Food Allergy Labeling Laws in the US: FALCPA and FASTER Act

Federal food allergy labeling law in the United States has expanded twice in the past two decades, first through the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and then through the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act). Together these statutes define which allergens must be disclosed on packaged food labels, how that disclosure must appear, and which food categories fall inside or outside mandatory requirements. Understanding the scope and mechanics of both laws is essential for anyone navigating food allergies or evaluating compliance obligations in the US food supply.

Definition and scope

FALCPA (Public Law 108-282) established the first federal framework requiring plain-language allergen disclosure on packaged foods regulated by the US Food and Drug Administration (FDA). The law identified eight "major food allergens": milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. These eight were chosen because, according to FDA allergen data, they accounted for approximately 90 percent of food allergic reactions in the United States at the time of enactment.

The FASTER Act (Public Law 117-11), signed in April 2021, added sesame as the ninth major food allergen, effective January 1, 2023. Sesame was added after evidence documented its role as a significant allergenic risk, with the FDA's FASTER Act page citing growing clinical recognition of sesame allergy prevalence, estimated to affect approximately 1.6 million Americans.

Both statutes apply to packaged foods regulated by FDA under the Federal Food, Drug, and Cosmetic Act. Foods exclusively regulated by the US Department of Agriculture (USDA)—primarily meat, poultry, and egg products—fall under separate USDA labeling authority and are not directly governed by FALCPA or the FASTER Act. Dietary supplements, however, are covered by FALCPA.

The broader regulatory context for allergy in the United States includes FDA enforcement authority, state-level restaurant disclosure requirements, and voluntary guidance—all of which layer on top of the federal labeling floor established by these two statutes.

How it works

FALCPA specifies two compliant methods for declaring a major food allergen on a label:

Ingredient list declaration — The allergen is identified in the ingredient list using the common or usual name of the food source (e.g., "milk" rather than "casein", "wheat" rather than "semolina").
"Contains" statement — A separate "Contains:" statement immediately follows or is adjacent to the ingredient list, naming each major allergen present (e.g., "Contains: Wheat, Milk, Peanuts").

Both methods are permissible; manufacturers choose one. If a "Contains" statement is used, it must be complete—it cannot list a subset of the allergens present.

For tree nuts and fish, FALCPA requires specificity at the species level. A label must state the specific type of tree nut (e.g., "almonds", "cashews", "walnuts") or the specific species of fish (e.g., "salmon", "tilapia") rather than using the generic category name alone.

The FASTER Act applied the same dual-method disclosure framework to sesame beginning January 1, 2023. Because sesame was not always listed prominently on prior labels—it was often embedded in compound ingredient names like "tahini" or "sesame oil"—the addition triggered reformulation and relabeling decisions across the food industry.

FDA enforces allergen labeling through the FDA Food Safety Modernization Act (FSMA) compliance framework, which includes facility inspections, import alerts, and recall authority. Misbranding violations under 21 U.S.C. § 343 can trigger mandatory or voluntary recalls coordinated through FDA's recall system.

Common scenarios

Precautionary allergen labeling (PAL): Statements such as "May contain peanuts" or "Manufactured in a facility that also processes tree nuts" are not required by FALCPA or the FASTER Act and are not standardized by federal regulation. FDA has issued draft guidance on voluntary PAL, but no binding rule mandates or standardizes the language. This creates inconsistency that the allergy action plans of medically advised patients must account for.

Restaurant and food service exemptions: FALCPA applies to packaged foods bearing a label; it does not apply to foods prepared and sold in restaurants, bakeries, or food service establishments without labeling. Restaurant allergen disclosure is addressed primarily through state laws and the FDA's voluntary Food Code guidance rather than FALCPA.

Highly refined oils: Highly refined oils derived from major allergens—such as highly refined poybean oil—are exempt from FALCPA declaration because the refining process typically removes detectable protein. Cold-pressed, expeller-pressed, or crude oils are not exempt and must be declared.

Flavors and spices: FALCPA requires that if a flavor or spice contains a major allergen, the allergen source must still be declared, even when the flavor itself is listed collectively as "natural flavor" or "spice."

Decision boundaries

The line between FALCPA coverage and non-coverage depends on several categorical tests:

Factor	Covered	Not Covered
Regulatory agency	FDA-regulated packaged foods	USDA-regulated meat/poultry/eggs
Format	Packaged with a label	Restaurant/food service without packaging
Oil type	Cold-pressed, expeller-pressed	Highly refined (protein-free)
Allergen count	All 9 named major allergens	Other allergens (e.g., corn, mustard)
Supplement type	Dietary supplements	Excluded alcoholic beverages (TTB-regulated)

Allergens not on the FALCPA/FASTER list—such as corn, mustard, lupin, and molluscan shellfish beyond those already specified—carry no mandatory declaration requirement under federal law, though the EU and other jurisdictions require disclosure of 14 allergens. The Allergy Authority index covers this comparative landscape across allergen categories and regulatory systems.

The distinction between fish and shellfish is structurally important: both are major allergens, but they are separate categories. An individual allergic to shrimp (shellfish) is not necessarily allergic to salmon (fish), and the law treats them as distinct declaration categories. Similarly, tree nuts must be declared at the species level precisely because cross-reactivity patterns across tree nut species vary clinically.

For sesame specifically, the 2023 FASTER Act compliance date created a transitional labeling period in which products manufactured before January 1, 2023 could remain in commerce under prior labeling, producing a gap period during which sesame may not have been declared on all products on shelves.

References

The law belongs to the people. Georgia v. Public.Resource.Org, 590 U.S. (2020)