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.
Tuesday, December 9, 2008
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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