FDA WARNING_LETTER - Whole Foods Market - December 22, 2020

The FDA issued a Warning Letter to Mr. Mackey on December 16, 2020, due to a pattern of receiving and offering for sale misbranded food products, specifically concerning undeclared allergens. This letter is part of the FDA's efforts to address undeclared allergens, which are a leading cause of food recalls.

From October 2019 to November 2020, the firm recalled 32 food products due to undeclared allergens, with similar patterns observed in previous years. These products were deemed misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], as their labels failed to declare all major food allergens present. The receipt and delivery of misbranded food are prohibited acts under section 301(c) of the Act [21 U.S.C. § 331(c)], and altering labeling resulting in misbranding is prohibited under section 301(k) of the Act [21 U.S.C. § 331(k)].

The FDA requires prompt corrective action to address these violations and prevent recurrence. Failure to do so may result in enforcement actions, including seizure and/or injunction. A written response detailing specific corrective actions, supporting documentation, and a timeline for completion is required within fifteen working days of