US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the first new major food allergen to join the list since its creation in 2004:
- Milk
- Eggs
- Fish
- Crustacean shellfish
- Tree nuts
- Wheat
- Peanuts
- Soybeans
Prior to the FASTER Act, US Food and Drug Administration (FDA) regulations only required food manufacturers to declare whole sesame seeds as an ingredient. Accordingly, other forms of sesame may currently be declared as simply “spice” or “flavor” on food labels.
Under the FASTER Act, all forms of sesame ingredients must be identified as allergens, whether present as a spice, flavoring, coloring, or incidental additive. Failure to declare sesame as a food allergen will cause the food to be misbranded.
The FASTER Act will come into effect on January 1, 2023. In the meantime, industry can look to FDA’s November 2020 draft guidance for the Voluntary Disclosure of Sesame as an Allergen for advice. There, FDA recommends that food manufacturers voluntarily declare sesame when used in foods as a flavor or spice, or when a food is or contains sesame, in a parenthetical; for example:
- “Spice (sesame)” or “Spices (including sesame)”
- “Flavor (including sesame)” or “Flavors (including sesame)”
- “Tahini (sesame)”
The FASTER Act’s passage is likely in response to the increase in the prevalence of sesame allergies, which are now estimated to afflict more than 1.5 million Americans. FDA found that one in four adverse event reports involving sesame occurred from products in which sesame was undeclared, with nearly half of those requiring medical attention.
The FASTER Act also requires FDA to submit a report by October 23, 2022, detailing, among other activities, specific recommendations on the development of a framework for “the timely, transparent, and evidence-based” modification of the list of “major food allergen.”
With sesame’s addition to the major food allergen list, advocates of increased labeling disclosures can cross one ingredient—and one of their top legislative priorities—off their to-do list. For industry, voluntarily disclosing the presence of potential allergens may reduce the number of adverse event reports.