This past month sesame allergen labeling has been a hot topic. From the U.S. Food and Drug Administration’s (FDA) draft guidance to the House passing the Food Allergy Safety, Treatment, Education and Research Act (FASTER), requirements for sesame allergen labeling are moving forward. The FDA has cited recent studies showing that 0.1% of Americans are allergic to sesame. This is equal to the percentage of Americans that are allergic to fish and soy, two of the eight major allergens in the United States. As a result of this growing concern, FDA and Congress are working towards adding sesame to the list of major allergens. This article will provide an overview of how the FDA regulates allergen labeling and recent developments in allergen labeling regarding sesame.

The Big-8 and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

In August of 2004, FDA published the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FALCPA is an amendment to the Food Drug and Cosmetic Act (FD&C) establishing the eight major allergens as milk, egg, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. These eight major allergens are often referred to as “the Big-8.” There are over one hundred and sixty foods that can cause allergic reactions, the Big-8 account for ninety percent of food allergy reactions.[1] Therefore, under the FALCPA, these major allergens require mandatory labeling. This mandatory labeling can be satisfied in one of two ways. The name of the allergenic food source can be included in parenthesis immediately following the usual name of the allergenic food source in the ingredient statement. For example, a food containing whey would be included on the ingredient label as “whey (milk).” Allergens may also be disclosed after the word “contains” after or beside the ingredient list. For instance, the packaging for the above product that includes whey would include the statement “Contains milk” adjacent to the ingredient list. However, the FALCPA does not require advisory statements such as “may contain.” If a manufacturer chooses to include such an advisory statement, it must be truthful and not misleading. One major issue that the FALCPA failed to account for is the naming of new major allergens. With the rising number of sesame allergies, this has become a public health issue that both FDA and Congress are working toward solving.

Guidance from FDA

In response to a 2014 Center for Science in the Public Interest Petition regarding labeling sesame as an allergen, the FDA issued a notice requesting data and information regarding sesame allergies in the U.S in October of 2018. FDA received comments that some allergic reactions may be occurring from products with undeclared sesame or products that contain ingredients like tahini, a mixture of ground hulled sesame. FDA also stated that recent studies have found that the number of Americans that suffer from sesame allergies is statistically equivalent to the number of Americans that suffer from allergies to soy and fish.

In response to the comments received, FDA issued draft guidance on sesame labeling on November 10, 2020. FDA states that the prevalence of severe sesame allergies in the U.S. are increasing. As a result, FDA is recommending that manufacturers voluntarily label products containing sesame as a “flavor” or “spice.” For example, if a spice blend contains sesame, FDA is recommending that the ingredient list contain the phrase “spices/flavor (sesame/including sesame).” The draft guidance also specifically mentions labeling tahini as “tahini (sesame)” on the ingredient list as many comments expressed concern about tahini. FDA’s intent is that the voluntary disclosure of sesame as part of the ingredient list will help affected consumers avoid foods that could cause an allergic reaction.

The other part of FDA’s draft guidance describes the want to emulate the systems for determining which products require allergen labeling that Australia, New Zealand and other countries have adopted. Specifically, FDA has stated that it is working to “develop our own set of factors for evaluating which food allergens, beyond the eight major food allergens specified in the FD&C Act, should be designated as requiring additional controls, including allergen labeling.”[2]

However, as this is simply draft guidance released by the FDA, the recommendations are not binding regulations. This means the FDA cannot take enforcement actions based on this draft guidance at this time. The draft guidance is available for comment until January 11, 2021. After receiving comments, the FDA should release a final version of the guidance. The final guidance document will not be binding regulation, instead it will serve as a representation of the FDA’s current thoughts on the topic.

Federal Legislation

On November 17, 2020, the U.S. House of Representatives unanimously passed the Food Allergy Safety, Treatment, Education, and Research Act (FASTER). This act would not only require mandatory labeling of sesame as the ninth major allergen, but also requires expanding and increasing the collection of data regarding the prevalence of food allergies. Specifically, the Act would amend the FD&C Act to include sesame in section 201(qq)(1)’s list of major allergens. The Act would also add a section to 201(qq) which establishes a system to define new major allergens based on scientific criteria showing an allergen presents a public health concern. The bill has been received by the Senate and is currently being reviewed by the Committee on Health, Education, Labor, and Pensions.

Conclusion

Moving forward, the issue of sesame allergen labeling is a concern for both Congress and the FDA. However, it is important to note that the issue is much larger than just sesame. The FDA and Congress are both looking at ways to change how we determine which foods are major allergens and require additional labeling. For facilities that manufacture products with sesame, declaring sesame as a major allergen could result in changes to their food safety plan under FSMA’s allergen, supply chain and sanitation preventive controls and current good manufacturing practices.

To view the NALC’s Food Labeling Reading Room, click here.

To view FDA’s information on allergen labeling, click here.

To view the FDA’s Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry, click here.

[1] Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry, Food and Drug Administration (November 30, 2020) https://www.fda.gov/media/143521/download

[2] Id.