FDA’s Addition of the 9th Allergen (Sesame)

FDA’s Addition of the 9th Allergen (Sesame)
Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The industry will have roughly two years to incorporate labeling changes to accommodate this new requirement. This clear labeling initiative is warranted to improve transparency, reduce allergic reactions, and protect this vulnerable population. 


Sesame allergies are more common than one would think. Approximately 0.1% or 350,000 Americans experience allergic reactions or sensitivity to the ingredient sesame, thus justifying this major change and the addition to the Priority Allergen List (PAL). Symptoms from sesame reactions can range anywhere from hives to anaphylaxis and can even be potentially fatal to some individuals. 

How to disclose allergens:

Mislabelling or misrepresentation of an allergy is a serious issue and can lead to enforcement action for your product. The proper format(s) to disclose a major allergen on food labeling in the United States is as follows: In parentheses following the name of the ingredient. Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)” or Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”


When this new change comes into force, sesame must appear clearly in the ingredients listing. However, sesame will not be required to be listed if it is within a spice or flavoring. It will also not need to be listed when sesame is assumed within the common or usual name of a food (e.g. Tahini is made from sesame seed). It is important that consumers are aware of any allergens within their foods at the time of purchase. Taking precautions and clearly labeling your ingredient can help save lives. The industry is urged to transparently disclose sesame wherever possible. Taking an honest approach is always suggested when it comes to allergens.  Other names for sesame are Benne, gingelly, seeds, sesamol, sesamum indicum, sim, tahini, and til. It is important that these ingredients will now be called out clearly as providing sesame to avoid where possible, any confusion, allergic reactions, and potential hospitalizations. 


The FDA can enforce incorrect allergen labeling similarly to an adulterated or misbranded product. They can take actions such as warning letters, recalls, import refusals, or product seizures. In most cases where incorrect labeling has been identified the company can and will recall the product voluntarily. The seriousness of incorrect labeling can be fatal and should be taken very seriously.  

International Recognition:

Sesame is a recognized priority allergen in many major markets such as Canada, the EU, and now the USA. Sesame is the largest food allergy in Israel and its commonality is spreading. 


The original/other eight major US allergens are Milk, Tree Nuts, Eggs, Peanuts, Fish, Wheat, Shellfish, and Soybeans.

How Quality Smart Solutions can help:

Please contact our team for more information on labeling of allergens, or other food labeling projects. Our specialists are here to help!  


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