Food Allergen Labeling: The Nine Allergens and Federal Rules

Federal food allergen labeling requirements force manufacturers to clearly identify nine major allergens on any packaged food regulated by the FDA. The rules come from the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), expanded by the FASTER Act of 2021 to add sesame. The allergen must appear either in a “Contains” statement placed with the ingredient list, or in parentheses after the ingredient that carries it. A product that fails to disclose is legally misbranded and can be seized, recalled, or pulled through criminal enforcement.¹

The Nine Major Food Allergens

Congress named eight allergens in 2004 after finding they accounted for roughly 90 percent of food allergies.² The FASTER Act added sesame as the ninth, effective January 1, 2023.³ The full list under 21 U.S.C. § 321(qq) is milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

For fish, crustacean shellfish, and tree nuts, the label must name the specific species or type — “cod” rather than just “fish,” “shrimp” rather than just “shellfish,” “walnut” rather than just “tree nut.” Someone allergic to shrimp may safely eat crab; someone allergic to walnuts may have no trouble with almonds. The specificity is the whole point.²

What Is Not on the List

Two common assumptions are wrong. Molluscan shellfish — clams, oysters, mussels, scallops — are not major allergens under federal law. Only crustacean shellfish qualifies. A person with a mollusk allergy will not find a “Contains” statement flagging it.⁴

Coconut is also not classified as a tree nut for allergen labeling. It appears in the ingredient list when used, but manufacturers are not required to include it in a tree nut “Contains” statement. Chestnuts, hickory nuts, and pine nuts are similarly excluded from the tree nut allergen category.⁵

How the Allergen Must Appear on the Label

Manufacturers get two options under 21 U.S.C. § 343(w), and either one satisfies the law. Most products use one, some use both.

The first is a standalone “Contains” statement printed right after or next to the ingredient list, in type at least as large as the ingredient list itself. It looks like this: “Contains: milk, wheat, soy.”¹

The second is a parenthetical inside the ingredient list, naming the allergen source right after the ingredient that carries it: “whey (milk)” or “lecithin (soy).” If the ingredient name already makes the source obvious — “buttermilk” clearly means milk — the parenthetical is not required.⁶

Allergens Hidden in “Spices” and “Natural Flavors”

Manufacturers are generally allowed to write “spices,” “natural flavors,” or “artificial colors” without breaking those categories into individual components. That shortcut does not override the allergen rule. If a spice blend or flavoring contains protein from a major allergen, the allergen still has to be declared.⁷ A “natural flavor” derived from soy or a spice blend containing wheat triggers the same disclosure as any other ingredient.

Labels in Other Languages

When a label carries text in a language other than English, all required information, including allergen declarations, must appear in that language too. There are narrow exceptions for words with no English equivalent or standard food names like “spaghetti,” but allergen warnings are not among them.⁸

“May Contain” and Other Advisory Statements

Phrases like “may contain traces of peanuts” or “produced in a facility that processes tree nuts” are voluntary. FALCPA does not require them, and no federal rule defines what they mean. The FDA’s position is that these statements must be truthful and not misleading, but they are not a substitute for controlling cross-contact during manufacturing.⁹

Because advisory language is unregulated, two products carrying the same “may contain” wording can mean very different things. One manufacturer may use it because peanut products run on the same line minutes earlier. Another may use it because peanuts are handled somewhere in the same building. There is no standardized risk threshold behind the phrase.

The FDA flags two combinations as potentially misleading: pairing an allergen-free claim like “wheat-free” with a “may contain wheat” advisory on the same package, and pairing a “Contains” statement with a “may contain” advisory for the same allergen.⁵ And an advisory statement does not shield a manufacturer from enforcement. If the FDA finds inadequate cross-contact controls, the product can be treated as adulterated regardless of what the label says.⁹

Which Foods These Rules Actually Cover

The labeling requirements apply to packaged foods regulated by the FDA: conventional grocery items, dietary supplements, and infant formulas. Domestic manufacturers and foreign importers are held to the same standard.¹ The rules also reach bulk containers and reusable totes moving between manufacturers, repackers, and distributors, even when a labeling agreement otherwise exempts the shipment from some labeling rules.¹⁰

Several categories fall outside the FDA framework. Meat, poultry, and certain egg products are regulated by USDA, not FDA, and FALCPA did not amend the statutes governing them; USDA’s Food Safety and Inspection Service has its own allergen guidelines under separate authority.¹¹ Fresh produce and other raw agricultural commodities in their natural state are not covered. Restaurant and bakery items sold without prepackaging are also outside these specific federal label rules, though some states impose their own allergen notification duties on food service.¹

Ingredients That Do Not Trigger the Requirement

Some ingredients derived from a major allergen do not have to be declared as allergens.

Highly refined oils. The statute excludes highly refined oils derived from a major allergen from the definition of “major food allergen.” Refining strips out the proteins that cause reactions, so highly refined soybean or peanut oil does not need an allergen declaration. Cold-pressed, expeller-pressed, and unrefined versions do not qualify because they retain allergenic proteins.¹²

Incidental additives and processing aids. Under 21 CFR 101.100, substances present at insignificant levels with no technical or functional effect in the finished food are exempt from ingredient declaration, including processing aids that are removed before packaging or converted into components naturally present in the food.¹³ For highly sensitive individuals, “insignificant” levels of an allergenic protein can still cause a reaction.

Petition and notification. A manufacturer can seek to exempt a particular ingredient by petitioning the FDA with scientific evidence that the ingredient does not cause an allergic response posing a risk to human health; the agency has 180 days to act or the petition is deemed denied. A faster notification route is available when the manufacturer can show the ingredient contains no allergenic protein at all, in which case sales can begin 90 days after filing unless FDA objects.¹⁴

What Happens When a Label Is Wrong

A packaged food that fails to properly declare a major allergen is misbranded. Undeclared allergens almost always trigger a Class I recall, defined by the FDA as a situation with a reasonable probability of serious harm or death.¹⁵ Undeclared allergens still account for roughly one-third of serious-risk food reports to the FDA, with milk the most common culprit.¹⁶

Beyond recalls, the FDA can seize misbranded product anywhere in interstate commerce and can seek a court injunction stopping further distribution. Criminal penalties for a first offense reach up to one year of imprisonment, a fine of up to $1,000, or both. Civil penalties for introducing adulterated food into interstate commerce can reach $50,000 per violation for an individual and $250,000 for a company, capped at $500,000 for all violations in a single proceeding.¹⁷

Reporting a Reaction or a Bad Label

If you have a reaction to a packaged food and think the label was incomplete or incorrect, contact a healthcare provider first, then report the problem to the FDA. Clinical details strengthen the report, and a provider can fill out the form for you.

The fastest route is a MedWatch report online using FDA Form 3500. You can also fax the form to 1-800-FDA-0178 or call 1-800-FDA-1088 during business hours.¹⁸ The general information line is 1-888-INFO-FDA (1-888-463-6332).¹⁹ Report even mild reactions. The FDA uses complaint data to spot patterns, prioritize inspections, and trigger recalls, and a single report about an unlabeled allergen can put an investigation in motion.

1
Office of the Law Revision Counsel. 21 USC 343 – Misbranded Food
2
U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004
3
U.S. Food and Drug Administration. The FASTER Act: Sesame Is the Ninth Major Food Allergen
4
U.S. Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Food Allergens (Edition 5)
5
U.S. Food and Drug Administration. Frequently Asked Questions: Food Allergen Labeling Guidance for Industry
6
Office of the Law Revision Counsel. 21 USC 343(w) – Major Food Allergen Labeling Requirements
7
U.S. Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
8
U.S. Food and Drug Administration. CPG Sec 562.400 Foreign Language Declarations on Food Labels
9
Food and Drug Administration. Sec. 555.250 Major Food Allergen Labeling and Cross-Contact – Draft Compliance Policy Guide
10
U.S. Food and Drug Administration. Do Food Allergen Labeling Requirements Apply to Bulk Containers?
11
Federal Register. Availability of FSIS Compliance Guidelines for Allergens and Ingredients of Public Health Concern
12
Office of the Law Revision Counsel. 21 USC 321 – Definitions; Generally
13
eCFR. 21 CFR 101.100 – Food; Exemptions From Labeling
14
U.S. Food and Drug Administration. Food Allergen Labeling Exemption Petitions and Notifications: Guidance for Industry
15
U.S. Food and Drug Administration. Recalls Background and Definitions
16
U.S. Food and Drug Administration. Food Allergies
17
Office of the Law Revision Counsel. 21 USC 333 – Penalties
18
U.S. Food and Drug Administration. FDA 101: How to Use the Consumer Complaint System and MedWatch
19
U.S. Food and Drug Administration. Consumer Complaint Coordinators