- The FDA is publishing draft guidance in the Federal Register this week that would ask manufacturers to voluntarily disclose sesame as an ingredient. This is part of an ongoing review of whether sesame will become an allergen that needs to be specifically called out on food labels.
- Under the guidance, products using sesame as part of a broad category listed on the ingredient label, including "natural flavors" or "spices," should use sesame in parentheses next to it so consumers know the ingredient is included. If the product includes an ingredient made from sesame that doesn't contain the word sesame, like tahini, the guidance asks that the word sesame follow it in parentheses as well.
- The FDA has been examining whether to make sesame a top allergen since 2018. Research published in JAMA last year showed as much as 0.49% of the U.S. population — about 1.6 million people — could be allergic to the seed.
While this draft labeling guidance is not final and does not constitute a finding that sesame will be joining the ranks of top allergens, it's a powerful indicator that change may be on the way. It's also a sign that it's time for manufacturers that might not have taken the new research on sesame seriously to change their outlook.
Sesame allergies are not only becoming more prevalent, but reactions to it are often severe. According to data cited by the Center for Science in the Public Interest and submitted to the FDA, 38.8% of children and 44.7% of adults with sesame allergies have had serious reactions to the seed. And with insurance claims for severe allergic reactions to food increasing 377% from 2007 to 2016, according to FAIR Health, it's clear this is a serious issue for many people.
After the FDA opened the docket on whether to declare sesame a top allergen two years ago, it received more than 4,800 comments from consumers, researchers, medical professionals and industry groups, the Federal Register entry stated. The FDA also received quite a bit of research on the prevalence and severity of sesame allergy. The agency asked consumers to submit incidents of reactions from sesame allergy to the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System. It received more than 500.
If sesame becomes a top allergen, it would be the first addition since the 2004 passage of the Food Allergen Labeling and Consumer Protection Act. This law mandates the plain language labeling of the "top eight" allergens — milk, soy, eggs, wheat, peanuts, tree nuts, fish and shellfish — on all items that may contain even trace amounts. These ingredients are responsible for 90% of all food allergies, and are the ones that cause the most severe reactions.
Even without the federal regulation, manufacturers may already be starting to make this labeling change. Last year, Illinois passed a state law requiring sesame to be disclosed on ingredient labels. The state's largest city, Chicago, is home to more than 4,500 food manufacturers and headquarters of many of the most powerful CPG businesses. Those companies should be aware of the state's mandate. By complying with that law, they could easily turn the tide to ensure sesame is disclosed on most items consumers buy throughout the U.S.
The FDA's draft guidance is very similar to labeling regulations for the rest of the top allergens. While it may take work and incur some costs to change labels, it would be prudent for manufacturers to take heed of this draft and start working toward this disclosure now, if they haven't already.
Considering the response to FDA's docket, state laws about sesame labeling and the fact that draft guidance will be published, a regulatory change seems likely. But even if sesame isn't eventually declared a top allergen by the FDA, today's consumers want transparency and simple ingredient labels. More explanation of what "natural flavors" entails would likely not hurt.