; decreased activity; vomiting; diarrhea, sometimes with blood; and increased water consumption and/or increased urination. If the dog shows any of these signs, stop feeding the chicken jerky product. Owners should consult their veterinarian if signs are severe or persist for more than 24 hours. Blood tests may indicate kidney failure (increased urea nitrogen and creatinine). Urine tests may indicate Fanconi syndrome (increased glucose).
Although most dogs appear to recover, some reports to the FDA have involved dogs that have died.
The FDA continues to actively investigate the problem. Many of the illnesses reported may be the result of causes other than eating chicken jerky. Veterinarians and consumers alike should report cases of animal illness associated with pet foods to the FDA Consumer Complaint Coordinator http://www.fda.gov/opacom/backgrounders/complain.html in their state.
Health Canada Releases Decision on the Labelling of Cough and Cold Products for Children
Health Canada Releases Decision on the Labelling of Cough and Cold Products for Children
Advisory2008-184
OTTAWA - Health Canada is advising consumers of the outcome of its review of cough and cold medicines for children under the age of 12.
Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines
that have dosing information for children to indicate that these medicines should not be used in children under 6. The products affected are those containing any of the active ingredients listed below that are given orally:
Table 1: Active Ingredients Affected by Health Canada's Decision on Cough and Cold Products for Children Therapeutic Category (Purpose) Active Ingredients Antihistamines in cough and cold medicines(used to treat sneezing, runny nose) brompheniramine maleate chlorpheniramine maleate clemastine hydrogen fumerate dexbrompheniramine maleate diphenhydramine
hydrochloride diphenylpyraline hydrochloride doxylamine succinate pheniramine maleate phenyltoloxamine citrate promethazine hydrochloride pyrilamine maleate triprolidine hydrochloride Antitussives(used to treat cough) dextromethorphan dextromethorphan hydrobromide diphenhydramine hydrochloride Expectorants (used to loosen mucus) guaifenesin (glyceryl guaiacolate) Decongestants (used to treat congestion) ephedrine hydrochloride/sulphate phenylephrine hydrochloride/sulphate pseudoephedrine hydrochloride/sulphate
The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season. During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under 6, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products.
These medicines can still be used in children 6 and older, and adults.
This decision is the result of a Health Canada review of these medicines, including the input of a Scientific Advisory Panel convened in March 2008. Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children. In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel's conclusions and details of the new Health Canada recommendations are posted on the Health Canada Web site.
Health Canada previously issued advice on the use of these medicines in an October 2007 Public Advisory. Based on a preliminary review, Health Canada at that time recommended not using over-the-counter cough and cold medicines in children under 2 years of age, unless instructed to do so by a health care practitioner. The current decision expands on those preliminary recommendations.
Until the relabelling of these products is completed, Health Canada advises parents and caregivers to follow these important guidelines:
Do not use these over-the-counter cough and cold medicines in children under 6 years of age.
With children older than 6, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included. Do not give children medications labelled only for adults. Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child. Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines. The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity. For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.
If you are concerned about the child's health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation. For more information about Health Canada's decision and the use of cough and cold products in children, consult the Health Canada Web site or call toll free at 1-866-558-2946.
For advice on how to properly dispose of medications, see the "It's Your Health" article entitled
The Proper Use and Disposal of Medication.
For more information on the safe use of medicines, see the "It's Your Health" article entitled Safe Use of Medicines.
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 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site.
Advisory2008-184
OTTAWA - Health Canada is advising consumers of the outcome of its review of cough and cold medicines for children under the age of 12.
Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines
that have dosing information for children to indicate that these medicines should not be used in children under 6. The products affected are those containing any of the active ingredients listed below that are given orally:
Table 1: Active Ingredients Affected by Health Canada's Decision on Cough and Cold Products for Children Therapeutic Category (Purpose) Active Ingredients Antihistamines in cough and cold medicines(used to treat sneezing, runny nose) brompheniramine maleate chlorpheniramine maleate clemastine hydrogen fumerate dexbrompheniramine maleate diphenhydramine
hydrochloride diphenylpyraline hydrochloride doxylamine succinate pheniramine maleate phenyltoloxamine citrate promethazine hydrochloride pyrilamine maleate triprolidine hydrochloride Antitussives(used to treat cough) dextromethorphan dextromethorphan hydrobromide diphenhydramine hydrochloride Expectorants (used to loosen mucus) guaifenesin (glyceryl guaiacolate) Decongestants (used to treat congestion) ephedrine hydrochloride/sulphate phenylephrine hydrochloride/sulphate pseudoephedrine hydrochloride/sulphate
The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season. During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under 6, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products.
These medicines can still be used in children 6 and older, and adults.
This decision is the result of a Health Canada review of these medicines, including the input of a Scientific Advisory Panel convened in March 2008. Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children. In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel's conclusions and details of the new Health Canada recommendations are posted on the Health Canada Web site.
Health Canada previously issued advice on the use of these medicines in an October 2007 Public Advisory. Based on a preliminary review, Health Canada at that time recommended not using over-the-counter cough and cold medicines in children under 2 years of age, unless instructed to do so by a health care practitioner. The current decision expands on those preliminary recommendations.
Until the relabelling of these products is completed, Health Canada advises parents and caregivers to follow these important guidelines:
Do not use these over-the-counter cough and cold medicines in children under 6 years of age.
With children older than 6, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included. Do not give children medications labelled only for adults. Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child. Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines. The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity. For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.
If you are concerned about the child's health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation. For more information about Health Canada's decision and the use of cough and cold products in children, consult the Health Canada Web site or call toll free at 1-866-558-2946.
For advice on how to properly dispose of medications, see the "It's Your Health" article entitled
The Proper Use and Disposal of Medication.
For more information on the safe use of medicines, see the "It's Your Health" article entitled Safe Use of Medicines.
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 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site.
Wednesday, December 17, 2008
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes
The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."
More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.
Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance, which has benefited from the July 2008 recommendation from FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required.
Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.
The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.
The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control.
The FDA is continuing to evaluate how today's recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.
The FDA's guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director, CDER, FDA.
"Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on FDA's website at http://www.fda.gov/cder/guidance/8576fnl.pdf.
It will be published in the Federal Register on December 19, 2008. In addition, the FDA has provided written notice of the recommendations from this guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.
The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.
"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."
More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.
Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance, which has benefited from the July 2008 recommendation from FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required.
Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.
The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.
The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control.
The FDA is continuing to evaluate how today's recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.
The FDA's guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director, CDER, FDA.
"Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on FDA's website at http://www.fda.gov/cder/guidance/8576fnl.pdf.
It will be published in the Federal Register on December 19, 2008. In addition, the FDA has provided written notice of the recommendations from this guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.
Internet Explorer enables hackers to steal users' passwords
Internet Explorer Has Serious Security Flaw
Exploit enables hackers to steal users' passwords
If you're browsing the Internet with Microsoft's Internet Explorer, you could be vulnerable to hackers. That's the warning from computer experts, who say the browser has a security flaw that allows criminals to take control of consumers' computers and steal passwords.
Until Microsoft fixes the problem, experts suggest using another browser.
The technology security firm Trend Micro said its engineers detected a malicious JavaScript called JS_DLOAD.MD on several Web sites that exploits a zero-day vulnerability in Internet Explorer 7 through a heap spray on SDHTML.
After a successful exploit, it triggers a series of redirections to multiple URLs, then finally connects to one of several different domains.
"Unfortunately, since Microsoft's security updates failed to provide protection against this vulnerability, users of Internet Explorer are at risk even while surfing the Web on fully patched Windows XP and Windows 2003 systems," Trend Micro said in an advisory.
Microsoft says seven versions of Internet Explorer, which is used by most of the world's computers, are vulnerable to this security flaw. Microsoft is now at work trying to find a security patch.
"Microsoft is continuing its investigation of public reports of attacks against a new vulnerability in Internet Explorer," the company said.
Security experts say those still using Internet Explorer should be very careful about which Web sites they visit, since compromised Web sites can download the Trojan. They say the rule about never clicking on a link in a spam email is especially important to follow in this case, since hackers may be using spam to direct victims to compromised sites.
Once a hacker gains access to your computer, the keylogger software can capture your key strokes, stealing user names and passwords to your bank and other secure online accounts.
Exploit enables hackers to steal users' passwords
If you're browsing the Internet with Microsoft's Internet Explorer, you could be vulnerable to hackers. That's the warning from computer experts, who say the browser has a security flaw that allows criminals to take control of consumers' computers and steal passwords.
Until Microsoft fixes the problem, experts suggest using another browser.
The technology security firm Trend Micro said its engineers detected a malicious JavaScript called JS_DLOAD.MD on several Web sites that exploits a zero-day vulnerability in Internet Explorer 7 through a heap spray on SDHTML.
After a successful exploit, it triggers a series of redirections to multiple URLs, then finally connects to one of several different domains.
"Unfortunately, since Microsoft's security updates failed to provide protection against this vulnerability, users of Internet Explorer are at risk even while surfing the Web on fully patched Windows XP and Windows 2003 systems," Trend Micro said in an advisory.
Microsoft says seven versions of Internet Explorer, which is used by most of the world's computers, are vulnerable to this security flaw. Microsoft is now at work trying to find a security patch.
"Microsoft is continuing its investigation of public reports of attacks against a new vulnerability in Internet Explorer," the company said.
Security experts say those still using Internet Explorer should be very careful about which Web sites they visit, since compromised Web sites can download the Trojan. They say the rule about never clicking on a link in a spam email is especially important to follow in this case, since hackers may be using spam to direct victims to compromised sites.
Once a hacker gains access to your computer, the keylogger software can capture your key strokes, stealing user names and passwords to your bank and other secure online accounts.
Tuesday, December 16, 2008
Health Canada Advises Diabetic Patients About the Risk of Inaccurate Blood Glucose Readings With Certain Types of Glucose Meters
Health Canada Advises Diabetic Patients About the Risk of Inaccurate Blood Glucose Readings With Certain Types of Glucose Meters
Advisory2008-183
OTTAWA - Health Canada is advising Canadians who rely on blood glucose meters that some medical products may interfere with test results and lead to falsely elevated glucose readings. Diabetic patients who may be exposed to the medical products described below are encouraged to determine what type of meter they are using to better understand the reliability of their glucose readings.
There are two types of glucose meters available on the Canadian market based on the test method they use: “glucose-specific” and “glucose non-specific.” The manufacturer of your glucose meter can assist you in determining your model type.
Meters that use a glucose-specific test method are not at risk of interference from medical products. However, meters that use a glucose non-specific test method are at an increased risk of inaccurately high glucose readings in diabetic patients who have recently had surgery, who have recently had certain diagnostic tests performed in the hospital, or who are on peritoneal dialysis.
This risk is because some medical products used in hospitals, including intravenous immune globulin preparations and xylose and galactose tolerance tests, contain substances that can interfere with glucose readings. The Extraneal™ peritoneal dialysis solution, used to treat kidney failure, can also lead to false high glucose readings. Health Canada has previously informed diabetics using Extraneal™ of this risk.
Health Canada advises diabetic patients that if they are using a glucose non-specific meter and they are getting unusually high blood glucose readings, this may be the result of interference from hospital or peritoneal dialysis treatments. These patients should talk to their physician or health care professional to determine whether the reading is false.
Diabetics who get a false high glucose reading may then take an excessive dose of insulin, which could in turn lead to low blood sugar. Similarly, cases of low blood sugar could go untreated if masked by glucose readings that are falsely elevated into the normal range. Patients with low blood sugar might feel unwell, confused, hungry, nervous, dizzy or irritable. Low blood sugar should be recognized and treated promptly to avoid serious complications such as coma.
Patients using a glucose non-specific meter who are exposed to the above-mentioned medical products may want to consider purchasing a glucose-specific model in the future to prevent the risk of inaccurate readings. Information about glucose-specific models can be obtained from manufacturers.
Health Canada also reminds Canadians using blood glucose monitors to only use test strips specified for their meter, as use of the wrong strip may also lead to inaccurate blood sugar readings.
Information for health care professionals out the risk of inaccurate blood glucose readings with certain types of glucose meters is available on the Health Canada Web site.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse event related to glucose monitoring systems, please contact the Health Products and Food Branch Inspectorate
Advisory2008-183
OTTAWA - Health Canada is advising Canadians who rely on blood glucose meters that some medical products may interfere with test results and lead to falsely elevated glucose readings. Diabetic patients who may be exposed to the medical products described below are encouraged to determine what type of meter they are using to better understand the reliability of their glucose readings.
There are two types of glucose meters available on the Canadian market based on the test method they use: “glucose-specific” and “glucose non-specific.” The manufacturer of your glucose meter can assist you in determining your model type.
Meters that use a glucose-specific test method are not at risk of interference from medical products. However, meters that use a glucose non-specific test method are at an increased risk of inaccurately high glucose readings in diabetic patients who have recently had surgery, who have recently had certain diagnostic tests performed in the hospital, or who are on peritoneal dialysis.
This risk is because some medical products used in hospitals, including intravenous immune globulin preparations and xylose and galactose tolerance tests, contain substances that can interfere with glucose readings. The Extraneal™ peritoneal dialysis solution, used to treat kidney failure, can also lead to false high glucose readings. Health Canada has previously informed diabetics using Extraneal™ of this risk.
Health Canada advises diabetic patients that if they are using a glucose non-specific meter and they are getting unusually high blood glucose readings, this may be the result of interference from hospital or peritoneal dialysis treatments. These patients should talk to their physician or health care professional to determine whether the reading is false.
Diabetics who get a false high glucose reading may then take an excessive dose of insulin, which could in turn lead to low blood sugar. Similarly, cases of low blood sugar could go untreated if masked by glucose readings that are falsely elevated into the normal range. Patients with low blood sugar might feel unwell, confused, hungry, nervous, dizzy or irritable. Low blood sugar should be recognized and treated promptly to avoid serious complications such as coma.
Patients using a glucose non-specific meter who are exposed to the above-mentioned medical products may want to consider purchasing a glucose-specific model in the future to prevent the risk of inaccurate readings. Information about glucose-specific models can be obtained from manufacturers.
Health Canada also reminds Canadians using blood glucose monitors to only use test strips specified for their meter, as use of the wrong strip may also lead to inaccurate blood sugar readings.
Information for health care professionals out the risk of inaccurate blood glucose readings with certain types of glucose meters is available on the Health Canada Web site.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse event related to glucose monitoring systems, please contact the Health Products and Food Branch Inspectorate
Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.
The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.
"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."
CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.
"We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.
In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.
The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector's progress.
The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy.
Shoppers trained to simulate patients visited pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.
There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.
For information: Expert and Consumer Evaluation of Consumer Medication Information, 2008 http://www.fda.gov/cder/news/CMI/default.htm
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.
The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.
"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."
CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.
"We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.
In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.
The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector's progress.
The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy.
Shoppers trained to simulate patients visited pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.
There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.
For information: Expert and Consumer Evaluation of Consumer Medication Information, 2008 http://www.fda.gov/cder/news/CMI/default.htm
Failure to comply with Pool And Spa Safety Law can result in closure
Release #09-065
CPSC Recall Hotline: (800) 638-2772CPSC Media Contact: (301) 504-7908
Pool And Spa Safety Law Aimed At Preventing Drain Entrapments of Children Goes Into Effect
This Week:Failure to comply with Congressionally-enacted law can result in closure
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) is again reminding public pool and spa owners and operators nationwide that the Virginia Graeme Baker Pool and Spa Safety Act becomes effective on December 19, 2008. This law requires installation of anti-entrapment drain covers and other systems as outlined in the Act.
The Pool and Spa Safety Act was enacted by Congress and signed by President Bush on December 19, 2007, and is designed to prevent the tragic and hidden hazard of drain entrapments and eviscerations in pools and spas. Under the law, all public pools and spas must have ASME/ANSI A112.19.8-2007 compliant drain covers installed and a second anti-entrapment system installed, when there is only a single main drain. Congress gave all affected pool and spa operators one year to comply with this law.
Public pools and spas that operate year-round are expected to be in compliance by December 19, 2008. CPSC staff has taken the position that seasonal public pools and spas that are currently closed must be in compliance with the law on the day that they reopen in 2009.
"Our mission at the CPSC is to keep American families safe," said Nancy Nord, CPSC Acting Chairman. "CPSC will enforce the requirements of this pool and spa safety law with a focus on where the greatest risk of drain entrapment to children exists, such as wading pools, pools designed specifically for toddlers and young children, and in-ground spas, particularly where these types of pools and spas have flat drain grates and single main drain systems."
Nord added, "State health and enforcement agencies share the responsibility to ensure this law is properly enforced. I recommend these agencies take the same approach as CPSC concerning enforcement priorities."
Pool and spa operators are encouraged to continue working as diligently as possible to come into compliance, as the agency and state Attorneys General are empowered to close down any pool or spa that fails to meet the Act's requirements.
For more information about the Pool and Spa Safety Act, how to comply, and which companies have been certified to manufacturer drain covers and safety vacuum release systems, please log on to: www.cpsc.gov/whatsnew.html#pool
To see this release on CPSC's web site, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml09/09065.html
CPSC Recall Hotline: (800) 638-2772CPSC Media Contact: (301) 504-7908
Pool And Spa Safety Law Aimed At Preventing Drain Entrapments of Children Goes Into Effect
This Week:Failure to comply with Congressionally-enacted law can result in closure
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) is again reminding public pool and spa owners and operators nationwide that the Virginia Graeme Baker Pool and Spa Safety Act becomes effective on December 19, 2008. This law requires installation of anti-entrapment drain covers and other systems as outlined in the Act.
The Pool and Spa Safety Act was enacted by Congress and signed by President Bush on December 19, 2007, and is designed to prevent the tragic and hidden hazard of drain entrapments and eviscerations in pools and spas. Under the law, all public pools and spas must have ASME/ANSI A112.19.8-2007 compliant drain covers installed and a second anti-entrapment system installed, when there is only a single main drain. Congress gave all affected pool and spa operators one year to comply with this law.
Public pools and spas that operate year-round are expected to be in compliance by December 19, 2008. CPSC staff has taken the position that seasonal public pools and spas that are currently closed must be in compliance with the law on the day that they reopen in 2009.
"Our mission at the CPSC is to keep American families safe," said Nancy Nord, CPSC Acting Chairman. "CPSC will enforce the requirements of this pool and spa safety law with a focus on where the greatest risk of drain entrapment to children exists, such as wading pools, pools designed specifically for toddlers and young children, and in-ground spas, particularly where these types of pools and spas have flat drain grates and single main drain systems."
Nord added, "State health and enforcement agencies share the responsibility to ensure this law is properly enforced. I recommend these agencies take the same approach as CPSC concerning enforcement priorities."
Pool and spa operators are encouraged to continue working as diligently as possible to come into compliance, as the agency and state Attorneys General are empowered to close down any pool or spa that fails to meet the Act's requirements.
For more information about the Pool and Spa Safety Act, how to comply, and which companies have been certified to manufacturer drain covers and safety vacuum release systems, please log on to: www.cpsc.gov/whatsnew.html#pool
To see this release on CPSC's web site, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml09/09065.html
Health Advisory- PPD In "Black Henna" Temporary Tattoos Is Not Safe
PPD In "Black Henna" Temporary Tattoos Is Not Safe
ISBN: 978-1-100-10414-0
Cat. No.: H128-1/08-547E
The Issue"Black henna" temporary tattoos are often sold and applied by artisans at markets, fairs and amusement parks in Canada and holiday or foreign travel destinations. Natural henna is redbrown in colour and is safe to use directly on skin, whereas "black henna" is produced when a colourant is added to natural henna. Some colourants are safe to add, but others, such as paraphenylenediamine (PPD), are not. PPD may be added to "black henna" ink by mixing it with hair dye. In some cases, hair dye is applied directly to the skin instead of a henna paste.
The use of PPD in cosmetics that are applied directly to the skin (such as temporary tattoos) can cause serious allergic reactions and poses a risk to the health and safety of the user. Therefore, cosmetics containing PPD that are applied directly to the skin are banned from sale in Canada.
PPD is an acceptable ingredient for use in hair dyes that are rinsed off after a maximum of 30 minutes. When used correctly, hair dye does not come directly into contact with skin for prolonged periods of time.
Allergic reactions to PPD include red skin rashes, itching, blisters, open sores, and scarring within 2 to 10 days following application. These allergic reactions may also lead to sensitivities to other products such as hair dye, sun block and some types of clothing dyes.
What you can doBefore receiving a temporary tattoo, ask the vendor to confirm that PPD or hair dye was not added to the ink or paste. Health Canada permits the use of natural henna and other safe dyes in cosmetics. Cosmetic products sold in Canada must have ingredient labels. Ask the vendor to see the ingredient label for the ink or paste. If there is no label, do not get a tattoo.
The following are some indicators that an ink or paste being used for "black henna" temporary tattoos may contain PPD:
If the formula and resulting tattoo are intense black; If the tattoo ink sets very quickly. Natural henna paste must set for 24 - 48 hours to completely darken; If the temporary tattoo lasts one to three weeks, without fading; and, If the ink or paste has very little or no scent (natural henna usually smells like soil, hay, or added essential oils). Note that even brown shades of ink/paste may contain PPD in order to make the temporary tattoo darker or last longer.
Please contact your nearest Health Canada Product Safety Office if you suspect that PPD is being used by a local vendor, or if you suspect you have suffered an adverse reaction from a "black henna" temporary tattoo. Call toll-free 1-866-662-0666 or send an email to cosmetics@hc-sc.gc.ca.
ISBN: 978-1-100-10414-0
Cat. No.: H128-1/08-547E
The Issue"Black henna" temporary tattoos are often sold and applied by artisans at markets, fairs and amusement parks in Canada and holiday or foreign travel destinations. Natural henna is redbrown in colour and is safe to use directly on skin, whereas "black henna" is produced when a colourant is added to natural henna. Some colourants are safe to add, but others, such as paraphenylenediamine (PPD), are not. PPD may be added to "black henna" ink by mixing it with hair dye. In some cases, hair dye is applied directly to the skin instead of a henna paste.
The use of PPD in cosmetics that are applied directly to the skin (such as temporary tattoos) can cause serious allergic reactions and poses a risk to the health and safety of the user. Therefore, cosmetics containing PPD that are applied directly to the skin are banned from sale in Canada.
PPD is an acceptable ingredient for use in hair dyes that are rinsed off after a maximum of 30 minutes. When used correctly, hair dye does not come directly into contact with skin for prolonged periods of time.
Allergic reactions to PPD include red skin rashes, itching, blisters, open sores, and scarring within 2 to 10 days following application. These allergic reactions may also lead to sensitivities to other products such as hair dye, sun block and some types of clothing dyes.
What you can doBefore receiving a temporary tattoo, ask the vendor to confirm that PPD or hair dye was not added to the ink or paste. Health Canada permits the use of natural henna and other safe dyes in cosmetics. Cosmetic products sold in Canada must have ingredient labels. Ask the vendor to see the ingredient label for the ink or paste. If there is no label, do not get a tattoo.
The following are some indicators that an ink or paste being used for "black henna" temporary tattoos may contain PPD:
If the formula and resulting tattoo are intense black; If the tattoo ink sets very quickly. Natural henna paste must set for 24 - 48 hours to completely darken; If the temporary tattoo lasts one to three weeks, without fading; and, If the ink or paste has very little or no scent (natural henna usually smells like soil, hay, or added essential oils). Note that even brown shades of ink/paste may contain PPD in order to make the temporary tattoo darker or last longer.
Please contact your nearest Health Canada Product Safety Office if you suspect that PPD is being used by a local vendor, or if you suspect you have suffered an adverse reaction from a "black henna" temporary tattoo. Call toll-free 1-866-662-0666 or send an email to cosmetics@hc-sc.gc.ca.
Wednesday, December 10, 2008
Health Canada Reminds Canadians of Electrical Safety This Holiday Season
Health Canada Reminds Canadians of Electrical Safety This Holiday Season
Advisory2008-180
Electrical products, such as sparkling lights, decorations and plug-in toys, form a central part of holiday celebrations in Canada. With the holiday season quickly approaching, Health Canada is reminding the public to choose certified electrical products and to use them properly.
Electrical products that are not properly certified to the standards required by provincial and territorial electrical authorities can lead to electrical shock and fire, resulting in property damage, injury, and even death. When buying electrical products, make sure that they bear one of the recognized Certification marks or Field Evaluation marks (below). These marks ensure that the products are certified to the required Canadian electrical safety standards. If you notice products which do not bear at least one of these marks, report them to the retailer and to your provincial, territorial, or municipal Electrical Safety Authority, or to Health Canada. Note that several marks require the letter 'c' to designate certification to Canadian electrical safety standards. Also note that marks are required on the product itself; marks on the packaging alone are not acceptable.
Recognized Certification Marks
Recognized Field Evaluation Agency Marks
Source: Electrical Safety Authority
If a mark is not present, the product may be counterfeit. Counterfeit electrical products pose health and safety hazards. However, counterfeiters are skilled at mimicking legitimate products, and can apply false certification markings. A reliable way to tell if a product is counterfeit is by its selling price; if a product is offered at an extremely low price, it could be counterfeit.
Purchasing from reputable establishments can help you avoid counterfeit products.
More information about electrical safety is available from:
City of Winnipeg 204-986-5258
Government of the Yukon 867-667-5485
Manitoba Hydro 204-992-7501
British Columbia Safety Authority 1-866-566-7233
City of Calgary 403-268-2113
Prince Edward Island Department of Community and Cultural Affairs 902-368-5470
Nova Scotia Department of Environment and Labour 902-424-8018
Saskatchewan -- SaskPower 306-566-2518
Ontario -- Electrical Safety Authority 1-877-372-7233
Government of the North West Territories 867-873-7461
Alberta Municipal Affairs 1-866-421-6929
Government of Newfoundland and Labrador 709-729-0907
Québec -- Régie du bâtiment du Québec 514-864-2903
New Brunswick -- Department of Public Safety 506-444-5185
City of Vancouver 604-873-7561
Government of Nunavut Community & Government Services 867-975-5448
You may also contact your regional Health Canada Product Safety office toll free at 1-866-662-0666 or by e-mail at cps-spc@hc.gc.ca (please indicate the province or territory from which you are corresponding).
Advisory2008-180
Electrical products, such as sparkling lights, decorations and plug-in toys, form a central part of holiday celebrations in Canada. With the holiday season quickly approaching, Health Canada is reminding the public to choose certified electrical products and to use them properly.
Electrical products that are not properly certified to the standards required by provincial and territorial electrical authorities can lead to electrical shock and fire, resulting in property damage, injury, and even death. When buying electrical products, make sure that they bear one of the recognized Certification marks or Field Evaluation marks (below). These marks ensure that the products are certified to the required Canadian electrical safety standards. If you notice products which do not bear at least one of these marks, report them to the retailer and to your provincial, territorial, or municipal Electrical Safety Authority, or to Health Canada. Note that several marks require the letter 'c' to designate certification to Canadian electrical safety standards. Also note that marks are required on the product itself; marks on the packaging alone are not acceptable.
Recognized Certification Marks
Recognized Field Evaluation Agency Marks
Source: Electrical Safety Authority
If a mark is not present, the product may be counterfeit. Counterfeit electrical products pose health and safety hazards. However, counterfeiters are skilled at mimicking legitimate products, and can apply false certification markings. A reliable way to tell if a product is counterfeit is by its selling price; if a product is offered at an extremely low price, it could be counterfeit.
Purchasing from reputable establishments can help you avoid counterfeit products.
More information about electrical safety is available from:
City of Winnipeg 204-986-5258
Government of the Yukon 867-667-5485
Manitoba Hydro 204-992-7501
British Columbia Safety Authority 1-866-566-7233
City of Calgary 403-268-2113
Prince Edward Island Department of Community and Cultural Affairs 902-368-5470
Nova Scotia Department of Environment and Labour 902-424-8018
Saskatchewan -- SaskPower 306-566-2518
Ontario -- Electrical Safety Authority 1-877-372-7233
Government of the North West Territories 867-873-7461
Alberta Municipal Affairs 1-866-421-6929
Government of Newfoundland and Labrador 709-729-0907
Québec -- Régie du bâtiment du Québec 514-864-2903
New Brunswick -- Department of Public Safety 506-444-5185
City of Vancouver 604-873-7561
Government of Nunavut Community & Government Services 867-975-5448
You may also contact your regional Health Canada Product Safety office toll free at 1-866-662-0666 or by e-mail at cps-spc@hc.gc.ca (please indicate the province or territory from which you are corresponding).
Tuesday, December 9, 2008
FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC
FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC
Company used Internet to claim its unapproved products treat serious health conditions
The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases.
Wilderness Family is a manufacturer and distributor of conventional foods, dietary supplements and various salves, all branded under the Wilderness Family name. The company promoted several of its products for the treatment, cure, mitigation or prevention of disease by making claims on their products' labels, their Web site, and on other Web sites accessed by links found on their Web site.
“The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”
Wilderness Family has a history of promoting its products for the treatment of diseases, and recently referred customers to seemingly independent Web sites that were actually controlled by Wilderness Family. The Web sites claimed benefits for its products against diseases such as cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.
Under the terms of the consent decree, the company and its owners, Kenneth H. Fischer and Annette C. Fischer, cannot promote claims related to their products’ ability to fight diseases unless the products receive FDA approval as new drugs or satisfy FDA’s investigational new drug requirements.
Wilderness Family and its owners also have agreed to remove disease claims from their products’ labels, labeling and Web sites, as well as references to other Web sites that contain such claims. The company and its owners have also agreed to hire an independent expert to review the claims they make for all of their products and to certify to the FDA that they are not making any illegal claims.
The FDA can order Wilderness Family to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. Defendants are also required to pay $1,000 per violation per day if they fail to comply with the consent decree.
The decree was signed by Judge Donovan W. Frank on December 8, 2008 in the U.S. District Court for the District of Minnesota.
Company used Internet to claim its unapproved products treat serious health conditions
The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases.
Wilderness Family is a manufacturer and distributor of conventional foods, dietary supplements and various salves, all branded under the Wilderness Family name. The company promoted several of its products for the treatment, cure, mitigation or prevention of disease by making claims on their products' labels, their Web site, and on other Web sites accessed by links found on their Web site.
“The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”
Wilderness Family has a history of promoting its products for the treatment of diseases, and recently referred customers to seemingly independent Web sites that were actually controlled by Wilderness Family. The Web sites claimed benefits for its products against diseases such as cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.
Under the terms of the consent decree, the company and its owners, Kenneth H. Fischer and Annette C. Fischer, cannot promote claims related to their products’ ability to fight diseases unless the products receive FDA approval as new drugs or satisfy FDA’s investigational new drug requirements.
Wilderness Family and its owners also have agreed to remove disease claims from their products’ labels, labeling and Web sites, as well as references to other Web sites that contain such claims. The company and its owners have also agreed to hire an independent expert to review the claims they make for all of their products and to certify to the FDA that they are not making any illegal claims.
The FDA can order Wilderness Family to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. Defendants are also required to pay $1,000 per violation per day if they fail to comply with the consent decree.
The decree was signed by Judge Donovan W. Frank on December 8, 2008 in the U.S. District Court for the District of Minnesota.
Monday, December 8, 2008
Mexican "Vanilla" With Coumarin: No Bargain
Mexican "Vanilla" With Coumarin: No Bargain
Coumarin Banned in Food Standards for Vanilla
Tips for Consumers Tourists tempted to pick up bargains south of the border should beware of one bargain that isn't always a good buy—so-called Mexican "vanilla." This flavoring product may smell like vanilla, taste like vanilla, and be offered at a cheap price. But it's often made with coumarin, a toxic substance banned in food in the United States.
In addition to being sold in Mexico and other Latin American countries, the coumarin-containing product has appeared on the shelves of some U.S. stores. The Food and Drug Administration (FDA) advises consumers not to purchase this product.
Pure vanilla is made with the extract of beans from the vanilla plant, a type of orchid that grows as a vine. Mexican vanilla is frequently made with the extract of beans from the tonka tree, an entirely different plant that belongs to the pea family. Tonka bean extract contains coumarin, a compound related to warfarin, which is in some blood-thinning medications. Eating food containing coumarin may be especially risky for people taking blood-thinning drugs because the interaction of coumarin and blood thinners can increase the likelihood of bleeding.
Coumarin Banned in FoodSince 1954, FDA has banned coumarin from all food products sold in the United States. Yet the agency has found Mexican vanilla with coumarin in some ethnic food stores and Mexican restaurants in the United States. These products usually have been improperly brought into the country.
If vanilla products that were suspected of containing coumarin were shipped through regular commercial channels, FDA and the U.S. Customs and Border Patrol would stop them at the border because these products are listed on an import alert. An import alert document identifies manufacturers and products that have a history of—or are suspected of—violating the law so that federal agents can keep the products from entering the United States. It is important to note that not all vanilla from Latin American countries contains coumarin.
Standards for VanillaFDA standards specify that only vanilla beans can be used to make vanilla for use in any food product. Vanilla-like flavors that don't meet the standard must be labeled as "imitation" vanilla and must be made from safe ingredients that are permitted for that use.
FDA does not allow tonka bean extract even in imitation vanilla. Because they contain coumarin, tonka beans do not meet the food safety requirements for sale in the United States under the Federal Food, Drug, and Cosmetic Act.
Tips for ConsumersBe wary about buying vanilla in Mexico and other Latin American countries. Look for "vanilla bean" in the ingredient list on the label. If it has "tonka bean" or if there is no ingredient list or a vague one, avoid this product. Don't risk your health to save a few dollars.
Vanilla with coumarin is generally sold at a lower price than pure vanilla because tonka beans are cheaper to grow than vanilla beans. If the price sounds too good to be true, pass it up. Don't buy a food product in the United States that is not labeled in English. Products may have Spanish or other non-English labeling, but they must also have complete English labeling to meet U.S. Government standards. (Products sold only in Puerto Rico are an exception—they are not required to be labeled in English.) Call the FDA Consumer Complaint Coordinator for your geographic area if you suspect that a food product sold in the United States has been imported illegally.
(See list of contacts at www.fda.gov/opacom/backgrounders/complain.html.)
For More InformationImport Alert on Coumarin in Vanilla Productswww.fda.gov/ora/fiars/ora_import_ia2807.html
Know Before You Go: Rules for Bringing Items Back From Your Tripwww.cbp.gov/xp/cgov/travel/vacation/kbyg/
Coumarin Banned in Food Standards for Vanilla
Tips for Consumers Tourists tempted to pick up bargains south of the border should beware of one bargain that isn't always a good buy—so-called Mexican "vanilla." This flavoring product may smell like vanilla, taste like vanilla, and be offered at a cheap price. But it's often made with coumarin, a toxic substance banned in food in the United States.
In addition to being sold in Mexico and other Latin American countries, the coumarin-containing product has appeared on the shelves of some U.S. stores. The Food and Drug Administration (FDA) advises consumers not to purchase this product.
Pure vanilla is made with the extract of beans from the vanilla plant, a type of orchid that grows as a vine. Mexican vanilla is frequently made with the extract of beans from the tonka tree, an entirely different plant that belongs to the pea family. Tonka bean extract contains coumarin, a compound related to warfarin, which is in some blood-thinning medications. Eating food containing coumarin may be especially risky for people taking blood-thinning drugs because the interaction of coumarin and blood thinners can increase the likelihood of bleeding.
Coumarin Banned in FoodSince 1954, FDA has banned coumarin from all food products sold in the United States. Yet the agency has found Mexican vanilla with coumarin in some ethnic food stores and Mexican restaurants in the United States. These products usually have been improperly brought into the country.
If vanilla products that were suspected of containing coumarin were shipped through regular commercial channels, FDA and the U.S. Customs and Border Patrol would stop them at the border because these products are listed on an import alert. An import alert document identifies manufacturers and products that have a history of—or are suspected of—violating the law so that federal agents can keep the products from entering the United States. It is important to note that not all vanilla from Latin American countries contains coumarin.
Standards for VanillaFDA standards specify that only vanilla beans can be used to make vanilla for use in any food product. Vanilla-like flavors that don't meet the standard must be labeled as "imitation" vanilla and must be made from safe ingredients that are permitted for that use.
FDA does not allow tonka bean extract even in imitation vanilla. Because they contain coumarin, tonka beans do not meet the food safety requirements for sale in the United States under the Federal Food, Drug, and Cosmetic Act.
Tips for ConsumersBe wary about buying vanilla in Mexico and other Latin American countries. Look for "vanilla bean" in the ingredient list on the label. If it has "tonka bean" or if there is no ingredient list or a vague one, avoid this product. Don't risk your health to save a few dollars.
Vanilla with coumarin is generally sold at a lower price than pure vanilla because tonka beans are cheaper to grow than vanilla beans. If the price sounds too good to be true, pass it up. Don't buy a food product in the United States that is not labeled in English. Products may have Spanish or other non-English labeling, but they must also have complete English labeling to meet U.S. Government standards. (Products sold only in Puerto Rico are an exception—they are not required to be labeled in English.) Call the FDA Consumer Complaint Coordinator for your geographic area if you suspect that a food product sold in the United States has been imported illegally.
(See list of contacts at www.fda.gov/opacom/backgrounders/complain.html.)
For More InformationImport Alert on Coumarin in Vanilla Productswww.fda.gov/ora/fiars/ora_import_ia2807.html
Know Before You Go: Rules for Bringing Items Back From Your Tripwww.cbp.gov/xp/cgov/travel/vacation/kbyg/
Safety tips from CSA International for the safe use of cord-connected, fan-forced electric space heaters
Safety tips from CSA International for the safe use of cord-connected, fan-forced electric space heaters
During the fall and winter months, space heaters are an effective way to provide temporary warmth to those involved in a profession such as construction or simply working in the garage or around the home. CSA International would like to remind consumers that all space heaters by their very design may present certain shock, fire and burn hazards when used or installed incorrectly.
It is especially important to use extra caution when operating large, electric fan, metal-sheathed, heating element heaters in the 240 volt, 3000 watt and greater range. Due to the high heat output of these devices, there may be an increased fire hazard if used incorrectly, in close proximity to combustibles or around objects that disrupt airflow. The elements in some of these heaters have unexpectedly failed resulting in serious fires. Extreme caution must be used when using these heaters.*
CSA International offers the following tips to help prevent unexpected failures of metal-sheathed heating elements in electric heaters that could lead to electrical shock or fires:
Selection: When purchasing a new heater, ensure that it has been tested and certified to the applicable standards by an accredited certification organization such as CSA International and that it is suitable for the intended application.
Instructions: Always follow the manufacturer's installation and operating instructions and all warnings before using a space heater. If you do not have or understand the instructions, contact the manufacturer directly.
Temporary use: Electric portable fan space heaters are designed to provide temporary warmth only. They should never be permanently installed or mounted and should not be operated continuously over extended periods of time. Portable heaters should never be suspended from ceilings or rafters or in any other manner.
Never hard-wire (removing the plug cap) a portable heater directly to a power supply or modify or tamper with the construction of the unit.
Ventilation: In order to avoid overheating, electric fan space heaters must have proper ventilation across the elements. Never position the heater in an area that will limit the airflow to or from the fan.
Connection: Before turning the heater on, make sure the power supply cord's plug cap is fully inserted into the outlet. To avoid overheating and a potential fire hazard, do not use an extension cord with the heater.
Breakers and GFCIs: Use of an electrical outlet with a Ground Fault Circuit Interrupter (GFCI) or a ground fault protected circuit is recommended. Only use a properly rated fused circuit or a breaker-protected circuit for powering the unit as indicated by the manufacturer's instructions.
Fire Hazards and Combustibles: To avoid the risk of fire, do not use heating equipment near combustible surfaces. Heaters should only be installed on a noncombustible surface that extends a minimum of 1.5 meters beyond the front of the heater. Never operate a heater near flammable materials or in proximity to any volatile or flammable chemicals or vapours.
Air: Never block a heater's air flow. Obstruction of a heater's air intake or exhaust could lead to overheating and a potential fire hazard. Do not insert or allow foreign objects to enter any air vent as this may cause a potential for electric shock, fire or damage to the equipment and never use the heater to dry clothes, boots or other items of apparel.
Maintenance and Storage: Always ensure heaters have had sufficient time to cool down after use before moving or storing and be sure to store heaters in a dry location. Check regularly if there are rust marks or degradation signs on the heating element and follow the manufacturer's instruction for proper maintenance and replacement. Do not use the heater if it has been exposed to any mechanical damage. Periodically clean the heater of any dust or particle accumulation. If you suspect the heater has been damaged or does not seem to work properly, discontinue use and refer to the manufacturer's instructions.
Extra caution: Use extra caution when operating portable heaters. Do not leave a heater running while unattended or use a heater in a position where it can be easily overturned or fall.
*CSA Standard C22.2 No. 46 for electric heaters has been amended to include an additional abnormal operation test to address safety issues that have arisen when devices are operated in extreme conditions or in a manner for which they were not intended. A revised Standard will be published in January, 2009, and effective April 24, 2009 manufacturers will be required to comply with the new abnormal testing requirements of the CSA standard in order to certify their products.
During the fall and winter months, space heaters are an effective way to provide temporary warmth to those involved in a profession such as construction or simply working in the garage or around the home. CSA International would like to remind consumers that all space heaters by their very design may present certain shock, fire and burn hazards when used or installed incorrectly.
It is especially important to use extra caution when operating large, electric fan, metal-sheathed, heating element heaters in the 240 volt, 3000 watt and greater range. Due to the high heat output of these devices, there may be an increased fire hazard if used incorrectly, in close proximity to combustibles or around objects that disrupt airflow. The elements in some of these heaters have unexpectedly failed resulting in serious fires. Extreme caution must be used when using these heaters.*
CSA International offers the following tips to help prevent unexpected failures of metal-sheathed heating elements in electric heaters that could lead to electrical shock or fires:
Selection: When purchasing a new heater, ensure that it has been tested and certified to the applicable standards by an accredited certification organization such as CSA International and that it is suitable for the intended application.
Instructions: Always follow the manufacturer's installation and operating instructions and all warnings before using a space heater. If you do not have or understand the instructions, contact the manufacturer directly.
Temporary use: Electric portable fan space heaters are designed to provide temporary warmth only. They should never be permanently installed or mounted and should not be operated continuously over extended periods of time. Portable heaters should never be suspended from ceilings or rafters or in any other manner.
Never hard-wire (removing the plug cap) a portable heater directly to a power supply or modify or tamper with the construction of the unit.
Ventilation: In order to avoid overheating, electric fan space heaters must have proper ventilation across the elements. Never position the heater in an area that will limit the airflow to or from the fan.
Connection: Before turning the heater on, make sure the power supply cord's plug cap is fully inserted into the outlet. To avoid overheating and a potential fire hazard, do not use an extension cord with the heater.
Breakers and GFCIs: Use of an electrical outlet with a Ground Fault Circuit Interrupter (GFCI) or a ground fault protected circuit is recommended. Only use a properly rated fused circuit or a breaker-protected circuit for powering the unit as indicated by the manufacturer's instructions.
Fire Hazards and Combustibles: To avoid the risk of fire, do not use heating equipment near combustible surfaces. Heaters should only be installed on a noncombustible surface that extends a minimum of 1.5 meters beyond the front of the heater. Never operate a heater near flammable materials or in proximity to any volatile or flammable chemicals or vapours.
Air: Never block a heater's air flow. Obstruction of a heater's air intake or exhaust could lead to overheating and a potential fire hazard. Do not insert or allow foreign objects to enter any air vent as this may cause a potential for electric shock, fire or damage to the equipment and never use the heater to dry clothes, boots or other items of apparel.
Maintenance and Storage: Always ensure heaters have had sufficient time to cool down after use before moving or storing and be sure to store heaters in a dry location. Check regularly if there are rust marks or degradation signs on the heating element and follow the manufacturer's instruction for proper maintenance and replacement. Do not use the heater if it has been exposed to any mechanical damage. Periodically clean the heater of any dust or particle accumulation. If you suspect the heater has been damaged or does not seem to work properly, discontinue use and refer to the manufacturer's instructions.
Extra caution: Use extra caution when operating portable heaters. Do not leave a heater running while unattended or use a heater in a position where it can be easily overturned or fall.
*CSA Standard C22.2 No. 46 for electric heaters has been amended to include an additional abnormal operation test to address safety issues that have arisen when devices are operated in extreme conditions or in a manner for which they were not intended. A revised Standard will be published in January, 2009, and effective April 24, 2009 manufacturers will be required to comply with the new abnormal testing requirements of the CSA standard in order to certify their products.
Arrangement on the control of natural health product.Canada/ Hong Kong
Arrangement on the control of natural health product
The health authorities of Hong Kong and Canada today (December 5) signed "Plan of Action for Regulatory Cooperation on Natural Health Products (NHP)" to further enhance their cooperation in the regulation of NHP.
The document was signed by the Director of Health of Hong Kong, Dr P Y Lam and the Assistant Deputy Minister of the Health Products and Food Branch of Health Canada, Ms Meena Ballantyne to establish formal mechanisms for joint co-operation and exchange of information on
NHP between the two places.
It came into effect immediately and will be reviewed prior to the expiry of the four-year term.
NHP include vitamins, minerals and traditional Chinese medicines.
The plan of action is formulated to establish a clear framework for communication, maintaining ongoing dialogue, developing mechanisms for joint collaboration and exchange of relevant information on NHP between Hong Kong and Canada.
It will enhance the safety, quality and efficacy of NHP and strengthen reciprocal knowledge, understanding and updates of regulatory frameworks of the two places.
"The signing of the action plan today will formulate our working relationship and I have confidence that the synergies we achieve will certainly go a long way safeguarding and promoting the health of people of Canada and Hong Kong," Dr Lam said.
Under the Plan of Action, the areas of cooperation between Hong Kong and Canada include:
1) exchange of information such as monographs, pharmacopoeia, standards, guidelines, terminology of natural health products;
2) communication of adverse reaction reports, recalls, and other public warnings; and
3) conduction of joint workshops, technical exchanges and visits
The health authorities of Hong Kong and Canada today (December 5) signed "Plan of Action for Regulatory Cooperation on Natural Health Products (NHP)" to further enhance their cooperation in the regulation of NHP.
The document was signed by the Director of Health of Hong Kong, Dr P Y Lam and the Assistant Deputy Minister of the Health Products and Food Branch of Health Canada, Ms Meena Ballantyne to establish formal mechanisms for joint co-operation and exchange of information on
NHP between the two places.
It came into effect immediately and will be reviewed prior to the expiry of the four-year term.
NHP include vitamins, minerals and traditional Chinese medicines.
The plan of action is formulated to establish a clear framework for communication, maintaining ongoing dialogue, developing mechanisms for joint collaboration and exchange of relevant information on NHP between Hong Kong and Canada.
It will enhance the safety, quality and efficacy of NHP and strengthen reciprocal knowledge, understanding and updates of regulatory frameworks of the two places.
"The signing of the action plan today will formulate our working relationship and I have confidence that the synergies we achieve will certainly go a long way safeguarding and promoting the health of people of Canada and Hong Kong," Dr Lam said.
Under the Plan of Action, the areas of cooperation between Hong Kong and Canada include:
1) exchange of information such as monographs, pharmacopoeia, standards, guidelines, terminology of natural health products;
2) communication of adverse reaction reports, recalls, and other public warnings; and
3) conduction of joint workshops, technical exchanges and visits
Thursday, December 4, 2008
Major Apparel Retailer To Pay a $60,000 Civil Penalty For Failure To Report Drawstrings In Children’s Outerwear
Major Apparel Retailer To Pay a $60,000 Civil Penalty For Failure To Report Drawstrings In Children’s Outerwear
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Nordstrom Inc., of Seattle, Wash., has agreed to pay a $60,000 civil penalty. The penalty settles allegations that the firm knowingly failed to report to the CPSC immediately, as required by federal law, that its children’s hooded jackets and sweaters were sold with drawstrings at the hood and neck. These products, which the firm eventually recalled, pose a strangulation hazard that can cause death to children. The settlement has been provisionally accepted by the Commission.
CPSC alleged that Nordstrom failed to report to the government in a timely manner that drawstring jackets and sweaters were sold by the firm. Nordstrom sold about 2,400 drawstring jackets and sweaters in the United States between November 2007 and December 2007. In February 2008 and March 2008, CPSC and Nordstrom announced the recall of the drawstring jackets and sweaters.
In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from getting entangled and possibly strangling on hood and neck drawstrings in upper outerwear, such as jackets and sweatshirts. 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 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 violates any consumer product safety rule, or any other rule, regulation, standard, or ban enforced by the CPSC.
In agreeing to settle the matter, Nordstrom Inc. denies CPSC's allegations that it knowingly violated the law.
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Nordstrom Inc., of Seattle, Wash., has agreed to pay a $60,000 civil penalty. The penalty settles allegations that the firm knowingly failed to report to the CPSC immediately, as required by federal law, that its children’s hooded jackets and sweaters were sold with drawstrings at the hood and neck. These products, which the firm eventually recalled, pose a strangulation hazard that can cause death to children. The settlement has been provisionally accepted by the Commission.
CPSC alleged that Nordstrom failed to report to the government in a timely manner that drawstring jackets and sweaters were sold by the firm. Nordstrom sold about 2,400 drawstring jackets and sweaters in the United States between November 2007 and December 2007. In February 2008 and March 2008, CPSC and Nordstrom announced the recall of the drawstring jackets and sweaters.
In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from getting entangled and possibly strangling on hood and neck drawstrings in upper outerwear, such as jackets and sweatshirts. 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 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 violates any consumer product safety rule, or any other rule, regulation, standard, or ban enforced by the CPSC.
In agreeing to settle the matter, Nordstrom Inc. denies CPSC's allegations that it knowingly violated the law.
Tuesday, December 2, 2008
Prescribing Information revised on the use of Innohep
Innohep (tinzaparin sodium injection)
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep.
Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.
In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older.
Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency.
Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep.
Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.
In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older.
Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency.
Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
Monday, December 1, 2008
FDA Reports Significant Progress in Protecting the Food Supply
FDA Reports Significant Progress in Protecting the Food Supply
The One-Year Summary of Progress under the Food Protection Plan describes FDA’s efforts to build safety in the U.S. and global food systems The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain.
"Science and 21st century technologies help drive the FDA's efforts to transform our food safety efforts from the Food Protection Plan into a reality," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "Every day, the FDA is working with foreign countries, state and local governments, regulated industry and consumer groups to ensure the safety of the food supply. We also continue to work with members of Congress to achieve new authorities requested in the Food Protection Plan."
Listed below are the highlights of the agency's accomplishments in implementing the Food Protection Plan's three core strategies: The prevention of outbreaks of food-borne disease, and intervention and response if they occur:
PREVENTION
The FDA is establishing offices in five regions that export food and other FDA-regulated products to the United States: China, India, Europe, Latin America, and the Middle East. The FDA has already hired staff for its offices in China and India. The FDA was part of a U.S. Department of Health and Human Services (HHS) delegation to China to address food safety issues in both countries and to share ideas to address global food safety. U.S. and Chinese government officials discussed recent outbreak of foodborne illness in the United States related to fresh produce as well as the melamine contamination of dairy products in China. The FDA released the CARVER self-assessment tool for industry, to minimize the risk of intentional contamination of food, and conducted training seminars for industry on how to use the tool. The FDA held a meeting of with more than 200 federal, state, local, tribal and territorial partners to address the challenges of protecting the nation's food supply. The FDA is hiring an International Notification Coordinator to manage enhanced information exchanges between the agency and foreign counterpart regulatory authorities. The FDA approved the use of irradiation of iceberg lettuce and spinach for the control of pathogens, such as Escherichia. coli, in or on those foods.
The FDA developed methods to detect melamine and cyanuric acid in feed and feed ingredients.
The FDA is using genetic analysis to identify hundreds of Salmonella strains from seafood imports. The analysis provides information to trace outbreaks of Salmonella outbreaks and implement surveillance programs to ensure food safety. INTERVENTION
The FDA completed inspections of 5,930 high-risk domestic food establishments during the Fiscal Year (FY) 2008. The FDA piloted the program for inspection and sampling of high-risk companies in Denver and Minneapolis during the Democratic and Republican National
Conventions. A targeted, risk-based inspection of a canning facility in 2008 identified cans with viable Clostridium botulinum spores and a recall was initiated. The FDA initiated this inspection, along with inspections of other Low Acid Canned Food (LACF) manufacturers, following four cases of botulism in consumers in 2007. The FDA increased inspection efforts to ensure that manufacturers of all types of LACF products are adhering to applicable FDA requirements.
These actions illustrate the need for companies to operate under adequate preventive control systems. The FDA issued "Draft Guidance for Industry on Voluntary Third-Party Certification
Programs for Food and Feed." Docket FDA-2008-D-0381 is available for viewing at www.regulations.gov. The FDA has developed a rapid detection method that uses flow cytometry to identify E. coli and Salmonella in food, now in use in poultry-processing facilities to detect and prevent bacterial contamination during food processing. The FDA is expanding its database of adverse drug events to include adverse feed events, which will allow the agency to respond faster to outbreaks of feedborne disease in animals, contamination episodes, and/or product defects. The FDA and U.S. Customs and Border Protection jointly issued a final rule on Prior Notice of Imported Food Shipments, and an accompanying Compliance Policy Guide (CPG) on Oct. 31, 2008; the rule and CPG were published in the Federal Register on Nov. 7, 2008.
RESPONSE
The FDA is working with industry and the public to identify best practices for tracing fresh produce throughout the supply chain. The FDA has enhanced the agency's ability to coordinate a comprehensive response to foodborne illness events by authoring tools used to track emergency response resources and other locations of interest. The FDA hired two emergency /complaint-response coordinators to improve its response to emergencies that involve animal feed, including pet food. Following the detection of melamine in infant formula and milk products from China, the FDA worked with its state and local counterparts to rapidly canvas over 2,100 vendors of Asian products to remove any Chinese infant formula from the market and to sample milk-derived Chinese products to check for melamine contamination. The FDA also provided regular updates on its Web site, advising consumers which products to avoid because of melamine contamination. The FDA held regular briefing calls for consumer organizations during the outbreak of Salmonella Saintpaul in the summer of 2008, and regularly updated a Web page that provided information on the investigation into the outbreak, and advised consumers how they could protect themselves and their families. The FDA has signed cooperative agreements with six U.S. states to form a Rapid Response Team to develop, implement, exercise, and integrate an all-hazards response capability for food and foodborne illness responses, to react more rapidly react to potential threats to our food supply. After reports from China of melamine-contaminated infant formula, the FDA worked with its state and local counterparts to quickly canvas over 2,100 Asian markets to remove any infant formula from China that might be available and to sample milk-derived products to check for melamine contamination. The entire
One-Year Summary of Progress under the Food Protection Plan is posted at www.fda.gov/oc/initiatives/advance/food/progressreport1108.html, and the Food Protection Plan is available at www.fda.gov/oc/initiatives/advance/food/plan.html.
The Food Protection Plan complements the Action Plan on Import Safety the President's Working Group On Import Safety unveiled one year ago to improve the safety of all imported products. HHS Secretary Mike Leavitt heads The Working Group. For additional information on the FDA's activities under the Action Plan for Import Safety, please visit: www.fda.gov/oc/initiatives/advance/imports/activities.html.
The One-Year Summary of Progress under the Food Protection Plan describes FDA’s efforts to build safety in the U.S. and global food systems The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain.
"Science and 21st century technologies help drive the FDA's efforts to transform our food safety efforts from the Food Protection Plan into a reality," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "Every day, the FDA is working with foreign countries, state and local governments, regulated industry and consumer groups to ensure the safety of the food supply. We also continue to work with members of Congress to achieve new authorities requested in the Food Protection Plan."
Listed below are the highlights of the agency's accomplishments in implementing the Food Protection Plan's three core strategies: The prevention of outbreaks of food-borne disease, and intervention and response if they occur:
PREVENTION
The FDA is establishing offices in five regions that export food and other FDA-regulated products to the United States: China, India, Europe, Latin America, and the Middle East. The FDA has already hired staff for its offices in China and India. The FDA was part of a U.S. Department of Health and Human Services (HHS) delegation to China to address food safety issues in both countries and to share ideas to address global food safety. U.S. and Chinese government officials discussed recent outbreak of foodborne illness in the United States related to fresh produce as well as the melamine contamination of dairy products in China. The FDA released the CARVER self-assessment tool for industry, to minimize the risk of intentional contamination of food, and conducted training seminars for industry on how to use the tool. The FDA held a meeting of with more than 200 federal, state, local, tribal and territorial partners to address the challenges of protecting the nation's food supply. The FDA is hiring an International Notification Coordinator to manage enhanced information exchanges between the agency and foreign counterpart regulatory authorities. The FDA approved the use of irradiation of iceberg lettuce and spinach for the control of pathogens, such as Escherichia. coli, in or on those foods.
The FDA developed methods to detect melamine and cyanuric acid in feed and feed ingredients.
The FDA is using genetic analysis to identify hundreds of Salmonella strains from seafood imports. The analysis provides information to trace outbreaks of Salmonella outbreaks and implement surveillance programs to ensure food safety. INTERVENTION
The FDA completed inspections of 5,930 high-risk domestic food establishments during the Fiscal Year (FY) 2008. The FDA piloted the program for inspection and sampling of high-risk companies in Denver and Minneapolis during the Democratic and Republican National
Conventions. A targeted, risk-based inspection of a canning facility in 2008 identified cans with viable Clostridium botulinum spores and a recall was initiated. The FDA initiated this inspection, along with inspections of other Low Acid Canned Food (LACF) manufacturers, following four cases of botulism in consumers in 2007. The FDA increased inspection efforts to ensure that manufacturers of all types of LACF products are adhering to applicable FDA requirements.
These actions illustrate the need for companies to operate under adequate preventive control systems. The FDA issued "Draft Guidance for Industry on Voluntary Third-Party Certification
Programs for Food and Feed." Docket FDA-2008-D-0381 is available for viewing at www.regulations.gov. The FDA has developed a rapid detection method that uses flow cytometry to identify E. coli and Salmonella in food, now in use in poultry-processing facilities to detect and prevent bacterial contamination during food processing. The FDA is expanding its database of adverse drug events to include adverse feed events, which will allow the agency to respond faster to outbreaks of feedborne disease in animals, contamination episodes, and/or product defects. The FDA and U.S. Customs and Border Protection jointly issued a final rule on Prior Notice of Imported Food Shipments, and an accompanying Compliance Policy Guide (CPG) on Oct. 31, 2008; the rule and CPG were published in the Federal Register on Nov. 7, 2008.
RESPONSE
The FDA is working with industry and the public to identify best practices for tracing fresh produce throughout the supply chain. The FDA has enhanced the agency's ability to coordinate a comprehensive response to foodborne illness events by authoring tools used to track emergency response resources and other locations of interest. The FDA hired two emergency /complaint-response coordinators to improve its response to emergencies that involve animal feed, including pet food. Following the detection of melamine in infant formula and milk products from China, the FDA worked with its state and local counterparts to rapidly canvas over 2,100 vendors of Asian products to remove any Chinese infant formula from the market and to sample milk-derived Chinese products to check for melamine contamination. The FDA also provided regular updates on its Web site, advising consumers which products to avoid because of melamine contamination. The FDA held regular briefing calls for consumer organizations during the outbreak of Salmonella Saintpaul in the summer of 2008, and regularly updated a Web page that provided information on the investigation into the outbreak, and advised consumers how they could protect themselves and their families. The FDA has signed cooperative agreements with six U.S. states to form a Rapid Response Team to develop, implement, exercise, and integrate an all-hazards response capability for food and foodborne illness responses, to react more rapidly react to potential threats to our food supply. After reports from China of melamine-contaminated infant formula, the FDA worked with its state and local counterparts to quickly canvas over 2,100 Asian markets to remove any infant formula from China that might be available and to sample milk-derived products to check for melamine contamination. The entire
One-Year Summary of Progress under the Food Protection Plan is posted at www.fda.gov/oc/initiatives/advance/food/progressreport1108.html, and the Food Protection Plan is available at www.fda.gov/oc/initiatives/advance/food/plan.html.
The Food Protection Plan complements the Action Plan on Import Safety the President's Working Group On Import Safety unveiled one year ago to improve the safety of all imported products. HHS Secretary Mike Leavitt heads The Working Group. For additional information on the FDA's activities under the Action Plan for Import Safety, please visit: www.fda.gov/oc/initiatives/advance/imports/activities.html.
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