On October 29, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that FDA is considering whether sesame should be disclosed on food labels as an allergen. Because sesame is not identified as a “major food allergen” under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the ingredient is not always required to be stated on the food label. Rather, in some cases, sesame can be listed generically as “spice,” “natural flavor,” “tahini,” or other nonspecific ingredient names, which can lead to consumer confusion and uncertainty.
Milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans are currently the only major food allergens that must be specifically declared on food labels. When Congress passed FALCPA, those eight ingredients accounted for 90% of serious food allergic reactions in the United States. FALCPA imposes strict requirements that the presence of these eight allergens be clearly marked on food labels, such as with a “contains” statement (e.g., “contains eggs”).
According to Commissioner Gottlieb’s statement, some studies suggest that the prevalence of sesame allergies in the United States is more than 0.1% of the population, which is on par with soy or fish allergies. FDA is therefore requesting information on the prevalence and severity of sesame allergies in the United States. FDA also seeks information on the prevalence of sesame-containing foods sold in the United States, including foods that are not currently required to list sesame on the food label. The comment period for FDA’s request for information closes December 31.
While the eight major food allergens are set by statute, FALCPA gives FDA the authority to issue regulations requiring the disclosure of nonmajor food allergens that are contained in spices, flavorings, colorings, and incidental additives. Specifically, 21 U.S.C. § 343(x) states: “[A] spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.”
Sesame seed labeling on foods has been a growing concern in recent years. In 2014, the Center for Science in the Public Interest, several medical professionals, and two consumer advocacy groups submitted a citizen petition requesting FDA to require that sesame be regulated in a manner similar to the major food allergens. The petition discussed scientific research in support of its argument that sesame is a major public health concern, and also noted that the European Union, Canada, New Zealand, and Australia require that sesame be identified as an allergen on food labels. In addition, bills that are currently in the US House and Senate seek to make sesame a major food allergen under federal law, although neither version has advanced since they were introduced in April. (H.R. 5425, Food Labeling Modernization Act of 2018 (115th Congress); S. 2647, Food Labeling Modernization Act of 2018 (115th Congress).)
While FDA and Congress consider whether to require that sesame be identified as an allergen, food manufacturers and retailers face uncertainty and perhaps increased product liability risks. Although state law claims premised on misleading labeling would likely be preempted under Section 403A(a)(2) of the Federal Food, Drug and Cosmetic Act, product liability claims might not be barred, especially if a reasonable consumer would not expect to find sesame in the food product. See, e.g.,Restatement (Second) of Torts § 402A, cmt. j (a warning is required when a product contains an ingredient to which a substantial percentage of the population is allergic and the ingredient is one whose danger is not generally known or that the consumer would not reasonably expect to find in the product).
If you would like assistance providing information to FDA on any of those issues, including on the risks or potential impact of any future regulatory action on food labeling, or for additional information on product liability risks, please contact Ann Begley, Benjamin P. Smith, or Hilary Lewis.