FDA sends Whole Foods CEO John Mackey warning letter over pattern of mislabeling allergens

The action indicates concern over repeated violations of food safety law. Whole Foods now has 15 days to submit a plan to prevent future errors.

The Food and Drug Administration (FDA) on Tuesday took the notable step of issuing a warning letter directly to Whole Foods CEO John Mackey over what the agency described as “a pattern” of selling food products with inaccurate allergen information.

“FDA reviewed the history of food recalls for your corporation,” the letter reads. “These recalls demonstrate that your corporation engaged in a pattern of receiving and offering for sale misbranded food products.”

The letter went on to list examples of Whole Foods-branded products recalled for undeclared allergens in the past year: minestrone soup with undeclared milk, cheesecake with undeclared egg, lime tarts with undeclared almonds. For anyone who subscribes to FDA’s recall alerts, it’s clear that these represent just a fraction of Whole Foods recalls in recent months. There were also the vegan cakes with undeclared soy, the mac and cheese with undeclared egg, and the popcorn chicken that may have contained undeclared shrimp, among others.

Over half of FDA’s 338 recalls this year were associated with allergen labeling issues.

FDA doesn’t send warning letters out willy-nilly. They are typically reserved for serious concerns about repeated violations of food safety law, with the intention of prompting companies to shore up their standards.

In a response to a request for comment, a Whole Foods spokesperson provided the following statement: “Whole Foods Market takes food safety very seriously. We are working closely with the FDA to ensure all practices and procedures in our stores meet if not exceed food safety requirements. We remain committed to maintaining the highest quality standards in the industry.”

Undeclared allergens are often the top cause of food recalls, and 2020 has been no exception: Over half of FDA’s 338 recalls this year were associated with allergen labeling issues, according to analysis by the Food Industry Association, a trade group for food retailers and marketers.

“The most common reason for unintentional exposure was cross-contact with an allergen.”

This can pose obvious issues for eaters with allergies. Food Allergy Research & Education (FARE), a nonprofit that advocates for allergy awareness, published a survey in September finding that more than half of people with food allergies report suffering a food-related allergic reaction every year.

“The most common reason for unintentional exposure was cross-contact with an allergen,” reads a FARE statement on the survey findings. “With 24.1 percent of children and 32.2 percent of adults citing cross-contact as the main reason for exposure.” (“Cross-contact” refers to incidents where allergens are accidentally introduced into food items without them. The term is used in lieu of “cross-contamination,” which more commonly refers to the presence of bacteria in food.)

FDA considers foods that contain undisclosed allergens as adulterated, and it has the authority to recall pertinent products—that is, unless companies like Whole Foods voluntarily recall offending items first. Such has been the case in the above-noted examples.

Now FDA appears to be signaling that voluntary recalls alone aren’t enough. Whole Foods has 15 days to respond to the agency’s letter with a plan to correct labeling violations and “to prevent recurrences,” otherwise FDA may take further enforcement action. In the meantime, be wary of the minestrone soup?

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Jessica Fu is a staff writer for The Counter. She previously worked for The Stranger, Seattle's alt-weekly newspaper. Her reporting has won awards from the Association of Food Journalists and the Newswomen’s Club of New York.