Food Allergen Labeling Laws: Requirements, Exemptions, and Penalties

Federal food allergen labeling laws require manufacturers to clearly identify any of nine major allergens on packaged food sold in the United States. The framework comes from two statutes: the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which named the original eight allergens, and the FASTER Act of 2021, which added sesame as the ninth effective January 2023.¹² A label that fails to disclose one of these ingredients renders the product misbranded and exposes the company to recalls, seizure, import refusal, and criminal penalties.

The Nine Major Allergens Covered by Federal Law

The nine major food allergens under federal law are milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame.² Congress selected these because they cause the vast majority of serious allergic reactions in the United States.

Three of them require more than a category name. Tree nuts, fish, and crustacean shellfish must be identified by specific type or species: “cashews,” not “tree nuts”; “salmon,” not “fish”; “shrimp,” not “crustacean shellfish.”³ Many people are allergic to one species within a group but tolerate others, and the specificity requirement exists so they can tell.

How Allergens Must Appear on the Label

Manufacturers have two legal ways to declare an allergen. They can print a standalone “Contains” statement immediately after or next to the ingredient list (“Contains: Milk, Wheat, Soy”), or they can name the allergen source parenthetically inside the ingredient list itself (“casein (milk),” “lecithin (soy)”).³ Either satisfies the law; many companies use both.

The allergen text must be at least as large as the surrounding ingredient text, and it must use plain English rather than scientific terms. Listing “casein” without noting it as a milk derivative doesn’t meet the standard.¹ There’s one shortcut: if the ingredient’s common name already identifies the source, no additional declaration is needed. “Milk” doesn’t need a parenthetical “(milk).” “Whey” does, because most shoppers wouldn’t recognize it as a milk protein.³

Multi-pack products carry the requirement inward. When individually wrapped units sit inside outer packaging, each inner wrapper must also display the allergen information. The only exception is a plain protective sleeve with no printed text or graphics at all, such as the wax paper around a stack of crackers.⁴

Allergens Hiding in Flavors, Spices, and Additives

One of the strongest features of the law is that allergens can’t hide behind vague ingredient descriptions. Flavors, colorings, and incidental additives that normally don’t need to be individually named must still disclose any major allergen they contain or are derived from.³ If a “natural flavor” carries a milk-derived protein, the label must say so.

The same rule reaches spice blends. When a spice mix contains an allergen as an incidental additive, that allergen must appear on the finished product’s label. There is one meaningful carve-out: if a flavor or color starts from an allergen source but the final product contains no allergenic protein from that source, no declaration is required.⁴ The question is always whether allergenic protein made it into the finished food.

What “May Contain” Statements Actually Mean

Labels reading “may contain peanuts” or “produced in a facility that processes tree nuts” are not required by federal law. These are voluntary advisory statements, and the FDA has never set formal rules governing their use, which leaves their meaning inconsistent from product to product.⁵

The FDA’s position is that advisory statements should address genuine cross-contact risk (the unintentional introduction of an allergen through shared equipment or production lines) and only after the manufacturer has implemented good manufacturing practices to minimize that risk. A “may contain” label is not an acceptable substitute for properly cleaning equipment.⁵ The FDA also prohibits pairing an allergen-free claim with an advisory statement for the same allergen on the same label; a product cannot say both “peanut-free” and “may contain peanuts.”⁶

Cross-contact allergens are distinct from actual ingredients and should not appear in the ingredient list or the mandatory “Contains” statement. Any disclosure about cross-contact belongs in a separate advisory line if the manufacturer chooses to include one.⁴

Which Products the Rules Cover

FALCPA applies to all packaged foods regulated by the FDA, both domestic and imported. That includes conventional grocery items, dietary supplements, and infant formulas.⁷ Bulk containers shipped between manufacturers for further processing must also carry allergen labeling; there is no exemption for business-to-business shipments.⁸

Several categories fall outside FALCPA. Meat, poultry, and certain egg products are regulated by the USDA’s Food Safety and Inspection Service, not the FDA. Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, all ingredients must be declared and undeclared ingredients render the product misbranded, but the FSIS treats “Contains” statements and parenthetical allergen clarifications as encouraged rather than required.⁹

Raw agricultural commodities, such as whole fruits and vegetables, are excluded from FALCPA entirely because there are no hidden ingredients to disclose.¹ Restaurants and other food-service establishments are also largely outside the law: a sandwich made to order at a deli counter carries no federal allergen labeling obligation, though pre-packaged food offered from a cooler does.⁵ Some states and cities have their own restaurant disclosure rules, but nothing federal requires a “Contains” statement on made-to-order food.

Gluten is not one of the nine major allergens. Wheat is, and must be declared, but rye and barley are not, so their presence may only be visible from the ingredient list. The “gluten-free” claim is regulated separately and is voluntary.¹⁰

Exemptions Manufacturers Can Use

Not every ingredient derived from a major allergen requires a declaration. The most common exemption covers highly refined oils, because the refining process removes the allergenic protein that causes reactions. Highly refined soybean oil or peanut oil generally doesn’t need an allergen declaration; an oil that is not highly refined does.⁴

Manufacturers can also petition the FDA to exempt a specific ingredient, provided they show scientific evidence that the ingredient as processed either doesn’t cause an allergic response or contains no allergenic protein. The agency has 180 days to act, and silence counts as denial. A faster notification pathway lets an ingredient enter commerce 90 days after filing if testing shows no allergenic protein, unless the FDA objects.³

Penalties for Mislabeled Products

Undeclared allergens are the single most common reason for FDA food recalls. Allergen mislabeling accounted for nearly 46% of all FDA food recalls in early 2025, with milk and dairy the most frequently missed.⁵

When the FDA finds an undeclared allergen, the product is misbranded and subject to enforcement actions including recalls, seizure, and import refusal. Most recalls are voluntary, initiated by the manufacturer once the problem is identified, and are typically classified as Class I, meaning there is a reasonable probability the product could cause serious health consequences or death.¹¹ The FDA can also issue warning letters or place imported products on import alert.⁵ On the USDA side, FSIS inspection personnel verify that labels match formulations and that the nine major allergens are properly declared, and may request a voluntary recall when they find an undeclared allergen.¹²

Criminal penalties for distributing misbranded food start at up to one year in prison and a fine of up to $1,000 for a first offense. A repeat violation, or one committed with intent to defraud, can bring up to three years in prison and a fine of up to $10,000.¹³

How to Report a Mislabeled Product

If you find a packaged food with a missing or incorrect allergen declaration, or if you have a reaction to a product that failed to disclose an allergen, you can report it to the FDA. Three options are available: call an FDA Consumer Complaint Coordinator directly, file an electronic MedWatch form online, or mail a paper MedWatch form. For meat or poultry products, which fall under USDA jurisdiction, call the USDA Meat and Poultry Hotline at 1-888-674-6854 instead.¹⁴

1
U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
2
U.S. Food and Drug Administration. The FASTER Act: Sesame Is the Ninth Major Food Allergen
3
Office of the Law Revision Counsel. 21 USC 343 – Misbranded Food
4
Food and Drug Administration. Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
5
U.S. Food and Drug Administration. Food Allergies
6
U.S. Food and Drug Administration. Frequently Asked Questions: Food Allergen Labeling Guidance for Industry
7
Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)
8
U.S. Food and Drug Administration. Do Food Allergen Labeling Requirements Apply to Bulk Containers, Reusable Totes, or Containers, etc.?
9
Food Safety and Inspection Service. Allergens – Voluntary Labeling Statements
10
eCFR. 21 CFR 101.91 – Gluten-Free Labeling of Food
11
U.S. Food and Drug Administration. Recalls Background and Definitions
12
USDA Food Safety and Inspection Service. FSIS Directive 7230.1 Revision 4 – Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common (“Big 9”) Food Allergens and Gluten
13
Office of the Law Revision Counsel. 21 USC 333 – Penalties
14
U.S. Food and Drug Administration. How to Report a Non-Emergency