Sesame: Ninth Major Food Allergen in U.S.

Declaration of Sesame as an Allergen on Food Labels

From hummus to baked goods to sushi, sesame is a prevalent and versatile ingredient found in foods around the world. Yet for individuals with an allergy to sesame, consumption can be dangerous, with reactions ranging from mild to severe.

It is estimated that around 1 million Americans have a sesame allergy. Yet, until recently, sesame was not considered to be one of the major food allergens in the United States; labeling of sesame as an allergen on packaged food products was not required until 2023. The Food Allergy Safety, Treatment, Education and Research Act was signed into law by President Biden on April 23, 2021, naming sesame as the ninth major food allergen in the U.S. and requiring it to be declared on food labels beginning January 1, 2023. However, foods that were produced and distributed before 2023 may still be available for purchase and may not reflect sesame as a food allergen.

Allergen Legislation

The Food Allergen Labeling and Consumer Protection Act of 2004 recognized what became known as the "Top 8" major allergens: milk, wheat, soybean, eggs, fish, shellfish, peanuts and tree nuts. These allergens were believed to account for 90% of the food allergies in the United States. The law required disclosure on most packaged foods sold in the U.S., regardless of whether they were made in this country or imported

Some foods and beverages are not covered by this legislation: meat, poultry and egg products, as they are regulated by the U.S. Department of Agriculture; alcoholic beverages, which are regulated by the Alcohol and Tobacco Tax and Trade Bureau; raw agricultural commodities such as fresh fruits and vegetables; and most foods sold without a label, such as in a restaurant.

Prior to 2023, labeling of sesame as an allergen in food has been required in various parts of the world; Australia, New Zealand, Canada, Taiwan, Turkey, Ukraine, GSO (Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar and Yemen) and much of Europe all require sesame labeling.

For years, consumers, advocacy groups and legislators advocated for sesame to be added to the list of major allergens. In November 2020, the U.S. Food and Drug Administration published guidance for food manufacturers to voluntarily disclose sesame in their products. However, there still was no mandatory compliance or uniform oversight by the FDA. To change this, the FASTER Act of 2021 was introduced.

The FASTER Act makes it safer for those with a sesame allergy by requiring declaration of sesame on food labels. Additionally, it requires the U.S. Department of Health and Human Services to report on research opportunities for prevention, treatment and potential cures for food allergies. The FASTER Act also develops a scientific framework for adding to the list of major food allergens in the future, if warranted.

While there is no clear data to indicate the introduction of a 10th major allergen in the U.S. anytime soon, some advocates are calling for clear labeling of substances such as corn, gluten, mustard and celery. In other regions of the world, labeling for these ingredients is sometimes required. More research is needed to identify the prevalence and severity of allergies to these ingredients in the U.S.

Sesame in Foods

According to Food Allergy Research & Education, foods produced prior to the introduction of the FASTER Act in the U.S. could refer to sesame by many names as an ingredient on a label, making it difficult for consumers to identify it in a product. Sesame may have appeared as benne, benne seed, benniseed, gingelly, gingelly oil, gomasio (sesame salt), halvah, sesame flour, sesame oil, sesame paste, sesame salt, sesame seed, sesamol, sesamum indicum, sesemolina, sim sim, tahini, tahina, tehina or til. It also may have been hidden as a "natural flavor" or "spices" in an ingredient statement.

Oils, such as peanut oil, that are derived from major allergens are often highly refined. This process removes the protein that causes an allergic reaction, making it safe for most people with that allergy. Sesame oil, however, typically is not highly refined, so the allergen is still present, making it unsafe for people who are allergic to sesame. Cold-pressed, expelled or extruded oils (sometimes referred to as gourmet oils) from any of the major allergens still contain the allergenic protein and should be avoided by people with that particular allergy.

Sesame in Non-Food Items

In addition to food, sesame can be found in items including cosmetics, medications, nutritional supplements, perfumes and pet foods. Typically, sesame is labeled with the scientific name Sesamum indicum on these items. People with a sesame allergy may experience a reaction from contact with these items. Except for dietary supplements, non-food items do not have the same labeling requirements and are not covered under FALCPA or the FASTER Act.

Prevalence, Severity and Treatment of Sesame Allergies

While the exact number of people with a sesame allergy is unknown, a cross-sectional study published in 2019 surveyed 51,819 U.S. households from October 1, 2015, through September 31, 2016, and estimated that more than 1.5 million children and adults — 0.49% of the U.S. population — may have a sesame allergy. However, further analysis indicated that only 0.23% met the criteria for a "convincing" IgE-mediated allergy based on self-reported symptoms, and 0.11% never experienced a reaction, despite being diagnosed with a sesame allergy by a physician.

Most respondents reported having more than one food allergy, particularly peanuts. In fact, more than 75% of those with a likely sesame allergy also reported an allergy to one or more of the other top eight allergens.

Allergic reactions to sesame can range from mild (hives) to severe (anaphylaxis or multiple organ system involvement). More than 37% of survey respondents reported having a severe reaction and more than 20% reported wheezing, fainting, dizziness or low blood pressure.

According to the individuals surveyed, hives were experienced more frequently with a sesame allergy. Gastrointestinal symptoms such as stomach pain, cramps, diarrhea, nausea or vomiting occurred less often in people with a sesame allergy compared to those who were allergic to one of the top eight allergens.

Treatment for sesame allergic reactions vary based on the severity of the reaction. In the same 2019 study, about one-third of participants reported use of an epinephrine autoinjector, a device that administers medicine to treat severe allergic reactions, at some point in their lifetime; nearly half reported antihistamine use; less than one-tenth reported use of an asthma inhaler, with slightly more reporting use of corticosteroids.

This study suggests a sesame allergy can be severe and identifies an opportunity for improved research, awareness, treatment and management of sesame allergy for people and the food and nutrition industry, as well as government regulation.

Putting It Into Practice for RDNs

To provide proper nutrition care and guidance, registered dietitian nutritionists should educate themselves on food allergens and allergies, as well as their potential impact on a patient's or client's lifestyle. Advise patients or clients who suspect they have a sesame allergy to seek a medical diagnosis. Oral food challenges are the gold standard for a food allergy diagnosis, but other evidence-based methods may be used, along with a comprehensive medical history. Self-diagnosed allergies and intolerances can lead to unnecessary dietary restrictions and inadequate nutrition. Patients and clients with a sesame allergy should also be encouraged to continue to review ingredients of foods that may not list sesame as a food allergen due to being produced prior to 2023 and to contact food manufacturers with any questions.

Additional Resources

For more information on food allergies, including diagnostic methods and when and how to introduce potential allergens into a child's diet, consider these resources:

• National Institutes of Health, National Institute of Allergy and Infectious Diseases
  • Guidelines for Clinicians and Patients for Diagnosis and Management of Food Allergy in the United States
• Food Allergy Research & Education (FARE)
• 2020-2025 Dietary Guidelines for Americans and the Scientific Report of the 2020 Dietary Guidelines Advisory Committee
• The American Academy of Pediatrics' "The Effects of Early Nutritional Interventions on the Development of Atopic Disease in Infants and Children: The Role of Maternal Dietary Restriction, Breastfeeding, Hydrolyzed Formulas, and Timing of Introduction of Allergenic Complementary Foods"

References

1. Allergic to Sesame? Food Labels Now Must List Sesame as an Allergen. U.S. Food and Drug Administration website. Updated January 10, 2023. Accessed January 20, 2023.
2. Biden signs law that makes sesame the ninth major food allergen. The Washington Post website. Published April 23, 2021. Accessed May 14, 2021.
3. FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels. Food and Drug Administration website. Published November 10, 2020. Accessed May 14, 2021.
4. FDA Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) page. Food and Drug Administration website. Accessed May 27, 2021.
5. Food Allergens – International Regulatory Chart. University of Nebraska-Lincoln website. Updated January 4, 2023. Accessed January 19, 2023.
6. Food Allergies. Food and Drug Administration website. Accessed May 8, 2021.
7. Sesame Allergy Rates Are Increasing: Here’s What to Know. Healthline website. Published August 2, 2019. Accessed May 8, 2021.
8. Warren C, Chadha A, Sicherer S, et al. Prevalence and Severity of Sesame Allergy in the United States. JAMA Netw Open. 2019;2(8):e199144.