Yesterday FDA released a video presentation summarizing the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act which adds sesame as the 9^th “major food allergen.”

Specifically, the presentation includes an overview of the definition of a “major food allergen” (21 USC 321 (qq)) and the labeling requirements for such allergens on packaged foods, including dietary supplements, regulated by FDA (21 USC 343 (w)). The Food Allergen Labeling and Consumer Protection Act (FALCPA), which was passed in 2004, provided the regulatory framework for allergen labeling of “major food allergen,” which was defined to only include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By adding sesame as the 9^th major food allergen, the FASTER Act extends the allergen labeling requirements to sesame as well. The effective date for the FASTER Act is January 1, 2023. Therefore, all FDA regulated packaged foods and dietary supplements containing sesame (or an ingredient derived from sesame) introduced or delivered for introduction into interstate commerce on or after this date must declare sesame as an allergen (either by declaring the food source in the ingredient list or with a separate “contains” statement).

Additionally, food facilities subject to the cGMP and preventive controls regulations in 21 CFR Part 117 must implement cGMP to prevent cross-contamination of major food allergens (if a major food allergen is present in the facility and cross-contact is reasonably likely to occur) and must also conduct a hazard analysis and implement a food safety plan which may consider allergen issues. After January 1, 2023, sesame would have to be considered in the implementation of these regulations as well.

The presentation also states that while FDA is not required to implement any new regulations (like FALCPA, FASTER is self-implementing), it will update guidance documents on an as-needed basis. FDA’s guidance document on voluntary labeling of sesame as an allergen will remain in effect until January 1, 2023 (at which point, labeling would no longer be voluntary). Furthermore, the presentation states that FDA plans to release a draft guidance related to its approach to evaluating the health and safety effects of other allergens (those that are not defined as “major food allergens”) by the end of June 2022. FDA also continues to work with other Health and Human Services (HHS) Agencies (ie., NIH and CDC) on a FASTER-mandated report to Congress which will include, among other things, recommendations for further modifications to the regulation of allergens.