FDA Food Label Requirements
What does the FDA require on a food label?
Under 21 CFR Part 101, a packaged food label must carry five core elements: a statement of identity, the net quantity of contents, an ingredient list, the name and place of business of the manufacturer, packer or distributor, and a Nutrition Facts panel. It must also declare any major food allergens, which comes from the FD&C Act rather than Part 101. Where each item goes, and in what format, is also set by rule.
Approach: I read the current eCFR text of 21 CFR Part 101 (food labeling). The allergen rule comes from statute and isn't in the regulatory text I can search, so that part relies on search snippets from FDA's own allergen pages.
Where things go
- Principal display panel (PDP): the part of the label most likely to be seen at retail. It must be big enough to hold all its mandatory information clearly, and if a package has more than one PDP, the information is repeated on each [1].
- Information panel: the panel immediately next to the PDP, on its right [2]. The ingredient list, name and address, and nutrition labeling must be on either the PDP or the information panel [3].
- Information-panel content must sit together, with nothing else in between [4].
- Type size: must be prominent and conspicuous, and never under 1/16 inch unless an exemption applies [5].
- Language: everything required must be in English. If the label uses a foreign language anywhere, all required information must also appear in that language [6][7].
Mandatory elements
| Element | Key requirements |
|---|---|
| Statement of identity (§101.3) | Must be one of the main features of the PDP [8]. In bold type, sized in proportion to the most prominent text, and running parallel to the base of the package [9]. If the food comes in forms such as whole, sliced or diced, the form is part of the name [10]. A nutritionally inferior substitute must be labeled "imitation" [11]. |
| Net quantity of contents (§101.7) | On the PDP, by weight, measure or count. Liquids use fluid measure; solids, semisolids and viscous products use weight [12]. Weight is given in avoirdupois pounds and ounces [13]. Must be a separate item in the bottom 30% of the PDP (not required for PDPs of 5 sq in or less), with no exaggerating terms like "jumbo quart" [14]. A metric statement can be added [15]. |
| Ingredient list (§101.4) | Each ingredient by its common or usual name, in descending order by weight [16]. Ingredients at 2% or less can be grouped at the end after a statement such as "Contains 2 percent or less of…" [17]. Use specific names, not collective names, except where the rule allows [18]. |
| Colors, flavors, preservatives (§101.22) | Certified colors are declared by their listed name, e.g. "Blue 1 Lake" [19]. Chemical preservatives need their name plus their function, e.g. "preservative" [20]. Spices and flavors can be declared as "spice", "natural flavor" or "artificial flavor" [21]. |
| Name and place of business (§101.5) | The manufacturer, packer or distributor, shown conspicuously [22]. Corporations use their actual corporate name [23]. If you didn't make the product, qualify the name, e.g. "Distributed by" [24]. Give street address, city, state and ZIP; the street can be left out if it's in a current directory [25]. |
| Nutrition Facts (§101.9) | Required on all foods offered for sale unless a §101.9(j) exemption applies [26][27]. Amounts are per serving, where a serving is the amount usually eaten at one time, given in a household measure [28][29]. Nutrients must use the set names, order and format, and nothing outside the mandatory and voluntary lists can go in the panel [30]. |
Required nutrients in the Nutrition Facts panel:
- Calories [31]
- Total fat [32], saturated fat [33] and trans fat [34]
- Cholesterol [35]
- Sodium [36]
- Total carbohydrate [37] and dietary fiber [38]
- Total sugars [39], with added sugars shown as "Includes X g Added Sugars" [40]
- Protein [41]
- Vitamin D, calcium, iron and potassium. Other vitamins and minerals become mandatory when they are added or when a claim is made about them [42].
Several of these can be left off at very low levels, but then a "Not a significant source of…" statement is required at the bottom of the panel.
Allergens
FDA's pages say labels must declare the nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame has been required since January 1, 2023, under the FASTER Act. Allergens can be declared in three ways:
- by name in the ingredient list
- in brackets after an ingredient's name
- in a "Contains" statement next to the ingredient list, which must then list every allergen in the product.
FDA also expects sesame to be named even when it is part of "natural flavor" or "spice."
Exemptions and special cases
- Small packages: individual serving packages used in food service, with 3 sq in or less of label space, may use 1/32-inch type [43].
- No label at all: FDA can allow other ways of giving the information, such as inserts or information at the point of purchase [44].
- Dietary supplements: must say "dietary supplement" in the statement of identity [45] and use a Supplement Facts panel under §101.36.
Sources:
Where are those rules in the CFR?
Almost everything from my last answer is in Title 21, Part 101 (Food Labeling), mostly in Subpart A. The main sections are §101.1 to §101.5, §101.7, §101.9, §101.15 and §101.22. The allergen requirement is the one exception: it comes from the FD&C Act, not from Part 101.
Approach: I matched each point from the earlier answer to its section and paragraph in the current eCFR text of 21 CFR Part 101. The allergen statute isn't in the regulatory text I can search, so I can't give you its section number from these sources.
Layout and presentation
| Rule | Citation |
|---|---|
| Principal display panel | §101.1, "Principal display panel of package form food" [1] |
| Information panel defined (immediately to the right of the PDP) | §101.2(a) [2] |
| Ingredients, name/address and nutrition labeling go on the PDP or the information panel | §101.2(b) [3] |
| 1/16-inch minimum type size | §101.2(c) [5] |
| Small food-service packages may use 1/32-inch type | §101.2(c)(2)(iii) [43] |
| Information-panel content kept together, with nothing in between | §101.2(e) [4] |
| Packages with no label: other ways to give the information | §101.2(f) [44] |
| English required; foreign-language labels must repeat all required information | §101.15(c)(1) and (c)(2), "Food; prominence of required statements" [6][7] |
Mandatory elements
| Element | Citation |
|---|---|
| Statement of identity | §101.3: on the PDP (a) [8]; form of the food (c) [10]; bold type, size and placement (d) [9]; "imitation" (e) [11]; "dietary supplement" (g) [45] |
| Ingredient list | §101.4: descending order by weight (a)(1) [16]; "2 percent or less" grouping (a)(2) [17]; specific rather than collective names (b) [18] |
| Name and place of business | §101.5(a) to (d): conspicuous statement, corporate name, "Distributed by" qualifier, address [22][23][24][25] |
| Net quantity of contents | §101.7: weight, measure or count (a) [12]; avoirdupois units (b)(1) [13]; bottom 30% of the PDP and no exaggerating terms (f) [14]; optional metric statement (p) [15] |
| Nutrition Facts | §101.9: when it applies (a) [26]; serving size (b) and (b)(1) [28][29]; nutrient names, order and format (c) [30]; exemptions (j) [27] |
| Colors, flavors, preservatives | §101.22: spices and flavors (h)(1) [21]; chemical preservatives (j) [20]; certified colors (k)(1) [19] |
Required nutrients, within §101.9(c)
- (c)(1) Calories [31]
- (c)(2) Total fat [32]
- (c)(3) Cholesterol [35]
- (c)(4) Sodium [36]
- (c)(6) Total carbohydrate [37]
- (c)(7) Protein [41]
- (c)(8)(ii) Vitamins and minerals [42]
Related sections
- §101.36, "Nutrition labeling of dietary supplements": the Supplement Facts panel.
- §101.100, "Food; exemptions from labeling": the general labeling exemptions.
- §101.10: nutrition labeling of restaurant foods that carry nutrient content claims or health claims [46].
- Subpart E (§101.71, §101.72 and others): health claims [47][48].
- Subpart F, including §101.95: terms such as "fresh" [49].
Is there an FDA guide for food labeling?
Yes. FDA publishes "Guidance for Industry: A Food Labeling Guide." It summarises the statements that must appear on food labels under the FD&C Act and the Fair Packaging and Labeling Act, and it is set out as questions and answers on the issues FDA is asked about most often.
Approach: The regulatory datasets I can search hold the 21 CFR Part 101 text but not FDA's food guidance documents. Everything below comes from search snippets of FDA's own guidance pages.
About the guide (as FDA's listing describes it):
- History: first issued in September 1994 and revised several times. The latest revision listed is January 2013.
- Layout: chapters by labeling topic, with a table of contents. That matches the elements we covered earlier: statement of identity, net quantity, ingredients, name and place of business, nutrition labeling and allergens.
- Status: it is guidance, so it is not binding. The binding requirements are the Part 101 sections cited in my last answer. FDA also says it does not pre-approve food labels.
Parts of the guide that are out of date, according to FDA:
- Chapter 6 (food allergen labeling): under revision and not fully current. FDA points to its 2025 final guidance for industry on food allergens for the current requirements.
- Chapter 7 (nutrition labeling): under revision and not fully current. FDA says to use the Nutrition Facts label final rule (the current §101.9) when updating nutrition labels.
Related FDA resources that came up in the same search:
- A separate guidance, Food Labeling: Serving Sizes of Foods, which is useful for the §101.9(b) serving-size rules.
- FDA's "Labeling & Nutrition Guidance Documents & Regulatory Information" page, which lists FDA's labeling guidance documents by topic.
- FDA's industry resources page on the changes to the Nutrition Facts label.
Because the 2013 guide is stale on allergens and nutrition labeling, I can look up the 2025 allergen guidance next to confirm how it updates Chapter 6, if that would help.
Sources:
What are the major allergens that have to be declared?
FDA requires nine major food allergens to be declared: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. The first eight come from FALCPA (2004). The FASTER Act added sesame for foods entering interstate commerce on or after January 1, 2023.
Approach: I searched the current eCFR text of 21 CFR Parts 100–169. That text defines "food allergen" only by pointing to the FD&C Act and doesn't list the allergens itself. The list and the labeling rules below come from search snippets of FDA's own guidance and allergen pages.
Where the list sits legally
- Statute, not Part 101: FALCPA added the definition of "major food allergen" to section 201(qq) of the FD&C Act. Under section 403(w), a food that contains a major food allergen is misbranded if its label doesn't declare it by its common or usual name, including the name of the food source it comes from.
- How the CFR uses it: 21 CFR 117.3 defines "food allergen" as "a major food allergen as defined in section 201(qq)" of the FD&C Act [50]. That definition drives the allergen cross-contact and allergen-control rules in Part 117, for example §117.135(c)(2) [51] and §117.80(b)(8) [52]. Those are manufacturing (CGMP/preventive control) rules, not labeling rules.
The nine allergens
| # | Allergen | Source |
|---|---|---|
| 1–8 | Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans | FALCPA 2004 |
| 9 | Sesame | FASTER Act 2021, effective for foods in interstate commerce from January 1, 2023 |
How the declaration works
- If an ingredient's common or usual name already shows the allergen's food source, no further declaration is needed. FDA's example is "buttermilk," which identifies milk.
- Otherwise, the food source name must appear at least once on the label. As covered last time, that means either in parentheses after the ingredient name in the ingredient list, or in a "Contains" statement next to the list.
A related CFR provision
- 21 CFR 105.62: this one is about allergen claims, not the mandatory declaration. If a food is sold for special dietary use because an allergenic property has been reduced or removed, or as a substitute for an allergenic food, its label must carry extra information [53]. That includes a statement of the processing that changed the allergenic property [54].
FDA's detailed guidance on these rules is its Questions and Answers Regarding Food Allergen Labeling (Edition 5). I can go through what it says on specific points next, such as tree nut species or how to name fish and crustacean species.
Sources: