U.S. Marshals Seize FDA-Regulated Food Stored at Rodent-Infested Warehouse in Georgia

/PRNewswire/ -- U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized an estimated $700,000 worth of rice and other packaged food products from a rodent-infested warehouse in East Point, Ga. The FDA-regulated food products were stored in a warehouse operated by Sun Hong Kai Holding Inc., which does business as United Food Service.

The U.S. District Court for the Northern District of Georgia issued a warrant for the seizure of all FDA-regulated food stored in the warehouse in permeable containers. The federal government's complaint alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act because they have been held under insanitary conditions and may have become contaminated with filth.

An FDA inspection of United Food Service's facility between Sept. 22, 2010, and Oct 1, 2010, revealed "an active and widespread rodent infestation, including live and dead rodents within the warehouse where food products are stored," according to the complaint.

"United Food Service not only failed to protect the food in this warehouse, it failed to act promptly to correct the violations," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. "This prompted the FDA, working together with its state partner, the Georgia Department of Agriculture, to take these aggressive enforcement actions to protect the health of consumers."

FDA investigators found 28 live rodents, one dead rodent, apparent rodent droppings, 26 apparent rodent gnaw holes in multiple packages of food products, rodent urine stains on food packaging and four rodent nesting sites. FDA laboratory analyses of samples collected during the inspection confirmed the investigators' observations. FDA investigators also found structural defects making the facility accessible to rodents.

On Sept. 30, 2010, the Georgia Department of Agriculture placed all food in the warehouse under an order that prevents sale of the products. A day later, FDA investigators provided the warehouse manager a list documenting the violations.

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U.S. Marshals Seize Food From Rodent-Infested GA Warehouse

/PRNewswire/ -- U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.

The U.S. District Court for the Middle District of Georgia issued a warrant for the seizure of all of the food in the warehouse from Mid-States Services Inc., that the FDA and the Georgia Department of Agriculture (GDA) determined to be susceptible to contamination by rodents. The food was valued at $859,000.

The government's complaint alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act because they have been held under insanitary conditions, whereby they may have become contaminated with filth.

The two agencies investigated the Mid-States Services facility from July 14 through July 21, 2010, and found "widespread active rodent infestation both inside and outside the facility" according to the government's complaint.

Investigators found 14 live rodents, seven dead rodents, 23 gnaw holes on multiple food containers, multiple containers of food containing rodent pellets, four rodent nests, and apparent rodent pellets too numerous to count, on and around food packages, as well as finding structural defects making the facilities accessible to rodents.

"This is an example of quick action by the FDA and our state partner to prevent contaminated food from reaching consumers," said Michael A. Chappell, acting associate commissioner for regulatory affairs. "The FDA took this action because the company failed to provide adequate safeguards to ensure that products they produce or hold for sale remain free of contamination."

On July 15, 2010, GDA placed all food in the warehouse under a stop sale order. Four days later, the firm voluntarily destroyed some of the food but, as alleged in the complaint, a significant amount of food was not destroyed. On July 21, 2010, FDA investigators provided the warehouse manager a list of inspectional observations documenting the violations, but the company did not formally respond.

"As soon as we heard about this unlicensed warehouse and the conditions under which food was held, we took action with FDA," said Tommy Irvin, Georgia commissioner of agriculture. "We used our authority under the Georgia Food Act to immediately stop the sale and movement of food from the warehouse. We also promptly alerted the facilities in Georgia that had received food from this warehouse."

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FDA Warns Public of Continued Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment.”

FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.

The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA’s concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.

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FDA Seeks Public Input on Tobacco Regulation

The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. All public comments will be posted online.

"We're interested in receiving input from across the country as the FDA begins to implement this important new authority intended to reduce the enormous toll of suffering and death caused by tobacco products in the United States," said Dr. Margaret A. Hamburg, Commissioner of Food and Drugs. "We look forward to the public's response."

The Federal Register notice can be viewed at: http://www.federalregister.gov/OFRUpload/OFRData/2009-15549_PI.pdf.

For more information about the FDA and tobacco regulation, see: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm168412.htm.

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FDA Confirms E. Coli O157:H7 In Prepackaged Nestlé Toll House Refrigerated Cookie Dough

Today (June 29), the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of prepackaged Nestlé Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, Nestlé USA. The contaminated sample was collected at Nestlé’s facility in Danville, Va. on June 25, 2009.

On June 19, the FDA and the U.S. Centers for Disease Control and Prevention warned consumers not to eat any varieties of prepackaged Nestlé Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7. The warning was based on an epidemiological study conducted by the CDC and several state and local health departments. As of Thursday, June 25, the CDC reports that 69 persons from 29 states have been infected with the outbreak strain. Thirty-four persons have been hospitalized, nine with a severe complication called hemolytic uremic syndrome. No one has died.

Further laboratory testing is needed to conclusively link the E. coli strain found in the product to the same strain that is causing the outbreak.

Nestlé USA has fully cooperated with the FDA and CDC investigation and has recalled all of its prepackaged Nestlé Toll House refrigerated cookie dough products.

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FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products

The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

Products that are offered for sale to the public with claims to diagnose, prevent, mitigate, treat, or cure infections caused by the H1N1 influenza virus that have not been proven to be safe and effective for these uses must be carefully evaluated. Many of these deceptive products are being sold over the Internet via illegitimate web sites. The operators of these web sites take advantage of the public’s concerns about H1N1 influenza and their desire to protect themselves and their families. These fraudulent products come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices or vaccines. Such fraudulent products will not prevent the transmission of the virus or offer effective treatments against infections caused by the H1N1 influenza virus.

“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz. “The FTC will act swiftly against companies that resort to deceptive advertising.”

Consumers are urged to contact their health care providers or legitimate medical supply services if they have questions or concerns about medical products or personal protective equipment. Consumers are also urged to visit the FDA and Centers for Disease Control and Prevention web sites for more information about this emergency, and to determine which products the FDA has approved, cleared or authorized for use to diagnose, treat, prevent, mitigate or cure infections caused by H1N1 influenza virus.

Consumers should also visit FDA's web site for tips about how to protect themselves when buying medicines online: http://www.fda.gov/buyonlineguide/

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). Tamiflu and Relenza, in addition to their approved labeling, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.

For more information about FDA-approved antiviral drugs for influenza, see http://www.fda.gov/cder/drug/antivirals/influenza/default.htm.

For more information on CDC recommendations regarding use of antiviral drugs against the current novel 2009 H1N1 influenza strain, see http://www.cdc.gov/swineflu/?s_cid=swineFlu_outbreak_001.

For more information about personal protective equipment see http://www.fda.gov/cdrh/ppe/.

At present, there are no licensed vaccines approved for this new H1N1 influenza virus.

Consumers are urged to report any suspected fraudulent products or criminal activity relating to FDA regulated products associated with H1N1 Flu Virus (Swine Flu), including the names of web sites that may be offering these products for sale, to the FDA by visiting: http://www.fda.gov/oci/flucontact.html .

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FBI to Assist FDA in Ongoing Investigation of the Peanut Corporation of America‏

Special Agent in Charge (SAC) Gregory Jones, FBI Atlanta, announces the FBI’s assistance to the Food and Drug Administration, Office of Criminal Investigations (FDA/OCI), in the ongoing investigation of the Peanut Corporation of America.

The FBI was asked to assist FDA/OCI in this matter, due to its ability to bring to bear a considerable amount of investigative resources. Although the FBI is fully involved in this investigation, FDA/OCI remains the lead federal investigative agency. As such, the FBI will defer to FDA/OCI for all public commentary regarding the details of this ongoing investigation.

For the time being, the FBI will make no further public comment on this matter.

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Recall Adds to Peanut Stockpile

In connection with a salmonella investigation, the Food and Drug Administration has warned consumers against eating processed foods made with peanut butter. The country already had a large surplus of peanuts. With any decline in consumption now, that stockpile will grow, says a University of Georgia peanut expert.

“It’s never a good time to have anything like this, especially when there is consumer concern for health. But it comes at a particularly bad time considering the rather large surplus of peanuts last season’s bumper crop produced,” said Nathan Smith, an economist with the UGA College of Agricultural and Environmental Sciences.

U.S. peanut farmers produced 2.58 million tons of peanuts in 2008, a record crop, Smith said. This helped create what is now growing to be an 800,000-ton surplus. Because of the way the crop is bought and sold before becoming food, the industry likes to keep 300,000 tons to 400,000 tons in the pipeline as a buffer against a major crop loss.

In recent years, peanut consumption has increased annually. In fact, consumption was on track to be 6 percent more than in 2007, or around 2.24 million tons. Average annual peanut consumption in the U.S. is 6.5 pounds per person.

Before the FDA warning, the peanut industry was adjusting to the surplus. Because of it, farmers are expected to plant fewer peanuts this year and produce less than the U.S. consumes in a year, eating into that surplus, Smith said. That would be in a typical year, one without a decline in consumer consumption.

“It’s too early to tell how the FDA warning will impact consumption this year,” Smith said. “We were probably on our way to correcting the supply and demand gap we have with this year’s crop, but now it may take another year to do that.”

The peanut stockpile has already affected farmers’ prices.

Last year at this time, farmers could contract peanuts for $500 a ton, some as high as $600 a ton. There are no contracts being offered right now for the ’09 crop. A farmer that sees a contract above $400 per ton this year should think hard about taking it, Smith said. Prices may not get much higher for a while.

As part of the warning, the FDA now lists more than 125 products containing peanut paste, which has been linked to a Peanut Corp. of America plant in south Georgia.

Consumers can find a list of the suspect products at the FDA’s Web site www.fda.gov. Jarred peanut butter is considered safe and not part of the safety alert.

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FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

The scheme most likely began with the theft of personal information from consumers who previously purchased drugs via the Internet or telephone or who were victims of credit card fraud.

The FDA is investigating and complaints or information regarding this scheme should be reported to the FDA Office of Criminal Investigations at (800) 521-5783.

The FDA reminds consumers to purchase prescription drugs only from licensed pharmacies located in the United States. Information about the proper purchase of on-line medicine can be found at: http://www.fda.gov/consumer/features/drugsonline0707.html.

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HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush’s Emergency Plan for AIDS Relief (PEPFAR).

Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

“HHS/FDA has helped save lives by making high quality, anti-retroviral generic drugs available quickly, at a lower cost, for those most in need under the President’s Emergency Plan," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."

“Tentative approval" means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of HHS/FDA's normal requirements for manufacturing quality and clinical safety and efficacy.

HHS/FDA performs all of its reviews of applications received in association with the Emergency Plan on an expedited basis; the agency reviewed this application for lamivudine tablets in less than six months. After receiving approval or tentative approval from HHS/FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows HHS/FDA to share data from its evaluations with the WHO team in Geneva. Generic anti-retrovirals given approval or tentative approval by HHS/FDA are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.

In 2003, President George W. Bush launched his Emergency Plan for AIDS Relief to combat global HIV/AIDS – the largest commitment by any nation to combat a single disease in history. At that time, about 50,000 people in sub-Saharan Africa were receiving anti-retroviral treatment. Today, the Emergency Plan reaches more than 1.7 million worldwide with anti-retroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for more than 6.6 million people, including 2.7 million orphans and vulnerable children. To date, interventions funded by the Emergency Plan have allowed mothers to give birth to nearly 200,000 HIV-free children.

In 2004, HHS/FDA implemented an expedited process under the Emergency Plan to review individual, generic anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The expedited process includes a commitment by HHS/FDA and the Office of the U.S. Global AIDS Coordinator to work closely with manufacturers before they submit a marketing application to HHS/FDA, especially those firms that have never previously submitted to the agency, and to conduct a priority assessment of those applications.

On July 30, 2008, President Bush signed into law the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, which reauthorized and expanded the Emergency Plan for five additional years, from 2009 through 2013. The legislation authorizes up to $38 billion over five years for bilateral HIV/AIDS programs under the Emergency Plan, activities under the President’s Malaria Initiative, and bilateral U.S. Government international work against tuberculosis, as well as contributions to the Global Fund.

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The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk

The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Salmonella can cause serious infections in dogs, and, if there is cross-contamination caused by handling of the rawhide chips, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The product involved is 4,850 - 2 pound plastic bags of Hartz Chicken-Basted Rawhide Chips, lot code JC23282, UPC number 3270096463 which were distributed to a national retail customer. While the normal testing that Hartz conducts through an independent outside laboratory did not detect the presence of Salmonella in any Hartz rawhide products, sample testing conducted by another laboratory did indicate the presence of the bacteria in a sample bag of the Chicken-Basted Rawhide Chips. Hartz is aggressively investigating the difference in test results and the potential source of the problem.

Although Hartz has not received any reports of animals or humans becoming ill as a result of coming into contact with this product, Hartz is taking immediate steps to remove the product from all retail stores and distribution centers. Dog owners who purchased this product should check the lot code on their bag, and, if the code is not visible, or if the bag has lot code JC23282 imprinted thereon, they should immediately discontinue use of the product and discard it in a proper manner.

Consumers can contact Hartz at 1-800-275-1414 with any questions they may have and to obtain reimbursement for purchased product.

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FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry

Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.

Food industry management will use the FIRST tool kit as part of ongoing employee food defense training programs. The tool kit focuses on five key points that industry and businesses can use to educate first line workers about the risks of food contamination. It also provides industry with measures to consider and implement to reduce these risks. Each of the letters in the FIRST acronym describes an action that a first line employee can take to mitigate risks of contamination.

F – FOLLOW company food defense plan and procedures

I – INSPECT your work area and surrounding areas

R – RECOGNIZE anything out of the ordinary

S – SECURE all ingredients, supplies and finished product

T – TELL management if you notice anything unusual or suspicious

Single copies of the kit are available in English and Spanish. The kit is free to employees and includes one DVD, a training poster, and on-screen instructions. Copies can be obtained by ordering online from the Food Defense & Terrorism Web site: http://www.cfsan.fda.gov/fooddefense . A Web-ready version of the kit will be available later this month.

The FIRST tool kit focuses on preventing food contamination. Prevention is the essential first step to help ensure the safety of the nation's food supply. A shift to an increased emphasis on prevention is at the core of the FDA's Food Protection Plan . The FDA released the Food Protection Plan last fall and has been implementing the plan since that time. The plan provides a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack.

The FIRST training kit is the second in a line of Food Defense Awareness Materials. ALERT, a program that was issued in July 2006, also focuses on prevention and identifies key points that supervisors and managers in industry and businesses can use to raise awareness of food defense issues and decrease the risks of food contamination.



A – AS SURE that the supplies and ingredients are from safe and secure sources

L – LOOK after the security of the products and ingredients

E – Know your EMPLOYEES

R – Provide REPORTS about the security of products

T – Know whom to notify if there's a THREAT , including suspicious behavior.

The FDA sets food safety standards, conducts inspections, takes regulatory action, and works with other government agencies and private sector organizations to help reduce the risk of tampering and other malicious, criminal or terrorist actions on our nation's food supply.

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FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.

FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.

Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.

FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.

All these areas are vital to support the development and review of data regarding the safe and effective use of these products.

FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.

Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
• Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
• Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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FDA Detects Melamine Contamination in Flavored Drink

TT Note: And they just keep on coming-----

The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA’s on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.
Other Recalls

On September 26, the FDA issued an alert to consumers that seven Mr. Brown instant coffee and milk tea products were being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are:

* Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandhling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)

The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.

Sunny Maid Corp. Monterey Park, Calif., who is an importer and distributor of Mr. Brown Instant Coffee products, is recalling the products in the United States.

The FDA is working with regulatory agencies in the United States as well as with other countries. The California Department of Public Health and the New Zealand Food Safety Authority reported that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA continues to recommend that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.

A recall by QFCO Inc., Burlingame, Calif., of the White Rabbit Creamy Candies, is underway in the United States.

The FDA is closely monitoring these recalls and will continue to perform follow up activities of other recalls that may develop.

To date, the FDA is not aware of any illnesses in the United States stemming from consumption of Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or the Mr. Brown instant coffee and milk tea products.

Individuals who have experienced any health problems after consuming Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.
Background

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,800 retail markets and have not found Chinese infant formula present on shelves in these markets.

The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.

The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to visit Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.

In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, Centers for Disease Control and Prevention, other federal agencies, and foreign governments.

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Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk

Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.

Consumers who have the product which is being recalled should stop using it immediately. If consumers have questions about possible health risks, they should contact their doctor.

Product was distributed nationwide in Asian grocery stores.

The product comes in 100 ml plastic bottles package with a BESTBEFORE date. There are four (4) flavors (see below) printed in Chinese. All packaging has a logo of blue cat on the back of the bottle and the word “blue cat” (in Chinese) on the front.

1. Strawberry, with red strawberry picture on the bottle.
2. Sweet Orange, with orange picture on the bottle
3. Pineapple, with green pineapple picture on the bottle
4. Peach, with pink peach picture on the bottle

No illnesses associated with this product have been reported to date.

The recall was initiated after FDA testing discovered that product was found to contain Melamine.

Consumers who have purchased Blue Cat Flavor Drink (Lanmao) are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201-938-2590, Monday to Friday, 8:30 to 5:00, Eastern Standard Time.

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FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.

The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity.

Infant Formula

FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:

1. the consequences of the continuous use of infant formulas as the sole source of nutrition;
2. the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and
3. for premature infants with immature kidney function, the possibility that they may be fed these formulas as the sole source of nutrition and thus on a body weight basis experience greater levels of intake for a longer time than is experienced by term infants.

There is too much uncertainty to set a level in infant formula and rule out any public health concern. However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.

Other Food Products

In food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.

FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.

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FDA Clears New CDC Test to Detect Human Influenza

The U.S. Food and Drug Administration (FDA) today cleared a new test
developed by the U.S. Centers for Disease Control and Prevention (CDC)
to diagnose human influenza infections and the highly pathogenic
influenza A (H5N1) viruses.

The device, called the Human Influenza Virus Real-Time RT-PCR Detection
and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology
technique to detect flu virus and differentiate between seasonal and
novel influenza.

The device is used to isolate and amplify viral genetic material present
in secretions taken from a patient's nose or throat. The viral genetic
material is labeled with fluorescent molecules, which are then detected
and analyzed by a diagnostic instrument called the Applied Biosystems
7500 Fast Dx, also cleared today by the FDA for diagnostic use
simultaneously with the CDC's rRT-PCR Flu Panel.

The test panel and diagnostic system can detect and identify commonly
circulating human influenza viruses as well as influenza A (H5N1)
viruses. Results can be available within four hours and the system can
test multiple samples at once.

"This is a significant achievement for public health surveillance," HHS
Secretary Mike Leavitt said. "The test allows us to better support
laboratories on the front line of influenza testing in the United States
and abroad."

"The application of the test to detect an emergent influenza virus would
be especially important in the early stages of a pandemic," Secretary
Leavitt added. "This breakthrough allows for a more timely detection of
a pandemic virus, which helps in determining when to begin broad control
strategies as well as life-saving mitigation measures, such as closing
schools, cancelling social gatherings and informing businesses to begin
work-at-home policies."

The test will be available to CDC-qualified laboratories for diagnosing
influenza this fall, and some laboratories will be able to obtain
reagents (certain substances used in the testing process) at no cost.
This test should help ensure the accuracy of influenza testing results
among the different qualified laboratories that conduct influenza
subtype testing.

"This new test provides us another tool in our toolbox to fight seasonal
influenza, a virus that unfortunately kills thousands of people each
year in the United States," said CDC Director Dr. Julie Gerberding.
"We'll now be able to detect influenza in the community faster, which
allows us to take steps more quickly to protect and save lives."

Since influenza viruses are always changing, test reagents need to be
evaluated regularly against circulating viruses to ensure the
sensitivity and specificity of the test to diagnose current influenza
viruses.

"Because the test can tell the difference between seasonal human
influenza viruses and novel viruses, it will also provide qualified
laboratories with a means to rapidly detect new influenza viruses that
have not been identified yet and that could pose a pandemic risk," said
FDA Principal Deputy Commissioner and Chief Scientist Dr. Frank Torti,
M.D., M.P.H.

The CDC, Applied Biosystems of Foster City, Calif., and the Association
of Public Health Laboratories collaborated on the development of this
new test. State public health laboratories in Virginia, Iowa,
California, Massachusetts, Wisconsin, and Washington performed clinical
evaluations of the new flu panel.

Scientists around the world are concerned that the H5N1 virus could one
day mutate and acquire the properties needed to quickly spread between
people, resulting in a pandemic. H5N1 viruses circulate widely in birds
in Asia, Africa and Europe and have caused human illness and death.
These viruses have never been detected in the Americas.

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Melamine Contamination Investigation Expands

The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. The products, manufactured by China’s Shandong Duqing Inc., are:

* Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandhling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)

The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.

As of September 25, 2008, the FDA testing of milk based products imported into the United States from China has not found melamine contamination.

The FDA is working with regulatory agencies in other countries. The New Zealand Food Safety Authority reports that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA recommends that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.

To date, the FDA is not aware of any illnesses in the United States stemming from consumption of either White Rabbit Creamy Candy or the Mr. Brown instant coffee and milk tea products.

Individuals who have experienced any health problems after consuming either White Rabbit Creamy Candy or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.

Background

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,400 retail markets and have not found Chinese infant formula present on shelves in these markets.

The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.

The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.

In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

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New FDA Update on Melamine Contamination

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,000 retail markets and have not found Chinese infant formula present on shelves in these markets.

In addition, the FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.

FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk proteins. Additionally, FDA is sampling and testing milk and milk-derived ingredients and finished food products that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein. This sampling and testing is done when these ingredients or products are imported into the United States or found during visits to Asian markets. If the products are adulterated because they contain melamine and/or a melamine analog, FDA will take action to prevent the products from entering the U.S. food supply.

In addition to state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

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FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

The FD&C Act classifies "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and/or any new products expressed from the inserted construct are safe for the health of the GE animal.

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.

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