FDA food allergen labeling requirements apply to most packaged foods sold in the US, including food sold on Amazon: if a product contains one of the nine major food allergens, the label must name the food source of that allergen. FDA’s Food Allergies page lists them in one sentence: “The major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.” There are exactly two ways to make the declaration — a parenthetical after the ingredient name, or a “Contains” statement next to the ingredient list — and dietary supplements are covered, not exempt (FDA page content current as of 03/11/2026, data checked 2026-10-09).
This guide sets out FDA’s criteria; it does not judge whether a specific recipe contains an allergen — that depends on your formula and your supplier’s specifications. Other sources: FDA’s FALCPA page and its FAQ on the Food Allergen Labeling Guidance (data checked 2026-10-09).
The Framework: Three Questions Before You Print a Label
- Is the product inside FDA’s allergen labeling rules? Meat, poultry and egg products, TTB-regulated alcohol, raw agricultural commodities and a few other categories are not (see the exemptions section).
- Does any ingredient or sub-ingredient contain a major food allergen? Flavorings, spice blends, lecithin and coatings count, not just the headline ingredients.
- Which declaration format will you use, and does it name the specific source? Tree nuts, fish and crustacean shellfish need the type or species, not the category word.
The Nine Major Food Allergens Under FDA Rules
The list grew in two steps. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) named eight: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. Sesame came from a separate law. Per FDA: “On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law,” “declaring sesame as the 9th major food allergen recognized by the United States.” FDA adds: “The change was effective on January 1, 2023.”
| # | Major food allergen | What the label must name (per FDA, data checked 2026-10-09) |
|---|---|---|
| 1 | Milk | Milk — FDA reads this as milk from domesticated cows, goats, sheep, or other ruminants |
| 2 | Eggs | Egg — FDA reads this as eggs from domesticated chickens, ducks, geese, quail, and other fowl |
| 3 | Fish | The specific species (e.g., bass, flounder, cod) |
| 4 | Crustacean shellfish | The specific species (e.g., crab, lobster, shrimp) |
| 5 | Tree nuts | The specific type of nut (e.g., almonds, pecans, walnuts) |
| 6 | Peanuts | Peanuts |
| 7 | Wheat | Wheat |
| 8 | Soybeans | Soy / soybeans |
| 9 | Sesame | Sesame (FASTER Act, effective January 1, 2023) |
The species rule is where labels most often fall short. FALCPA requires “the name of the specific type of nut or species of fish or Crustacean shellfish.” A granola that says “Contains: tree nuts” does not meet that standard; “Contains: almonds, cashews” does.
Two refinements came with FDA’s revised guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), which FDA’s FAQ page says was published “On January 6, 2025”:
- Coconut is off the tree nut list. The FAQ: “Coconut is no longer one of the tree nuts considered a major food allergen.” Coconut still belongs in the ingredient list when it is an ingredient.
- Milk and eggs are broader than cow’s milk and chicken eggs. The FAQ: “FDA considers “milk” as milk from domesticated cows, goats, sheep, or other ruminants” “and “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl.” Goat milk caramels and duck egg pasta both need a declaration.
On timing, the FAQ notes that FDA’s uniform compliance date of January 1, 2028 for new food labeling regulations “is not applicable to major food allergen labeling requirements in the FD&C Act.” The allergen rules apply now.
Two Ways to Declare Allergens: Parenthetical or “Contains” Statement
FDA’s Food Allergies page describes the two permitted formats:
- Parenthetical: “In parentheses following the name of the ingredient.”
- “Contains” statement: “Immediately after or next to the list of ingredients in a “contains” statement.”
| Format | How it looks on the label | Where it works well |
|---|---|---|
| Parenthetical | Ingredients: enriched flour (wheat), sugar, lecithin (soy), whey (milk) | Short ingredient lists where each allergen-bearing ingredient appears once |
| “Contains” statement | Ingredients: enriched flour, sugar, soy lecithin, whey. Contains: wheat, soy, milk. | Long ingredient lists, multi-component products, labels shared across flavors |
The label examples in this table are illustrative formatting, not FDA text. Practical points that follow from FDA’s wording:
- The food source has to be named on the label. Ingredient names like “lecithin,” “whey” or “casein” do not say where they come from, so they need the parenthetical or the “Contains” statement.
- We recommend making a “Contains” statement complete. If you use one, list every major food allergen in the product; a line naming two of three allergens reads to an allergic shopper as if the third is absent.
- Placement matters. The “Contains” statement sits immediately after or next to the ingredient list, not on a different panel.
- Name the species. “Contains: fish” is not enough; “Contains: anchovy” is.
Sesame: What Changed on January 1, 2023
Sesame is the allergen most likely to be missing from an older private-label design. Since FDA’s effective date of January 1, 2023, it is a major food allergen and is declared the same way as the other eight.
FDA set one transition rule: “Products already in interstate commerce—for example, products that are on retail shelves, before January 1, 2023—” “do not need to be removed from the marketplace or relabeled.” That covers product already distributed before the date, not new production runs. Any label printed for current inventory should treat sesame like any other allergen.
A useful habit: ask your co-packer or ingredient supplier in writing whether any spice blend, seasoning, sauce or flavoring contains sesame, and keep the answer in your product file.
What Is Exempt From FDA Food Allergen Labeling Requirements
FDA’s Food Allergies page says the labeling requirements cover FDA-regulated packaged foods — “This includes dietary supplements but does not include meat, poultry, and egg products” — and then lists the other exclusions:
| Category | FDA wording (Food Allergies page, data checked 2026-10-09) | Note for sellers |
|---|---|---|
| Meat, poultry and egg products | “(which are regulated by the U.S. Department of Agriculture)” | USDA labeling rules apply instead |
| Alcoholic beverages | “alcoholic beverages subject to Alcohol and Tobacco Tax” “and Trade Bureau labeling regulations” | TTB rules apply instead |
| Raw agricultural commodities | “raw agricultural commodities” | A packaged nut mix is not this |
| Highly refined oils | “highly refined oils” | See the next section |
| Drugs | “drugs” | |
| Cosmetics | “cosmetics” | Separate cosmetics rules |
| Unpackaged retail/food service food | “most foods sold at retail or food service establishments that are not pre-packaged with a label” | Written for counters and kitchens |
| Food wrapped after ordering | “following a customer’s order at the point of purchase” | Point-of-purchase situations |
The last two exemptions describe shops and restaurants. Product sitting in an FBA warehouse or your own stock room in sealed, labeled packaging is prepackaged food, so these exemptions do not describe a typical Amazon food listing.
Highly Refined Oils and “May Contain” Statements
Highly refined oils. FALCPA’s definition of “major food allergen” excludes “Any highly refined oil derived from a food specified in paragraph (1)” — that is, from one of the original eight foods. The exclusion is limited to oils that are highly refined; it does not extend to cold-pressed or unrefined oils. Whether a given oil qualifies is a question for your oil supplier’s specification sheet.
“May contain” and other advisory statements. These are voluntary. FDA’s Food Allergies page: “Such statements are not required by law.” FDA attaches conditions: they are meant only for unavoidable cross-contact, which FDA defines as “the inadvertent introduction of a major food allergen into a product”; “advisory statements should not be used as a substitute for adhering to current good manufacturing practices”; and they “must be truthful and not misleading.”
FDA’s guidance FAQ flags two combinations: an allergen-free claim (such as “wheat-free”) alongside an advisory statement for the same allergen is not appropriate, and pairing a “Contains” statement with an advisory statement for the same allergen “could be misleading to consumers.”
An advisory statement is not one of the two declaration formats. If an allergen is an ingredient, “may contain” does not declare it.
Why Dietary Supplements Are Not Exempt
Supplement sellers sometimes assume food allergen rules stop at food. FDA’s wording says otherwise: “This includes dietary supplements.” The same page, describing FDA’s Edition 5 guidance, lists “dietary supplement products” among the topics that guidance covers.
For a supplement, allergens typically enter through the source material — fish oil, shellfish-derived ingredients, whey or other milk proteins, soy-derived ingredients — and through capsule shells and excipients. The same two declaration formats and the same species rule apply. For the rest of the supplement label and Amazon’s testing requirement, see our guide to selling dietary supplements on Amazon.
Where Allergen Labeling Fits With Amazon Food Compliance
Allergen labeling is one layer of a food listing:
- Imports: food shipped into the US needs prior notice — see FDA prior notice for Amazon FBA.
- Dates: see Amazon FBA expiration date requirements.
- Packaging: see Amazon FBA prep requirements.
- Document requests: see Manage Your Compliance.
- Cosmetics are a different regime: MoCRA for Amazon sellers.
On the listing itself, we treat the physical label as the source of truth: copy its ingredient list and “Contains” line into the detail page word for word, and show the label panel in the images. When listing and package disagree, the shopper has no way to know which is right.
When allergen problems surface after products ship, FDA says “the FDA works with firms to recall products and provide public notification,” and “firms generally recall such food products from the marketplace voluntarily.” Our guide to Amazon product recalls covers the Amazon side.
Allergen Label Checklist for Amazon Food Sellers
- Product is FDA-regulated packaged food or a dietary supplement (not a USDA meat/poultry/egg product, not TTB alcohol).
- Every ingredient and sub-ingredient checked against the nine allergens using written supplier specifications.
- Sesame checked in spices, seasonings, flavorings and sauces.
- One declaration format: parenthetical, or a “Contains” statement immediately after or next to the ingredient list.
- Tree nuts, fish and crustacean shellfish named by type or species.
- Milk and eggs from goats, sheep, ducks, quail and similar animals declared as milk or egg.
- Coconut kept in the ingredient list (no longer a tree nut allergen per FDA’s Edition 5 guidance).
- Any “may contain” line reserved for unavoidable cross-contact, not paired with a “free” claim or “Contains” line for the same allergen.
- Detail page ingredient list and allergen line match the printed label.
Frequently Asked Questions
Do I have to relabel old inventory for sesame?
FDA says products already in interstate commerce before January 1, 2023 “do not need to be removed from the marketplace or relabeled.” Product labeled for distribution after that date should declare sesame.
Is a “may contain” statement required?
No. FDA states: “Such statements are not required by law.” If you use one, FDA says it must be truthful and not misleading, and it does not replace good manufacturing practices.
Is coconut a tree nut allergen?
Not anymore. FDA’s FAQ on its Edition 5 guidance says: “Coconut is no longer one of the tree nuts considered a major food allergen.”
Are dietary supplements exempt from allergen labeling?
No. FDA’s Food Allergies page says the requirements include dietary supplements. The exempt categories are meat, poultry and egg products, TTB-regulated alcohol, raw agricultural commodities, highly refined oils, drugs, cosmetics, and certain unpackaged retail foods.
Conclusion
FDA food allergen labeling for Amazon sellers is a short rule with sharp edges: nine allergens, sesame included since January 1, 2023; two declaration formats; species-level names for tree nuts, fish and shellfish; and a fixed list of exemptions that does not include dietary supplements. Audit each label against the nine allergens using written supplier specifications, pick one declaration format, and make the Amazon detail page match the package.