The FDA is issuing a request for information on the prevalence and severity of sesame allergies in the U.S. to inform possible regulatory action that would require sesame to be labeled as an allergen on packaged foods. Currently, sesame is not required to be disclosed as an allergen, and in some circumstances, may be exempt from being listed by name in the ingredient statement on food packages. FDA also wants to know about possible costs of any future regulatory action FDA.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that a food containing a major food allergen declare the source of the allergen. The Act defines a major food allergen as one of the following: milk, eggs, fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. In addition to requiring the disclosure of these eight major food allergens, the FD&C Act gives the FDA the authority to issue regulations requiring the disclosure of spices, flavorings, colorings, and incidental additives that are, or contain, allergens other than the eight major food allergens, and FDA is not restricted from requiring labeling regarding other food allergens.
According to FDA, in the case of food allergens other than the eight major food allergens, it can be difficult, in some cases, for consumers who have allergies to avoid them because they may not always be specifically listed in the ingredient statement or identified by allergen labeling. An ingredient that contains a food that is not a major food allergen may only be listed by its common or usual name and not always declare the name of the food source. In the case of an ingredient list declaring “tahini,” the source of the ingredient, sesame, is not included as part of the name listed in the ingredient statement. In addition, spice mixes, flavors, and colors used as ingredients can be labeled generically without stating individual ingredients.
The comment period closes on Dec. 31, 2018. To submit electronic comments, go to https://www.regulations.gov and search for Docket No. FDA-2018-N-3809.