United States: Enforcement Updates - Issue 15 | October 2014

Last Updated: October 13 2014
Article by Jonathan Berman and Colleen Heisey

Recent Product Recalls

Recent food recalls involved microbial contaminations, undeclared allergens, and inspection and storage temperature failures.

Companies continue to recall food products that contain undeclared allergens. According to FDA's website, packages of milk chocolate candies were recalled after some packages were found containing undeclared peanut butter. A brand of bread crumbs was called back for not properly listing wheat, whey, and soy ingredients, and another manufacturer recalled several batches of lobster bisque that contained undeclared shrimp.

A seafood importer recalled packages of dried fish following a routine sanitary inspection by a state agriculture department that revealed a high risk of botulism contamination. In addition, carob powder products and certain pet foods were recalled because of potential Salmonella contamination.

USDA posted information about recalled beef products due to potential E. coli contamination and recalled chicken strips for Listeria concerns. There were also recalls of beef corndogs for improper storage temperatures and certain beef jerky products for being shipped without inspection.

For a complete list of product recalls, click here for FDA-regulated products, and here for USDA-regulated products.

Recent Warning Letters

FDA recently warned a baked goods producer for myriad misbranding violations related to false or misleading claims on the packaging, failure to declare allergens, and failure to list all ingredients in the ingredient statement. Notably, FDA issued a rare warning on the term "natural," which the agency has declined to define, but instructed the baked goods manufacturer that its "all-natural" claim was misleading because the product contained a synthetic ingredient. FDA also cited the manufacturer for failing to make required reports to the Reportable Food Registry on two occasions where customers complained about allergic reactions to a product. A frozen food processor was cited following an inspection that revealed Listeria contamination and multiple labeling violations related to the ingredient statement and failure to declare an allergen. Two other companies were issued warning letters for rodent and insect activity.

In a significant move, FDA and FTC jointly issued warning letters to three companies for marketing essential oils and other products for the purposes of preventing or treating the Ebola virus. Such claims make the products unapproved drugs, sold in violation of the FD&C Act, and also lack adequate substantiation, in violation of the fair advertising provisions of the Federal Trade Commission Act. The warning letters note these products were advertised on various social media sites, including Pinterest.

FDA also posted warning letters to two dietary supplement manufacturers for illegally marketing, as dietary supplements, products that contain active pharmaceutical ingredients. The companies were also cited for making disease claims on dietary supplement products, and one of the firms was additionally cited for failing to comply with CGMP requirements.

Four seafood processing facilities were cited for hazard analysis and critical control points, or HACCP, violations, including failures to conduct risk analyses for each product and to implement affirmative steps. FDA also issued warning letters to three cattle farms and a feeder for illegal drug residue found in cows sold for slaughter.

Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Jonathan Berman
Colleen Heisey
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