FDA’s draft guidance on allergen labeling met with lukewarm reception from consumer group

In announcing a draft compliance guide for FDA staff on enforcement about major food allergen labeling the agency has missed the mark with a comment about sesame activities, according to the Center for Science in the Public Interest.

An aside in the announcement about the guidance about allergen labeling, the Food and Drug Administration says that it “is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. . . The FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume-an outcome that the FDA does not support.”

The Center for Science in the Public Interest (CPSI) is less than impressed with the FDA’s efforts, according to a statement put out by the consumer advocacy group.

“The Center for Science in the Public Interest petitioned the agency in January to prohibit companies from adding sesame and other major allergens as a way to avoid the careful cleaning and processing steps needed to prevent cross-contamination. CSPI argues that the practice, which elevates risks for consumers, violates federal requirements to mitigate allergen risks.”

The FDA states that while it’s draft guidance does not specifically address the industry’s new practice of adding sesame to products that previously did not contain it, the guidance does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. The agency is “engaged with various stakeholders on this issue,” according to its announcement.

Calling the FDA’s response to the sesame situation “tepid,” the CSPI took the FDA to task.

“A lukewarm statement like this is simply not adequate,” the CSPI countered. “Companies are playing games with the rules designed to protect us, and it’s causing harm. The very least the agency could do is warn that this practice raises risks for consumers, and actively oppose it.” 

The CSPI contends that in the absence of firmer steps industry will interpret the draft guidance as a green light for further additions of sesame to the food supply, simultaneously reducing consumer choice and increase the risk of serious allergic reactions. “Industry will continue to decide that it’s cheaper and easier to add major allergens to foods, rather than actually prevent contamination risks.” 

The FDA’s announcement presents its main point of the draft guidance document to regard enforcement policy about major food allergen labeling and cross-contact, which leads to cross-contamination of non-allergic foods with the list of major allergens. That list is milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.

“Among the updates, the draft (guidance) describes the labeling requirements for major food allergens and the proper use of the ingredient list and the ‘Contains’ statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact,” according to FDA officials.

In addition to informing FDA staff, the draft guidance also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. 

The draft guidance also describes additional allergen labeling violations. It directs FDA staff to examine potential product adulteration from allergen cross-contact as well as potential labeling violations.

To ensure that comments are received before work begins on the final version of the guidance, consumers and industry and other interested parties may submit electronic or written comments within 60 days of publication in the Federal Register. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number FDA-2023-D-1103. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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