Sesame at the Cross Roads
Further Down the Road
Preparing for the Road Ahead
Sesame seeds have been consumed for thousands of years worldwide, but the popular ingredient recently reached the crossroads of food safety and labeling in the United States. On April 23, President Biden signed the Food Allergy Safety, Treatment, and Research (FASTER) Act into law requiring the food industry to declare sesame on the labels of packaged foods beginning January 1, 2023. Sesame is now the ninth major food allergen to require food labeling and food allergen controls, which could pose significant challenges for the food industry.
As a highly versatile ingredient, sesame is commonly used as seeds, paste, oil, or seasoning blends. Sesame is found in various foods, including granola, cereals, baked goods, dressings, sauces, soups, snack chips, tahini, and Asian cuisine. Moreover, sesame seeds are a source of nutrients and associated with numerous health benefits. Despite the nutritional benefits, many people are allergic or sensitive to sesame.
According to a recent survey, the estimated prevalence of sesame allergy is similar to the prevalence of allergies to soy and fish and impacts approximately 1.5 million Americans.
Sesame was not identified as a major food allergen in the Food Allergen Labeling and Consumer Protection Act (FALCPA), but sesame labeling requirements already exist in Canada, Australia, and the European Union. Under the U.S. food allergen law, the presence of any of the “Big 8” major food allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans) must be declared on the labels of prepackaged food.
The Food Allergy Safety, Treatment, and Research (FASTER) Act (S. 578/H.R. 1202) was introduced to the new legislative session this year, and the U.S. Senate quickly passed the bill. Upon the passage of the bill by the House on April 14, the FASTER Act was sent to President Biden for his signature. The Food and Drug Administration (FDA) will not issue a regulation for sesame labeling, but the agency will update its allergen guidance to include sesame.
Sesame at the Crossroads
Under the new allergy law, the FALCPA labeling requirements apply to sesame products and any pre-packaged food products containing sesame. Consumer exposure to the allergen can occur from foods containing sesame or food exposed to sesame during manufacturing on shared equipment. Accurate labeling of sesame will be essential as undeclared allergens are the leading reason for recalls of FDA-regulated food products.
Beyond labeling, the new law will prompt food companies to re-evaluate their food safety plans related to allergen controls, including employee training and sanitation controls.
Under the Food Safety Modernization Act (FSMA), undeclared food allergens were classified as adulterants, which requires companies to consider allergens as potential hazards in terms of preventive controls and a company’s food safety plan. In alignment with FSMA, the FDA implemented regulations for preventive controls and hazard analysis, which mandated the control of all hazards, including food allergens. In November, the FDA released draft guidance for the voluntary declaration of sesame on food labels.
Further Down the Road
Within 18 months after the date of enactment, the FASTER Act will require the federal government to submit a report to Congress addressing current activities related to food allergens, including the following priorities:
- the collection of data on the prevalence and severity of allergic reactions for specific food or food ingredients;
- the development of effective food allergy diagnostics;
- the prevention of the onset of food allergies;
- the development of new therapeutics to prevent, treat, cure, and manage food allergies.
The future addition of allergens to the list of major food allergens should be simplified. The FASTER Act contains a provision requesting federal agency recommendations for an improved regulatory process and framework that would facilitate the addition of new allergens to the list of major food allergens.
An industry petition to require the inclusion of sesame as a major food allergen was under consideration by the FDA for years prior to the passage of the FASTER Act. Currently, the FDA is considering industry petitions for the addition of coconut (2019), rye, and barley (2018) to the list of major food allergens.
Preparing for the Road Ahead
Mérieux NutriSciences offers qualitative and/or quantitative testing services for allergens in all food matrices, including raw materials and finished products, utilizing a range of technologies, including Enzyme-Linked Immunosorbent Assay (ELISA) methods. For sesame, we offer product and swab testing using an ELISA method.
Our Food Labeling Compliance experts can review specific aspects of your food label, including the development of regulatory compliant labels for nutrition, ingredient statements, and allergen statements. We offer complete nutrition labeling options and food label review services to meet U.S. and Canadian regulations.
We take a holistic approach with Allergen Program Development, Allergen Risk Assessments, and Allergen Sanitation Validation Studies. Our experienced consultants can help you ensure that your Allergen Management Program is robust enough to cover all the important components needed to protect your brand. Contact us today to learn more.