FDA labeling requirements for food labels under 21 CFR 101
FDA food labels need a statement of identity, net quantity, ingredients, name and address, Nutrition Facts and allergens. Where each rule sits in 21 CFR.
FDA labeling requirements for food
For most packaged foods, FDA labeling requirements are a statement of identity, the net quantity of contents, an ingredient list, the name and place of business, and Nutrition Facts. The label also declares any of the nine major food allergens (21 U.S.C. 343). Most of these rules sit in 21 CFR Part 101. Allergen and metric-unit rules come from statute. FDA's Food Labeling Guide explains them in question-and-answer form.
Drugs, devices and cosmetics have separate FDA labeling rules.
Where the information goes on the package
FDA labeling regulations use two panels. The principal display panel (PDP) is the part of the label most likely to be seen at retail. If a package has an alternate PDP, the required PDP information is repeated there (21 CFR 101.1).
The information panel is the panel immediately to the right of the PDP. The ingredient list, the name and place of business, and nutrition labeling go on either the PDP or the information panel. On the information panel they're kept together, with no other material in between (21 CFR 101.2).
Information that 101.2 requires on the PDP or the information panel must be at least 1/16 inch high. Individual serving-size packages served with meals in restaurants, institutions or on passenger carriers, and not sold at retail, may use 1/32 inch type. The package also needs 3 square inches or less available for labeling, and not enough room for 1/16 inch type (21 CFR 101.2).
Required information must be in English. If any foreign language appears on the label, all required information must appear in that language too (21 CFR 101.15).
The five core elements
Statement of identity
The name of the food is a principal feature of the PDP: bold type, generally parallel to the base, sized in reasonable relation to the most prominent print. Use the name the law or a regulation prescribes. If none exists, use the common or usual name, or an appropriately descriptive name. Include the form when it matters, such as whole, sliced or diced. A nutritionally inferior substitute is labeled "imitation" (21 CFR 101.3).
Net quantity of contents
Net quantity is stated by weight, measure or count. Liquids use fluid measure. Solids, semisolids and viscous foods use weight. The statement is a separate line in the bottom 30% of the PDP, generally parallel to the base, though the bottom-30% rule doesn't apply to PDPs of 5 square inches or less. Words that exaggerate the amount, like "jumbo quart", aren't allowed (21 CFR 101.7).
Minimum type height scales with PDP area:
| PDP area | Minimum height |
|---|---|
| 5 sq in or less | 1/16 in |
| over 5, up to 25 sq in | 1/8 in |
| over 25, up to 100 sq in | 3/16 in |
| over 100, up to 400 sq in | 1/4 in |
| over 400 sq in | 1/2 in |
Section 101.7(p) only says a metric statement "may" appear. But the Fair Packaging and Labeling Act, 15 U.S.C. 1453(a)(2) requires both inch-pound and SI metric units, with statutory exceptions such as random-weight packages and foods packaged at retail.
Ingredient list
Ingredient labeling means listing each ingredient by its common or usual name, in descending order of predominance by weight. Ingredients present at 2% or less can be grouped at the end after a statement such as "Contains 2 percent or less of". Specific names are required instead of collective names, except where the rule allows them (21 CFR 101.4). The legal basis is section 403(i) of the FD&C Act (21 U.S.C. 343).
Colors, flavors and preservatives follow 21 CFR 101.22. Certified colors use the listed name, such as "Blue 1" or "Blue 1 Lake". A chemical preservative needs its common name and its function, such as "preservative". Spices and flavors may be declared as "spice", "natural flavor" or "artificial flavor".
Name and place of business
The label names the manufacturer, packer or distributor, shown conspicuously. A corporation uses its corporate name. If the named firm didn't make the food, the name is qualified with words like "Manufactured for" or "Distributed by". The address includes street, city, state and ZIP code. The street address can be dropped if the firm is listed in a current city or telephone directory (21 CFR 101.5).
Nutrition Facts
Nutrition Facts are required on food offered for sale unless a 101.9(j) exemption applies. Values are per serving. The serving size uses a household measure and is based on the amount customarily consumed. The mandatory nutrients are calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars (shown as "Includes X g Added Sugars"), protein, vitamin D, calcium, iron and potassium. Other vitamins and minerals become mandatory when they're added as a nutrient supplement or when a claim is made about them (21 CFR 101.9). Dietary supplements use a "Supplement Facts" panel under 21 CFR 101.36 instead, and the statement of identity includes "dietary supplement" (21 CFR 101.3).
Major food allergens
The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame (21 U.S.C. 321(qq)). The first eight came from FALCPA in 2004 and applied to food labeled from January 1, 2006. Sesame was added by the FASTER Act and became required on January 1, 2023.
Section 403(w) of the FD&C Act gives two ways to declare them (21 U.S.C. 343):
- the food source name in parentheses after the ingredient in the ingredient list, or
- a "Contains" statement immediately after or next to the ingredient list, in type no smaller than the list.
No repeat is needed when the ingredient's common name already names the source, as with "buttermilk". Name the specific type of tree nut and the species of fish or Crustacean shellfish. Highly refined oils are outside the definition. FDA's current reading of these rules is in its allergen labeling Q&A, Edition 5, finalized in January 2025. It's guidance, not binding law.
The FDA Food Labeling Guide
Guidance for Industry: A Food Labeling Guide was last revised in January 2013. It is not binding law (FDA). FDA flags Chapter 6 (allergens) and Chapter 7 (nutrition labeling) as under revision. Use the Edition 5 allergen guidance and the current 101.9 for those chapters. FDA doesn't pre-approve food labels.
Where the rules sit in 21 CFR
Food labeling is in Title 21, Chapter I, Subchapter B, "Food for Human Consumption":
| Part | Covers |
|---|---|
| 100 | General |
| 101 | Food labeling |
| 102 | Common or usual names for nonstandardized foods |
| 104 | Nutritional quality guidelines |
| 105 | Foods for special dietary use |
| 130 | Food standards, general |
| 131-169 | Standards of identity by commodity, from milk and cream to food dressings and flavorings |
Inside 21 CFR 101, Subpart A holds the general rules, including Nutrition Facts. Later subparts cover colors and flavors, dietary supplements, nutrient content claims such as "healthy", health claims, descriptive claims such as "fresh", and exemptions (eCFR Part 101). A food with a standard of identity in Parts 130-169 has to meet that standard to use the standardized name.
Exemptions and who regulates what
21 CFR 101.9(j) lists several Nutrition Facts exemptions. The small-business and low-volume rules do not waive the other label elements or allergen declarations.
The small-business rule covers firms with total annual gross sales of $500,000 or less, or food sales to consumers of $50,000 or less. Any nutrition claim or other nutrition information on the label ends the exemption.
The low-volume rule is for a firm with fewer than 100 full-time equivalent employees that sells fewer than 100,000 units of the product in the US a year. It needs an annual notice to FDA, except for a non-importer with fewer than 10 full-time equivalent employees selling fewer than 10,000 units (FDA, small business exemption).
Meat, poultry and processed egg products are a different system. USDA FSIS handles those labels and requires approval under 9 CFR 412.1, though many labels are generically approved without submission.
Recent and pending changes
- "Healthy" is still voluntary. The updated criteria, food-group amounts plus limits on saturated fat, sodium and added sugars, took effect April 28, 2025. Compliance is due February 25, 2028 (89 FR 106064; delay notice).
- Front-of-package nutrition labeling, a "Nutrition Info box" rating saturated fat, sodium and added sugars, was proposed on January 16, 2025 (90 FR 5426). It's still a proposal, not a requirement.
- FD&C Red No. 3 lost its food authorization on January 15, 2025. A stay was lifted on August 5, 2026, and the food deadline, including dietary supplements, remains January 15, 2027 (FDA).
- FDA announced a plan to revoke 52 standards of identity. Eleven canned fruit and vegetable standards were revoked on September 22, 2025 (90 FR 46348). Dairy and other proposals are not final (FDA announcement).
Common mistakes on US food labels
- Citing the former 21 CFR 101.105 for net quantity. It was renumbered 101.7 in 2016 (81 FR, Aug 29 2016), though FDA's 2013 guide still uses the old number.
- Dropping the metric figure because 101.7(p) says "may". The FPLA still requires both units on most packaged consumer foods.
- Working from the 2013 guide's allergen or nutrition chapters, which FDA says are out of date (FDA).
- Reading a small-business exemption as a pass for the whole label. It reaches Nutrition Facts only.
- Putting a standardized name, such as a cheese or jam term, on a food that doesn't meet its standard in Parts 130-169.
RegAffairs AI's answer on FDA food label requirements links to the relevant CFR sections. Before a label goes to print, check the amendment history eCFR shows for each section you rely on.