The Food and Drug Administration is requesting comments on the prevalence and severity of sesame allergies in the United States and may take regulatory action that would require sesame to be labeled as an allergen on packaged foods, the agency said Oct. 29. Sesame currently is not required to be disclosed as an allergen as it is not one of eight major allergens listed by the F.D.A.: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
“Unfortunately, we’re beginning to see evidence that sesame allergies may be a growing concern in the U.S.,” said Scott Gottlieb, M.D., commissioner of the F.D.A. “A handful of studies, for example, suggest that the prevalence of sesame allergies in the U.S. is more than 0.1%, on par with allergies to soy and fish.”
The comment period will open Oct. 30 and stay open for 60 days. Electronic comments must be sent to www.regulations.gov. Written comments may be sent to Docket Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville MD 20852. All submissions must include the Docket No. FDA-2018-N-3809. More information may be found here.
“Specifically, we’d like to hear from epidemiologists, nutritionists, allergy researchers and physicians concerning their clinical experiences and relevant findings,” Dr. Gottlieb said. “We’re also looking for feedback from the food industry and consumers to help us gain a more complete understanding of the risks and to learn more about the potential impact of any future regulatory action that could include new disclosure requirements for sesame. All of this will help inform our next steps.”
Health Canada, Ottawa, considers sesame seeds to be a priority food allergen along with eggs, milk, mustard, peanuts, crustaceans and mollusks, fish, soy, sulfites, tree nuts, wheat and triticale. mainstream.
The F.D.A. in 2014 received a citizen petition from the Center for Science in the Public Interest, several medical professionals and two consumer advocacy groups requesting that sesame seeds and sesame products be regulated in a manner similar to the manner in which major food allergens are regulated under the F.D.&C. Act. The petition noted the European Union, Canada, Australia and New Zealand require labeling of sesame. The petition also requested the F.D.A. add sesame to its list of allergens.