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April 03, 2020

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FDA Considering Labeling for Sesame Allergies

  • In a statement from U.S. Food and Drug Administration (FDA) Commissioner Gottlieb, the agency announced that it is considering mandatory food labeling for sesame to help protect those that have sesame allergies. As required by the Food Allergen Labeling Consumer Protection Act, federal law provides that foods containing one of the eight “major food allergens”-milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans-declare the food source of the allergen using its common or usual name on food labels. When the law was first passed in 2004, those eight food groups, out of more than 160 identified food allergens, accounted for 90 percent of serious food allergic reactions occurring in the US.

  • Both the FDA and the United State Department of Agriculture’s Food Safety and Inspection Service (FSIS) have been under pressure for food recalls, with the leading reason being undeclared food allergens. Gottlieb has pledged to reform the agency’s approach to food recalls amid increased attention on the agency over food recalls, and possible regulatory action to add an additional major food allergen for mandatory disclosure is a sign of FDA’s expanding its efforts to protect and promote public health.

  • In light of new evidence that sesame allergies may be a growing concern in the US, FDA has issued a request for information “to learn more about the prevalence and severity of sesame allergies in the U.S., as well as the prevalence of sesame-containing foods sold in this country.” In addition, the request for information asks for comment on the possible costs of any future regulatory action regarding labeling for sesame allergies. Comments are due December 31, 2018.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...