September 19, 2021

Volume XI, Number 262

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September 17, 2021

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September 16, 2021

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FDA Issues Two Warning Letters for Undeclared Allergens

On May 4, the FDA issued two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 331(a)).

In a letter sent to Hanover Foods Corporation, the FDA stated that its recalled Baked Rice Pudding and Cheddar Flavored Popcorn were misbranded within the meaning of section 403(w) of the FD&C Act because the labels failed to declare the major food allergens of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn). Specifically, the Rice Pudding was manufactured with milk and egg, but the label incorrectly declared an ingredient list for another product that did not contain milk or egg. Similarly, the Cheddar Flavored Popcorn incorrectly declared another product’s ingredient list, which did not contain milk.

A separate letter was sent to George DeLallo Company Inc. for their recalled Holiday Cookie Platter and Provolini Antipasti products. FDA stated that the products were misbranded within the meaning of section 403(w) of the FD&C Act because the products did not declare the presence of pecans (tree nuts) and milk, respectively.

In comments to both Warning Letters, FDA noted that the manufacturing facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule). Thus, both Hanover and DeLallo are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) would be significantly minimized or prevented. In other words, the presence of the undeclared allergens may have been a result of the manufacturers’ inadequate prevention or failure to comply with CGMP and PCs.

As our readers know, food or ingredients that contain one of the now nine major allergens must be specifically labeled with the names of the allergen source. The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. These Warning Letters, in addition to the one sent to Whole Foods in December, reconfirm the FDA’s attention and efforts to reduce the prevalence of undeclared allergens and allergen recalls.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 125
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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