FDA Food Labeling Requirements and Nutrition Facts

Federal food labeling law governs what information must appear on packaged foods sold in the United States, who bears responsibility for compliance, and what happens when labels omit or misrepresent required content. The FDA's labeling framework is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implemented through regulations codified at 21 C.F.R. Parts 101–105. This page explains the scope of those requirements, how the Nutrition Facts panel works mechanically, which product categories face distinct rules, and where the regulatory boundaries between food and other FDA-regulated products become decisive. For a broader orientation to FDA jurisdiction across all product categories, see the FDA overview.

Definition and Scope

Food labeling requirements under FDA jurisdiction apply to any food product in interstate commerce, with limited exemptions for small businesses, certain raw agricultural commodities, and restaurant menu items regulated separately under the Affordable Care Act's menu labeling provisions (21 C.F.R. § 101.11).

The statutory basis is the FD&C Act, codified at 21 U.S.C. §§ 321, 343, which defines a food as misbranded if its labeling is false or misleading in any particular, fails to state required information, or uses unauthorized nutrient content or health claims. The Nutrition Labeling and Education Act of 1990 (NLEA) substantially expanded mandatory labeling requirements and gave FDA explicit authority to require Nutrition Facts panels on most packaged foods.

The scope of mandatory labeling spans five principal information categories:

1. Statement of identity — the common or usual name of the food (21 C.F.R. § 101.3)
2. Net quantity of contents — expressed in both metric and U.S. customary units (21 C.F.R. § 101.7)
3. Nutrition Facts panel — a standardized format disclosing calories, macronutrients, and selected micronutrients
4. Ingredient declaration — listed in descending order by weight (21 C.F.R. § 101.4)
5. Name and place of business — of the manufacturer, packer, or distributor (21 C.F.R. § 101.5)

Major food allergen disclosure constitutes a sixth mandatory element under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires declaration of the 8 major allergens — tree nuts, peanuts, milk, eggs, fish, shellfish, wheat, and soybeans — with sesame added as a ninth by the FASTER Act of 2021, effective January 1, 2023 (FDA FALCPA guidance).

How It Works

The Nutrition Facts Panel

The Nutrition Facts panel format was revised by FDA in 2016 (81 Fed. Reg. 33742), with large manufacturers required to comply by January 1, 2020, and manufacturers with less than $10 million in annual food sales given until January 1, 2021 (FDA Nutrition Facts Label page).

The panel must disclose, in order:

• Serving size — expressed in a common household measure plus metric equivalent, based on Reference Amounts Customarily Consumed (RACCs) set by FDA at 21 C.F.R. § 101.12
• Calories — in bold, larger type under the 2016 format
• Total fat, saturated fat, trans fat — trans fat must be listed with no percent Daily Value (%DV) assigned
• Cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars — added sugars became mandatory under the 2016 revision; %DV is set at 10% of a 2,000-calorie diet
• Protein — no %DV required unless a protein claim is made
• Vitamin D, calcium, iron, potassium — mandatory micronutrients under the 2016 revision, replacing vitamins A and C

The %DV figures are calibrated to a 2,000-calorie daily reference intake, codified at 21 C.F.R. § 101.9.

Nutrient Content and Health Claims

Nutrient content claims — terms such as "low fat," "high fiber," or "reduced sodium" — are authorized only if the product meets the definitional criteria in 21 C.F.R. Part 101, Subpart D. For example, "low sodium" requires 140 mg or less of sodium per reference amount, while "reduced sodium" requires at least 25% less sodium than the reference food (21 C.F.R. § 101.61).

Health claims — statements linking a nutrient or food substance to reduced disease risk — require either premarket authorization by FDA through rulemaking or qualification as an authorized health claim based on significant scientific agreement (SSA). Qualified health claims carry a lower evidentiary standard but must include qualifying language that limits the strength of the claim (FDA health claims guidance).

Common Scenarios

Small business exemptions. Manufacturers with fewer than 10 full-time employees and fewer than 10,000 units sold annually may apply for a labeling exemption under 21 C.F.R. § 101.9(j)(18). This exemption does not apply to products making nutrient content or health claims.

Dietary supplements. Products regulated as dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA) carry a Supplement Facts panel governed by 21 C.F.R. § 101.36, not a Nutrition Facts panel. The structure is similar but requires listing the "% Daily Value" column only when an established DV exists for the ingredient. For more on how the FDA regulates this product category, see FDA Dietary Supplement Regulation.

Imported foods. Packaged foods imported into the United States must carry labels compliant with all applicable 21 C.F.R. Part 101 requirements before distribution. FDA's import examination authority under 21 U.S.C. § 381 allows refusal of entry for noncompliant labeling. Details of the import examination process are covered at FDA Import Regulations and Detentions.

Restaurant and foodservice. Chain restaurants with 20 or more locations operating under the same name and offering substantially the same menu must disclose calorie counts on menus and menu boards, with written nutrition information available upon request (21 C.F.R. § 101.11). Vending machine operators with 20 or more machines face parallel calorie disclosure requirements.

Decision Boundaries

The most consequential regulatory boundary in food labeling is the distinction between a food and a drug. Under 21 U.S.C. § 321(g), a product becomes a drug if its labeling bears claims that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A packaged food carrying a disease treatment claim — even if the product itself is a conventional food — is reclassified as a drug and subject to premarket approval. This boundary directly affects permissible label language and is a primary driver of FDA warning letters to food manufacturers.