Under the FASTER Act, sesame will be treated the same way as the other eight major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.2 Specifically, the Act will:
- Expand the allergen labeling requirements to include sesame
- Collect national information on Americans’ exposure to food allergens and the prevalence of food allergies to specific allergens
- Expand current guidance on patient experience data to include food allergies
- Require a study of the economic costs of food allergies
In 2020, FDA issued a draft guidance to encourage food manufacturers to voluntarily disclose the presence of sesame as an ingredient on food labeling.3 Starting January 1, 2023, the updated labeling requirements will apply to any packaged foods sold or distributed in interstate commerce. Foods containing any sesame must identify the allergen’s food source on the food label in one of the two ways:
- Manufacturers may either declare the name of the allergen in the parentheses following the name of the ingredient (e.g., “tahini (sesame)”), or
- They may declare in a separate statement “Contains: sesame” immediately after or next to the ingredient list4
If a food product fails to comply with the food allergen labeling requirements, it will be considered misbranded and subject to FDA enforcement action. FDA generally will expect the food to be recalled, and it can also be subject to import refusal and seizure by the agency.5
Notably, the FASTER Act involves more than just updating food labels. It also implicates preventive controls, sanitation practices, and other procedures. Through the Food Safety Modernization Act (FSMA), FDA will now require facilities that use sesame to have procedures in place to protect against cross-contamination. Because cross-contamination can increase the risk of food safety issues (and therefore, FDA recalls), manufacturers and suppliers that handle sesame must carefully analyze their sanitation practices to ensure compliance with FDA requirements.
Moving forward, manufacturers should review their formulations with suppliers - especially formulations providing flavors or spices where the presence of sesame may not be obvious.
Manufacturers that use sesame should update their labeling and advertising accordingly. For example, an “allergen free” claim in a food containing sesame will likely trigger a recall and, in some cases, an FDA Warning Letter. Additionally, companies that handle foods containing sesame should revisit their policies and procedures as soon as possible to ensure compliance with FDA’s major food allergen requirements.
- Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act of 2021), Pub. L. No. 117-11, § 2, 135 Stat. 262 (2021).
- 21 U.S.C. § 321(qq)(1).
- FDA Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen (November 2020)
- 21 U.S.C. § 343(w).
- FDA Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (November 2022) at 5-6.
Client Alert 2022-397
