GOVERNMENT OF CANADA RESPONSE TO THE OUTBREAK OF SALMONELLA SAINTPAUL IN THE UNITED STATES
Updates
Ottawa, July 31, 2008 – In keeping with the Government’s commitment to food safety, the Canadian Food Inspection Agency (CFIA) is taking precautionary actions to prevent the implicated source of the Salmonella Saintpaul outbreak in the United States (U.S.) from entering Canada. Specifically, shipments of jalapeño and Serrano peppers from Mexico are being held by the CFIA pending laboratory results. Shipments found to be contaminated will not be allowed in the marketplace. The CFIA and the Public Health Agency of Canada (PHAC) will continue to monitor the situation closely.
This action is based on the U.S. Food and Drug Administration (FDA) recent advice to Americans to avoid eating raw jalapeño and raw Serrano peppers, and any foods that contain them, if they have been grown, harvested or packed in Mexico. These peppers have been associated with the current outbreak in many states. However, commercially canned, pickled, and cooked jalapeño and Serrano peppers are not associated with the current Salmonella Saintpaul outbreak.
Jalapeño and Serrano peppers grown in Canada and the U.S. have not been connected with the current Salmonella Saintpaul outbreak in the U.S.
The Centers for Disease Control and Prevention (CDC) in the U.S. has found that many, but not all of the people who have become ill during the outbreak also reported eating jalapeño or Serrano peppers. The FDA and the CDC continue to update their respective websites to provide ongoing information about their investigation. Canadians travelling to the United States should be aware of U.S. advice to consumers regarding jalapeño and Serrano peppers.
The current situation in Canada remains unchanged from previous Government of Canada advisories issued on this topic. Public health officials are reporting five cases of Salmonella
Saintpaul infection in Canada with the same strain of Salmonella infection associated with the outbreak in the United States. Four of the cases involve individuals who became ill upon return from travel to the U.S., suggesting they were infected during their trip. Cross border cases are expected given the size of the outbreak in the U.S., and the fact that many Canadians travel to the U.S. Officials with PHAC will continue to work with their colleagues in Canada and the U.S. to monitor the situation and assess further cases.
More information on the CDC's investigation is available at http://www.cdc.gov/salmonella/saintpaul/.
For more information, consumers and industry can call the CFIA at 1-800-442-2342 / TTY 1-800-465-7735 (8:00 a.m. to 8:00 p.m. Eastern time, Monday to Friday). People who believe they have experienced symptoms of illness are urged to contact their health care provider.
For information on Salmonella, visit the Food Facts webpage at http://www.inspection.gc.ca/english/fssa/concen/causee.shtml.
More information on the U.S. CDC’s investigation is available at http://www.cdc.gov/salmonella/saintpaul/ or on the FDA’s website at http://www.fda.gov/.
Thursday, July 31, 2008
Mexican Farm Tied to Salmonella Outbreak
Mexican Farm Tied to Salmonella Outbreak
Bacteria Found in Water, Pepper Samples FDA official David Acheson says tomatoes may be the source of early phases of the outbreak.
A three-month-old salmonella outbreak initially linked to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.
Investigators discovered the Salmonella saintpaul strain in irrigation water and in serrano pepper samples from the farm, which is in the northeastern state of Nuevo Leon partially bordering Texas. The Food and Drug Administration is now warning consumers not to eat raw serrano peppers, in addition to raw jalapeños.
"We have a smoking gun, it appears," Lonnie King, a director at the Centers for Disease Control, said yesterday.
The discovery of the outbreak strain on a farm does not answer all of the questions confronting investigators. But it will improve their chances of stopping the outbreak, which has sickened more than 1,300 people since April. It also gets them closer to a full explanation of an outbreak that stumped the nation's most experienced disease detectives and drew criticism from tomato growers and Congress about the FDA and CDC's handling of the case.
Lawmakers yesterday began the first of two hearings on what went wrong in the investigation, which was initially focused on tomatoes, and later expanded to include jalapeño and serrano peppers. They had summoned top FDA and CDC officials to testify.
Anyone expecting a grilling was disappointed. Almost as soon as he took his seat in front of the microphone, the FDA's top food safety official, David Acheson, went off script, starting not with his prepared testimony but with news of the Salmonella saintpaul finding in Mexico, information he said he had learned just two hours before the hearing.
The discovery did not let the FDA and the CDC off the hook entirely. Rep. Dennis Cardoza (D-Calif.), who chairs the House subcommittee on horticulture and organic agriculture, asked Acheson to get back to the panel with answers to several questions, including when he first heard CDC officials suspected jalapeño peppers were making people sick.
Investigators did not look into whether jalapeño and serrano peppers could be making people sick until early July when the illness count kept rising despite a nationwide warning against eating raw red plum, Roma and vineless red round tomatoes.
The FDA recently lifted the tomato warning, saying tomatoes now on the market are safe. But by then, tomato growers had incurred more than $100 million in losses.
Investigators have yet to find a contaminated tomato, and many growers assert that tomatoes were never involved. FDA and CDC officials, however, continued to insist that tomatoes and jalapeño peppers could have spread the bacteria if they were contaminated on the same farm or if one cross-contaminated the other somewhere in the distribution chain.
The discovery of Salmonella saintpaul in both jalapeño and serrano peppers partly vindicated proponents of that theory. Acheson told lawmakers yesterday that investigators may still find a packing facility or warehouse where tomatoes and jalapeño and serrano peppers crossed paths.
"We know [the salmonella] was on two [produce items]; it could easily have been on three," Acheson said. "It is certainly plausible that tomatoes were responsible for the early phases of [the outbreak]."
Investigators still have a lot to sort out, starting with the relationships between the farm in Nuevo Leon where the contaminated water and peppers were found and another farm in Tamaulipas that supplied tainted jalapeños to Agricola Zaragoza, a small distributor in Texas. So far the only connection is a packing facility in Nuevo Leon. It bought peppers from both farms and supplied Agricola Zaragoza.
Investigators are figuring out where peppers and tomatoes from the Nuevo Leon farm were shipped to, Acheson said, and awaiting the results of lab tests of samples from the Tamaulipas farm.
It's possible that peppers were contaminated by irrigation water on one farm, then sent to a packing facility where they contaminated other produce.
So far, samples from the packing facility that connects the two farms and the Texas distributor have not contained the outbreak strain, Acheson said. The packing facility handles jalapeño and serrano peppers and tomatoes.
Bacteria Found in Water, Pepper Samples FDA official David Acheson says tomatoes may be the source of early phases of the outbreak.
A three-month-old salmonella outbreak initially linked to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.
Investigators discovered the Salmonella saintpaul strain in irrigation water and in serrano pepper samples from the farm, which is in the northeastern state of Nuevo Leon partially bordering Texas. The Food and Drug Administration is now warning consumers not to eat raw serrano peppers, in addition to raw jalapeños.
"We have a smoking gun, it appears," Lonnie King, a director at the Centers for Disease Control, said yesterday.
The discovery of the outbreak strain on a farm does not answer all of the questions confronting investigators. But it will improve their chances of stopping the outbreak, which has sickened more than 1,300 people since April. It also gets them closer to a full explanation of an outbreak that stumped the nation's most experienced disease detectives and drew criticism from tomato growers and Congress about the FDA and CDC's handling of the case.
Lawmakers yesterday began the first of two hearings on what went wrong in the investigation, which was initially focused on tomatoes, and later expanded to include jalapeño and serrano peppers. They had summoned top FDA and CDC officials to testify.
Anyone expecting a grilling was disappointed. Almost as soon as he took his seat in front of the microphone, the FDA's top food safety official, David Acheson, went off script, starting not with his prepared testimony but with news of the Salmonella saintpaul finding in Mexico, information he said he had learned just two hours before the hearing.
The discovery did not let the FDA and the CDC off the hook entirely. Rep. Dennis Cardoza (D-Calif.), who chairs the House subcommittee on horticulture and organic agriculture, asked Acheson to get back to the panel with answers to several questions, including when he first heard CDC officials suspected jalapeño peppers were making people sick.
Investigators did not look into whether jalapeño and serrano peppers could be making people sick until early July when the illness count kept rising despite a nationwide warning against eating raw red plum, Roma and vineless red round tomatoes.
The FDA recently lifted the tomato warning, saying tomatoes now on the market are safe. But by then, tomato growers had incurred more than $100 million in losses.
Investigators have yet to find a contaminated tomato, and many growers assert that tomatoes were never involved. FDA and CDC officials, however, continued to insist that tomatoes and jalapeño peppers could have spread the bacteria if they were contaminated on the same farm or if one cross-contaminated the other somewhere in the distribution chain.
The discovery of Salmonella saintpaul in both jalapeño and serrano peppers partly vindicated proponents of that theory. Acheson told lawmakers yesterday that investigators may still find a packing facility or warehouse where tomatoes and jalapeño and serrano peppers crossed paths.
"We know [the salmonella] was on two [produce items]; it could easily have been on three," Acheson said. "It is certainly plausible that tomatoes were responsible for the early phases of [the outbreak]."
Investigators still have a lot to sort out, starting with the relationships between the farm in Nuevo Leon where the contaminated water and peppers were found and another farm in Tamaulipas that supplied tainted jalapeños to Agricola Zaragoza, a small distributor in Texas. So far the only connection is a packing facility in Nuevo Leon. It bought peppers from both farms and supplied Agricola Zaragoza.
Investigators are figuring out where peppers and tomatoes from the Nuevo Leon farm were shipped to, Acheson said, and awaiting the results of lab tests of samples from the Tamaulipas farm.
It's possible that peppers were contaminated by irrigation water on one farm, then sent to a packing facility where they contaminated other produce.
So far, samples from the packing facility that connects the two farms and the Texas distributor have not contained the outbreak strain, Acheson said. The packing facility handles jalapeño and serrano peppers and tomatoes.
FSA publishes listeria factsheet- U.K.
FSA publishes listeria factsheet
The Agency has today published a factsheet that details key control measures that can be taken to minimise the risk of developing an illness from listeria (listeriosis). The guidance has particular relevance to those preparing and supplying chilled ready-to-eat foods for vulnerable groups.
Although listeria isn't common, it can affect vulnerable groups such as pregnant women and people with reduced immunity, particularly those over the age of 60. People with weakened immunity could include those who have had transplants, are taking drugs that weaken their immune system, or who have cancers that affect their immune system, such as leukaemia or lymphoma.
Listeria might be present in chilled ready-to-eat foods at low levels. However, poor refrigeration and failure to follow shelf-life labeling can result in the bacteria multiplying to unsafe levels.
The Agency's factsheet details some of the key steps to minimise the risks. These include keeping these foods properly refrigerated and following ‘use by’ instructions on the label
The Agency has today published a factsheet that details key control measures that can be taken to minimise the risk of developing an illness from listeria (listeriosis). The guidance has particular relevance to those preparing and supplying chilled ready-to-eat foods for vulnerable groups.
Although listeria isn't common, it can affect vulnerable groups such as pregnant women and people with reduced immunity, particularly those over the age of 60. People with weakened immunity could include those who have had transplants, are taking drugs that weaken their immune system, or who have cancers that affect their immune system, such as leukaemia or lymphoma.
Listeria might be present in chilled ready-to-eat foods at low levels. However, poor refrigeration and failure to follow shelf-life labeling can result in the bacteria multiplying to unsafe levels.
The Agency's factsheet details some of the key steps to minimise the risks. These include keeping these foods properly refrigerated and following ‘use by’ instructions on the label
Wednesday, July 30, 2008
FDA Extends Consumer Warning on Serrano Peppers from Mexico
FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.
As a result, until further notice, the FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them.
The test results announced today are part of the FDA's continuing intensive investigation into the outbreak of Salmonella Saintpaul. The investigation has involved tracing back, through complex distribution channels, the origins of products associated with clusters of illness in the United States, as well as inspections and evaluation of farms and facilities in this country and in Mexico, and the collection and testing of environmental and product samples. One of these tracebacks led to a packing facility in Mexico, and to a particular farm, where the agency obtained the samples.
Previously, FDA inspectors collected a positive sample of jalapeño pepper from a produce-distribution center owned by Agricola Zaragosa in McAllen, Texas. The FDA continues to work on pinpointing where and how in the supply chain this first positive jalapeño pepper sample became contaminated. It originated from a different farm in Mexico than the positive samples of serrano pepper and irrigation water.
The FDA is still analyzing many of the samples taken at various farms in Mexico. If laboratory results warrant, the FDA will provide consumers with additional cautions or warnings necessary to protect their health.
On July 17, the FDA announced it had determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency removed its June 7 warning against eating certain types of red raw tomatoes.
For more information consult http://www.fda.gov/oc/opacom/hottopics/tomatoes.html.
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.
As a result, until further notice, the FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them.
The test results announced today are part of the FDA's continuing intensive investigation into the outbreak of Salmonella Saintpaul. The investigation has involved tracing back, through complex distribution channels, the origins of products associated with clusters of illness in the United States, as well as inspections and evaluation of farms and facilities in this country and in Mexico, and the collection and testing of environmental and product samples. One of these tracebacks led to a packing facility in Mexico, and to a particular farm, where the agency obtained the samples.
Previously, FDA inspectors collected a positive sample of jalapeño pepper from a produce-distribution center owned by Agricola Zaragosa in McAllen, Texas. The FDA continues to work on pinpointing where and how in the supply chain this first positive jalapeño pepper sample became contaminated. It originated from a different farm in Mexico than the positive samples of serrano pepper and irrigation water.
The FDA is still analyzing many of the samples taken at various farms in Mexico. If laboratory results warrant, the FDA will provide consumers with additional cautions or warnings necessary to protect their health.
On July 17, the FDA announced it had determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency removed its June 7 warning against eating certain types of red raw tomatoes.
For more information consult http://www.fda.gov/oc/opacom/hottopics/tomatoes.html.
CPSC Staff Finds Synthetic Turf Fields OK to Install, OK to Play On
CPSC Staff Finds Synthetic Turf Fields OK to Install, OK to Play On
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) staff today released its evaluation (pdf) of various synthetic athletic fields. The evaluation concludes that young children are not at risk from exposure to lead in these fields.
CPSC staff evaluation showed that newer fields had no lead or generally had the lowest lead levels. Although small amounts of lead were detected on the surface of some older fields, none of these tested fields released amounts of lead that would be harmful to children.
Lead is present in the pigments of some synthetic turf products to give the turf its various colors. Staff recognizes that some conditions such as age, weathering, exposure to sunlight, and wear and tear might change the amount of lead that could be released from the turf. As turf is used during athletics or play and exposed over time to sunlight, heat and other weather conditions, the surface of the turf may start to become worn and small particles of the lead-containing synthetic grass fibers might be released. The staff considered in the evaluation that particles on a child’s hand transferred to his/her mouth would be the most likely route of exposure and determined young children would not be at risk.
Although this evaluation found no harmful lead levels, CPSC staff is asking that voluntary standards be developed for synthetic turf to preclude the use of lead in future products. This action is being taken proactively to address any future production of synthetic turf and to set a standard for any new entrants to the market to follow.
As an overall guideline, CPSC staff recommends young children wash their hands after playing outside, especially before eating.
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) staff today released its evaluation (pdf) of various synthetic athletic fields. The evaluation concludes that young children are not at risk from exposure to lead in these fields.
CPSC staff evaluation showed that newer fields had no lead or generally had the lowest lead levels. Although small amounts of lead were detected on the surface of some older fields, none of these tested fields released amounts of lead that would be harmful to children.
Lead is present in the pigments of some synthetic turf products to give the turf its various colors. Staff recognizes that some conditions such as age, weathering, exposure to sunlight, and wear and tear might change the amount of lead that could be released from the turf. As turf is used during athletics or play and exposed over time to sunlight, heat and other weather conditions, the surface of the turf may start to become worn and small particles of the lead-containing synthetic grass fibers might be released. The staff considered in the evaluation that particles on a child’s hand transferred to his/her mouth would be the most likely route of exposure and determined young children would not be at risk.
Although this evaluation found no harmful lead levels, CPSC staff is asking that voluntary standards be developed for synthetic turf to preclude the use of lead in future products. This action is being taken proactively to address any future production of synthetic turf and to set a standard for any new entrants to the market to follow.
As an overall guideline, CPSC staff recommends young children wash their hands after playing outside, especially before eating.
Federal Agents Seize more than $24 Million in Unapproved New Drugs
Federal Agents Seize more than $24 Million in Unapproved New Drugs
Products made after the FDA required an end to production
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.
"American consumers are entitled to have safe and effective drugs," said Hanaway.
The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.
"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."
In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.
FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.
The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.
The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.
The following drug products were seized and will be destroyed:
PhenaVent Capsules
PhenaVent LA Capsules
PhenaVent PED Capsules
Ethezyme Papain-Urea Ointment
Ethezyme 650 Papain-Urea Ointment
Ethezyme 830 Papain-Urea Ointment
Hista-Vent DA Tablets
Meperidine/Promethazine Capsules
Pseudovent Capsules
Pseudovent 400 Capsules
Pseudovent PED Capsules
Tri-Vent DM Syrup
Tri-Vent DPC Syrup
Hydro-Tussin DM Liquid
Hydro-Tussin CBX Syrup
Hydro-Tussin DHC Syrup
Hydro- Tussin EXP Syrup
Hydro-Tussin HD Syrup
Hyoscyamine Sulfate Sublingual Tablets
Hydroquinone 4% Cream
Hydroquinone 4% Cream with Sunscreen
Bromfenex Extended Release Capsules
Bromfenex PD Extended Release Capsules
The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.
"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."
In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.
The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.
Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm
Products made after the FDA required an end to production
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.
"American consumers are entitled to have safe and effective drugs," said Hanaway.
The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.
"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."
In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.
FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.
The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.
The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.
The following drug products were seized and will be destroyed:
PhenaVent Capsules
PhenaVent LA Capsules
PhenaVent PED Capsules
Ethezyme Papain-Urea Ointment
Ethezyme 650 Papain-Urea Ointment
Ethezyme 830 Papain-Urea Ointment
Hista-Vent DA Tablets
Meperidine/Promethazine Capsules
Pseudovent Capsules
Pseudovent 400 Capsules
Pseudovent PED Capsules
Tri-Vent DM Syrup
Tri-Vent DPC Syrup
Hydro-Tussin DM Liquid
Hydro-Tussin CBX Syrup
Hydro-Tussin DHC Syrup
Hydro- Tussin EXP Syrup
Hydro-Tussin HD Syrup
Hyoscyamine Sulfate Sublingual Tablets
Hydroquinone 4% Cream
Hydroquinone 4% Cream with Sunscreen
Bromfenex Extended Release Capsules
Bromfenex PD Extended Release Capsules
The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.
"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."
In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.
The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.
Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm
Tuesday, July 29, 2008
Views wanted on Touchi extract- U.K.
Views wanted on Touchi extract A Japanese company has applied to the Agency for approval to market its Touchi extract from fermented black beans as a novel food ingredient.
A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997.
Touchi extract is a protein-rich powder extracted from the fermentation of small soybeans with the fungus Aspergillus oryzae. The ingredient contains an alpha-glucosidase inhibitor and the company, CBC Co Ltd, intends for it to be consumed by anyone who wants to slow the breakdown of carbohydrates.
The extract is similar to black bean sauce, which has been on the market in the European Union for many years. One portion of black bean sauce contains 15g of fermented black beans, which corresponds to 4.5g of the novel food ingredient on extraction.
The company plans to market the ingredient as a food supplement and a tea/soup style formulation at levels that would not exceed 4.5g per daily serving/dose.
Before any new food product can be introduced on the European market, it must be rigorously
assessed for safety. In the UK, the assessment of novel foods is normally carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory
Committee on Novel Foods and Processes (ACNFP).
A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997.
Touchi extract is a protein-rich powder extracted from the fermentation of small soybeans with the fungus Aspergillus oryzae. The ingredient contains an alpha-glucosidase inhibitor and the company, CBC Co Ltd, intends for it to be consumed by anyone who wants to slow the breakdown of carbohydrates.
The extract is similar to black bean sauce, which has been on the market in the European Union for many years. One portion of black bean sauce contains 15g of fermented black beans, which corresponds to 4.5g of the novel food ingredient on extraction.
The company plans to market the ingredient as a food supplement and a tea/soup style formulation at levels that would not exceed 4.5g per daily serving/dose.
Before any new food product can be introduced on the European market, it must be rigorously
assessed for safety. In the UK, the assessment of novel foods is normally carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory
Committee on Novel Foods and Processes (ACNFP).
51 drug products with safety labeling changes
The June 2008 posting includes 51 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/SAFETY/2008/jun08_quickview.htm
The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2008/jun08.htm
In June 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or MEDICATION GUIDES:
Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP)
Viramune (nevirapine) Tablets and Oral Suspension
Aptivus (tipranavir) Capsules and Oral Solution
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Avodart (dutasteride) Soft Gelatin Capsules
Concerta (methylphenidate HCl) Extended-Release Tablets
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Reclast (zoledronic acid) Injection
Zyvox (linezolid) Injection, Zyvox (linezolid) Tablets, and Zyvox (linezolid) for Oral Suspension
Forteo (teriparatide [rDNA origin]) Injection
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/SAFETY/2008/jun08_quickview.htm
The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2008/jun08.htm
In June 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or MEDICATION GUIDES:
Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP)
Viramune (nevirapine) Tablets and Oral Suspension
Aptivus (tipranavir) Capsules and Oral Solution
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Avodart (dutasteride) Soft Gelatin Capsules
Concerta (methylphenidate HCl) Extended-Release Tablets
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Reclast (zoledronic acid) Injection
Zyvox (linezolid) Injection, Zyvox (linezolid) Tablets, and Zyvox (linezolid) for Oral Suspension
Forteo (teriparatide [rDNA origin]) Injection
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules
Saturday, July 26, 2008
U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
The U.S. Food and Drug Administration is advising consumers that jalapeño and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak.
However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.
In addition to domestically grown raw jalapeño peppers, commercially canned, pickled and cooked jalapeño peppers from any and all geographic locations also are not connected with the current Salmonella Saintpaul outbreak.
The FDA is working with state regulatory agencies and food industry groups that represent restaurants, grocery stores and wholesalers to ensure everyone clearly understands this new, more narrow, advisory. The FDA will continue to refine its consumer guidance as the agency’s investigation continues.
The more narrow advisory the FDA is issuing today is based on evidence gathered during a multi-week, intensive investigation conducted in partnership with the U.S. Centers for Disease Control and Prevention and public health authorities in several U.S. states to find the source of the contamination that led to the outbreak. The collective review of the current traceback investigation and harvesting dates, matched with the dates that people became ill, have combined to indicate that the contaminated jalapeño pepper originated in Mexico.
Additional traceback and traceforward information obtained this week has led to the determination that the Agricola Zarigoza produce-distribution center in McAllen, Texas--from where FDA took the positive jalapeño pepper sample--was not the original source of the contamination.
The FDA is continuing to advise that people in high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw Serrano peppers from Mexico or food made from raw Serrano peppers from Mexico until further notice.
The U.S. Food and Drug Administration is advising consumers that jalapeño and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak.
However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.
In addition to domestically grown raw jalapeño peppers, commercially canned, pickled and cooked jalapeño peppers from any and all geographic locations also are not connected with the current Salmonella Saintpaul outbreak.
The FDA is working with state regulatory agencies and food industry groups that represent restaurants, grocery stores and wholesalers to ensure everyone clearly understands this new, more narrow, advisory. The FDA will continue to refine its consumer guidance as the agency’s investigation continues.
The more narrow advisory the FDA is issuing today is based on evidence gathered during a multi-week, intensive investigation conducted in partnership with the U.S. Centers for Disease Control and Prevention and public health authorities in several U.S. states to find the source of the contamination that led to the outbreak. The collective review of the current traceback investigation and harvesting dates, matched with the dates that people became ill, have combined to indicate that the contaminated jalapeño pepper originated in Mexico.
Additional traceback and traceforward information obtained this week has led to the determination that the Agricola Zarigoza produce-distribution center in McAllen, Texas--from where FDA took the positive jalapeño pepper sample--was not the original source of the contamination.
The FDA is continuing to advise that people in high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw Serrano peppers from Mexico or food made from raw Serrano peppers from Mexico until further notice.
Friday, July 25, 2008
Views wanted on gluten regulation- U.K.
Views wanted on gluten regulation
The FSA is seeking views on a proposed European Commission regulation, concerning the composition and labelling of foods suitable for people intolerant to gluten.
The proposed regulation will put in place compositional criteria related to the claims ‘gluten free’ and ‘very low gluten’ for foods that have been specifically produced for people who are sensitive to gluten.
In addition, the proposed regulation introduces a provision to allow foods that are naturally free of gluten (i.e. those for normal consumption) to be labelled as ‘gluten free’, as long as the foods meet certain compositional requirements, in relation to the levels of gluten.
This regulation will ensure that all foods, which are labelled to indicate their suitability for people intolerant to gluten, will use harmonised labelling terms and reduce consumer confusion about these products. In addition, this new regime will facilitate better consumer understanding about how much gluten there is in the foods that they buy, and thereby help improve the health of these consumers. This regulation will also align the European Commission legislation with the recently agreed Codex international standard for foods targeted at people intolerant to gluten.
This will help facilitate international trade.
Once in force, the regulation will apply in all European Union Member States and will be implemented and enforced in national regulations for England, Scotland, Wales and Northern Ireland.
Read the full consultation at the link below.
Responses are required by 30 September 2008.
The science behind the storyAbout 1% of the UK population has an intolerance to gluten. Anyone with a sensitivity to gluten – also known as coeliac disease – must avoid eating cereals that contain gluten, such as wheat, rye, barley, spelt, kamut or any variety of these crops.
Gluten intolerance is an auto-immune disease, which means the body's immune system attacks itself. The type of reaction it causes is different to a food allergy – it doesn't cause anaphylaxis.
Many people with coeliac disease don't realise they have it.
When people with coeliac disease eat foods containing gluten, it damages the lining of the small intestine, which stops the body from absorbing nutrients. This can lead to a range of symptoms including diarrhoea, weight loss and eventually malnutrition.
The FSA is seeking views on a proposed European Commission regulation, concerning the composition and labelling of foods suitable for people intolerant to gluten.
The proposed regulation will put in place compositional criteria related to the claims ‘gluten free’ and ‘very low gluten’ for foods that have been specifically produced for people who are sensitive to gluten.
In addition, the proposed regulation introduces a provision to allow foods that are naturally free of gluten (i.e. those for normal consumption) to be labelled as ‘gluten free’, as long as the foods meet certain compositional requirements, in relation to the levels of gluten.
This regulation will ensure that all foods, which are labelled to indicate their suitability for people intolerant to gluten, will use harmonised labelling terms and reduce consumer confusion about these products. In addition, this new regime will facilitate better consumer understanding about how much gluten there is in the foods that they buy, and thereby help improve the health of these consumers. This regulation will also align the European Commission legislation with the recently agreed Codex international standard for foods targeted at people intolerant to gluten.
This will help facilitate international trade.
Once in force, the regulation will apply in all European Union Member States and will be implemented and enforced in national regulations for England, Scotland, Wales and Northern Ireland.
Read the full consultation at the link below.
Responses are required by 30 September 2008.
The science behind the storyAbout 1% of the UK population has an intolerance to gluten. Anyone with a sensitivity to gluten – also known as coeliac disease – must avoid eating cereals that contain gluten, such as wheat, rye, barley, spelt, kamut or any variety of these crops.
Gluten intolerance is an auto-immune disease, which means the body's immune system attacks itself. The type of reaction it causes is different to a food allergy – it doesn't cause anaphylaxis.
Many people with coeliac disease don't realise they have it.
When people with coeliac disease eat foods containing gluten, it damages the lining of the small intestine, which stops the body from absorbing nutrients. This can lead to a range of symptoms including diarrhoea, weight loss and eventually malnutrition.
Guidance on vacuum packed food safety
Guidance on vacuum packed food safety
The Agency has today published new guidance and a factsheet on the safe production of vacuum and modified atmosphere packed foods. The guidance has been developed for small businesses and environmental health officers to tackle the problem of Clostridium botulinum.
Although vacuum packing techniques increase the shelf-life of chilled foods by removing air, certain bacteria including C. botulinum are still able to grow. C. botulinum is a bacterium that can produce a very harmful toxin that can cause a fatal form of food poisoning – foodborne botulism.
It is therefore important that appropriate controls are in place to keep food safe.
This guidance sets out processes, such as heat treatment, pH and salt levels, that should be used if food businesses are setting a shelf-life of more than ten days.
The technical guidance and the factsheet are available at the link below. A copy of the factsheet is also available to order from Food Standards Agency Publications at: foodstandards@ecgroup.co.uk or tel: 0845 606 0667.
The Agency has today published new guidance and a factsheet on the safe production of vacuum and modified atmosphere packed foods. The guidance has been developed for small businesses and environmental health officers to tackle the problem of Clostridium botulinum.
Although vacuum packing techniques increase the shelf-life of chilled foods by removing air, certain bacteria including C. botulinum are still able to grow. C. botulinum is a bacterium that can produce a very harmful toxin that can cause a fatal form of food poisoning – foodborne botulism.
It is therefore important that appropriate controls are in place to keep food safe.
This guidance sets out processes, such as heat treatment, pH and salt levels, that should be used if food businesses are setting a shelf-life of more than ten days.
The technical guidance and the factsheet are available at the link below. A copy of the factsheet is also available to order from Food Standards Agency Publications at: foodstandards@ecgroup.co.uk or tel: 0845 606 0667.
UPDATE OF SALMONELLA SAINTPAUL SITUATION IN CANADA
UPDATE OF SALMONELLA SAINTPAUL SITUATION IN CANADA
The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) are notifying Canadians that the United States (U.S.) Food and Drug Administration (FDA) announced on July 21, 2008, that one jalapeño pepper sample is a positive genetic match with the Salmonella Saintpaul strain causing the current Salmonella outbreak.
Consumers in Canada should note that the produce distribution center where the jalapeño pepper was found, Agricola Zaragoza in McAllen, Texas, does not export to Canada, as such, no recall is necessary in Canada at this time.
The FDA is asking consumers to avoid eating raw jalapeño peppers or foods made from raw jalapeño peppers until further notice in order to prevent additional cases of illness. This recommendation does not include cooked or pickled jalapeño peppers. The FDA is also continuing to advise that people from high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw serrano peppers or foods made from raw serrano peppers until further notice.
The Centers for Disease Control and Prevention (CDC) has found that many, but not all, of the people who have become ill during the outbreak also reported eating jalapeño or serrano peppers. The FDA and the CDC continue to update their respective websites to provide ongoing information about their investigation. Canadians travelling to the United States should be aware of U.S. advice to consumers regarding jalapeño peppers or serrano peppers.
Canadian Public Health officials are reporting five cases of Salmonella Saintpaul infection in Canada with the same strain of Salmonella infection associated with the outbreak in the United States. One case is under investigation while the four other cases involve individuals who became ill upon return from travel to the United States, suggesting they were infected during their trip. Cross border cases are expected given the size of the outbreak in the U.S., and travel by Canadians to the U.S.. Officials with the Public Health Agency of Canada will continue to work with their colleagues in Canada and the U.S. to monitor the situation and assess further cases.
The CFIA is continuing to follow the outbreak investigation related to Salmonella Saintpaul by the FDA. It is unlikely that Canadian-grown jalapeño and serrano peppers would be implicated as they were not in production during the time of the outbreak.
More information on the CDC's investigation is available at http://www.cdc.gov/salmonella/saintpaul/.
For more information, consumers and industry can call the CFIA at 1-800-442-2342 / TTY 1-800-465-7735 (8:00 a.m. to 8:00 p.m. Eastern time, Monday to Friday). People who believe they have experienced symptoms of illness are urged to contact their health care provider.
The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) are notifying Canadians that the United States (U.S.) Food and Drug Administration (FDA) announced on July 21, 2008, that one jalapeño pepper sample is a positive genetic match with the Salmonella Saintpaul strain causing the current Salmonella outbreak.
Consumers in Canada should note that the produce distribution center where the jalapeño pepper was found, Agricola Zaragoza in McAllen, Texas, does not export to Canada, as such, no recall is necessary in Canada at this time.
The FDA is asking consumers to avoid eating raw jalapeño peppers or foods made from raw jalapeño peppers until further notice in order to prevent additional cases of illness. This recommendation does not include cooked or pickled jalapeño peppers. The FDA is also continuing to advise that people from high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw serrano peppers or foods made from raw serrano peppers until further notice.
The Centers for Disease Control and Prevention (CDC) has found that many, but not all, of the people who have become ill during the outbreak also reported eating jalapeño or serrano peppers. The FDA and the CDC continue to update their respective websites to provide ongoing information about their investigation. Canadians travelling to the United States should be aware of U.S. advice to consumers regarding jalapeño peppers or serrano peppers.
Canadian Public Health officials are reporting five cases of Salmonella Saintpaul infection in Canada with the same strain of Salmonella infection associated with the outbreak in the United States. One case is under investigation while the four other cases involve individuals who became ill upon return from travel to the United States, suggesting they were infected during their trip. Cross border cases are expected given the size of the outbreak in the U.S., and travel by Canadians to the U.S.. Officials with the Public Health Agency of Canada will continue to work with their colleagues in Canada and the U.S. to monitor the situation and assess further cases.
The CFIA is continuing to follow the outbreak investigation related to Salmonella Saintpaul by the FDA. It is unlikely that Canadian-grown jalapeño and serrano peppers would be implicated as they were not in production during the time of the outbreak.
More information on the CDC's investigation is available at http://www.cdc.gov/salmonella/saintpaul/.
For more information, consumers and industry can call the CFIA at 1-800-442-2342 / TTY 1-800-465-7735 (8:00 a.m. to 8:00 p.m. Eastern time, Monday to Friday). People who believe they have experienced symptoms of illness are urged to contact their health care provider.
Health Canada Advises Canadians to Exercise Caution When Purchasing and Using Bunk Beds
Health Canada Advises Canadians to Exercise Caution When Purchasing and Using Bunk Beds
Warning
2008-116
OTTAWA - Health Canada is advising Canadians to exercise caution when purchasing and using bunk beds. Since 1987, there have been 61 incidents that involved injuries associated with bunk beds reported to Health Canada. Twelve of these incidents were related to strangulation or suffocation by entrapment, of which eight resulted in death. The remaining injuries were related to falls.
A report from the Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) indicates that between 1999 and 2006, there were 2,530 bunk bed-related injuries in Canada. Over 65%, 1650 in total, were related to the top bunk.
Important Safety Tips
Children should be taught how to use bunk beds safely. The top bunk is not safe for children under 6 years of age. Allow only one person on the top bunk, and do not allow children to play on or under bunk beds unless the area under the bed is designed by the manufacturer as a play area or study centre. The bed should have all guard rails installed at all times, even if the bed is pushed up against a wall. Check regularly to make sure the bed frame is sturdy. Never tie ropes or cords, such as belts for bathrobes or skipping ropes, to any part of the bed. These can pose serious strangulation hazards. When purchasing a bunk bed, make sure it meets the latest version of the ASTM F1427 standard. The current edition is 2007. If there are no labels indicating compliance with the latest ASTM F1427 standard, ask the store before you buy, or contact the manufacturer for more information Check to ensure the bed comes with instructions for assembly and has a label with safety warnings. Read and follow these instructions and warnings carefully For more safety tips, please see our Bunk Bed Safety Public Education Bulletin.
For further information or to report an injury or complaint, please contact Health Canada's Consumer Product Safety program at 1-866-662-0666 (toll-free) or CPS-SPC@hc-sc.gc.ca or visit the Consumer Product Safety (CPS) section of Health Canada's Web site.
Warning
2008-116
OTTAWA - Health Canada is advising Canadians to exercise caution when purchasing and using bunk beds. Since 1987, there have been 61 incidents that involved injuries associated with bunk beds reported to Health Canada. Twelve of these incidents were related to strangulation or suffocation by entrapment, of which eight resulted in death. The remaining injuries were related to falls.
A report from the Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) indicates that between 1999 and 2006, there were 2,530 bunk bed-related injuries in Canada. Over 65%, 1650 in total, were related to the top bunk.
Important Safety Tips
Children should be taught how to use bunk beds safely. The top bunk is not safe for children under 6 years of age. Allow only one person on the top bunk, and do not allow children to play on or under bunk beds unless the area under the bed is designed by the manufacturer as a play area or study centre. The bed should have all guard rails installed at all times, even if the bed is pushed up against a wall. Check regularly to make sure the bed frame is sturdy. Never tie ropes or cords, such as belts for bathrobes or skipping ropes, to any part of the bed. These can pose serious strangulation hazards. When purchasing a bunk bed, make sure it meets the latest version of the ASTM F1427 standard. The current edition is 2007. If there are no labels indicating compliance with the latest ASTM F1427 standard, ask the store before you buy, or contact the manufacturer for more information Check to ensure the bed comes with instructions for assembly and has a label with safety warnings. Read and follow these instructions and warnings carefully For more safety tips, please see our Bunk Bed Safety Public Education Bulletin.
For further information or to report an injury or complaint, please contact Health Canada's Consumer Product Safety program at 1-866-662-0666 (toll-free) or CPS-SPC@hc-sc.gc.ca or visit the Consumer Product Safety (CPS) section of Health Canada's Web site.
New Report Reveals More Than 1000 People Died in Illegal Fentanyl Epidemic of 2005-2007
New Report Reveals More Than 1000 People Died in Illegal Fentanyl Epidemic of 2005-2007
Report highlights the successes of public health responses to this epidemic, but also warns of sharp rise in all drug overdose deaths
A new report provides an unprecedented look at the scope and nature of an epidemic of overdoses related to illegally produced (non-pharmaceutical) fentanyl -- an epidemic that ultimately killed at least 1,013 people within less than two years. Published in the July 25 issue of the Centers for Disease Control and Prevention’s (CDC) Mortality and Morbidity Weekly Report (MMWR), Non-Pharmaceutical Fentanyl-related Deaths, Multiple States chronicles the steps public health and law enforcement authorities at the federal, state and local level took in identifying and responding to the problem, and notes how these measures could be applied to public health threats.
Fentanyl is a synthetic opioid medication that when properly manufactured and administered is an effective treatment for severe or chronic pain. It is a very potent drug; however (30-50 times more potent than heroin), and can be extraordinarily dangerous when produced illicitly or used non-medically. Non-pharmaceutical versions of fentanyl have not only been sold directly as street drugs, but have also been mixed in with other street drugs such as heroin and cocaine –sometimes with fatal consequences.
An April 2006 spike in the number of drug overdoses in Camden, N.J., was reported to the Epidemic Information Exchange (EpiX), a communications network developed by the U.S. Centers for Disease Control and Prevention. Similar reports of sudden increases in overdoses and deaths from other parts of the country led the CDC, the Office of National Drug Control Policy, the Substance Abuse and Mental Health Services Administration, the Drug Enforcement Administration, and other public health and law enforcement officials to launch a government-wide effort to investigate the problem and protect the public health.
Working closely with state and local authorities, experts from these agencies were able to determine that what were initially suspected to be heroin overdoses were actually overdoses related to illicit drugs containing non-pharmaceutical fentanyl. Federal authorities immediately undertook a wide range of efforts to determine the source and extent of the problem – including epidemiologic studies to assess its origins.
Federal, state and local authorities simultaneously launched intensive outreach efforts throughout the medical and substance abuse treatment communities to alert people of the dangers. Practical information and measures were also provided for helping prevent exposure to illicit fentanyl drugs and for treating those who had been exposed. Thanks in large part to these efforts, the epidemic, which was determined to have begun around April of 2005, ended by March 2007.
“This MMWR report details the effective measures CDC, ONDCP, DEA, SAMHSA and others implemented to stem this epidemic, save countless lives and help address possible future outbreaks,” said SAMHSA Administrator Terry Cline, Ph.D. “It also highlights the very disturbing rise in overdose deaths related to both the abuse of street and prescription drugs, and the continuing need to address this dire problem.”
The report’s editorial notes point out that the non-pharmaceutical epidemic occurred against a backdrop of dramatic rises in deaths from drug overdoses. For example, unintentional drug poisoning (primarily drug overdoses) deaths rose from 11,155 in 1999 to 22,448 in 2005 – an increase of more than 100 percent. The editorial notes that many of these fatal overdoses involved the use of opioid prescription drugs. In light of this public health problem, the report recommends building upon many of the measures put in place to address the non-pharmaceutical fentanyl epidemic, including enhancing mechanisms for identifying and reporting drug-related deaths, establishing national standards for guiding the toxicological testing and analysis of these deaths and maintaining outreach programs for effectively providing vital information to potentially affected communities.
A copy of the full report and accompanying editorial can be obtained at www.cdc.gov/mmwr.
Report highlights the successes of public health responses to this epidemic, but also warns of sharp rise in all drug overdose deaths
A new report provides an unprecedented look at the scope and nature of an epidemic of overdoses related to illegally produced (non-pharmaceutical) fentanyl -- an epidemic that ultimately killed at least 1,013 people within less than two years. Published in the July 25 issue of the Centers for Disease Control and Prevention’s (CDC) Mortality and Morbidity Weekly Report (MMWR), Non-Pharmaceutical Fentanyl-related Deaths, Multiple States chronicles the steps public health and law enforcement authorities at the federal, state and local level took in identifying and responding to the problem, and notes how these measures could be applied to public health threats.
Fentanyl is a synthetic opioid medication that when properly manufactured and administered is an effective treatment for severe or chronic pain. It is a very potent drug; however (30-50 times more potent than heroin), and can be extraordinarily dangerous when produced illicitly or used non-medically. Non-pharmaceutical versions of fentanyl have not only been sold directly as street drugs, but have also been mixed in with other street drugs such as heroin and cocaine –sometimes with fatal consequences.
An April 2006 spike in the number of drug overdoses in Camden, N.J., was reported to the Epidemic Information Exchange (EpiX), a communications network developed by the U.S. Centers for Disease Control and Prevention. Similar reports of sudden increases in overdoses and deaths from other parts of the country led the CDC, the Office of National Drug Control Policy, the Substance Abuse and Mental Health Services Administration, the Drug Enforcement Administration, and other public health and law enforcement officials to launch a government-wide effort to investigate the problem and protect the public health.
Working closely with state and local authorities, experts from these agencies were able to determine that what were initially suspected to be heroin overdoses were actually overdoses related to illicit drugs containing non-pharmaceutical fentanyl. Federal authorities immediately undertook a wide range of efforts to determine the source and extent of the problem – including epidemiologic studies to assess its origins.
Federal, state and local authorities simultaneously launched intensive outreach efforts throughout the medical and substance abuse treatment communities to alert people of the dangers. Practical information and measures were also provided for helping prevent exposure to illicit fentanyl drugs and for treating those who had been exposed. Thanks in large part to these efforts, the epidemic, which was determined to have begun around April of 2005, ended by March 2007.
“This MMWR report details the effective measures CDC, ONDCP, DEA, SAMHSA and others implemented to stem this epidemic, save countless lives and help address possible future outbreaks,” said SAMHSA Administrator Terry Cline, Ph.D. “It also highlights the very disturbing rise in overdose deaths related to both the abuse of street and prescription drugs, and the continuing need to address this dire problem.”
The report’s editorial notes point out that the non-pharmaceutical epidemic occurred against a backdrop of dramatic rises in deaths from drug overdoses. For example, unintentional drug poisoning (primarily drug overdoses) deaths rose from 11,155 in 1999 to 22,448 in 2005 – an increase of more than 100 percent. The editorial notes that many of these fatal overdoses involved the use of opioid prescription drugs. In light of this public health problem, the report recommends building upon many of the measures put in place to address the non-pharmaceutical fentanyl epidemic, including enhancing mechanisms for identifying and reporting drug-related deaths, establishing national standards for guiding the toxicological testing and analysis of these deaths and maintaining outreach programs for effectively providing vital information to potentially affected communities.
A copy of the full report and accompanying editorial can be obtained at www.cdc.gov/mmwr.
EPA Acts to Address Carbofuran Residues in Food
EPA Acts to Address Carbofuran Residues in Food
Due to considerable risks associated with the pesticide carbofuran in food and drinking water, EPA is revoking the regulations that allow carbofuran residues in food. Even though carbofuran is used on a small percentage of the U.S. food supply and therefore the likelihood of exposure through food is low, EPA has identified risks that that do not meet our rigorous food safety standards. EPA is taking the necessary steps to address these risks to ensure we have the safest food supply possible. The United States has a safe and abundant food supply, and children and others should continue to eat a variety of foods, as recommended by the federal government and nutritional experts.
In addition, EPA is proceeding on the path toward cancellation of the pesticide registration, which will address the risks to pesticide applicators and birds in treated fields. As part of this effort, EPA is also releasing its response to the peer review conducted by the independent Scientific Advisory Panel and the agency's response to the U.S. Department of Agriculture's comments on the effect of the cancellation of carbofuran on the agricultural economy.
EPA will accept public comments on the proposed tolerance revocation for 60 days.
For additional information, visit:
epa.gov/pesticides/reregistration/carbofuran/carbofuran_noic.htm
Due to considerable risks associated with the pesticide carbofuran in food and drinking water, EPA is revoking the regulations that allow carbofuran residues in food. Even though carbofuran is used on a small percentage of the U.S. food supply and therefore the likelihood of exposure through food is low, EPA has identified risks that that do not meet our rigorous food safety standards. EPA is taking the necessary steps to address these risks to ensure we have the safest food supply possible. The United States has a safe and abundant food supply, and children and others should continue to eat a variety of foods, as recommended by the federal government and nutritional experts.
In addition, EPA is proceeding on the path toward cancellation of the pesticide registration, which will address the risks to pesticide applicators and birds in treated fields. As part of this effort, EPA is also releasing its response to the peer review conducted by the independent Scientific Advisory Panel and the agency's response to the U.S. Department of Agriculture's comments on the effect of the cancellation of carbofuran on the agricultural economy.
EPA will accept public comments on the proposed tolerance revocation for 60 days.
For additional information, visit:
epa.gov/pesticides/reregistration/carbofuran/carbofuran_noic.htm
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