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.

Contact Us

Husch Blackwell has experience working with food retailers and the food service industry to assist with meeting FDA’s food safety requirements, including those related to allergen labeling.  Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney for more information.

Print:
EmailTweetLikeLinkedIn
Photo of Seth Mailhot Seth Mailhot

With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array…

With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.

Photo of Emily Lyons Emily Lyons

Emily grew up on a northern Illinois dairy farm, and now helps clients bridge the gap from farm to fork. She guides clients on complex regulatory issues as they bring dairy products, beverages, fruits and vegetables, processed foods and other agricultural goods to…

Emily grew up on a northern Illinois dairy farm, and now helps clients bridge the gap from farm to fork. She guides clients on complex regulatory issues as they bring dairy products, beverages, fruits and vegetables, processed foods and other agricultural goods to market. At the intersection of agriculture, food and environment, Emily handles compliance matters such as labeling, marketing, permitting and agency inquiries including the Food Safety Modernization Act, Pasteurized Milk Ordinance, USDA National Organic Program and bioengineered food disclosure standard, Generally Recognized as Safe status for food additives and food contact substances, and the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

Photo of Brayton Deprey Brayton Deprey

Brayton enjoys helping clients with the transactional work of establishing, funding, licensing, growing and selling their businesses. Dedicated to due diligence, she understands that proactive and strategic contracts today are a critical element to reaching business goals tomorrow.