OKK Trading To Pay $665,000 Civil Penalty for Violating Federal Lead Paint Ban and Other Child Safety Rules
WASHINGTON, D.C. - As part of its commitment to protecting the safety of children, the U.S. Consumer Product Safety Commission (CPSC) announced today that OKK Trading, of Commerce, Calif., has agreed to pay a $665,000 civil penalty (PDF) for failing to comply with a 30-year old ban on lead paint on toys, as well as violating other federal child safety standards.
The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that from November 2007 through August 2008, OKK Trading knowingly imported and sold toys with paints that contained lead levels that exceeded legal limits. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. Lead can be toxic if ingested by young children and can cause adverse health consequences.
The penalty settlement also resolves CPSC staff allegations that OKK Trading knowingly imported and sold toys, games, rattles, pacifiers, and art materials that violated the Federal Hazardous Substances Act. These allegations include:
From December 2004 through August 2008, OKK Trading imported and sold toys that had small parts in violation of CPSC regulations. To protect young children from choking, aspiration, or ingestion hazards, federal law prohibits toys intended for children under three from having small parts.
From November 2004 through January 2005, OKK Trading imported rattles that violated CPSC’s safety requirements for rattles.
From July 2007 through January 2008, OKK Trading imported and sold pacifiers that violated CPSC’s safety requirements for pacifiers, including the prohibition on small parts.
From January 2005 through April 2007, OKK Trading imported toys and games that violated CPSC’s labeling requirements for balloons, small balls, and small parts.
From September 2005 through April 2007, OKK Trading imported art materials that violated CPSC’s labeling requirements.
The settlement also covers staff allegations that from May 2007 through December 2007, the company knowingly exported noncompliant toys in violation of federal notification requirements.
OKK Trading informed CPSC that it received no reports of incidents or injuries involving the products covered by this settlement. In agreeing to the settlement, OKK Trading denies CPSC's allegations that it knowingly violated the law.
Thursday, June 25, 2009
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
FDA acts to prevent repeated drug quality problemsU.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”
This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.
The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.
"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
To view Questions and Answers on Caraco Drugs, Including a List of Effected Drugs: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169095.htm
To view Facts About Current Good Manufacturing Practices: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
To view the October 31, 2008 FDA Warning Letter to Caraco Pharmaceutical Laboratories, Ltd: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048080.htm
Consumer Inquiries: 888-INFO-FDA
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.
FDA acts to prevent repeated drug quality problemsU.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”
This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.
The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.
"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
To view Questions and Answers on Caraco Drugs, Including a List of Effected Drugs: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169095.htm
To view Facts About Current Good Manufacturing Practices: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
To view the October 31, 2008 FDA Warning Letter to Caraco Pharmaceutical Laboratories, Ltd: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048080.htm
Wednesday, June 24, 2009
Medicare Fraud Strike Force Operations Lead to Charges Against 53 Doctors, Health Care Executives and Beneficiaries for More Than $50 Million
Medicare Fraud Strike Force Operations Lead to Charges Against 53 Doctors, Health Care Executives and Beneficiaries for More Than $50 Million in Alleged False Billing in Detroit
Early Morning Takedown Leads to Arrests in Detroit, Miami and Denver
Fifty-three people have been indicted for schemes to submit more than $50 million in false Medicare claims in the continuing operation of the Medicare Fraud Strike Force in Detroit,
Attorney General Eric Holder, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and FBI Director Robert Mueller announced today. The Strike Force in Detroit is the third phase of a targeted criminal, civil and administrative effort against individuals and health care companies that fraudulently bill the Medicare program.
While the indictments were returned by a grand jury in Detroit, individuals were arrested today in Detroit, Miami and Denver as a result of phase three operations of the Strike Force. The joint DOJ-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing.
“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health care costs that all Americans must bear,” said Attorney General Holder. “The vast majority of doctors, patients, and medical companies do the right thing and work with the Medicare program to provide access to medical services. To those who work diligently and ethically to provide medical care through the Medicare program, we will work with you to root out the few who corrupt the system and taint the good reputations of health professionals everywhere.”
“The Obama Administration is committed to turning up the heat on Medicare fraud and employing all the weapons in the federal government’s arsenal to target those who are defrauding the American taxpayer,” said HHS Secretary Kathleen Sebelius. “Thanks to cooperation from across the government and some of the best law enforcement professionals in the country, today we were able to save millions of dollars from being lost to criminals and send a powerful message to those who seek to defraud the system, that we are coming after them. But our joint efforts on HEAT don’t just stop at the jailhouse door. Our Medicare program is working closely in partnership with our own and other law enforcement operations to prevent fraud from happening in the first place. Every dollar we can save by stopping fraud can be used to strengthen the long-term fiscal health of Medicare, bring down costs and deliver better service to Medicare beneficiaries.”
The Strike Force operations in Detroit are part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a renewed effort announced in May 2009 between the Department of Justice and HHS to focus their joint efforts to prevent fraud and enforce current anti-fraud laws around the country. The HEAT taskforce, co-chaired by Deputy Attorney General David Ogden and Deputy Secretary Bill Corr, is made up of top-level law enforcement agents, prosecutors and staff from both Departments and their operating divisions. In the May 2009 announcement, Attorney General Holder and Secretary Sebelius announced the expansion of the Strike Force into Detroit and Houston to build upon existing partnerships between the agencies in a heightened effort to reduce fraud and recover taxpayer dollars.
Today, federal agents from the FBI and the HHS Office of Inspector General (HHS-OIG) began executing arrest warrants in Detroit, Miami and Denver as part of a concentrated effort to address fraud in the metro-Detroit area. Charges were unsealed today against 53 individuals who are accused of various Medicare fraud offenses, including conspiracy to defraud the Medicare program, criminal false claims and violations of the anti-kickback statutes. The Strike Force operations in Detroit have identified two primary areas – infusion therapy and physical/occupational therapy providers – in which schemes were allegedly orchestrated to defraud the Medicare program.
According to the indictments, the defendants charged today participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided. In many cases, indictments allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments. Collectively, the physicians, medical assistants, patients, company owners and executives charged in the indictments are accused of conspiring to submit more than $50 million in false claims to the Medicare program.
“We will continue to work together in the months to come to identify and stop those who would line their own pockets with taxpayer money – those who seek to benefit at the expense of our health care system, our economy and our collective well-being,” said FBI Director Mueller.
“Today’s landmark series of arrests in Detroit and across the country demonstrates that health care fraud can happen anywhere in America,” said Daniel R. Levinson, Inspector General of the Department of Health & Human Services. “We will continue to detect and respond rapidly to emerging fraud schemes to protect our federal health care programs and conserve scarce health care dollars so critically needed for the care of our beneficiaries.”
The work of the Detroit Strike Force is another important step in the multi-phase enforcement and regulatory HEAT initiative designed to reduce the potential for Medicare and Medicaid fraud. Since its inception in March 2007 with phase one in South Florida and expansion to phase two in Los Angeles in May 2008, the Strike Force has obtained indictments of more than 250 individuals and organizations that collectively have billed the Medicare program for more than $600 million. In addition, HHS’s Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, is taking steps to increase accountability and decrease the presence of fraudulent providers.
Each of the three Detroit Strike Force teams is led by a federal prosecutor supervised by the Justice Department’s Criminal Division’s Fraud Section in Washington, D.C., and the U.S. Attorney’s Office for the Eastern District of Michigan. Each team has four to six agents, with at least one agent from the FBI and HHS-OIG.
The cases are being prosecuted by attorneys from the Fraud Section in the Justice Department’s Criminal Division, including Deputy Chief Kirk Ogrosky and Trial Attorneys John K. Neal and Benjamin D. Singer as well Special Assistant U.S. Attorney Thomas W. Beimers in the U.S. Attorney’s Office for the Eastern District of Michigan, on detail from HHS-OIG.
An indictment is merely an allegation, and defendants are presumed innocent until and unless proven guilty.
To learn more about the HEAT team, go to: www.hhs.gov/stopmedicarefraud
Early Morning Takedown Leads to Arrests in Detroit, Miami and Denver
Fifty-three people have been indicted for schemes to submit more than $50 million in false Medicare claims in the continuing operation of the Medicare Fraud Strike Force in Detroit,
Attorney General Eric Holder, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and FBI Director Robert Mueller announced today. The Strike Force in Detroit is the third phase of a targeted criminal, civil and administrative effort against individuals and health care companies that fraudulently bill the Medicare program.
While the indictments were returned by a grand jury in Detroit, individuals were arrested today in Detroit, Miami and Denver as a result of phase three operations of the Strike Force. The joint DOJ-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing.
“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health care costs that all Americans must bear,” said Attorney General Holder. “The vast majority of doctors, patients, and medical companies do the right thing and work with the Medicare program to provide access to medical services. To those who work diligently and ethically to provide medical care through the Medicare program, we will work with you to root out the few who corrupt the system and taint the good reputations of health professionals everywhere.”
“The Obama Administration is committed to turning up the heat on Medicare fraud and employing all the weapons in the federal government’s arsenal to target those who are defrauding the American taxpayer,” said HHS Secretary Kathleen Sebelius. “Thanks to cooperation from across the government and some of the best law enforcement professionals in the country, today we were able to save millions of dollars from being lost to criminals and send a powerful message to those who seek to defraud the system, that we are coming after them. But our joint efforts on HEAT don’t just stop at the jailhouse door. Our Medicare program is working closely in partnership with our own and other law enforcement operations to prevent fraud from happening in the first place. Every dollar we can save by stopping fraud can be used to strengthen the long-term fiscal health of Medicare, bring down costs and deliver better service to Medicare beneficiaries.”
The Strike Force operations in Detroit are part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a renewed effort announced in May 2009 between the Department of Justice and HHS to focus their joint efforts to prevent fraud and enforce current anti-fraud laws around the country. The HEAT taskforce, co-chaired by Deputy Attorney General David Ogden and Deputy Secretary Bill Corr, is made up of top-level law enforcement agents, prosecutors and staff from both Departments and their operating divisions. In the May 2009 announcement, Attorney General Holder and Secretary Sebelius announced the expansion of the Strike Force into Detroit and Houston to build upon existing partnerships between the agencies in a heightened effort to reduce fraud and recover taxpayer dollars.
Today, federal agents from the FBI and the HHS Office of Inspector General (HHS-OIG) began executing arrest warrants in Detroit, Miami and Denver as part of a concentrated effort to address fraud in the metro-Detroit area. Charges were unsealed today against 53 individuals who are accused of various Medicare fraud offenses, including conspiracy to defraud the Medicare program, criminal false claims and violations of the anti-kickback statutes. The Strike Force operations in Detroit have identified two primary areas – infusion therapy and physical/occupational therapy providers – in which schemes were allegedly orchestrated to defraud the Medicare program.
According to the indictments, the defendants charged today participated in schemes to submit claims to Medicare for treatments that were in fact medically unnecessary and oftentimes, never provided. In many cases, indictments allege that beneficiaries accepted cash kickbacks in return for allowing providers to submit forms saying they had received the unnecessary and not provided treatments. Collectively, the physicians, medical assistants, patients, company owners and executives charged in the indictments are accused of conspiring to submit more than $50 million in false claims to the Medicare program.
“We will continue to work together in the months to come to identify and stop those who would line their own pockets with taxpayer money – those who seek to benefit at the expense of our health care system, our economy and our collective well-being,” said FBI Director Mueller.
“Today’s landmark series of arrests in Detroit and across the country demonstrates that health care fraud can happen anywhere in America,” said Daniel R. Levinson, Inspector General of the Department of Health & Human Services. “We will continue to detect and respond rapidly to emerging fraud schemes to protect our federal health care programs and conserve scarce health care dollars so critically needed for the care of our beneficiaries.”
The work of the Detroit Strike Force is another important step in the multi-phase enforcement and regulatory HEAT initiative designed to reduce the potential for Medicare and Medicaid fraud. Since its inception in March 2007 with phase one in South Florida and expansion to phase two in Los Angeles in May 2008, the Strike Force has obtained indictments of more than 250 individuals and organizations that collectively have billed the Medicare program for more than $600 million. In addition, HHS’s Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, is taking steps to increase accountability and decrease the presence of fraudulent providers.
Each of the three Detroit Strike Force teams is led by a federal prosecutor supervised by the Justice Department’s Criminal Division’s Fraud Section in Washington, D.C., and the U.S. Attorney’s Office for the Eastern District of Michigan. Each team has four to six agents, with at least one agent from the FBI and HHS-OIG.
The cases are being prosecuted by attorneys from the Fraud Section in the Justice Department’s Criminal Division, including Deputy Chief Kirk Ogrosky and Trial Attorneys John K. Neal and Benjamin D. Singer as well Special Assistant U.S. Attorney Thomas W. Beimers in the U.S. Attorney’s Office for the Eastern District of Michigan, on detail from HHS-OIG.
An indictment is merely an allegation, and defendants are presumed innocent until and unless proven guilty.
To learn more about the HEAT team, go to: www.hhs.gov/stopmedicarefraud
Health Canada Reminds Canadians to Avoid Cross-Contamination When Using Reusable Grocery Bags and Bins
Health Canada Reminds Canadians to Avoid Cross-Contamination When Using Reusable Grocery Bags and Bins
Information Update2009-99
Health Canada is reminding Canadians to take steps to prevent cross-contamination of foods when shopping using reusable grocery bags and bins.
As an environmental choice, many Canadians are now shopping with reusable bins, reusable plastic bags and cloth bags to reduce the amount of plastic they are using. Health Canada supports the proper use of these products, but it is important that Canadians use them safely to prevent cross-contamination of food with bacteria that can cause foodborne illness.
Because these bags and plastic bins are reused frequently, they can pick up bacteria from the foods they carry, or from their environment (the ground, the back of your car or the items stored in them between grocery trips).
The following steps can help you prevent cross-contamination:
•When using cloth bags, make sure to wash them frequently, especially after carrying fresh produce, meat, poultry or fish. Reusable grocery bags may not all be machine washable. If you are using this type of grocery bag, you should make sure to wash them by hand frequently with hot soapy water. Plastic bins should be washed using hot soapy water on a regular basis as well.
•Put your fresh or frozen raw meat, poultry and fish in separate bins or bags from fresh produce and other ready-to-eat foods.
•Putting your fresh or frozen raw meat, poultry or fish in plastic bags (the clear bags found in the produce and some meat sections work well) will help prevent the juices from leaking out and contaminating your reusable containers and other foods. Fresh produce should also always be put in plastic bags to protect them from contamination.
•If you are using your grocery bags or bins to store or transport non-food items, they should be thoroughly washed before using them for groceries.
It is estimated that there are approximately 11 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.
For more information on food safety tips for reusable grocery bags and bins, please visit:
Government of Canada's Food Safety Tips for Reusable Grocery Bags and Bins
Partnership for Consumer Food Safety Education's Be Food Safe Canada Campaign
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Information Update2009-99
Health Canada is reminding Canadians to take steps to prevent cross-contamination of foods when shopping using reusable grocery bags and bins.
As an environmental choice, many Canadians are now shopping with reusable bins, reusable plastic bags and cloth bags to reduce the amount of plastic they are using. Health Canada supports the proper use of these products, but it is important that Canadians use them safely to prevent cross-contamination of food with bacteria that can cause foodborne illness.
Because these bags and plastic bins are reused frequently, they can pick up bacteria from the foods they carry, or from their environment (the ground, the back of your car or the items stored in them between grocery trips).
The following steps can help you prevent cross-contamination:
•When using cloth bags, make sure to wash them frequently, especially after carrying fresh produce, meat, poultry or fish. Reusable grocery bags may not all be machine washable. If you are using this type of grocery bag, you should make sure to wash them by hand frequently with hot soapy water. Plastic bins should be washed using hot soapy water on a regular basis as well.
•Put your fresh or frozen raw meat, poultry and fish in separate bins or bags from fresh produce and other ready-to-eat foods.
•Putting your fresh or frozen raw meat, poultry or fish in plastic bags (the clear bags found in the produce and some meat sections work well) will help prevent the juices from leaking out and contaminating your reusable containers and other foods. Fresh produce should also always be put in plastic bags to protect them from contamination.
•If you are using your grocery bags or bins to store or transport non-food items, they should be thoroughly washed before using them for groceries.
It is estimated that there are approximately 11 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.
For more information on food safety tips for reusable grocery bags and bins, please visit:
Government of Canada's Food Safety Tips for Reusable Grocery Bags and Bins
Partnership for Consumer Food Safety Education's Be Food Safe Canada Campaign
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Tuesday, June 23, 2009
Aspartame study to begin---U.K.
Aspartame study to begin
The Food Standards Agency is to begin a new study looking at aspartame. The research will focus on people who have reported bad reactions to the artificial sweetener.
Aspartame is being linked anecdotally by some people to different conditions, including headaches and upset stomachs.
Andrew Wadge, Chief Scientist at the Food Standards Agency, said: ‘This research is not to test the safety of aspartame – that is already established. The study will address consumer concerns, including anecdotal reports that have linked a range of conditions to aspartame.
‘The Agency’s view remains that aspartame can be consumed safely and we are not recommending any changes to its current use. However, we know that some people consider they react badly to consuming this sweetener so we think it is important to increase our knowledge about what is happening.’
This pilot study will start next month and could be used to inform the design and feasibility of a larger scale study that could be done at the European level.* The Agency expects the pilot study to take 18 months and is currently in the process of identifying volunteers who are interested in taking part. Prospective participants should email aspartame@foodstandards.gsi.gov.uk to
register their interest and obtain further information.
The Agency hopes to publish the results early in 2011.
The Food Standards Agency is to begin a new study looking at aspartame. The research will focus on people who have reported bad reactions to the artificial sweetener.
Aspartame is being linked anecdotally by some people to different conditions, including headaches and upset stomachs.
Andrew Wadge, Chief Scientist at the Food Standards Agency, said: ‘This research is not to test the safety of aspartame – that is already established. The study will address consumer concerns, including anecdotal reports that have linked a range of conditions to aspartame.
‘The Agency’s view remains that aspartame can be consumed safely and we are not recommending any changes to its current use. However, we know that some people consider they react badly to consuming this sweetener so we think it is important to increase our knowledge about what is happening.’
This pilot study will start next month and could be used to inform the design and feasibility of a larger scale study that could be done at the European level.* The Agency expects the pilot study to take 18 months and is currently in the process of identifying volunteers who are interested in taking part. Prospective participants should email aspartame@foodstandards.gsi.gov.uk to
register their interest and obtain further information.
The Agency hopes to publish the results early in 2011.
Friday, June 19, 2009
BUSINESS OWNERS PLEAD GUILTY TO DISTRIBUTING TAINTED INGREDIENT USED IN PET FOOD
BUSINESS OWNERS PLEAD GUILTY TO DISTRIBUTING
TAINTED INGREDIENT USED IN PET FOOD
THOUSANDS OF PETS SUFFERED ILLNESS, DEATH
THROUGHOUT THE UNITED STATES
Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.
“Millions of pet owners were impacted by the pet food recall in 2007,” Whitworth said. “The conduct of these defendants in violating federal health and safety standards caused the deaths and illness of thousands of family pets, as well as anxiety among dog and cat owners across the country and economic harm to many pet food manufacturers.”
Sally Qing Miller, 43, a Chinese national, and her husband, Stephen S. Miller, 56, both of Las Vegas, Nev., along with their company, Chemnutra, Inc., pleaded guilty before U.S. Magistrate Judge John Maughmer this afternoon to some of the charges contained in a Feb. 6, 2008, federal indictment, and agreed that the conduct charged against them in the remaining counts could be considered by the court as relevant conduct and used against them at the time of sentencing.
“The FDA’s Office of Criminal Investigations acted aggressively in 2007 to investigate Chemnutra,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today’s announcement reflects our continued commitment to investigate and prosecute companies and individuals that violate the law and endanger the public’s health through illegal conduct.”
Chemnutra is a company that buys food and food components in China and imports those items into the United States to sell to companies in the food industry. Sally Miller is the controlling owner and president of Chemnutra; Stephen Miller is an owner and chief executive officer of Chemnutra. Each of the three co-defendants pleaded guilty to one count of selling adulterated food and one count of selling misbranded food.
More than 800 metric tons of tainted wheat gluten was imported by Chemnutra and the Millers into the United States from China in at least 13 separate shipments, with invoices totaling nearly $850,000, between Nov. 6, 2006, and Feb. 21, 2007. Those shipments of wheat gluten were tainted with melamine, an unsafe food additive. Chemnutra and the Millers received the melamine-tainted product at a port of entry in Kansas City, Mo., and then sold and shipped the product to their customers across the United States, who used it to manufacture various brands of pet food.
By pleading guilty today, Chemnutra and the Millers admitted that melamine was substituted wholly or in part for the protein requirement of the wheat gluten so as to make it appear the wheat gluten was better or of greater value than it was. They also admitted that the labeling of the wheat gluten was false and misleading because the wheat gluten was represented to have a minimum protein level of 75 percent, when in fact it did not. The labeling was also false and misleading because melamine was not listed on the label as an ingredient.
Pet Food Recall
Pet food manufacturers recalled more than 150 brands of dog and cat food across the nation in 2007, following reports of cats and dogs suffering kidney failure after eating the affected products. There is no coordinated national tracking system to monitor the number of pet deaths. However, consumer reports received by the FDA suggest that approximately 1,950 cats and 2,200 dogs died after eating pet food contaminated with melamine.
Melamine Contamination
Wheat gluten is the natural protein derived from wheat or wheat flour, which is extracted and
dried to yield a powder of high protein content. Pet food manufacturers use wheat gluten as a binding agent in the manufacture of certain types of pet food to thicken pet food “gravy.”
Melamine has a number of commercial and industrial uses, but it has no approved use as an ingredient in human or animal food in the United States. Melamine can be used to create products such as plastics, cleaning products, counter tops, glues, inks and fertilizers. Mixing melamine with wheat gluten made the wheat gluten appear to have a higher protein level than was actually present.
Under federal statutes, the Millers are each subject to a sentence of up to two years in federal prison without parole, plus a fine up to $200,000 and an order of restitution. ChemNutra is subject to a fine up to $400,000 and an order of restitution. Sentencing hearings will be scheduled after the completion of presentence investigations by the United States Probation Office.
This case is being prosecuted by Assistant U.S. Attorneys Gene Porter and Joseph Marquez. It was investigated by the U.S. Food and Drug Administration Office of Criminal Investigation and
U.S. Immigration and Customs Enforcement.
TAINTED INGREDIENT USED IN PET FOOD
THOUSANDS OF PETS SUFFERED ILLNESS, DEATH
THROUGHOUT THE UNITED STATES
Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.
“Millions of pet owners were impacted by the pet food recall in 2007,” Whitworth said. “The conduct of these defendants in violating federal health and safety standards caused the deaths and illness of thousands of family pets, as well as anxiety among dog and cat owners across the country and economic harm to many pet food manufacturers.”
Sally Qing Miller, 43, a Chinese national, and her husband, Stephen S. Miller, 56, both of Las Vegas, Nev., along with their company, Chemnutra, Inc., pleaded guilty before U.S. Magistrate Judge John Maughmer this afternoon to some of the charges contained in a Feb. 6, 2008, federal indictment, and agreed that the conduct charged against them in the remaining counts could be considered by the court as relevant conduct and used against them at the time of sentencing.
“The FDA’s Office of Criminal Investigations acted aggressively in 2007 to investigate Chemnutra,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today’s announcement reflects our continued commitment to investigate and prosecute companies and individuals that violate the law and endanger the public’s health through illegal conduct.”
Chemnutra is a company that buys food and food components in China and imports those items into the United States to sell to companies in the food industry. Sally Miller is the controlling owner and president of Chemnutra; Stephen Miller is an owner and chief executive officer of Chemnutra. Each of the three co-defendants pleaded guilty to one count of selling adulterated food and one count of selling misbranded food.
More than 800 metric tons of tainted wheat gluten was imported by Chemnutra and the Millers into the United States from China in at least 13 separate shipments, with invoices totaling nearly $850,000, between Nov. 6, 2006, and Feb. 21, 2007. Those shipments of wheat gluten were tainted with melamine, an unsafe food additive. Chemnutra and the Millers received the melamine-tainted product at a port of entry in Kansas City, Mo., and then sold and shipped the product to their customers across the United States, who used it to manufacture various brands of pet food.
By pleading guilty today, Chemnutra and the Millers admitted that melamine was substituted wholly or in part for the protein requirement of the wheat gluten so as to make it appear the wheat gluten was better or of greater value than it was. They also admitted that the labeling of the wheat gluten was false and misleading because the wheat gluten was represented to have a minimum protein level of 75 percent, when in fact it did not. The labeling was also false and misleading because melamine was not listed on the label as an ingredient.
Pet Food Recall
Pet food manufacturers recalled more than 150 brands of dog and cat food across the nation in 2007, following reports of cats and dogs suffering kidney failure after eating the affected products. There is no coordinated national tracking system to monitor the number of pet deaths. However, consumer reports received by the FDA suggest that approximately 1,950 cats and 2,200 dogs died after eating pet food contaminated with melamine.
Melamine Contamination
Wheat gluten is the natural protein derived from wheat or wheat flour, which is extracted and
dried to yield a powder of high protein content. Pet food manufacturers use wheat gluten as a binding agent in the manufacture of certain types of pet food to thicken pet food “gravy.”
Melamine has a number of commercial and industrial uses, but it has no approved use as an ingredient in human or animal food in the United States. Melamine can be used to create products such as plastics, cleaning products, counter tops, glues, inks and fertilizers. Mixing melamine with wheat gluten made the wheat gluten appear to have a higher protein level than was actually present.
Under federal statutes, the Millers are each subject to a sentence of up to two years in federal prison without parole, plus a fine up to $200,000 and an order of restitution. ChemNutra is subject to a fine up to $400,000 and an order of restitution. Sentencing hearings will be scheduled after the completion of presentence investigations by the United States Probation Office.
This case is being prosecuted by Assistant U.S. Attorneys Gene Porter and Joseph Marquez. It was investigated by the U.S. Food and Drug Administration Office of Criminal Investigation and
U.S. Immigration and Customs Enforcement.
EPA Declares Public Health Emergency In Montana Asbestos illnesses prompt first-ever declaration
EPA Declares Public Health Emergency In Montana
Asbestos illnesses prompt first-ever declaration
U.S. Environmental Protection Agency has declared that a public health emergency exists at the Libby asbestos site in northwest Montana. It's the first time the agency has declared such a condition.
Over the past years, hundreds of asbestos-related disease cases have been documented in this small community, which covers the towns of Libby and Troy, according to EPA. The announcement was made by Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Senators Max Baucus and Jon Tester.
The declaration "recognizes the serious impact to the public health from the contamination at Libby and underscores the need for further action and health care for area residents who have been or may be exposed to asbestos," the agency said.
Investigations performed by the Agency for Toxic Substance and Disease Registry have found the incidence of occurrence of asbestosis, a lung condition, in the Libby area staggeringly higher than the national average for the period from 1979-1998. EPA said it is working closely with the Department of Health and Human Services, which is making available a short-term grant to provide needed asbestos-related medical care to Libby and Troy residents.
During her Senate confirmation hearing, EPA Administrator Lisa P. Jackson committed to review the situation at the Libby asbestos site based on current site information, sound science and EPA’s legal authorities. As a result of her review, the Administrator has decided that conditions at the site present a significant threat to public health and that making a public health
emergency determination is appropriate.
"This is a tragic public health situation that has not received the recognition it deserves by the federal government for far too long. We're making a long-delayed commitment to the people of Libby and Troy. Based on a rigorous re-evaluation of the situation on the ground, we will continue to move aggressively on the cleanup efforts and protect the health of the people," Jackson said. "We're here to help create a long and prosperous future for this town."
Sebelius credited the two Montana lawmakers with pushing the issue to the forefront.
"They refused to give up on finding the best ways to help those who have suffered so much," she said.
The Libby asbestos site has been on the EPA's Superfund National Priorities List since 2002, and cleanup has taken place since 2000. EPA said it has made progress in helping to remove the threat of asbestos in the land and air, and with it, the increased risks of lung cancer, asbestosis, and other respiratory problems. While EPA's cleanup efforts have greatly reduced exposure, actual and potential releases of amphibole asbestos remain a significant threat to public health in that area, the agency said.
The Libby asbestos site includes portions of the towns of Libby and Troy and an inactive vermiculite mine seven miles northeast of the town. Gold miners discovered vermiculite in Libby in 1881; in the 1920s the Zonolite Company formed and began mining the vermiculite. In 1963, W.R. Grace bought the Zonolite mining operations. The mine closed in 1990. It is estimated that the Libby mine was the source of over 70 percent of all vermiculite sold in the United States from 1919 to 1990.
http://www.consumeraffairs.com/news04/2009/06/mt_epa_emergency.html#ixzz0IpZu2pOs&D
Asbestos illnesses prompt first-ever declaration
U.S. Environmental Protection Agency has declared that a public health emergency exists at the Libby asbestos site in northwest Montana. It's the first time the agency has declared such a condition.
Over the past years, hundreds of asbestos-related disease cases have been documented in this small community, which covers the towns of Libby and Troy, according to EPA. The announcement was made by Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Senators Max Baucus and Jon Tester.
The declaration "recognizes the serious impact to the public health from the contamination at Libby and underscores the need for further action and health care for area residents who have been or may be exposed to asbestos," the agency said.
Investigations performed by the Agency for Toxic Substance and Disease Registry have found the incidence of occurrence of asbestosis, a lung condition, in the Libby area staggeringly higher than the national average for the period from 1979-1998. EPA said it is working closely with the Department of Health and Human Services, which is making available a short-term grant to provide needed asbestos-related medical care to Libby and Troy residents.
During her Senate confirmation hearing, EPA Administrator Lisa P. Jackson committed to review the situation at the Libby asbestos site based on current site information, sound science and EPA’s legal authorities. As a result of her review, the Administrator has decided that conditions at the site present a significant threat to public health and that making a public health
emergency determination is appropriate.
"This is a tragic public health situation that has not received the recognition it deserves by the federal government for far too long. We're making a long-delayed commitment to the people of Libby and Troy. Based on a rigorous re-evaluation of the situation on the ground, we will continue to move aggressively on the cleanup efforts and protect the health of the people," Jackson said. "We're here to help create a long and prosperous future for this town."
Sebelius credited the two Montana lawmakers with pushing the issue to the forefront.
"They refused to give up on finding the best ways to help those who have suffered so much," she said.
The Libby asbestos site has been on the EPA's Superfund National Priorities List since 2002, and cleanup has taken place since 2000. EPA said it has made progress in helping to remove the threat of asbestos in the land and air, and with it, the increased risks of lung cancer, asbestosis, and other respiratory problems. While EPA's cleanup efforts have greatly reduced exposure, actual and potential releases of amphibole asbestos remain a significant threat to public health in that area, the agency said.
The Libby asbestos site includes portions of the towns of Libby and Troy and an inactive vermiculite mine seven miles northeast of the town. Gold miners discovered vermiculite in Libby in 1881; in the 1920s the Zonolite Company formed and began mining the vermiculite. In 1963, W.R. Grace bought the Zonolite mining operations. The mine closed in 1990. It is estimated that the Libby mine was the source of over 70 percent of all vermiculite sold in the United States from 1919 to 1990.
http://www.consumeraffairs.com/news04/2009/06/mt_epa_emergency.html#ixzz0IpZu2pOs&D
INTERNATIONAL MEDICAL DEVICE MAKER AND FOUR EXECUTIVES CHARGED IN CONNECTION WITH UNLAWFUL CLINICAL TRIALS
U.S. Department of Justice United States Attorney Eastern District of Pennsylvania 615 Chestnut Street Suite 1250 Philadelphia, Pennsylvania 19106-4476 (215) 861-8200
INTERNATIONAL MEDICAL DEVICE MAKER AND FOUR EXECUTIVES CHARGED IN CONNECTION WITH UNLAWFUL CLINICAL TRIALS
United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz today announced the return of an indictment 1 against Norian Corporation (“Norian”), Synthes, Inc. (“Synthes”), and four top Synthes executives, Michael D. Huggins (“Huggins”), Thomas B. Higgins (“Higgins”), Richard E. Bohner (“Bohner”) and John J. Walsh (“Walsh”), charging them for their involvement in conducting clinical trials of a medical device without the authorization of the FDA. Joining in today’s announcement were Food and Drug Administration (“FDA”) Office of Criminal Investigations Special Agent-in-Charge Kim A. Rice; Department of Health and Human Services (“HHS”) Office of Inspector General Office of Investigations Special Agent-in-Charge Patrick Doyle; Defense Criminal Investigative Service (“DCIS”) Special Agent-in-Charge Edward Bradley; and Department of Veterans Affairs (“VA”) Special Agent-in-Charge Jeffrey G. Hughes, Northeast Field Office, Office of Inspector General.
The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud. The parent company, Synthes, is charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. As explained below, these crimes allegedly prevented the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provided by FDA oversight of clinical trials.
1An indictment or information is an accusation. A defendant is presumed innocent unless and until proven guilty.
According to the indictment, Synthes, a Delaware corporation based in West Chester, Pennsylvania, is the United States branch of a large multinational medical device manufacturer which specializes in trauma products to treat damaged human bone. Norian, it is alleged, is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pennsylvania.
Defendant Huggins was allegedly employed by Synthes as the President of Synthes North America, a subsidiary of Synthes. It is alleged that in February 2004, Huggins became the President of Synthes Spine, a division of Synthes. Defendant Higgins was allegedly the President of Synthes Spine, a division of Synthes, reporting to Huggins. In February 2004, Higgins allegedly left that position and became Synthes’s Senior Vice President of Global Strategy. The indictment alleges that defendant Bohner was employed by Synthes as its Vice President of Operations, reporting to Huggins. Defendant Walsh was allegedly employed by Synthes starting in August 2003 as its Director of Regulatory and Clinical Affairs, Spine Division, and reported first to Bohner and later to Huggins.
The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes’s medical devices, Norian XR and Norian SRS, in surgeries to treat vertebral compression fracturesof the spine (“VCFs”), a painful condition commonly suffered by elderly individuals. These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine. According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such Norian-caused clots became lodged in the lungs. Notwithstanding this knowledge, the company allegedly proceeded to market the product for VCFs without putting it through FDA-required testing. The company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. The indictment further alleges that after the death of the third patient in January 2004, Norian and Synthes did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA – but, instead, compounded their crimes by carrying out a coverup in which they lied to the FDA during an official inspection in May and June 2004.
Levy said, “We have an FDA approval process to be certain that medicines and medical devices that are used in the United States have gone through appropriate testing to determine that the products are safe and effective. The FDA requires its independent review of the tests to ensure that companies do not put their financial interests ahead of the health and safety of the American people. The defendants charged today bypassed the process, with the knowledge that the product that they were marketing posed potentially significant risks. When predictable bad results occurred, they lied to the FDA investigators. They put their profits ahead of responsible business practices and the truth.”
Norian SRS and Norian XR were bone cements that were used in treating fractures.
Hertz said, “This case is another example of the Department of Justice working together as a team to enforce the Food, Drug, and Cosmetic Act against companies and individuals that fail to market their products in compliance with that statute.”
“The FDA's Office of Criminal Investigations aggressively pursues and supports the prosecution of those who endanger the public health by circumventing the safeguards the FDA has in place to ensure that clinical trials are adequately supervised and controlled and that the public receives medical devices that have been shown to be safe and effective,” said Michael Chappell, acting associate commissioner for regulatory affairs. “We will continue to do all we can to protect the public against companies and their representatives who are not truthful, put patients’s health at risk and undermine the regulatory process.”
“It is never acceptable for the health care industry to place the profit motive over people’s well being,” said Patrick Doyle. “The FDA review process was put in place to protect the nation’s citizens. Should these companies and executives ultimately be found guilty, they will have to pay a price for placing at risk the very people for whom they purported to provide relief.”
Summary of the Charges
The indictment charges that from the beginning, the intended market for Norian XR was for an unapproved use, i.e., in surgeries to treat VCFs. According to the indictment, the company recognized early on that there were two possible solutions to this problem: (1) the legal solution, which was to disclose to the FDA the intended use of the product and then to try to secure FDA approval of XR for use in surgeries to treat VCFs after obtaining an investigational device exemption (“IDE”) to investigate the safety and efficacy of the product, and (2) the illegal solution, which was to promote XR for use in VCFs through a limited so-called “test market,” during which the company would evaluate the safety and efficacy of the product in unapproved clinical trials and judge their success according to its own standards. The indictment charges that the company and its coconspirators consciously and deliberately chose the illegal solution. That is, according to the indictment , the company intentionally bypassed the requirement that it obtain permission from the FDA to conduct clinical trials of the XR device on human beings for an unapproved use – permission that it knew it needed. With the so-called “test market,” the company allegedly tried to save time and money by cutting out the FDA’s oversight of clinical trials of its device. The indictment charges that the company did this for two principal reasons: to rush XR to the market first, before its competitors, and to generate published studies that it could use later to convince other surgeons to use XR off-label to treat VCFs.
Starting as early as late summer 2002, the company allegedly approached selected spine surgeons and asked them to use a predecessor device, SRS, in VCF procedures as part of an initial Synthes “test market” for SRS. Despite a June 2002 plea from one of Synthes’s own surgeon consultants that conducting such a “test market” would “amount to human experimentation whose only defense seems to be that it will be a small study [,]” Norian and its coconspirators allegedly embarked on the SRS “test market.” According to the indictment, the company taught the selected surgeons the recipe for mixing SRS with barium sulfate to make it more radiopaque, a process called “back-table mixing,” and trained two groups of surgeons in the use of SRS to treat VCFs. After training the two groups of surgeons as initial “test market” sites, the company allegedly enlisted these “test market site” surgeons to train other surgeons on how to use XR to treat VCFs.
According to the indictment, the company conducted two XR “Test Market Kick-Off” surgeon meetings, and one surgeon forum, from August of 2003 through mid-January 2004, training approximately 52 spine surgeons how to use Norian XR to treat VCFs. It is charged that, after the third person died on the operating table during a surgery in which a Norian cement was used to treat VCFs, the company cancelled the future surgeon forums. The indictment alleges that the company considered, but rejected, the idea of recalling or removing XR from the market, either of which actions would have required them to notify the FDA.
Three months later, according to the indictment , when the FDA conducted an unannounced inspection at the Norian plant in West Chester, focused on whether or not Norian and Synthes had conducted an unauthorized clinical trial of XR, a number of Synthes employees, including individual defendants Huggins, Bohner and Walsh, made materially false and misleading statements to the FDA investigator.
“The Department of Defense is outraged by a company that potentially puts our military personnel, their family members, and veterans at undue risk for serious medical complications or even death, just to increase their corporate bottom line,” said DCIS Assistant Special Agent in Charge Kenneth Maupin. “Criminal matters that affect the welfare, morale and readiness of our men and women in the military are of the highest priority to the Defense Criminal Investigative Service. Our military put their lives on the line every day for the American people. They deserve to feel safe that they and their families are not put at undue risk when having a medical procedure.”
“Corporate profits and individual greed, which caused senior managers of Synthes to skirt the rules and compromise patient safety, were at the core of this investigation,” said VA Inspector General George Opfer. “This team of investigators worked tirelessly to move this case forward and our citizens were well served by their efforts.”
INFORMATION REGARDING THE DEFENDANTS
NAME ADDRESS AGE OR YEAR OF BIRTH Norian Corporation West Chester PA Synthes, Inc. West Chester PA Michael D. Huggins West Chester PA 51
NAME ADDRESS AGE OR YEAR OF BIRTH Thomas B. Higgins Berwyn PA 52 Richard E. Bohner Malvern PA 55 John J. Walsh Coatesville PA 46
If convicted defendant Norian Corporation faces a maximum possible sentence of a fine of $26,000,000, five years probation, full restitution, forfeiture of $469,800 and special assessments of $20,800. Defendant Synthes faces a maximum possible sentence of a fine of $8,800,000, five years probation, full restitution, forfeiture of $469,800 and a special assessment of $5,500. Each of the individual defendants faces a maximum sentence of one year in prison, a fine of $100,000, full restitution and one year of supervised release.
This case was investigated by the United States Food and Drug Administration (“FDA”) Office of Criminal Investigations; the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”); the Department of Defense Criminal Investigative Service (“DCIS”), and the Veterans’ Administration OIG. The case is being prosecuted by Assistant United States Attorneys Mary E. Crawley, Gerald B. Sullivan, David J. Caputo, Laura
A. Pawloski, Associate Chief Counsel, FDA Office of Chief Counsel, and Joel Schwartz, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation. UNITED STATES ATTORNEY'S OFFICE Contact: PATTY HARTMAN EASTERN DISTRICT, PENNSYLVANIA Media Contact Suite 1250, 615 Chestnut Street 215-861-8525
Philadelphia, PA 19106
COPIES OF NEWS MEMOS AND RELATED DOCUMENTS CAN ALSO BE FOUND AT http://www.usdoj.gov/usao/pae
INTERNATIONAL MEDICAL DEVICE MAKER AND FOUR EXECUTIVES CHARGED IN CONNECTION WITH UNLAWFUL CLINICAL TRIALS
United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz today announced the return of an indictment 1 against Norian Corporation (“Norian”), Synthes, Inc. (“Synthes”), and four top Synthes executives, Michael D. Huggins (“Huggins”), Thomas B. Higgins (“Higgins”), Richard E. Bohner (“Bohner”) and John J. Walsh (“Walsh”), charging them for their involvement in conducting clinical trials of a medical device without the authorization of the FDA. Joining in today’s announcement were Food and Drug Administration (“FDA”) Office of Criminal Investigations Special Agent-in-Charge Kim A. Rice; Department of Health and Human Services (“HHS”) Office of Inspector General Office of Investigations Special Agent-in-Charge Patrick Doyle; Defense Criminal Investigative Service (“DCIS”) Special Agent-in-Charge Edward Bradley; and Department of Veterans Affairs (“VA”) Special Agent-in-Charge Jeffrey G. Hughes, Northeast Field Office, Office of Inspector General.
The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud. The parent company, Synthes, is charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. As explained below, these crimes allegedly prevented the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provided by FDA oversight of clinical trials.
1An indictment or information is an accusation. A defendant is presumed innocent unless and until proven guilty.
According to the indictment, Synthes, a Delaware corporation based in West Chester, Pennsylvania, is the United States branch of a large multinational medical device manufacturer which specializes in trauma products to treat damaged human bone. Norian, it is alleged, is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pennsylvania.
Defendant Huggins was allegedly employed by Synthes as the President of Synthes North America, a subsidiary of Synthes. It is alleged that in February 2004, Huggins became the President of Synthes Spine, a division of Synthes. Defendant Higgins was allegedly the President of Synthes Spine, a division of Synthes, reporting to Huggins. In February 2004, Higgins allegedly left that position and became Synthes’s Senior Vice President of Global Strategy. The indictment alleges that defendant Bohner was employed by Synthes as its Vice President of Operations, reporting to Huggins. Defendant Walsh was allegedly employed by Synthes starting in August 2003 as its Director of Regulatory and Clinical Affairs, Spine Division, and reported first to Bohner and later to Huggins.
The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes’s medical devices, Norian XR and Norian SRS, in surgeries to treat vertebral compression fracturesof the spine (“VCFs”), a painful condition commonly suffered by elderly individuals. These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine. According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such Norian-caused clots became lodged in the lungs. Notwithstanding this knowledge, the company allegedly proceeded to market the product for VCFs without putting it through FDA-required testing. The company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. The indictment further alleges that after the death of the third patient in January 2004, Norian and Synthes did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA – but, instead, compounded their crimes by carrying out a coverup in which they lied to the FDA during an official inspection in May and June 2004.
Levy said, “We have an FDA approval process to be certain that medicines and medical devices that are used in the United States have gone through appropriate testing to determine that the products are safe and effective. The FDA requires its independent review of the tests to ensure that companies do not put their financial interests ahead of the health and safety of the American people. The defendants charged today bypassed the process, with the knowledge that the product that they were marketing posed potentially significant risks. When predictable bad results occurred, they lied to the FDA investigators. They put their profits ahead of responsible business practices and the truth.”
Norian SRS and Norian XR were bone cements that were used in treating fractures.
Hertz said, “This case is another example of the Department of Justice working together as a team to enforce the Food, Drug, and Cosmetic Act against companies and individuals that fail to market their products in compliance with that statute.”
“The FDA's Office of Criminal Investigations aggressively pursues and supports the prosecution of those who endanger the public health by circumventing the safeguards the FDA has in place to ensure that clinical trials are adequately supervised and controlled and that the public receives medical devices that have been shown to be safe and effective,” said Michael Chappell, acting associate commissioner for regulatory affairs. “We will continue to do all we can to protect the public against companies and their representatives who are not truthful, put patients’s health at risk and undermine the regulatory process.”
“It is never acceptable for the health care industry to place the profit motive over people’s well being,” said Patrick Doyle. “The FDA review process was put in place to protect the nation’s citizens. Should these companies and executives ultimately be found guilty, they will have to pay a price for placing at risk the very people for whom they purported to provide relief.”
Summary of the Charges
The indictment charges that from the beginning, the intended market for Norian XR was for an unapproved use, i.e., in surgeries to treat VCFs. According to the indictment, the company recognized early on that there were two possible solutions to this problem: (1) the legal solution, which was to disclose to the FDA the intended use of the product and then to try to secure FDA approval of XR for use in surgeries to treat VCFs after obtaining an investigational device exemption (“IDE”) to investigate the safety and efficacy of the product, and (2) the illegal solution, which was to promote XR for use in VCFs through a limited so-called “test market,” during which the company would evaluate the safety and efficacy of the product in unapproved clinical trials and judge their success according to its own standards. The indictment charges that the company and its coconspirators consciously and deliberately chose the illegal solution. That is, according to the indictment , the company intentionally bypassed the requirement that it obtain permission from the FDA to conduct clinical trials of the XR device on human beings for an unapproved use – permission that it knew it needed. With the so-called “test market,” the company allegedly tried to save time and money by cutting out the FDA’s oversight of clinical trials of its device. The indictment charges that the company did this for two principal reasons: to rush XR to the market first, before its competitors, and to generate published studies that it could use later to convince other surgeons to use XR off-label to treat VCFs.
Starting as early as late summer 2002, the company allegedly approached selected spine surgeons and asked them to use a predecessor device, SRS, in VCF procedures as part of an initial Synthes “test market” for SRS. Despite a June 2002 plea from one of Synthes’s own surgeon consultants that conducting such a “test market” would “amount to human experimentation whose only defense seems to be that it will be a small study [,]” Norian and its coconspirators allegedly embarked on the SRS “test market.” According to the indictment, the company taught the selected surgeons the recipe for mixing SRS with barium sulfate to make it more radiopaque, a process called “back-table mixing,” and trained two groups of surgeons in the use of SRS to treat VCFs. After training the two groups of surgeons as initial “test market” sites, the company allegedly enlisted these “test market site” surgeons to train other surgeons on how to use XR to treat VCFs.
According to the indictment, the company conducted two XR “Test Market Kick-Off” surgeon meetings, and one surgeon forum, from August of 2003 through mid-January 2004, training approximately 52 spine surgeons how to use Norian XR to treat VCFs. It is charged that, after the third person died on the operating table during a surgery in which a Norian cement was used to treat VCFs, the company cancelled the future surgeon forums. The indictment alleges that the company considered, but rejected, the idea of recalling or removing XR from the market, either of which actions would have required them to notify the FDA.
Three months later, according to the indictment , when the FDA conducted an unannounced inspection at the Norian plant in West Chester, focused on whether or not Norian and Synthes had conducted an unauthorized clinical trial of XR, a number of Synthes employees, including individual defendants Huggins, Bohner and Walsh, made materially false and misleading statements to the FDA investigator.
“The Department of Defense is outraged by a company that potentially puts our military personnel, their family members, and veterans at undue risk for serious medical complications or even death, just to increase their corporate bottom line,” said DCIS Assistant Special Agent in Charge Kenneth Maupin. “Criminal matters that affect the welfare, morale and readiness of our men and women in the military are of the highest priority to the Defense Criminal Investigative Service. Our military put their lives on the line every day for the American people. They deserve to feel safe that they and their families are not put at undue risk when having a medical procedure.”
“Corporate profits and individual greed, which caused senior managers of Synthes to skirt the rules and compromise patient safety, were at the core of this investigation,” said VA Inspector General George Opfer. “This team of investigators worked tirelessly to move this case forward and our citizens were well served by their efforts.”
INFORMATION REGARDING THE DEFENDANTS
NAME ADDRESS AGE OR YEAR OF BIRTH Norian Corporation West Chester PA Synthes, Inc. West Chester PA Michael D. Huggins West Chester PA 51
NAME ADDRESS AGE OR YEAR OF BIRTH Thomas B. Higgins Berwyn PA 52 Richard E. Bohner Malvern PA 55 John J. Walsh Coatesville PA 46
If convicted defendant Norian Corporation faces a maximum possible sentence of a fine of $26,000,000, five years probation, full restitution, forfeiture of $469,800 and special assessments of $20,800. Defendant Synthes faces a maximum possible sentence of a fine of $8,800,000, five years probation, full restitution, forfeiture of $469,800 and a special assessment of $5,500. Each of the individual defendants faces a maximum sentence of one year in prison, a fine of $100,000, full restitution and one year of supervised release.
This case was investigated by the United States Food and Drug Administration (“FDA”) Office of Criminal Investigations; the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”); the Department of Defense Criminal Investigative Service (“DCIS”), and the Veterans’ Administration OIG. The case is being prosecuted by Assistant United States Attorneys Mary E. Crawley, Gerald B. Sullivan, David J. Caputo, Laura
A. Pawloski, Associate Chief Counsel, FDA Office of Chief Counsel, and Joel Schwartz, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation. UNITED STATES ATTORNEY'S OFFICE Contact: PATTY HARTMAN EASTERN DISTRICT, PENNSYLVANIA Media Contact Suite 1250, 615 Chestnut Street 215-861-8525
Philadelphia, PA 19106
COPIES OF NEWS MEMOS AND RELATED DOCUMENTS CAN ALSO BE FOUND AT http://www.usdoj.gov/usao/pae
Nevada Couple Pleads Guilty to Distributing Melamine-Tainted Gluten
Nevada Couple Pleads Guilty to Distributing Melamine-Tainted Gluten
Possible sentence of two years in prison, $200,000 fine
A Nevada couple pled guilty in federal court today to distributing melamine-tainted wheat gluten, the ingredient blamed for the illnesses of deaths of thousands dogs and cats nationwide during the massive 2007 pet food recall.
Sally Qing Miller, 43, a Chinese national, and her husband, Stephen S. Miller, 56 — along with their company, Chemnutra, Inc., — entered their guilty pleas late this afternoon before U.S. Magistrate Judge John Maughmer.
Sally Miller is the controlling owner and president of Chemnutra; Stephen Miller is an owner and chief executive officer of Chemnutra.
Each of the co-defendants pleaded guilty to one count of selling adulterated food and one count of selling misbranded food.
"Millions of pet owners were impacted by the pet food recall in 2007," said Matt J. Whitworth, acting United States Attorney for the Western District of Missouri. "The conduct of these defendants in violating federal health and safety standards caused the deaths and illness of thousands of family pets, as well as anxiety among dog and cat owners across the country and economic harm to many pet food manufacturers."
FULL STORY: http://www.consumeraffairs.com/news04/2009/06/chinese_formula21.html#ixzz0Ipb6RESY&D
Possible sentence of two years in prison, $200,000 fine
A Nevada couple pled guilty in federal court today to distributing melamine-tainted wheat gluten, the ingredient blamed for the illnesses of deaths of thousands dogs and cats nationwide during the massive 2007 pet food recall.
Sally Qing Miller, 43, a Chinese national, and her husband, Stephen S. Miller, 56 — along with their company, Chemnutra, Inc., — entered their guilty pleas late this afternoon before U.S. Magistrate Judge John Maughmer.
Sally Miller is the controlling owner and president of Chemnutra; Stephen Miller is an owner and chief executive officer of Chemnutra.
Each of the co-defendants pleaded guilty to one count of selling adulterated food and one count of selling misbranded food.
"Millions of pet owners were impacted by the pet food recall in 2007," said Matt J. Whitworth, acting United States Attorney for the Western District of Missouri. "The conduct of these defendants in violating federal health and safety standards caused the deaths and illness of thousands of family pets, as well as anxiety among dog and cat owners across the country and economic harm to many pet food manufacturers."
FULL STORY: http://www.consumeraffairs.com/news04/2009/06/chinese_formula21.html#ixzz0Ipb6RESY&D
Tuesday, June 16, 2009
STEAMING MAD! Consumers way of thinking about recalls must be updated!
We are STEAMING MAD!
WHY?
"Six Reported Deaths Prompt Urgent Re-announcement of Blair Recall of Women’s Chenille Robes" http://www.totalrecallinfo.com/recalls.php?id=12051
We announced this recall in April along with the CPSC.
We have contacted the governments of several countrys, senators, media outlets, government & corporate recall sources, etc. all in the hopes that one or two may let you, the consumer, know there now exists a One-Stop Recall Service that would eliminate such deadly headlines.
Instead of helping you, these entitys decided to keep you in the dark about our life saving service!
As sad as these are, I suggest to you these six deaths could have been avoided.
Every Government/ Media outlet we contacted in our 2 years of operation, has some of these poor souls blood on their hands.
Shame!
This is less a promo, and more of a community service, as we offer free and paid services.
Of course, we are like any other corporation. We want to maximize profits like anyone. But we never falter from our goal, and that is keeping consumers in the know about all recalls
worldwide.
STEAMING MAD (part 2)
Somebody emails us the other day. "Why don't you put flags on your recalls so we know which ones are dangerous"
I tell you what I told him.
Who am I, or the Government, or the Media to decide for you what is dangerous to you, or your family?
One persons allergy alert is anothers e-coli recall! You have the final word, as long as you ARE AWARE, is the key.
Another thing.
Do you think companys announce a recall that will cost them (sometimes millions) for the fun of it? Maybe get some publicity?
No!
They announce recalls because they ARE dangerous, sometimes more than is lead to believe.
But they also rely on OUR old, antiquated way of thinking about recalls to avoid lost profits!
"That recall doesn't affect us"
"Recalls are usually not dangerous, they tell us about dangerous ones"
"I don't have the time to look up recalls"
The simple fact is companys must announce a recall by law!
MOST do not want you to know about it!
It still baffles us that people will go to great lengths to make sure their child is safe on the drive to the store, but not be concerned that a product from that store may harm them!
Consumers way of thinking about recalls must be updated!
WHY?
"Six Reported Deaths Prompt Urgent Re-announcement of Blair Recall of Women’s Chenille Robes" http://www.totalrecallinfo.com/recalls.php?id=12051
We announced this recall in April along with the CPSC.
We have contacted the governments of several countrys, senators, media outlets, government & corporate recall sources, etc. all in the hopes that one or two may let you, the consumer, know there now exists a One-Stop Recall Service that would eliminate such deadly headlines.
Instead of helping you, these entitys decided to keep you in the dark about our life saving service!
As sad as these are, I suggest to you these six deaths could have been avoided.
Every Government/ Media outlet we contacted in our 2 years of operation, has some of these poor souls blood on their hands.
Shame!
This is less a promo, and more of a community service, as we offer free and paid services.
Of course, we are like any other corporation. We want to maximize profits like anyone. But we never falter from our goal, and that is keeping consumers in the know about all recalls
worldwide.
STEAMING MAD (part 2)
Somebody emails us the other day. "Why don't you put flags on your recalls so we know which ones are dangerous"
I tell you what I told him.
Who am I, or the Government, or the Media to decide for you what is dangerous to you, or your family?
One persons allergy alert is anothers e-coli recall! You have the final word, as long as you ARE AWARE, is the key.
Another thing.
Do you think companys announce a recall that will cost them (sometimes millions) for the fun of it? Maybe get some publicity?
No!
They announce recalls because they ARE dangerous, sometimes more than is lead to believe.
But they also rely on OUR old, antiquated way of thinking about recalls to avoid lost profits!
"That recall doesn't affect us"
"Recalls are usually not dangerous, they tell us about dangerous ones"
"I don't have the time to look up recalls"
The simple fact is companys must announce a recall by law!
MOST do not want you to know about it!
It still baffles us that people will go to great lengths to make sure their child is safe on the drive to the store, but not be concerned that a product from that store may harm them!
Consumers way of thinking about recalls must be updated!
Cat-food irradiation banned as pet theory proved- Australia
Cat-food irradiation banned as pet theory proved
A series of mysterious cat deaths was caused by the government-mandated practice of irradiating imported pet food.
The Agriculture Minister, Tony Burke, has ordered the controversial sterilization process, which has been in place for more than a decade, to cease immediately, following compelling overseas evidence that some cats can suffer fatal neurological damage after eating irradiated dry food.
Dogs do not appear to be affected by similarly treated food.
About 90 cats fell ill last year [2008] and 30 died before a Sydney vet, Georgina Child, made the link in November between the mystery illness and a brand of Canadian gourmet pet food called Orijen.
The manufacturer, Champion Petfoods, blamed the contaminated food on Australian quarantine regulations, which demand that pet food not cooked over a specified temperature undergo irradiation of 50 kiloGrays upon arrival in the country. Of the 60 countries Champion Petfoods exports to, only Australia makes irradiation compulsory.
The Australian Quarantine and Inspection Service and the company that carries out the process, Steritech, insisted at the time the irradiation process was harmless. A limited range of imported human foods, including dried herbs and some tropical fruits, are also irradiated before landing on store shelves, but at much lower levels than that mandated for pet food.
Mr Burke said the inspection service decided to act in response to international reports his department received only late last week [week of 18 May 2009]. Work was being done in state and federal governments to see how safety standards for pet food could be improved. "People expect that any treatments conducted on imported pet food will result in food that is still safe for pets," he said.
Dr Child said the move was welcome but did not go far enough. The irradiation ban is not being extended to imported dog food, leaving cats with access to such food still at risk. "We still don't know why this problem is unique to cats, and we're still not certain why some brands of pet food are affected by irradiation and not others," she said. "What this does show is that all food that has been irradiated needs to be labelled, which isn't the case at the moment."
Champion Petfoods has set up a fund to disperse compensation for veterinary bills for all affected Australian cat owners.
A series of mysterious cat deaths was caused by the government-mandated practice of irradiating imported pet food.
The Agriculture Minister, Tony Burke, has ordered the controversial sterilization process, which has been in place for more than a decade, to cease immediately, following compelling overseas evidence that some cats can suffer fatal neurological damage after eating irradiated dry food.
Dogs do not appear to be affected by similarly treated food.
About 90 cats fell ill last year [2008] and 30 died before a Sydney vet, Georgina Child, made the link in November between the mystery illness and a brand of Canadian gourmet pet food called Orijen.
The manufacturer, Champion Petfoods, blamed the contaminated food on Australian quarantine regulations, which demand that pet food not cooked over a specified temperature undergo irradiation of 50 kiloGrays upon arrival in the country. Of the 60 countries Champion Petfoods exports to, only Australia makes irradiation compulsory.
The Australian Quarantine and Inspection Service and the company that carries out the process, Steritech, insisted at the time the irradiation process was harmless. A limited range of imported human foods, including dried herbs and some tropical fruits, are also irradiated before landing on store shelves, but at much lower levels than that mandated for pet food.
Mr Burke said the inspection service decided to act in response to international reports his department received only late last week [week of 18 May 2009]. Work was being done in state and federal governments to see how safety standards for pet food could be improved. "People expect that any treatments conducted on imported pet food will result in food that is still safe for pets," he said.
Dr Child said the move was welcome but did not go far enough. The irradiation ban is not being extended to imported dog food, leaving cats with access to such food still at risk. "We still don't know why this problem is unique to cats, and we're still not certain why some brands of pet food are affected by irradiation and not others," she said. "What this does show is that all food that has been irradiated needs to be labelled, which isn't the case at the moment."
Champion Petfoods has set up a fund to disperse compensation for veterinary bills for all affected Australian cat owners.
Monday, June 15, 2009
FDA Suspends Temporary Emergency Permit of Pet Food Maker Evanger's Dog & Cat Food Co.
FDA Suspends Temporary Emergency Permit of Pet Food Maker
The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.
Evanger's, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products. The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.
In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit” after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit. During inspections conducted between March 2009 and April 2009, FDA determined Evanger’s was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit.
“The FDA is stopping Evanger's ability to ship pet food in interstate commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”
In order for Evanger's to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.
Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.
While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA's Center for Veterinary Medicine has authority over animal feed and foods. The two centers are collaborating on this enforcement action.
The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.
Evanger's, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products. The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.
In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit” after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit. During inspections conducted between March 2009 and April 2009, FDA determined Evanger’s was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit.
“The FDA is stopping Evanger's ability to ship pet food in interstate commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”
In order for Evanger's to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.
Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.
While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA's Center for Veterinary Medicine has authority over animal feed and foods. The two centers are collaborating on this enforcement action.
Wednesday, June 10, 2009
FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
Patients Still Have Access to Approved Narcotics for Pain Relief
The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.
The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.
"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."
Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.
Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products.
These consumers should consult a health care professional for detailed guidance on treatment options.
"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."
Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.
To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at:http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics
Information on FDA-approved drugs
Drugs Marketed in the United States That Do Not Have Required FDA Approval:http://www.fda.gov/cder/drug/unapproved_drugs
If you would like to hear a replay of the FDA's telebriefing on this issue, callers in the United States and Canada may dial 1-888-566-0502. International callers may dial 1-203-369-3058.
The replay will be available until April 6, 2009 at 11:59 p.m. EDT.
Patients Still Have Access to Approved Narcotics for Pain Relief
The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.
The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.
"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."
Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.
Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products.
These consumers should consult a health care professional for detailed guidance on treatment options.
"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."
Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.
To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at:http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics
Information on FDA-approved drugs
Drugs Marketed in the United States That Do Not Have Required FDA Approval:http://www.fda.gov/cder/drug/unapproved_drugs
If you would like to hear a replay of the FDA's telebriefing on this issue, callers in the United States and Canada may dial 1-888-566-0502. International callers may dial 1-203-369-3058.
The replay will be available until April 6, 2009 at 11:59 p.m. EDT.
Sunday, June 7, 2009
Mattel, Fisher-Price to Pay $2.3 Million Civil Penalty for Violating Federal Lead Paint Ban
Mattel, Fisher-Price to Pay $2.3 Million Civil Penalty for Violating Federal Lead Paint Ban
Penalty is highest ever for CPSC regulated product violations
WASHINGTON, D.C. - As part of its commitment to protecting the safety of children, the U.S. Consumer Product Safety Commission (CPSC) announced today that Mattel Inc., of El Segundo, Calif. and its wholly owned subsidiary, Fisher-Price Inc., of East Aurora, N.Y. have agreed to pay a $2.3 million civil penalty for violating the federal lead paint ban.
The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Mattel and Fisher-Price knowingly (as defined in the Consumer Product Safety Act) imported and sold children’s toys with paints or other surface coatings that contained lead levels that violated a 30-year-old federal law. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. In 2007, about 95 Mattel and Fisher-Price toy models were determined to have exceeded this limit. Lead can be toxic if ingested by young children and can cause adverse health consequences.
This civil penalty, which is the highest for violations involving importation or distribution in commerce of a regulated product and is the third highest of any kind in CPSC history, settles the following allegations:
Mattel imported up to 900,000 non-compliant toys between September 2006 and August 2007, including the “Sarge” toy car and numerous Barbie accessory toys, and distributed most of them to its retail customers for sale to U.S. consumers. The “Sarge” car was recalled in August 2007 and the Barbie toys were recalled in September 2007.
Fisher-Price imported up to 1.1 million non-compliant toys between July 2006 and August 2007, including certain licensed character toys and the Bongo Band, GEOTRAX locomotive, and Go Diego Go Rescue Boat toys. Most of these toys were distributed to retail stores for sale to consumers. The licensed character toys were recalled in August 2007, the Bongo Band and GEO TRAX toys were recalled in September 2007, and the Go Diego Go Boat toys were recalled in October 2007.
“These highly publicized toy recalls helped spur Congressional action last year to strengthen CPSC and make even stricter the ban on lead paint on toys,” said CPSC Acting Chairman Thomas Moore. “This penalty should serve notice to toy makers that CPSC is committed to the safety of children, to reducing their exposure to lead, and to the implementation of the Consumer Product Safety Improvement Act.”
This settlement also resolves other potential matters. In agreeing to the settlement, Mattel and Fisher-Price deny that they knowingly violated federal law, as alleged by CPSC staff.
Penalty is highest ever for CPSC regulated product violations
WASHINGTON, D.C. - As part of its commitment to protecting the safety of children, the U.S. Consumer Product Safety Commission (CPSC) announced today that Mattel Inc., of El Segundo, Calif. and its wholly owned subsidiary, Fisher-Price Inc., of East Aurora, N.Y. have agreed to pay a $2.3 million civil penalty for violating the federal lead paint ban.
The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Mattel and Fisher-Price knowingly (as defined in the Consumer Product Safety Act) imported and sold children’s toys with paints or other surface coatings that contained lead levels that violated a 30-year-old federal law. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. In 2007, about 95 Mattel and Fisher-Price toy models were determined to have exceeded this limit. Lead can be toxic if ingested by young children and can cause adverse health consequences.
This civil penalty, which is the highest for violations involving importation or distribution in commerce of a regulated product and is the third highest of any kind in CPSC history, settles the following allegations:
Mattel imported up to 900,000 non-compliant toys between September 2006 and August 2007, including the “Sarge” toy car and numerous Barbie accessory toys, and distributed most of them to its retail customers for sale to U.S. consumers. The “Sarge” car was recalled in August 2007 and the Barbie toys were recalled in September 2007.
Fisher-Price imported up to 1.1 million non-compliant toys between July 2006 and August 2007, including certain licensed character toys and the Bongo Band, GEOTRAX locomotive, and Go Diego Go Rescue Boat toys. Most of these toys were distributed to retail stores for sale to consumers. The licensed character toys were recalled in August 2007, the Bongo Band and GEO TRAX toys were recalled in September 2007, and the Go Diego Go Boat toys were recalled in October 2007.
“These highly publicized toy recalls helped spur Congressional action last year to strengthen CPSC and make even stricter the ban on lead paint on toys,” said CPSC Acting Chairman Thomas Moore. “This penalty should serve notice to toy makers that CPSC is committed to the safety of children, to reducing their exposure to lead, and to the implementation of the Consumer Product Safety Improvement Act.”
This settlement also resolves other potential matters. In agreeing to the settlement, Mattel and Fisher-Price deny that they knowingly violated federal law, as alleged by CPSC staff.
Friday, June 5, 2009
Massachusetts Department of Public Health Reminds Consumers of State Fish Advisory
Massachusetts Department of Public Health Reminds Consumers of State Fish Advisory
In preparation for this summer’s fishing season, the Massachusetts Department of Public Health (DPH) is reminding the public about eating certain types of fish because of concerns about contaminants in marine fish, shellfish and freshwater fish. DPH advises pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age not to eat the following marine fish because they contain mercury: shark, swordfish, king mackerel, tuna and tilefish. In addition, DPH also advises this population not to eat freshwater fish for the same reason.
Because of concerns about chemicals such as PCBs and mercury, DPH also recommends the following:
•No one should consume lobster tomalley from any source. Lobster tomalley is the soft green substance found in the tail and body section of the lobster . Lobster meat does not normally accumulate toxins, so it is safe to eat.
•Pregnant women, women who may become pregnant, and breastfeeding women should not eat bluefish.
•No one should take and eat lobsters and certain other fish/shellfish from the closed areas of New Bedford Harbor.
•Pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age and people with lowered immunity should not eat lobster, flounder, soft shell clams or bivalves from Boston Harbor.
•In addition, DPH recommends pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age limit their consumption of any fish to no more than 12 ounces (or about two meals) per week. This includes eating no more than two cans of tuna per week. Very small children, including toddlers, should eat even less.
Consumers may wish to eat light tuna rather than white or chunk white tuna because white tuna has higher levels of mercury.
Despite the fish consumption advisories, DPH recognizes the substantial benefits of fish consumption for everyone. Fish is one of the best sources of natural fatty acids that are helpful in reducing the risk of heart disease. Salmon, for example, has among the highest levels of natural fatty acids. Fish is also low in saturated fats and high in protein. A varied diet, including fish, will lead to improved nutrition and better health.
In order to avoid exposure to a harmful level of contaminates, people should choose a variety of fish and shellfish and obtain them from a variety of sources. These sources include commercial fish and recreationally-caught marine fish and shellfish.
A full list of advisories specific to recreationally caught freshwater and marine species are listed on the DPH website: www.mass.gov/dph/fishadvisories.
Population Type of Fish/Shellfish to Avoid Everyone From any location: Lobster Tomalley
From closed areas of New Bedford Harbor: Lobsters
Certain Fish and Shellfish
Pregnant Woman
Woman Who May Become Pregnant
Nursing Mothers From Any Location:
Bluefish
Freshwater Fish
Shark
Swordfish
King Mackerel
Tuna
Tilefish
From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves Children Under 12 From Any Location:
Bluefish
Freshwater Fish
Shark
Swordfish
King Mackerel
Tuna
Tilefish
From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves
People with Weakened Immune Systems From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves
In preparation for this summer’s fishing season, the Massachusetts Department of Public Health (DPH) is reminding the public about eating certain types of fish because of concerns about contaminants in marine fish, shellfish and freshwater fish. DPH advises pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age not to eat the following marine fish because they contain mercury: shark, swordfish, king mackerel, tuna and tilefish. In addition, DPH also advises this population not to eat freshwater fish for the same reason.
Because of concerns about chemicals such as PCBs and mercury, DPH also recommends the following:
•No one should consume lobster tomalley from any source. Lobster tomalley is the soft green substance found in the tail and body section of the lobster . Lobster meat does not normally accumulate toxins, so it is safe to eat.
•Pregnant women, women who may become pregnant, and breastfeeding women should not eat bluefish.
•No one should take and eat lobsters and certain other fish/shellfish from the closed areas of New Bedford Harbor.
•Pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age and people with lowered immunity should not eat lobster, flounder, soft shell clams or bivalves from Boston Harbor.
•In addition, DPH recommends pregnant women, women who may become pregnant, nursing mothers and children under 12 years of age limit their consumption of any fish to no more than 12 ounces (or about two meals) per week. This includes eating no more than two cans of tuna per week. Very small children, including toddlers, should eat even less.
Consumers may wish to eat light tuna rather than white or chunk white tuna because white tuna has higher levels of mercury.
Despite the fish consumption advisories, DPH recognizes the substantial benefits of fish consumption for everyone. Fish is one of the best sources of natural fatty acids that are helpful in reducing the risk of heart disease. Salmon, for example, has among the highest levels of natural fatty acids. Fish is also low in saturated fats and high in protein. A varied diet, including fish, will lead to improved nutrition and better health.
In order to avoid exposure to a harmful level of contaminates, people should choose a variety of fish and shellfish and obtain them from a variety of sources. These sources include commercial fish and recreationally-caught marine fish and shellfish.
A full list of advisories specific to recreationally caught freshwater and marine species are listed on the DPH website: www.mass.gov/dph/fishadvisories.
Population Type of Fish/Shellfish to Avoid Everyone From any location: Lobster Tomalley
From closed areas of New Bedford Harbor: Lobsters
Certain Fish and Shellfish
Pregnant Woman
Woman Who May Become Pregnant
Nursing Mothers From Any Location:
Bluefish
Freshwater Fish
Shark
Swordfish
King Mackerel
Tuna
Tilefish
From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves Children Under 12 From Any Location:
Bluefish
Freshwater Fish
Shark
Swordfish
King Mackerel
Tuna
Tilefish
From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves
People with Weakened Immune Systems From Boston Harbor:
Lobster
Flounder
Soft shell clams
Bivalves
New study highlights undeclared ingredients in chicken products---U.K.
New study highlights undeclared ingredients in chicken products
The Food Standards Agency (FSA) has carried out an exploratory study into injection powders used to retain water in chicken breast products supplied mainly to the catering trade.
Water can be added to chicken products by manufacturers for a number of reasons, for example to improve the succulence of the meat. Adding water to chicken is permitted, but where the water content is greater than 5%, water must be declared in the name of the food and listed as an ingredient. Fresh chicken meat that you buy from supermarkets or butchers cannot have any ingredients, including water, deliberately added to it.
The agents used to hold added water in chicken can include salt, phosphates and hydrolysed animal proteins; these are supplied to manufacturers in mixtures as injection powders. When water retaining agents are used, they must be described accurately on the label.
The FSA’s snapshot study looked at a small number of injection powders that claimed to contain only chicken protein. Analysis using a new approach developed under the Agency’s authenticity programme indicated that proteins from beef or pork were also present in some of the samples. Hydrolysed pork and beef proteins can be used as water retaining agents in chicken as long as they are properly labelled. Use of these proteins does not make chicken products unsafe, but it is important that people are given accurate information about their food.
There is no evidence to suggest that there is a widespread problem with undeclared proteins in chicken products but the Agency is carrying out further studies and gathering more information in partnership with other European Member States.
Consumer advice
If you choose not to eat pork or beef you may wish to avoid chicken that contains hydrolysed animal proteins. If you are eating food from a restaurant or takeaway, you should ask if the chicken contains hydrolysed animal proteins. Restaurants and catering establishments will have this information available to them as it will be on the ingredients list of the products they buy.
More on the study
This small study was the first time this new approach has been used to look at the proteins used as water-retaining agents in injection powders. The FSA is working with researchers to establish what further work needs to be done to enable this cutting edge method to be used for routine analysis. The Agency is also considering what further surveys and enforcement activities will allow us, and enforcement authorities, to continue to monitor this issue.
The results published today are a full picture of the findings of the study as it stands. The Agency has omitted certain identifying details in relation to the specific products and companies involved; this is to ensure that any possible enforcement actions or follow-up investigations are not compromised.
Following a request from the FSA, an inspection of the factories that produce the injection powders sampled has been carried out. This is being followed up by discussion with the relevant food inspectors.
The Food Standards Agency has informed the European Commission of the results of the study and will be having further meetings with the Commission and the relevant Member States to address this issue in more depth.
The Food Standards Agency (FSA) has carried out an exploratory study into injection powders used to retain water in chicken breast products supplied mainly to the catering trade.
Water can be added to chicken products by manufacturers for a number of reasons, for example to improve the succulence of the meat. Adding water to chicken is permitted, but where the water content is greater than 5%, water must be declared in the name of the food and listed as an ingredient. Fresh chicken meat that you buy from supermarkets or butchers cannot have any ingredients, including water, deliberately added to it.
The agents used to hold added water in chicken can include salt, phosphates and hydrolysed animal proteins; these are supplied to manufacturers in mixtures as injection powders. When water retaining agents are used, they must be described accurately on the label.
The FSA’s snapshot study looked at a small number of injection powders that claimed to contain only chicken protein. Analysis using a new approach developed under the Agency’s authenticity programme indicated that proteins from beef or pork were also present in some of the samples. Hydrolysed pork and beef proteins can be used as water retaining agents in chicken as long as they are properly labelled. Use of these proteins does not make chicken products unsafe, but it is important that people are given accurate information about their food.
There is no evidence to suggest that there is a widespread problem with undeclared proteins in chicken products but the Agency is carrying out further studies and gathering more information in partnership with other European Member States.
Consumer advice
If you choose not to eat pork or beef you may wish to avoid chicken that contains hydrolysed animal proteins. If you are eating food from a restaurant or takeaway, you should ask if the chicken contains hydrolysed animal proteins. Restaurants and catering establishments will have this information available to them as it will be on the ingredients list of the products they buy.
More on the study
This small study was the first time this new approach has been used to look at the proteins used as water-retaining agents in injection powders. The FSA is working with researchers to establish what further work needs to be done to enable this cutting edge method to be used for routine analysis. The Agency is also considering what further surveys and enforcement activities will allow us, and enforcement authorities, to continue to monitor this issue.
The results published today are a full picture of the findings of the study as it stands. The Agency has omitted certain identifying details in relation to the specific products and companies involved; this is to ensure that any possible enforcement actions or follow-up investigations are not compromised.
Following a request from the FSA, an inspection of the factories that produce the injection powders sampled has been carried out. This is being followed up by discussion with the relevant food inspectors.
The Food Standards Agency has informed the European Commission of the results of the study and will be having further meetings with the Commission and the relevant Member States to address this issue in more depth.
Tuesday, June 2, 2009
FDA Awards $1 Million in Grants to Three States to Enhance Food and Feed Safety
FDA Awards $1 Million in Grants to Three States to Enhance Food and Feed Safety
Arkansas, Nebraska, and Wisconsin funded for Food Safety and Security Monitoring
The U.S. Food and Drug Administration recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds support cooperative agreements designed to create a national integrated food safety system through enhanced federal and state collaboration in food emergency response activities.
"We are excited to partner with these states as they perform such critical roles in ensuring food safety," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. "The FDA is committed to investing in efforts that will better protect American consumers from food safety and food defense threats."
The three states each received $350,000 to fund Food Emergency Response Network (FERN) chemistry laboratories. FERN labs are essential to the FDA’s regulatory efforts and the grants may be used for facility upgrades, training in current food testing methodologies, and increased laboratory sample analysis capacity, and other activities.
In the event of a large-scale event affecting food or food products, the grant recipients may be required to perform selected analyses of food samples collected by the FDA or provided by other government agencies through the FDA.
The state recipients and highlights for each grant include:
Arkansas – Arkansas Department of Health, Little Rock, Ark. The grant award will be used to increase the department’s ability to test for toxic and unknown substances in food products, provide regional support for national responses during food surveillance activities, increase state and local emergency response capacities and become more proficient in testing foods for toxic and unknown substances.
Nebraska – Nebraska Department of Agriculture, Lincoln, Neb. The award will enable analyses of foods and food products in the event redundancy or additional laboratory capacity is needed for chemical-related analyses.
Wisconsin – Wisconsin Department of Agriculture, Madison, Wis. The grant will provide for standing reserve capacity within the FERN for response to chemical-related analysis needs, or an event of such significance that it threatens the national food supply.
In 2008, the FDA awarded $5.2 million in food and feed safety grants to state and local agencies selected by a review panel that scored proposals based on technical and programmatic merit.
The grants fund major cooperative agreements in four major areas: the Ruminant Feed Ban Support Program, Innovative Food Defense, Rapid Response Teams, and Food Safety and Security Monitoring. California, Ohio, and Colorado were the 2008 recipients of the Food Safety and Security Monitoring grants.
Arkansas, Nebraska, and Wisconsin funded for Food Safety and Security Monitoring
The U.S. Food and Drug Administration recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds support cooperative agreements designed to create a national integrated food safety system through enhanced federal and state collaboration in food emergency response activities.
"We are excited to partner with these states as they perform such critical roles in ensuring food safety," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. "The FDA is committed to investing in efforts that will better protect American consumers from food safety and food defense threats."
The three states each received $350,000 to fund Food Emergency Response Network (FERN) chemistry laboratories. FERN labs are essential to the FDA’s regulatory efforts and the grants may be used for facility upgrades, training in current food testing methodologies, and increased laboratory sample analysis capacity, and other activities.
In the event of a large-scale event affecting food or food products, the grant recipients may be required to perform selected analyses of food samples collected by the FDA or provided by other government agencies through the FDA.
The state recipients and highlights for each grant include:
Arkansas – Arkansas Department of Health, Little Rock, Ark. The grant award will be used to increase the department’s ability to test for toxic and unknown substances in food products, provide regional support for national responses during food surveillance activities, increase state and local emergency response capacities and become more proficient in testing foods for toxic and unknown substances.
Nebraska – Nebraska Department of Agriculture, Lincoln, Neb. The award will enable analyses of foods and food products in the event redundancy or additional laboratory capacity is needed for chemical-related analyses.
Wisconsin – Wisconsin Department of Agriculture, Madison, Wis. The grant will provide for standing reserve capacity within the FERN for response to chemical-related analysis needs, or an event of such significance that it threatens the national food supply.
In 2008, the FDA awarded $5.2 million in food and feed safety grants to state and local agencies selected by a review panel that scored proposals based on technical and programmatic merit.
The grants fund major cooperative agreements in four major areas: the Ruminant Feed Ban Support Program, Innovative Food Defense, Rapid Response Teams, and Food Safety and Security Monitoring. California, Ohio, and Colorado were the 2008 recipients of the Food Safety and Security Monitoring grants.
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