On January of 2023, the U.S. FDA added sesame to the official list of major food allergens, as identified by the Food Allergen Labeling and Consumer Protection Act of 2004, that includes milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
Consequently, sesame, will now be subject to the same labeling and manufacturing requirements as other major food allergens identified by FDA. The change comes over a year and a half after the Food Allergy Safety, Treatment, Education and Research (FASTER) Act was signed into law in April 2021 and expanded the definition of “major food allergen” to include sesame. By doing so, US is aligning with other countries such as Canada and Australia, and the European Union, that have included sesame in their labeling laws for years already.
The commitment to understanding and protecting the food allergen consumer continues to be a priority for food manufacturers. The impact from a safety and purchasing standpoint is significant. 32 million Americans live with food allergies that impact their well-being and quality of life. Retail establishments, food companies are key players in building empathy and trust with the customer.
Sesame can be found in seed, oil or paste form in a variety of foods, from baked goods and bread crumbs to sushi, soups, dressings and sauces.
Regulations in recent years have sought to assist allergen-aware consumers by requiring changes in labeling to reflect individual ingredients and sourcing, but challenges remain in creating labeling clarity and providing relatable education that can facilitate a better understanding for consumers of what labels mean.
As of Jan. 1, sesame has officially joined the list of major food allergens, the U.S. Food and Drug Administration said.
Food already in circulation before 2023 doesn’t need to be removed from retail shelves or relabeled to declare sesame an allergen .
What Is an Allergen Declaration?
The FDA is responsible for the enforcement of the Food Allergen Labeling and Consumer Protection Act (FALCPA) in most packaged foods but does not oversee enforcement of foods like meat and egg products regulated by the US Department of Agriculture (USDA) or alcoholic beverages, drugs, cosmetics, and foods sold in retail establishments that are not prepackaged with a label.
FALCPA requires that manufacturers label major food allergens specifically with the name of the allergen source. Manufacturers may provide the food allergen information on the label in one of two ways:
Following the name of the ingredient, in parenthesis; e.g., “semolina flour (wheat).”
After or next to the list of ingredients, with a “contains” statement; e.g., “Contains, egg, wheat.”
What Is the Most Recent FDA Labeling Update?
The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law in April 2021 and added sesame to the list of major allergens.
Changes go into effect on January 1, 2023, and manufacturers are not required to list sesame until then.
FARE backed the law in an effort to reduce the risk for the 1.5 million people in the US with a sesame allergy. But the FASTER Act has additional components beyond requiring manufacturers to label sesame in clear language on the label.
Learn more about the FDA allergen changes read below
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico & Korea.
GRP helps many life science companies register their products in different countries in compliance with local regulations.