The LabelCalc Blog

Sesame: The New FDA-Required Allergen Starting Jan 1, 2023

Effective January 1st, 2023, the FDA will declare sesame as the ninth major food allergen. This means food manufacturers that create products with Sesame in them, must now declare Sesame on their Contains Statement.  

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the Federal Food, Drug, and Cosmetic Act for foods under FDA jurisdiction and requires that the label of a food that contains an ingredient that is or contains protein from a “major food allergen ” declare the presence of the allergen in a “contains” statement. The “big eight” major food allergens under FALCPA are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. 

In April of 2021, the FASTER Act was signed into law and declared sesame as the “ninth” major food allergen.  The FASTER Act only applies to FDA regulated products and becomes effective on January 01, 2023.

How the FDA is Helping Consumers With a Sesame Allergy

Food allergies and other types of food hypersensitivities affect millions of people living in the U.S. To protect those with food allergies and other food hypersensitivities, the FDA enforces laws requiring food manufacturers to specify ingredients that are major food allergens on the labels of packaged foods and beverages. The FDA also enforces regulations that require food manufactures to prevent allergen cross-contact (the unintentional incorporation of a major food allergen into a food). Before sesame was declared the ninth major food allergen, these were the eight allergens:

  • Milk
  • Eggs
  • Fish
  • Tree Nuts
  • Peanuts
  • Soy
  • Wheat
  • Shellfish
  • And as of January 1st 2023, now sesame. 

For many years, sesame was only classified as a spice. It was not required to be labeled on menus or nutrition statements. As allergies have evolved with time, many people have developed a sesame allergy. Many customers have reported severe allergic reactions to sesame seeds, sesame oil, or sesame flavoring. This ultimately forced the FDA to reevaluate and rework its regulations. 

How does this change affect your food and beverage products?

All foods entering interstate commerce on or after January 1, 2023, that contain sesame allergens must bear a sesame allergen declaration. Entering interstate commerce typically means a food that is packaged and labeled for sale.

The law requires that food labels identify the food source of all major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient already identifies that allergen’s food source name (for example, buttermilk). The law also requires that the type of tree nut (for example, almonds, pecans, walnuts), and the species of fish (for example, bass, flounder, cod) and Crustacean shellfish (for example, crab, lobster, shrimp) be declared.  The allergen’s food source must be declared at least once on the food label in one of two ways.

1: The name of the food source of a major food allergen must appear:

In parentheses following the name of the ingredient.

Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

— OR —

2: Immediately after or next to the list of ingredients in a “contains” statement.

Example: “Contains wheat, milk, and soy.”

Starting now, LabelCalc suggests you begin to review your current recipes within your LabelCalc account, and look for trigger recipes and ingredient listings such as:

Some ingredients to watch for:

  • benne, bene seed, benniseed
  • gingilly, gingilly oil
  • sesamol, semolina, sesamum indicum
  • sim
  • tahini
  • til
  • vegetable oil
  • natural flavoring
  • spice
  • seasoning

If you suspect your ingredient suppliers may be the source of sesame in your finished product, we recommend that you reach out and request recent and updated recipe spec sheets and Allergen Contains statements, so you can update your recipes accordingly in LabelCalc.  

Be careful to review both within labelCalc and your suppliers any spices, seasonings and flavorings.

What is LabelCalc doing to assist with the January 1st 2023 compliance date? 

LabelCalc has already begun to flag and track known Sesame ingredients within our database.  The Allergen flagging feature will automatically track any Sesame ingredients from our Standard Ingredient Database and Branded Ingredient database through to your recipe, and will automatically be shown in the Allergens section below: 

It’s important to note that ingredients from the Branded Ingredient Database will need to be confirmed for accuracy in the Allergens page.  This is due to un-reported Sesame from Brands that submit to our database.  We recommend that you reach out and request recent and updated recipe spec sheets from your ingredient suppliers and Allergen Contains statements, so you can update your recipes accordingly in LabelCalc.  

For all new and current recipes, any associated Sesame allergens will now appear automatically in the Allergen “contains” statement on the above ‘Allergens’ feature. Please be sure to always review any ingredients and allergen changes before your print your Nutrition Facts Labels.

As good manufacturing practices, we always suggest manually reviewing all allergen  statements within your recipe (not just Sesame) to confirm accurate reporting of these ingredients on your label. 

Choose LabelCalc for Easy FDA Compliance

LabelCalc has analyzed over 30,000 food products without a single recall. Trusted brands use LabelCalc to receive FDA-approved labels in a matter of minutes. If you’re a new food business and need accurate analysis for your product, schedule a free consultation today.  An FDA-certified nutritionist will guide you in the right direction.