FDA COMPLIANCE · FOOD & BEVERAGE
Quick answer
Packaged foods sold in the United States must generally declare the food source of each major food allergen on the label, either in a “Contains” statement next to the ingredient list or inside the ingredient list with the allergen food source named. The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame. Separate rules cover Nutrition Facts, identity, net quantity and responsible-party information. Allergen labeling failures are a common reason foods are misbranded.
Updated November 2026. Food brands selling into Amazon FBA, Walmart, Shopify and retail need labels that match both FDA rules and marketplace catalog fields. This guide covers major food allergen declarations under FALCPA and the FASTER Act, how they sit next to Nutrition Facts and ingredient rules, and how Eva Commerce supports food facility registration and label review. It is general information, not legal advice.
Table of Contents
- What are FDA food labeling and allergen requirements?
- What are the nine major food allergens?
- How must major allergens appear on the label?
- What is the difference between a Contains statement and a “may contain” advisory?
- How do Nutrition Facts and other panels fit in?
- Do Amazon and other marketplaces change allergen rules?
- How should brands handle formula changes and co-manufacturers?
- What Eva Commerce charges for food labeling support
- Common food allergen labeling mistakes
- Frequently asked questions
What are FDA food labeling and allergen requirements?
FDA food labeling rules come from the FD&C Act and implementing regulations. For most packaged foods, labels need:
- a statement of identity;
- net quantity of contents;
- the name and place of business of the manufacturer, packer or distributor;
- an ingredient list;
- Nutrition Facts when required; and
- major food allergen declarations when the food contains a major allergen.
Allergen rules are specific and strict. Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) so shoppers can spot major allergens by their food source names. The Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) added sesame to the major allergen list, effective January 1, 2023.
What are the nine major food allergens?
FDA identifies these major food allergens:
- milk;
- eggs;
- fish (with the specific species declared, such as bass, flounder or cod);
- Crustacean shellfish (with the specific type declared, such as crab, lobster or shrimp);
- tree nuts (with the specific type declared, such as almonds, pecans or walnuts);
- wheat;
- peanuts;
- soybeans; and
- sesame.
Molluscan shellfish such as oysters and clams are not on the major allergen list under FALCPA, though they can still cause reactions and may need careful ingredient naming. Always check current FDA allergen guidance before printing a new label run.
How must major allergens appear on the label?
Section 403(w) of the FD&C Act requires that packaged foods declare each major food allergen using the name of the food source. Either:
- print a “Contains” statement immediately after or adjacent to the ingredient list, naming each major allergen food source, in a type size no smaller than the ingredient list; or
- name the allergen food source in the ingredient list itself, usually in parentheses after the ingredient, unless the ingredient’s common name already uses that food source name.
For tree nuts, fish and Crustacean shellfish, declare the specific type or species. “Contains tree nuts” without naming almond or cashew is not enough when those nuts are present. FDA’s Food Allergies page and the Questions and Answers Regarding Food Allergen Labeling guidance (Edition 5) walk through examples.
What is the difference between a Contains statement and a “may contain” advisory?
A “Contains” statement declares allergens that are ingredients in the food. An advisory statement such as “may contain peanuts” or “made in a facility that also processes wheat” is voluntary language about possible cross-contact. FDA says it is not appropriate to use a Contains statement for an allergen that is not an ingredient. Using both a Contains claim and a “may contain” advisory for the same allergen can create inconsistent, misleading information. Cross-contact controls belong in manufacturing under CGMP and preventive controls, not only on the label.
Keep supplier specs versioned. An old spec that omitted sesame whey or a tree nut oil is a frequent root cause when a label looks clean but the formula changed upstream.
How do Nutrition Facts and other panels fit in?
Nutrition Facts formatting follows FDA’s nutrition labeling rules, including the updates described on FDA’s Changes to the Nutrition Facts Label page. Serving size, calories, added sugars and other required nutrients must match the product as labeled. Ingredient lists declare ingredients by common or usual name in descending order of predominance. Claims such as “healthy,” “gluten free” or nutrient content claims have their own conditions. Structure/function style disease treatment claims can turn a conventional food into an unapproved drug problem. For imported food, Prior Notice and facility registration are separate from the label. See our drafts on FDA Prior Notice and food facility registration renewal.
For multi-pack and variety packs, check whether each unit and the outer sleeve need full declarations. Shoppers and inspectors both look at the label they can see without opening every inner pack.
Do Amazon and other marketplaces change allergen rules?
No. Selling on Amazon FBA or Shopify does not replace FDA label requirements. Marketplaces may ask for label images, ingredient attributes and allergen fields that should match the physical package. A mismatch between the jar and the detail page creates both regulatory and account-health risk. Our answer on whether Amazon food sellers need FDA facility registration covers the facility side. Labels still need allergen declarations when major allergens are present.
How should brands handle formula changes and co-manufacturers?
Every formula change needs an allergen re-check. New flavors, sauces, inclusions, processing aids and shared equipment can introduce major allergens. Ask co-manufacturers for a current ingredient specification, allergen matrix and label proof before you approve a production run. When sesame, milk proteins or tree nut derivatives appear under unfamiliar ingredient names, declare the food source clearly. Update Nutrition Facts, ingredient lists, Contains statements, outer case labels and marketplace attributes in the same release so FBA inbound labels match the live detail page.
If you import packaged food, confirm the U.S. label is applied before entry when required, and that Prior Notice and facility registration are current. A perfect allergen panel does not fix a missing Prior Notice, and a clean Prior Notice does not fix a missing sesame declaration.
What Eva Commerce charges for food labeling support
Eva Commerce’s published food track includes U.S. Agent service at $250 per year, food facility registration at $240 every two years, DUNS application support at $90 one-time, Prior Notice at $30 per shipment, basic formatting label review at $340 per label, and full compliance label review at $590 per label. Full review goes deeper on claims, allergens and category rules. Prices are on our FDA compliance services page. Reviewed label facts can also inform Amazon, Walmart and Shopify listings. Book a call or call 858-315-2020 with your ingredient deck and label draft.
Common food allergen labeling mistakes
- Missing sesame after the FASTER Act effective date.
- Declaring “tree nuts” or “fish” without the specific type or species.
- Contains statement that does not match the ingredient list.
- Using “may contain” as a substitute for declaring an allergen that is actually an ingredient.
- Updating a formula without updating allergen artwork and marketplace attributes.
- Assuming a foreign-language label or a small pack ships without U.S. allergen declarations.
Frequently asked questions
What are the nine major food allergens?
Milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame.
Is sesame required on food labels?
Yes. Sesame was added as a major food allergen under the FASTER Act and has been required since January 1, 2023.
Do I need both a Contains statement and parentheses in the ingredient list?
No. Either method can satisfy the law when done correctly. Pick one clear approach and keep it consistent with the actual ingredients.
Does “may contain peanuts” replace a Contains statement?
No. Advisory statements about possible cross-contact are not a substitute for declaring major allergens that are ingredients in the food.
Do restaurant foods prepared to order need FALCPA labels?
FALCPA’s labeling requirements generally apply to packaged foods. Foods placed in a wrapper or container after a customer’s order at the point of purchase are treated differently under FDA’s allergen materials. Packaged grocery and DTC foods sold online still need compliant labels.
How much does Eva charge for food label review?
Basic formatting review is $340 per label. Full compliance review is $590 per label. Food facility registration is $240 every two years, and U.S. Agent service is $250 per year.
Sources: FDA, Food Allergies; FDA, FALCPA; FDA, Food Allergen Labeling Q&A (Edition 5); FDA, Nutrition, Food Labeling and Critical Foods; FDA, Changes to the Nutrition Facts Label. General information, not legal advice.
