On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for undeclared allergen(s). FDA reported that investigators found similar patterns of recalls in previous years. According to a Constituent Update accompanying the Warning Letter, FDA has sent eight Warning Letters to companies that have manufactured and distributed foods with undeclared allergens in 2020.
This Warning Letter is significant because it is the first time that FDA has issued a Warning Letter to a retailer for the labeling of allergens. According to FDA, its action was warranted because the company allegedly “engaged in a pattern of receiving and offering for sale misbranded food products” that contained undeclared allergens over multiple years. While retail establishments are excluded from certain requirements under the Federal Food Drug and Cosmetic Act, retailers have a responsibility to ensure that food labeled within a store contain accurate allergen declarations as well as have a responsibility to ensure packaged foods under the retailer’s brand also have accurate allergen declarations. The Warning Letter highlights that a retailer is “responsible for investigating and determining the causes of the violations . . . and for preventing their recurrence or the occurrence of other violations. It is [a retailer’s] responsibility to ensure [the] firm complies with all requirements of federal law and implementing regulations” including when products are relabeled in store.
Over half of the FDA’s 338 recalls in 2020 were associated with allergen labeling issues, according to an analysis by the Food Industry Association. The FDA considers foods that contain undisclosed allergens as adulterated, and has the authority to take enforcement actions with respect to such products – unless the offending company voluntarily recalls those products first. With this Warning Letter, FDA is suggesting that food retailers have the responsibility to take proactive steps to ensure food is appropriately labeled for allergens when consumer labeling occurs in store.
Continue Reading FDA Reiterates Importance of Allergen Labeling by Issuing Warning Letter Following Repeated Recalls