Regulatory perspectives on labeling coconut and sesame as allergens
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight major food allergen categories that accounted for more than 90 percent of all documented food allergies in the U.S. These top eight allergen categories are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. While the FDA fully realizes that there are more than 160 foods that have been identified to cause food allergies in sensitive individuals, the final act only mandated disclosure of these top eight. While the categories of fish, shellfish and tree nuts represent numerous species and varieties, the actual food allergen name used for disclosure is the name of the species or variety.
Coconut. This need for specificity has led FDA to issue a guidance document that identified 19 nuts, including coconut, which they consider to be a tree nut.
The Coconut Coalition of the Americas (CCA) recently launched an initiative to clarify that although FDA recognizes coconut as a tree nut, coconuts are not a tree nut and should not be considered a tree nut allergen. Therefore, CCA argues that most people who are allergic to tree nuts can safely eat coconut.
The CCA believes FDA misclassified coconut, which is causing confusion. “Consumers with a tree nut allergy, but not a coconut allergy, are being deprived of this fruit,” says Len Monheit, executive director, CCA. “And, industry is being greatly impacted, as contract manufacturers wanting to use coconut have to unnecessarily classify their facility as a tree nut facility when they’re not.”
Stay tuned for more information on this ongoing CCA initiative to remove coconut from the list of “tree nuts” FDA identifies as major food allergens.
Sesame. On October 30, 2018, the FDA released a “request for comments” notice in the Federal Register regarding the labeling of sesame as a major food allergen. In a statement released at that time, then FDA Commissioner Scott Gottlieb indicated that a handful of studies suggest that the prevalence of sesame allergies in the U.S. is more than 0.1 percent, which is on par with allergies to soy and fish.
Because sesame is not currently considered a major food allergen, it may not always be listed by name in the ingredient statement. For example, the identifier “tahini” has, over time, become a common name for a ground toasted sesame seed paste without additional ingredients. Not all consumers realize that tahini is a sesame ingredient. Additionally, natural flavors derived from sesame seed are not required to disclose their food source.
Gottlieb stated that the agency issued the request for information so they could learn more about the prevalence and severity of sesame allergies in the United States, as well as the prevalence of food sold here containing sesame. Specifically, they were seeking information from epidemiologists, nutritionists, allergy researchers and physicians concerning their clinical experiences and relevant findings.
Nearly 5,000 comments were received in response to the notice, but there has been no further action on including sesame as a major food allergen by the FDA. If the FDA were to add sesame to the list of major food allergens, it would be the first allergen added since FALCPA was finalized.
The state of Illinois appears to be tired of waiting for action on adding sesame as a major food allergen. On July 26, 2019, Governor J. B. Pritzker signed into law a bill mandating that food manufacturers indicate the presence of sesame on their packaged food labels. The misbranding section of the Illinois Food, Drug and Cosmetic Act now includes a provision that a food is misbranded, “If it contains sesame, is offered for sale in package form but not for immediate consumption, and the label does not include sesame.”
Note that this new provision is not adding sesame directly to the group of major food allergens, which continues to be under the purview of the federal government and cannot be changed by the individual states. Illinois is simply mandating that the word “sesame” be called out when it is the source of an ingredient. This could potentially be stepping into the FDA’s territory. However, there has been no response from them yet.