FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

FOR IMMEDIATE RELEASE May 16, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
Company manufactures and distributes unapproved and adulterated drugs

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government's complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

"The FDA will not allow a company to put the public's health at risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide" (CPG). This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland.

Tags: FDA Regulations, FDA News, Scientific Laboratories, Inc

FDA Shuts Down Hope Food Supply Inc., Requires fish and fishery Products Be Recalled

FOR IMMEDIATE RELEASE May 16, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
Failure to follow consent decree drives action

The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.

"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "The FDA will take action against companies and against their executives who violate the law and endanger public health."

The FDA's HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product that they process, and set forth preventative measures to control those hazards.

The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, Hope Food Supply's seafood products could harbor pathogenic bacteria such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.

The company's products have been distributed nationwide. The FDA is advising consumers who bought smoked seafood products to check with the place of purchase to determine if the products came from Hope Foods. If so, consumers should throw the products out by placing them in a trash receptacle.

Consumers who have been eating Hope Seafood Supply's dried smoked catfish or other smoked seafood products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found online at www.fda.gov/opacom/backgrounders/complain.html.

For more information, consumers can call the FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD.

Tags: FDA Regulations, fish and fishery products Recall, Hope Food Supply Inc Shutdown

FDA Shuts Down Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc. Cream Cheese Companies.

FOR IMMEDIATE RELEASE May 15, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-0955 Consumer Inquiries: 888-INFO-FDA

FDA Takes Action against Cream Cheese Companies, Executives
Repeated federal violations and failure to correct drove action

The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. A consent decree of permanent injunction, signed by both corporations and two of their top executives, Julie and Edward Smolyansky (the defendants), halts cream cheese and seafood processing in facilities in Skokie, Ill., and Philadelphia, Pa.

The FDA's enforcement action follows the defendants' extensive history of violations of the Federal Food, Drug, and Cosmetic Act dating back to at least 2004. The complaint, filed by the U.S. Department of Justice, alleges that the defendants:

• Labeled and distributed cream cheese products with inadequate labels, including labels that did not disclose major food allergens, trans fat levels, and complete ingredient lists;
• Processed and distributed products with seafood, including whitefish salad, ground nova salmon, and lox cream cheese and lox cream cheese spreads, without adequate Hazard Analysis and Critical Control Point (HACCP) plans to ensure the safe and sanitary processing of seafood containing products; and
• Failed to document that they monitored sanitation conditions to keep food contact surfaces clean, to prevent cross-contamination from unsanitary objects, and to maintain hand washing, hand sanitizing, and toilet facilities.

"We simply can’t allow companies to put the public's health at risk by not having adequate procedures and plans to produce safe food and proper labeling," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "We will work to take action against companies and their executives that violate the law."

Under the consent decree, operations may resume only after the FDA determines that the defendants have come into full compliance will all food-safety requirements. The consent decree requires the defendants to hire a seafood-processing expert to prepare a HACCP plan and to submit the plan to the FDA.

The HACCP violations pose a public health hazard because, without adequate controls, the defendants' seafood products could foster dangerous bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listereria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses for people who eat them. Further, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe or life-threatening allergic reactions in people who are allergic to the undisclosed allergens.

The decree does not include other products manufactured by Lifeway including kefir, Farmers cheese, and spreadable cheese products.

The decree was signed by Judge Wayne R. Andersen on May 15, 2008, in the U.S. District Court for the Northern District of Illinois.

Tags: FDA Regulations, LFI Enterprises, Lifeway Foods

FDA Issues Regulation on Animal Feeds with Added Safeguards Against BSE "mad cow disease",

FDA Strengthens Safeguards for Consumers of Beef
Issues Regulation on Animal Feeds with Added Safeguards Against BSE

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").

"This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE," said Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine. "The new rule strengthens existing safeguards."

The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.

The removal of high-risk materials from all animal feed will further protect against inadvertent transmission of the agent thought to cause BSE, which could occur through cross-contamination of ruminant feed (intended for animals with four-chambered stomachs, such as cattle) with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm. The added measure of excluding high-risk materials from all animal feeds prevents any accidental feeding of such ingredients to cattle.

Today's regulation finalizes a proposed rule that the FDA issued for public comment in October 2005. The final rule is effective 12 months from today to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation. Under the new requirements of the final rule, renderers that process cattle not inspected and passed for human consumption must make available for FDA inspection their written protocols for determining the age of cattle and demonstrating that the brain and spinal cords of cattle have been effectively removed.

Scientific studies have linked BSE to cases of variant Creutzfeldt-Jakob Disease (vCJD) in humans, an invariably fatal disease that most likely results from human consumption of infectious material from cattle with BSE. Rules issued in 2004 prohibited specified risk materials from use in the human food supply. There have been no vCJD cases linked to consumption of U.S. beef and the risk of BSE among U.S. cattle is low.

FDA regulates animal feed and drugs. The U.S. Department of Agriculture (USDA) and FDA promulgate and enforce the regulations that ensure the exclusion of specific risk materials from the human food supply.
tag: FDA, FDA News, BSE, FDA Regulations, mad cow disease, mammalian protein, 1997 feed regulation, four-chambered stomachs, Creutzfeldt-Jakob Disease

FDA Orders Evanger's Dog & Cat Food Co., Inc., to Obtain Emergency Operating Permit

FOR IMMEDIATE RELEASE April 24, 2008

Media Inquiries: Kimberly Rawlings, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Orders Pet Food Maker to Obtain Emergency Operating Permit

The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems 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.

"As outlined in the Food Protection Plan, the FDA uses a risk-based approach to locate the areas of greatest risk for foods, and targets preventive controls and inspections to those areas, " said Dr. Stephen Sundlof, director, Center for Food Safety and Applied Nutrition. "The FDA's authority to issue an order requiring an emergency permit is an enforcement tool designed to prevent unsafe foods from reaching consumers.”

The FDA issues an "Order of Need for Emergency Permit” if the agency determines that a company fails to meet the regulatory requirements to process a product that does not present a health risk. For Evanger's to resume business, 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.

In light of human botulism illnesses and recalls that occurred due to under-processed hot dog chili sauce, and potentially under-processed canned green beans, FDA has urged all LACF processors to review their operations and the apply scientific principals and regulations that have been established to provide a safe product.

While FDA's Center for Veterinary Medicine has authority over animal feed and foods, CFSAN is responsible for regulating all human and animal LACF processing. The two centers are collaborating on this enforcement action.

tag: FDA Warning, FDA Regulations, Evanger's Dog & Cat Food Co, canned pet food, low acid canned food, LACF, Clostridium botulinum, C. botulinum,