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FDA Warns Bakery to Fix cGMP Violations and Remove the “Love”

  • On September 22, 2017, following an inspection of the company’s manufacturing facility, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nashoba Brook Bakery regarding significant current Good Manufacturing Practice (cGMP) violations.  cGMPs describe the methods, equipment, facilities, and controls for producing food.  cGMPs prescribe the minimum sanitary and processing requirements for producing safe and wholesome food, and are an important part of regulatory control over the safety of the nation’s food supply.  In their warning letter, the FDA deemed Nashoba’s food adulterated for failure to manufacture foods in accordance with the cGMP requirements in 21 CFR Part 110 because the foods had been prepared, packed, or held in unsanitary conditions whereby they might have become contaminated with filth, or whereby they might have been rendered injurious to health.  Noted violations included failure to maintain sanitary buildings, fixtures, and facilities in order to prevent food from becoming adulterated, as required by 21 CFR 110.35(a), as well as a failure to provide an adequate screening or protection against pests, as required by 21 CFR 110.20(b)(7).  (As our readership is well aware, Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.  Here, Nashoba Brook Bakery is subject to Part 110 due to its business size).

  • FDA also found several labeling violations, and one in particular caught media attention.  Based on FDA review, the granola products were found to be in violation of the food labeling regulations, 21 CFR Part 101, which causes the products to be misbranded within the meaning of Section 403 of the Food, Drug, and Cosmetic Act (FD&C Act).  As Law360 first reported, the Nashoba Brook Granola label listed the ingredient “Love.”  As our readers may know, ingredients required to be declared on the label or labeling of food must be listed by their common or usual name.  21 CFR 101.4(a)(1).  According to the FDA, “love” is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.  Nashoba CEO John Gates disagreed with FDA’s position on “love,” and stated, “[t]elling an artisan bakery that we can’t list love in our ingredients in our granola feels overreaching.”

  • FDA made clear, however, that the concerns about “love” were “not among the agency’s top concerns.”  The FDA stressed the significance of the sanitary issues found during the inspection, and the need for the company to follow the cGMPs and correct the violations noted in the warning letter.

© 2018 Keller and Heckman LLP


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...