• On July 26, the FDA responded to a January 30, 2023 citizen petition filed by the Center for Science in the Public Interest (CSPI) regarding sesame allergen labeling by denying two of CSPI’s petition requests and granting one request. See Docket FDA-2023-P-0342.

• Specifically, CSPI’s petition requests were as follows:

  • Request 1. “Issue a notice to manufacturers, similar to [FDA’s] June 1996 “Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers,” declaring that companies cannot meet their obligation to control allergen cross-contact risks by adding major food allergens intentionally to foods;”

  • Request 2. “Finalize [FDA’s] “Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)”…to likewise reflect the policy that companies cannot add major food allergens to mitigate cross-contact risks;” and

  • Request 3. “Clarify in guidance that while cross-contact risks can be declared voluntarily in a ‘may contains’ advisory statement, they cannot be declared by naming the allergen in the ‘Contains’ statement or ingredient list, as these are reserved for declaring actual ingredients.”

• Regarding Requests 1 and 2, CSPI stated that certain manufacturers are intentionally adding sesame to products instead of implementing allergen preventive controls and included examples of companies who have either publicly or privately shared that they have added sesame to their products in response to the FASTER Act. CSPI argued that this practice is illegal and violative of both the law and the intent of FDA’s food safety rules because it “further elevates the risk to consumers by increasing potential exposure to the food allergen.” In response, FDA denied Requests 1 and 2. The Agency stated that they expect firms to adhere to good manufacturing practices and preventive controls, and that the Agency does not encourage the intentional addition of sesame to foods where it is not normally an ingredient, but that such a practice is not violative.

• As for Request 3, CSPI asked the FDA to clarify that declaring an ingredient or allergen in the ingredients list when it has not been intentionally added to food is a prohibited practice and renders the food misbranded. FDA granted CSPI’s third request and stated that “the laws and regulations do not permit the addition of “sesame,” or any other major food allergen, on the label in the ingredient list or the “Contains” statement if that major food allergen is not an ingredient used to make the food.” FDA recently addressed the practice of using allergen advisory statements in a final guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry,” which notes that allergen advisory statements are not a substitute for adherence to current good manufacturing practices or, when applicable, food allergen preventive controls. The guidance also states that any allergen advisory statement must be truthful and not misleading. Further, in May of 2023, FDA announced the availability of draft compliance policy guide (CPG) entitled “Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact,” in which the Agency states that “Major food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the “Contains” statement.

• In the conclusion to their response, FDA stated that while the Agency is not taking action with respect to Requests 1 and 2, they are “actively looking into and engaging on this practice of companies intentionally adding sesame to foods that, prior to the passage of the FASTER Act, did not contain sesame.”