ARTICLE
24 April 2015

Recent Warning Letters - Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 8

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Jones Day

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FDA warned two juice manufacturers for failing to comply with juice hazard analysis and critical control points regulations, for CGMP violations, and for insanitary conditions.
United States Food, Drugs, Healthcare, Life Sciences

Since we last reported on enforcement actions in March 2015, FDA posted warning letters to seafood processors, juice processors, dairies, and other food companies or violations related to CGMP (current good manufacturing practice), commodity-specific regulations, labeling, illegal drug residues, unapproved drug claims, and cosmetics, among others.

FDA warned two juice manufacturers for failing to comply with juice hazard analysis and critical control points regulations, for CGMP violations, and for insanitary conditions. Three seafood processing facilities were cited for failing to comply with hazard analysis and critical control points regulations and for various CGMP violations, and two of the facilities were additionally warned for processing seafood in insanitary conditions. FDA also warned two dairy farms for selling cattle adulterated with illegal drug residue for slaughter. One acidified foods manufacturer, located overseas, was warned for various violations of the Acidified Foods and Emergency Permit regulations. 

FDA continues to review product labels for incorrect or incomplete claims. FDA cited a Japanese manufacturer of soy sauce for improperly formatted nutrition information and failure to use the common or usual name of ingredients on the label. An American cereal manufacturer was cited for bearing an unauthorized health claim related to whole grains. 

FDA cited only two dietary supplement manufacturers since our March 2015 issue. One manufacturer of eye care products was warned for marketing unapproved drugs because its product is promoted for therapeutic claims. Another manufacturer was warned for using melatonin, an unsafe food additive, in a beverage product that was improperly marketed as a dietary supplement. 

Finally, in a rare warning letter to a cosmetics manufacturer, FDA warned a skin care products manufacturer that therapeutic claims on its website rendered the products unapproved new drugs.

View 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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