The U.S. Food and Drug Administration (FDA) is requesting information about the prevalence and severity of sesame allergies in the U.S. The details gathered will be used to then initiate possible regulations that would require sesame to be labeled as an allergen on food packaging. Currently, sesame is not required to be disclosed as an allergen, and in some circumstances, sesame may be exempt from being listed by name in the ingredient statement on food packages.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) currently acknowledges eight major food allergen categories: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The disclosure of these allergens on food packaging is required by the FD&C Act.

According to a statement released by FDA Commissioner Scott Gottlieb, "we're beginning to see evidence that sesame allergies may be a growing concern in the U.S. A handful of studies, for example, suggest that the prevalence of sesame allergies in the U.S. is more than 0.1 percent, on par with allergies to soy and fish.

When it comes to allergens not included in the eight major categories, it can be difficult for consumers to avoid them because they are not always labeled on food packaging. This is particularly an issue with foods like spice mixes, flavors, and colors because they are identified and labeled generically without revealing individual ingredients.

To get around this, FDA is also asking for input on the prevalence of sesame-containing foods sold in the U.S. that are not required by law to disclose sesame in the ingredient list on food packages. The agency also wants to know about possible costs of any future regulatory action FDA might take regarding sesame disclosure for foods.

In addition to issuing this request for information, the FDA will continue to monitor the scientific literature and consumer complaint databases to identify emerging food allergen concerns and continues to evaluate whether other food allergens pose a risk to U.S. consumers, thus warranting possible agency action.

The comment period opens October 30, 2018 and will remain open for 60 days.

To submit electronic comments, go to https://www.regulations.gov and search for Docket No. FDA-2018-N-3809.   

Written comments must be sent to:

Docket Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

All submissions received must include the Docket No. FDA-2018-N-3809.

Further instructions can be found in the Federal Register's Request for Information.

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