In the story of “Ali Baba and the Forty Thieves” from The Arabian Nights, the phrase “Open Sesame” magically opens the mouth of a cave in which the Forty Thieves have hidden their plundered treasure. And now FDA is opening up discussion with industry regarding sesame regulations as the ninth major food allergen after observing practices involving manufacturers’ intentionally adding sesame to products that previously did not contain sesame.
Earlier this year, sesame became the ninth major food allergen under the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, which became effective January 1, 2023. This means that foods entering interstate commerce that contain sesame are now required to clearly be listed on food products as a major food allergen. The first eight major allergens – peanuts, tree nuts, fish, Crustacean shellfish, soy, milk, eggs and wheat – were designated major allergens with the passage of the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004. The FASTER Act amended the Federal Food, Drug and Cosmetic Act (FDCA) and subjects sesame to the FDCA requirements for major food allergens, including cGMP and preventive controls requirements for allergen control, and labeling disclosure.
Recently, FDA Commissioner Robert M. Califf provided an update on sesame allergen labeling on food packages. The Commissioner noted that the FDA is pleased to see a number of manufacturers, after implementation of the FASTER Act, dedicating their facilities and/or equipment as sesame-free, and other manufacturers using procedures to reduce the risk of sesame being unintentionally included in their products by cross-contact. Califf also noted that when sesame is present as an ingredient, the Agency is seeing manufacturers meeting compliance by adding the appropriate declaration to their labels, resulting in safer products for consumers with sesame allergies.
However, the Commissioner also denounced a practice that the FDA did not reasonably or unreasonably expect: manufacturers intentionally adding sesame to products that previously did not contain sesame, labeling the products to indicate its presence, and avoiding potential penalties and consequences for accidental cross-contamination. The result, FDA advised, is that this limits options for consumers who are allergic to sesame, and is contrary to the rule’s intent.
In recognizing the challenges with ensuring products are free of allergens, FDA is meeting with industry and consumer advocates to obtain perspective and find solutions in implementing effective cross-contract controls and allergen labeling, and ultimately, allowing consumers who are allergic to sesame, to find safe foods. FDA earlier this year issued an updated Draft Compliance Policy Guide detailing the Agency’s enforcement policy on major food allergen labeling and cross-contact controls. See our previous News & Insights article here.
We recommend that businesses who are facing these challenges consider meeting with the FDA to offer industry perspective and continue to monitor FDA’s ongoing regulation and updates to major food allergen labeling and cross-contact. It is also important to ensure that your food product labels and packaging are compliant with labeling disclosures for major food allergens, including for flavorings, colorings or incidental additives that contain a major food allergen.
So, remember – don’t be like Ali Baba’s brother Kasim who forgot the magic words and was caught by the Forty Thieves. Remember to list sesame on all your packaging and labeling if present in your products.
For questions on labeling or GMP compliance, please contact us at firstname.lastname@example.org.