Background on food allergens
As background, food allergies and other types of food hypersensitivities affect millions of Americans and their families. Food allergies occur when the body's immune system reacts to certain proteins in food, and the most severe and life-threatening symptoms include anaphylaxis, which can involve fatal respiratory problems and shock. In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) which identified eight major food allergens including milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybean. The law was self-implementing, meaning that the U.S. Food and Drug Administration (FDA) has never issued regulations implementing FALCPA, though it has issued guidance on the labeling of major food allergens.
Implications for the food and beverage industry
The FASTER Act contains two substantive provisions. First, it amends the Federal Food, Drug, and Cosmetic Act (FFDCA) by including sesame in the list of “major food allergens.” Second, it requires the HHS to prepare a report to Congress. The FASTER Act does not make any other modifications to the FFDCA. Once the FASTER Act is enacted, sesame will be the ninth major food allergen, and food products containing sesame will be subject to the same labeling requirements and allergen control measures as other major food allergens.3 The statute does not require the FDA to undertake rulemaking to implement the new requirements, so while it is possible the agency will issue new guidance or update its existing guidance on allergen labeling to reference sesame, the law should be self-implementing with the compliance date of 1 January 2023.
The FASTER Act also intends to strengthen the federal government’s activities related to the safety, treatment, education, and research of food allergens. In particular, the Act would require the Secretary of the HHS, no later than 18 months after the date of the enactment, to submit a report to Congress that details the federal government’s activities in the following areas:
- the surveillance and collection of data on prevalence and severity of allergic reactions (including any gaps in such activities);
- the development of effective food allergy diagnostics;
- the prevention of the onset of food allergies;
- the reduction of risks related to living with food allergies, and the development of new therapeutics to prevent, treat, cure, and manage food allergies; as well as
- specific recommendations to improve these activities.
Most notably, the Act contains a provision that calls for agency recommendations on a regulatory process and framework to facilitate the inclusion of additional food allergens as major food allergens. This would require the agency to develop scientific criteria for defining a food or food ingredient as a major food allergen, including a standard for the prevalence and severity of reaction that would merit classification as a major food allergen. It would also require the agency to provide appropriate opportunities for stakeholder engagement and comment in considering any future changes to the definition.
We will continue to monitor the FASTER Act and the legal and regulatory developments related to allergen control at the federal level. If you have any questions in the meantime, please don’t hesitate to contact us.
1 The full-text of the bill is available at: Text - S.578 - 117th Congress (2021-2022): FASTER Act of 2021 | Congress.gov | Library of Congress (accessed 15 April 2021).
2 In particular, once enacted, Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) will be amended by striking “and soybeans” and inserting “soybeans, and sesame”.
3 In November 2020, the FDA issued a draft guidance to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame, available at: Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen | FDA (accessed 15 April 2021).
Authored by Martin Hahn, Veronica Colas, and Xin Tao.