FDA receives criticism related to draft policy on food allergen labeling

The Food and Drug Administration (FDA) has recently released a draft guidance updating its enforcement policy regarding major food allergen labeling and cross-contact controls. While the draft guidance addresses requirements and policy related to major food allergens, including sesame, the Center for Science in the Public Interest (CSPI) criticized the FDA’s statement regarding manufacturers intentionally adding sesame to products as inadequate.    

The FDA’s draft guidance outlines requirements for labeling major food allergens like milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans and sesame as well as controls needed to prevent cross-contamination. The guidance directs FDA staff to evaluate potential allergen safety risks and labeling violations.    

In a recent announcement, the FDA acknowledged that some companies have started adding sesame to items that did not previously contain it and are updating labels accordingly. The FDA said 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 CSPI condemned this statement as “tepid” and argued that it gives companies permission to continue the practice, reducing choice and endangering consumers with allergies.    

In January, the CSPI petitioned the FDA to ban adding allergens to avoid proper cleaning and cross-contamination prevention.    

Sarah Sorscher, CSPI Director of Regulatory Affairs said, “A lukewarm statement like this is simply not adequate. 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 stressed that without stronger action, companies will see this as approval to add more sesame and allergens to foods, increasing risks. “Industry will continue to decide that it’s cheaper and easier to add major allergens to foods, rather than actually prevent contamination risks,” added Sorscher.    

Comments on the FDA's draft guidance can be submitted by consumers, industry, and other interested parties until July 17, 2023.