FDA Reiterates Importance Of Allergen Labeling By Issuing Warning Letter Following Repeated Recalls

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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.

We anticipate that FDA will continue to focus on undeclared allergens in 2021 and extend its oversight over the retail and food service industry. Retailers and food service companies that perform in-store labeling of food should carefully review their allergen control programs as well as their labels to determine if updates are warranted. In particular, in-store labeling programs should include appropriate controls and monitoring of allergen declarations. Larger retail and food service chains should consider incorporating more sophisticated controls such as corrective and preventive action systems, routine audits of labeling operations and employee training on allergen labeling requirements to help limit mislabeling occurrences. Retailers with products manufactured by a third party should ensure to work closely with their contract manufacturers or packers to ensure that products sold under the retailer’s brand are also appropriately labeled. In those situations, the retailer should also protect itself from liability under the Federal Food, Drug and Cosmetic Act through a Letter of Guaranty issued by all contract manufacturers and packers supplying the retailer with retailer-branded product.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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