Sesame Becomes the Ninth Major Food Allergen (2023)

Table of Contents

1. What Took Effect on January 1, 2023
2. The Law Behind It: Congress, Not a U.S. Food and Drug Administration Rule
3. The Nine Major Food Allergens
4. How Sesame Has to Appear on a Label
5. The Transition Period and Changed Recipes
6. Which Foods the Requirement Covers
7. How the U.S. Food and Drug Administration Checks Allergen Labeling
8. What the Change Does Not Do
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Earlier and Later U.S. Food and Drug Administration Allergen Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What Took Effect on January 1, 2023

The U.S. Food and Drug Administration’s Food Allergies program page states that the FASTER Act, signed into law on April 23, 2021, declared sesame “the 9th major food allergen recognized by the United States,” and that “The change was effective on January 1, 2023.” It adds that “All U.S. Food and Drug Administration requirements applicable to major food allergens, including labeling and manufacturing requirements, apply to sesame as of January 1, 2023.”

The U.S. Food and Drug Administration consumer update published for the change, “Allergic to Sesame? Food Labels Now Must List Sesame as an Allergen,” puts it in one sentence: “As of January 1, 2023, sesame is required to be labeled as an allergen on packaged foods, including dietary supplements.” The U.S. Food and Drug Administration’s FASTER Act page says the same and adds that the change is meant to help people allergic to sesame “quickly identify foods that contain sesame.”

A food allergen is a food that can set off an allergic reaction. The U.S. Food and Drug Administration page explains that food allergies occur “when the body’s immune system reacts to certain proteins in food,” and that reactions range from mild symptoms such as hives and lip swelling to severe, life-threatening reactions, often called anaphylaxis. The same page states that food allergies currently cannot be cured.

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2. The Law Behind It: Congress, Not a U.S. Food and Drug Administration Rule

Sesame was not added by a U.S. Food and Drug Administration regulation. The U.S. Food and Drug Administration consumer update says sesame “became the ninth major food allergen through the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, a federal law passed in 2021.” The U.S. Food and Drug Administration’s role is to enforce the requirements and to explain them to industry and the public; the consumer update describes the U.S. Food and Drug Administration as the agency “responsible for enforcing the labeling requirements.” A check of the Federal Register, the U.S. government’s daily publication of rules and official notices, found no U.S. Food and Drug Administration rule on sesame in 2023.

The earlier list of eight major allergens came from another act of Congress. The U.S. Food and Drug Administration program page states that Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which identified milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat and soybeans as major food allergens. It explains the purpose of that law in these words: “Congress passed this law to make it easier for consumers who are allergic to foods and their caregivers to identify and avoid foods that contain major food allergens.” The FASTER Act added sesame to that list, so the labeling rules written for the first eight now apply to sesame as well.

The U.S. Food and Drug Administration’s FASTER Act page links the text of the Act on Congress.gov (S.578, 117th Congress).

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3. The Nine Major Food Allergens

Since January 1, 2023, the U.S. Food and Drug Administration lists the nine major food allergens as follows (examples are the U.S. Food and Drug Administration’s):

1. Milk
2. Eggs
3. Fish, such as bass, flounder and cod
4. Crustacean shellfish, such as crab, lobster and shrimp
5. Tree nuts, such as almonds, walnuts and pecans
6. Peanuts
7. Wheat
8. Soybeans
9. Sesame

Why these foods? The consumer update says that while many kinds of foods can cause allergies, “the federal laws focus on the most common ones,” and that “The nine major food allergens cause the majority of serious food allergic reactions in the U.S.” The program page adds that at the time FALCPA passed in 2004, the original eight “accounted for 90 percent of food allergies and serious allergic reactions in the U.S.” It also notes that more than 160 foods have been identified as causing food allergies in sensitive people, so the list of nine does not cover every food allergy.

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4. How Sesame Has to Appear on a Label

The U.S. Food and Drug Administration’s FASTER Act page notes that sesame “has always been required to be listed on food labels as an ingredient, with a few exceptions,” as is true of any added ingredient. What changed is that it must now be declared as an allergen, including when it is part of another ingredient. The U.S. Food and Drug Administration documents describe three ways the declaration can appear:

• By its common name in the ingredient list. The U.S. Food and Drug Administration’s example: “Ingredients: Brown rice flour, sesame seeds, potato starch, flax seeds, olive oil, amaranth, quinoa, salt.”
• In parentheses after an ingredient. The U.S. Food and Drug Administration’s examples include “natural flavor (sesame),” “spices (sesame)” and “Tahini paste (sesame, canola oil).”
• In a “Contains” statement immediately after or next to the ingredient list, for example “Contains sesame” or “CONTAINS: Wheat, Sesame.”

The consumer update also addresses sesame that is part of another ingredient: “Now that sesame is a major food allergen, the U.S. Food and Drug Administration expects that it be specifically listed as sesame on the label if it’s part of another ingredient, like ‘natural flavor,’ or ‘spice mix.’” It adds that if a package carries a “Contains” statement and sesame is an ingredient, “sesame will now have to be included in that ‘Contains’ statement.” The FASTER Act page likewise says products must declare sesame as an allergen “if they have an ingredient made from sesame.”

The program page explains the general rule behind these formats: the law requires food labels to identify the food source of every major food allergen used to make the food, at least once on the label, and the requirement is already met if an ingredient’s usual name identifies the source (its example is “buttermilk” for milk).

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5. The Transition Period and Changed Recipes

The requirement did not reach every shelf at once. According to the consumer update, the law “does not require food products that were already on their way to the store or in stock before 2023 to list sesame as an allergen on the label,” so those products “do not need to be removed from the marketplace or relabeled.” Because some packaged foods have a long shelf life, the U.S. Food and Drug Administration wrote, “it’s hard to say when pre-2023 stock will be replaced with food products carrying the required labels.”

The U.S. Food and Drug Administration’s FASTER Act page reports a second development: “Some food manufacturers have recently changed their recipes since the FASTER Act went into effect. There are now food products with small amounts of sesame that did not have it before.”

The U.S. Food and Drug Administration’s own advice to consumers, as stated on these pages, is to check the ingredient list and the “Contains” statement every time a product is bought, “even if you have eaten it before,” because ingredients can change at any time. During the transition period the U.S. Food and Drug Administration “recommends consumers check with the manufacturer or distributor identified on the food product” when unsure whether a food contains sesame. For restaurant food, the FASTER Act page lists asking a staff member about the ingredients. These are the U.S. Food and Drug Administration’s statements; decisions about managing a diagnosed allergy belong with a clinician.

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6. Which Foods the Requirement Covers

The U.S. Food and Drug Administration program page states that the agency enforces the allergen labeling law in “most packaged food products,” and that this includes dietary supplements. It lists what the law does not cover:

• meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture;
• alcoholic beverages subject to the labeling rules of the Alcohol and Tobacco Tax and Trade Bureau;
• raw agricultural commodities;
• highly refined oils;
• drugs and cosmetics;
• most foods sold at retail or food-service establishments that are not pre-packaged with a label.

The program page adds that the labeling requirements do extend to retail and food-service businesses that package, label and offer products for human consumption, but not to foods put in a wrapper or container (such as paper or a box for a sandwich) after a customer orders at the point of purchase. The consumer update notes that for foods that are not packaged, “like bagels in a grocery bin or bakery goods displayed on trays,” allergen labeling requirements “may vary,” and it mentions asking store staff for allergen information about those products.

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7. How the U.S. Food and Drug Administration Checks Allergen Labeling

Because all U.S. Food and Drug Administration requirements for major food allergens, including manufacturing requirements, apply to sesame from January 1, 2023, the agency’s general allergen program now covers sesame too. The program page describes that program:

• Manufacturing controls. The U.S. Food and Drug Administration’s food manufacturing rule (the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule, 21 CFR part 117) requires food facilities to have allergen controls. These are meant to prevent cross-contact, which the U.S. Food and Drug Administration defines as “the inadvertent introduction of a major food allergen into a product,” and to make sure products are labeled accurately for allergens.
• Inspections and sampling. The U.S. Food and Drug Administration inspects food manufacturers against those requirements and samples products to check that major allergens are properly labeled.
• Laboratory testing. The U.S. Food and Drug Administration tests foods for allergens mainly with ELISA tests, in which antibodies attach to allergen proteins, and confirms results with two different types of ELISA kits. It has also developed a test (the xMAP food allergen detection assay) that can detect 16 allergens, including sesame, in a single analysis.
• Monitoring. The U.S. Food and Drug Administration reviews reports of allergic reactions sent to its Consumer Complaint System and reports from industry through the Reportable Food Registry.
• Regulatory action. A food whose label lacks required allergen information, or that contains an allergen through cross-contact, is considered misbranded or adulterated, depending on the circumstances. It can be subject to recalls, import refusal or seizure; the U.S. Food and Drug Administration may also issue warning letters or place imported foods on import alert. The program page says that firms generally recall such products voluntarily.

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8. What the Change Does Not Do

• It does not ban sesame. It requires sesame to be declared on the label when it is an ingredient or part of one.
• It did not require relabeling of older stock. Products already in interstate commerce before January 1, 2023, for example those already on retail shelves, did not have to be removed or relabeled.
• It does not set a safe amount. The U.S. Food and Drug Administration program page states: “At this time, the U.S. Food and Drug Administration has not established a threshold level for any allergens.” It defines a threshold as “a value below which it is unlikely that a food allergic individual would experience an adverse effect.”
• It does not cover every food. Meat, poultry and egg products, most alcoholic beverages, raw agricultural commodities, highly refined oils, drugs, cosmetics, and most unpackaged restaurant and retail food fall outside the allergen labeling law (section 6).
• It is not a new U.S. Food and Drug Administration regulation. The requirement comes from the FASTER Act itself; the U.S. Food and Drug Administration enforces it and issues guidance about it.

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9. Dates and Legal Status as of October 18, 2026

• April 23, 2021: the FASTER Act is signed into law, declaring sesame the ninth major food allergen.
• November 30, 2022: the U.S. Food and Drug Administration publishes draft and final guidance on allergen labeling (Edition 5), covering the FASTER Act (87 FR 73561; Docket No. FDA-2022-D-0099). Comments on the draft were due January 30, 2023.
• January 1, 2023: the requirement takes effect; sesame must be declared as an allergen on packaged foods and dietary supplements.
• January 7, 2025: the U.S. Food and Drug Administration announces revised final allergen labeling guidance (Edition 5) in the Federal Register (90 FR 1133; same docket), announced on its program page on January 6, 2025.
• February 18–20, 2026: the U.S. Food and Drug Administration holds a virtual public meeting and listening session on food allergen thresholds and their potential applications.

Status as of October 18, 2026: in force. The sesame labeling requirement has applied since January 1, 2023. A check of the Federal Register through October 18, 2026 found no U.S. Food and Drug Administration document that changes it; the later U.S. Food and Drug Administration allergen documents found are guidance notices, which explain the agency’s current thinking rather than change the law. The threshold meeting of February 2026 has not, as of this date, produced a threshold; the program page, current as of March 11, 2026, still states that none has been set.

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10. How It Fits Earlier and Later U.S. Food and Drug Administration Allergen Actions

The sesame change sits in a sequence of allergen steps described in the U.S. Food and Drug Administration documents and Federal Register records:

• 2004. FALCPA defines the first eight major food allergens and the labeling formats (parentheses or a “Contains” statement) that sesame now follows.
• April 19, 2022. The U.S. Food and Drug Administration publishes draft guidance on how it evaluates the public health importance of food allergens other than the major ones listed in the law (87 FR 23181; Docket No. FDA-2021-N-0553).
• November 30, 2022. The U.S. Food and Drug Administration publishes Edition 5 of its allergen labeling questions and answers in draft and final parts. The Federal Register notice says the draft explains the U.S. Food and Drug Administration’s current thinking on labeling requirements in both FALCPA and the FASTER Act.
• January 1, 2023. Sesame becomes the ninth major food allergen.
• January 6–7, 2025. The U.S. Food and Drug Administration issues the revised final Edition 5 guidance, which its program page says covers the labeling of tree nuts, sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products and certain packaging situations, and the final guidance on evaluating allergens other than the nine (90 FR 1163). That guidance, in the program page’s words, sets out how the U.S. Food and Drug Administration intends to evaluate “food allergens that are not one of the nine major food allergens identified by law in the U.S.”
• February 2026. The public meeting on allergen thresholds.

A guidance document describes how the U.S. Food and Drug Administration reads and applies a law; it does not itself create new legal requirements. A Federal Register docket is the public file for an action, where the documents and public comments are kept on regulations.gov.

Other U.S. Food and Drug Administration actions on allergy and food labeling are reported on their own pages: the 2024 approval of the first needle-free epinephrine for anaphylaxis, the 2024 “healthy” claim final rule and the 2025 front-of-package nutrition label proposal. Among the 2023 actions, the plant-based milk labeling draft also concerns what a food label tells the reader.

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11. Primary Documents

1. U.S. Food and Drug Administration. Food Allergies. Program page, content current as of March 11, 2026 — fda.gov Food Allergies page
2. U.S. Food and Drug Administration. The FASTER Act: Sesame Is the Ninth Major Food Allergen. Content current as of April 12, 2024 — fda.gov FASTER Act page
3. U.S. Food and Drug Administration. Allergic to Sesame? Food Labels Now Must List Sesame as an Allergen. Consumer Update, content current as of January 10, 2023 — fda.gov consumer update
4. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2022). Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; and Final Guidance for Industry. Notice of availability. Federal Register 87 FR 73561, November 30, 2022. Docket No. FDA-2022-D-0099 — FR Doc. 2022-26110
5. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry; Availability. Federal Register 90 FR 1133, January 7, 2025. Docket No. FDA-2022-D-0099 — FR Doc. 2024-31533
6. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for U.S. Food and Drug Administration Staff and Interested Parties; Availability. Federal Register 90 FR 1163, January 7, 2025. Docket No. FDA-2021-N-0553 — FR Doc. 2024-31529
7. Public docket FDA-2022-D-0099 — regulations.gov FDA-2022-D-0099

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Key Research Papers

1. Warren CM, Chadha AS, Sicherer SH, Jiang J, Gupta RS (2019). Prevalence and Severity of Sesame Allergy in the United States. JAMA Network Open 2(8):e199144 — PubMed PMID: 31373655
2. Gupta RS, Warren CM, Smith BM, Jiang J, Blumenstock JA, Davis MM, Schleimer RP, Nadeau KC (2019). Prevalence and Severity of Food Allergies Among US Adults. JAMA Network Open 2(1):e185630 — PubMed PMID: 30646188
3. Gupta RS, Warren CM, Smith BM, Blumenstock JA, Jiang J, Davis MM, Nadeau KC (2018). The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics 142(6):e20181235 — PubMed PMID: 30455345
4. Nguyen K, Greenthal E, Sorscher S, Lurie P, Spergel JM, Kennedy K (2022). Adverse events and labeling issues related to suspected sesame allergy reported in an online survey. Annals of Allergy, Asthma & Immunology 128(3):279-282 — PubMed PMID: 34883240
5. Oriel RC, Elizur A, Sicherer SH (2024). Comprehensive Diagnosis, Management, and Treatment of Sesame Allergy. The Journal of Allergy and Clinical Immunology: In Practice 12(3):590-597 — PubMed PMID: 37952774
6. Shah A, Schaible A, Topper C, Epstein R, Groetch M (2024). The unique characteristics of sesame allergy and sesame labeling. The Journal of Allergy and Clinical Immunology: In Practice 12(10):2861-2864 — PubMed PMID: 38901619
7. Dinardo G, Fierro V, Del Giudice MM, Urbani S, Fiocchi A (2023). Food-labeling issues for severe food-allergic consumers. Current Opinion in Allergy and Clinical Immunology 23(3):233-238 — PubMed PMID: 37185828

The first three papers are U.S. population surveys of how common sesame allergy and food allergies in general are among adults and children. The fourth reports a survey of reactions and labeling problems described by people with suspected sesame allergy, published before the labeling requirement took effect. The last three are reviews of sesame allergy and of food-allergen labeling.

PubMed Topic Searches

1. PubMed: sesame allergy
2. PubMed: sesame allergen labeling
3. PubMed: food allergen labeling and thresholds

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Sesame Seeds
• Nuts
• Seeds
• Food Allergy
• Anaphylaxis
• Allergies
• Needle-Free Epinephrine for Anaphylaxis (2024)
• “Healthy” Claim Final Rule (2024)
• Front-of-Package Nutrition Label Proposal (2025)
• Plant-Based Milk Labeling Draft (2023)
• Dietary Supplement Ingredient Directory (2023)
• Infant Formula Safety Letters (2023)

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