What must be on a US food label?

FDA implements federal food labeling requirements in 21 CFR Part 101. A packaged food sold in the United States must carry a statement of identity and the net quantity of contents on the principal display panel (PDP). The PDP or the information panel must also carry the ingredient list, the name and place of business of the manufacturer or distributor, Nutrition Facts, and the nine major food allergens.

Where FDA food label requirements come from

21 CFR Part 101 implements the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the amendments made by the Nutrition Labeling and Education Act of 1990 (NLEA), and the Fair Packaging and Labeling Act (FPLA). The NLEA is itself an amendment to the FD&C Act, not a separate statute enforced in its own right.

Allergen labeling is the exception. It sits in the statute itself, FD&C Act § 403(w), and the allergens are listed in § 201(qq).

The two label panels: principal display panel and information panel

• Principal display panel (PDP), 21 CFR 101.1. This is the part of the label most likely to be displayed or examined at retail. If a package has alternate PDPs, the PDP information must be repeated on each one.
• Information panel, 21 CFR 101.2(a). This is the panel immediately to the right of the PDP. If that panel is unusable, such as a fold, the next panel to the right is used.

Under 101.2(b), the ingredient list, the name and place of business, and Nutrition Facts go on the PDP or the information panel. They belong together on one panel unless space runs out, and the items required by any one section must stay together (101.2(d)(1)). The information panel may carry no intervening material (101.2(e)).

The checklist: what must be on a US food label

Statement of identity (101.3)

Use the name a federal standard or regulation requires, else the common or usual name, else a descriptive term (101.3(b)). It must be bold on the PDP and sized in reasonable relation to the most prominent printed matter on that panel (101.3(d)).

Ingredient list (101.4) and flavors and colors (101.22)

Ingredients are listed by common or usual name in descending order of predominance by weight (101.4(a)(1)). Ingredients at 2 percent or less may follow a statement such as "Contains 2% or less of" (101.4(a)(2)). A compound ingredient may be declared by its name followed by its components in parentheses, or by listing each component in its place in the ingredient list without naming the compound ingredient (101.4(b)(2)(i), (ii)).

• Flavors. "Spice," "natural flavor" and "artificial flavor" may be declared generically (101.22(h)(1)). Salt, monosodium glutamate and protein hydrolysates must be named (101.22(h)(4), (5), (7)). Paprika, turmeric and saffron are declared as "spice and coloring" unless named (101.22(a)(2)).
• Certified colors. These are declared by their listed name. "FD&C" and "No." may be dropped, but "Lake" must stay, as in "Blue 1 Lake" (101.22(k)(1)).
• Colors exempt from certification. These may be declared as "Artificial Color," "Color Added" or "Colored with ___" (101.22(k)(2)).
• Chemical preservatives. These need the name and the function, for example "to retard spoilage" (101.22(j)).

Major food allergens (FD&C Act § 403(w))

The nine major food allergens are milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame (21 U.S.C. 321(qq)). The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) set the original eight. The FASTER Act of 2021 added sesame for food introduced or delivered for introduction into interstate commerce on or after 1 January 2023.

Each allergen must be declared in one of two ways:

• a "Contains" statement immediately after or adjacent to the ingredient list, in type no smaller than the list (403(w)(1)(A)); or
• a parenthetical after the ingredient name, such as "lecithin (soy)" (403(w)(1)(B)). No parenthetical is needed where the ingredient's common or usual name already names the source (such as "buttermilk"), or where the source name already appears elsewhere in the ingredient list (403(w)(1)(B)(i), (ii)).

A "Contains" statement must list every major food allergen in the product, not just some of them.

For tree nuts, fish and Crustacean shellfish, the specific nut or species must be named (403(w)(2)). Flavorings, colorings and incidental additives are not exempt (403(w)(4)).

FDA's Edition 5 allergen guidance, issued in January 2025, lists in Table 1 the 12 tree nuts that FDA considers major food allergens: almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut, pecan, pine nut, pistachio and walnut (English, Persian). Coconut is not on the list. The guidance also counts goat and sheep milk as "milk" and recommends naming the source, for example "goat milk." The FDA Food Labeling Guide (revised January 2013) still describes eight allergens; FDA notes that its allergen chapter is under revision and points readers to Edition 5.

Name and place of business (101.5)

A corporation must use its actual corporate name (101.5(b)). The address gives street, city, state and ZIP code. The street may be omitted only if it is listed in a current city or telephone directory (101.5(d)). A firm that did not manufacture the food qualifies its name with wording such as "Manufactured for" or "Distributed by" (101.5(c)).

Net quantity of contents (101.7)

• Units. Solids are declared by weight and liquids by fluid measure (101.7(a)). Packages under 4 lb or 1 gal give ounces first, as in "Net Wt 24 oz (1 lb 8 oz)" (101.7(j), (m)); the metric figure is still required alongside, e.g. "Net Wt 24 oz (1 lb 8 oz) 680 g".
• Metric. FPLA § 4(a)(2) requires both customary and metric units, except for random-weight packages and foods packaged at the retail store level (15 U.S.C. 1453(a)(3)(A)(ii), (a)(6)). FDA's Food Labeling Guide says the same. However, 21 CFR 101.7 itself was not updated after the 1992 FPLA amendment. Section 101.7(p) says only that a metric statement "is not regarded as a supplemental statement" and may appear on the PDP or on other panels. It does not make metric mandatory.
• Placement. The declaration goes in the bottom 30 percent of the PDP, except on PDPs of 5 sq in or less. It must be clear of surrounding print (101.7(f)) and may not use terms such as "jumbo quart."

Minimum type height for net quantity of contents (101.7(i))

Where lowercase letters are used, the height is measured on the lowercase "o" (101.7(h)(2)).

Nutrition Facts label requirements (101.9)

Mandatory nutrients (101.9(c)) are calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars and protein, followed by vitamin D, calcium, iron and potassium, in that order.

Format (101.9(d)):

• The panel is boxed in hairlines.
• "Nutrition Facts" is set no smaller than any other type in the panel, apart from the calorie number.
• "Calories" is at least 16 point bold and its number at least 22 point bold.
• "Serving size" is at least 10 point bold.
• Nutrient lines are at least 8 point; subheadings and footnotes are at least 6 point.
• The tabular and linear displays for small packages have lower minimums: 10 point for "Calories," 14 point for its number and 9 point for servings per container (type sizes in 101.9(d), for the displays in 101.9(j)(13)(ii)(A)).

Where the standard vertical display does not fit, 101.9(d)(11) allows three alternatives: moving the footnote to the right, moving the remaining vitamins and minerals to the right, and using a tabular display where there is not approximately 3 inches of continuous vertical space.

Dual columns. A package sold individually that holds 200 to 300 percent of the RACC shows a column per serving and a column per package (101.9(b)(12)(i)). Where each discrete unit weighs 200 to 300 percent of the RACC, the label shows a column per serving and a column per unit (101.9(b)(2)(i)(D)).

Exemptions and format alternatives (101.9(j)). Any nutrition claim or other nutrition information on the label removes the exemptions below. The last row is a format option, not an exemption.

Serving size and RACC (101.12)

Serving size comes from the RACC for the category in 101.12(b), not from the brand's preferred portion. It is then converted to a household measure under 101.9(b). For example, the RACC for carbonated and noncarbonated beverages is 360 mL (12 fl oz).

A package sold individually that contains less than 200 percent of the RACC must be labeled as one serving (101.9(b)(6)).

Prominence and type size (101.15, 101.2(c))

Information required on the PDP or information panel must be at least 1/16 inch high (101.2(c)). Restaurant and institutional single-serve packages with 3 sq in or less may use 1/32 inch (101.2(c)(2)).

Required information can still fail the prominence test through crowding, poor contrast or obscuring designs, even when the type is large enough (101.15(a)).

Warning statements (101.17)

Section 101.17 prescribes exact wording for warnings on self-pressurized containers, foods containing or packaged in chlorofluorocarbons or other ozone-depleting substances, weight-loss protein products, iron-containing supplements, psyllium foods bearing the related health claim, juice not processed to a 5-log pathogen reduction, and shell eggs.

Some warnings sit outside Part 101, such as the aspartame statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" (21 CFR 172.804(d)(2)).

Claims: an overview

Claims are optional, but each carries conditions. They are covered in depth in Which food claims are allowed in the US and the EU?.

• Nutrient content claims (101.13). Only defined claims may be used, at no more than twice the type size of the statement of identity (101.13(f)). A "See nutrition information for ___ content" disclosure is triggered above 13.0 g fat, 4.0 g saturated fat, 60 mg cholesterol or 480 mg sodium (101.13(h)).
• Health claims (101.14). Authorized claims are in Subpart E (101.72–101.83). The same four levels disqualify a food from bearing a health claim (101.14(a)(4)). Qualified health claims rely on FDA letters of enforcement discretion and need qualifying language.
• "Healthy" (101.65(d)). This claim was redefined by the final rule of 27 December 2024 (89 FR 106064). Its effective date was delayed to 28 April 2025 (90 FR 10592), and the compliance date is 25 February 2028. In its 2026 priorities, FDA says it will assess whether the criteria need changes to align with the 2025–2030 Dietary Guidelines; no change has been proposed as of 12 October 2026.
• Gluten-free (101.91). Gluten must be below 20 ppm. A food that declares wheat and claims "gluten-free" needs the explanatory statement in 101.91(b)(3).
• Structure/function. Dietary supplements need FDA notification and the disclaimer under 101.93. Conventional foods need neither, but the effect must derive from nutritive value.

Common mistakes

How RegaaS checks this

RegaaS reviews an uploaded label against 21 CFR Part 101 and FD&C Act § 403(w), and cites the provision behind every finding. Under Part 101 it covers:

• Nutrition Facts;
• ingredient declarations;
• name and place of business;
• net quantity of contents;
• serving sizes derived from the RACC;
• mandatory warnings;
• flavorings and colorings;
• the conditions for nutrient content, health, "gluten-free" and structure/function claims.

The redefined "healthy" claim and the proposed front-of-package box are each applied with the date on which their status was checked. Findings are marked on the label image, with suggested replacement text.

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

What this guide does not cover

RegaaS reports the following as out of scope rather than assessing them against the wrong provisions:

• meat, poultry and egg products regulated by USDA FSIS;
• most alcoholic beverages, which are regulated by TTB;
• bioengineered food disclosure and USDA organic labeling;
• country of origin marking;
• weights and measures requirements beyond FDA's net quantity rules. States actually enforce the Uniform Packaging and Labeling Regulation (UPLR) in NIST Handbook 130, which is adopted state by state and is not identical to 21 CFR 101.7, so check it separately;
• vertical commodity standards;
• FTC advertising substantiation;
• state requirements, including California Proposition 65.

Dietary supplements follow the Supplement Facts regime of 21 CFR 101.36, covered separately. A RegaaS report is a documented review, not legal advice, and does not replace sign-off by a qualified regulatory professional.

Frequently asked questions

Which regulation sets FDA food label requirements? 21 CFR Part 101, which implements the FD&C Act (including the 1990 NLEA amendments) and the FPLA. Allergen labeling is set directly by FD&C Act § 403(w).

What must appear on the principal display panel? The statement of identity (21 CFR 101.3) and the net quantity of contents (101.7), plus any characterizing flavor statement (101.22(i)).

How many major food allergens must be declared? Nine. Sesame became the ninth under the FASTER Act of 2021, for food introduced into interstate commerce on or after 1 January 2023.

Where is the net quantity rule now, 101.105 or 101.7? 21 CFR 101.7. Section 101.105 was redesignated as 101.7 in 2016 (81 FR 59131).

Is the front-of-package nutrition box required? No. It was proposed on 16 January 2025, and as of 12 October 2026 no final rule has been published.

Primary sources

• 21 CFR Part 101 (eCFR)
• 21 CFR 101.7 (eCFR)
• 21 CFR 101.9 (eCFR)
• 21 CFR 101.30 (eCFR)
• 21 CFR 101.12 (eCFR)
• 21 U.S.C. 343, including § 403(w)
• 21 U.S.C. 321(qq)
• 15 U.S.C. 1453 (FPLA)
• FDA — Human Foods Program 2026 priority deliverables
• "Healthy" final rule, 89 FR 106064
• "Healthy" effective date delay, 90 FR 10592
• Front-of-package proposed rule, 90 FR 5426
• Front-of-package comment period extension, 90 FR 19664
• FDA allergen labeling Q&A, Edition 5
• FDA, Food Labeling Guide
• FDA, Structure/Function Claims