What must be on a dietary supplement label in the US?

A dietary supplement sold in the United States must carry a statement of identity that includes "dietary supplement" (21 CFR 101.3(g)), the net quantity of contents, a Supplement Facts panel formatted under 21 CFR 101.36, an ingredient list for anything not declared in the panel (21 CFR 101.4(g)), the name and place of business of the responsible firm, and a domestic address or phone number for serious adverse event reports (FD&C Act § 403(y)). Botanicals must name the part of the plant, any structure/function claim needs FDA's boldface disclaimer (21 CFR 101.93), and the nine major food allergens must be declared (FD&C Act § 403(w)).

Why supplements are a separate regime

Under FD&C Act § 201(ff), a dietary supplement is deemed to be a food, but it does not follow the Nutrition Facts rules. 21 CFR 101.9(j)(6) exempts supplements from 101.9 and requires them to be labeled under 21 CFR 101.36 instead.

A supplement label is therefore a third regime, with its own panel, nutrient rules and ingredient-list heading. The statute adds supplement-specific provisions in FD&C Act § 403(s), § 403(r)(6) and § 403(y).

Supplement label checklist

The panel, the ingredient list and the name and place of business go on the principal display panel or the information panel (21 CFR 101.2(b); 101.36(g)). A "Contains" statement goes immediately after or next to the ingredient list (FD&C Act § 403(w)(1)(A)).

The Supplement Facts panel

Title and format

The title "Supplement Facts" is set larger than all other print in the panel and, unless impractical, runs its full width. The title and all headings are bold (21 CFR 101.36(e)(1)).

The panel is boxed with hairlines and, under 101.36(e)(2)–(3), uses:

• one easy-to-read type style;
• black or one-color type on a white or neutral background where practical;
• upper- and lowercase letters, with all capitals allowed only below 12 square inches;
• at least one point of leading, and letters that do not touch.

Body text is at least 8 point, and column headings and footnotes at least 6 point (101.36(e)(4)). Small packages have lower minimums: 4.5 point below 12 square inches, and 6 point from 12 to 40 square inches, or 4.5 point when an intermediate package lists many ingredients (more than 8 below 20 square inches; more than 16 at 20 to 40 square inches) (101.36(i)(2)).

Serving size

"Serving Size" sits directly under the title. It is expressed in a unit suited to the form, such as "tablets", "capsules" or "packets" (21 CFR 101.36(b)(1)(i)).

The amount comes from 21 CFR 101.12(b), Table 2. It is the maximum amount the label recommends per eating occasion or, if the label makes no recommendation, one unit. "Servings Per Container" follows unless the net quantity already states it (101.36(b)(1)(ii)).

Dietary ingredients with a Daily Value

Fifteen items are declared when present above the amounts that 101.9(c) allows to be declared as zero: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron and potassium (21 CFR 101.36(b)(2)(i)).

Further rules:

• Order. Vitamins and minerals follow the sequence in 101.36(b)(2)(i)(B).
• Nutrient, not source. The amount is the weight of calcium, not of calcium carbonate (101.36(b)(2)(ii)).
• Units. Vitamin D is declared in mcg, and IU may follow in parentheses (101.36(b)(2)(ii)(B)). Folate is declared in mcg DFE (21 CFR 101.9(c)(8)(vii)).
• Footnote. A % Daily Value declared for total fat, saturated fat, total carbohydrate, dietary fiber, protein or added sugars needs the footnote "Percent Daily Values are based on a 2,000 calorie diet." (101.36(b)(2)(iii)(D)).

Ingredients without a Daily Value: the † convention

"Other dietary ingredients", such as botanicals and amino acids, are declared by their common or usual name, with a metric amount per serving. The amount is the weight of the ingredient itself (21 CFR 101.36(b)(3)(i)–(ii)).

Each one carries a symbol in the % Daily Value column. The symbol leads to the footnote "Daily Value not established" (101.36(b)(3)(iv)). The regulation's example is an asterisk. Many labels use a dagger (†) instead, because an asterisk is commonly used for the 2,000-calorie footnote.

An extract that still contains its solvent is declared by the volume or weight of the total extract. One with the solvent removed is declared by the weight of the dried extract (101.36(b)(3)(ii)(B)–(C)).

Proprietary blends

A blend is labeled "Proprietary Blend" or given another descriptive or fanciful name (21 CFR 101.36(c)). Three rules apply:

• Blend ingredients that have a Daily Value are still declared individually (101.36(c)(1)).
• The others are indented beneath the blend name, in descending order by weight (101.36(c)(2)).
• The blend line shows the total weight of those other ingredients, with the "Daily Value not established" symbol (101.36(c)(3)).

Individual weights of those ingredients are not required (FD&C Act § 403(s)(2)(A)(ii)(II)).

Source ingredients and botanicals

A source may be named in the panel with "as" or "from", for example "Calcium (as calcium carbonate)". A source named this way need not be repeated in the ingredient list. Any source the panel does not name goes into that list (21 CFR 101.36(d)).

Under 21 CFR 101.4(h), applied through 101.36(d)(1), a botanical (including fungi and algae) is named:

• consistently with Herbs of Commerce, 1992 edition;
• with the part of the plant in English, for example "Garlic (bulb)" (not required for algae);
• with the Latin binomial in parentheses, unless Herbs of Commerce covers the common name used.

A supplement is misbranded if the label fails to identify any part of the plant from which a botanical is derived (FD&C Act § 403(s)(2)(C)).

The statement of identity

The principal display panel must include "dietary supplement" in the statement of identity (21 CFR 101.3(g)). "Dietary" may be replaced by the ingredient name ("calcium supplement") or a descriptive term ("herbal supplement with vitamins").

A brand name alone does not qualify. The statement is in bold type, sized in reasonable relation to the most prominent print on the panel (101.3(d)).

The "Other ingredients" list

The ingredient list sits immediately below the panel. Where space is insufficient, it sits immediately to the right of the panel (21 CFR 101.4(g)).

It is headed "Ingredients", or "Other ingredients" when some sources are already named in the panel. It must include excipients, fillers, artificial colors, artificial sweeteners, flavors and binders, in descending order of predominance (101.4(a)(1), (g)).

Structure/function claims and the disclaimer

A structure/function claim describes how a nutrient or dietary ingredient affects the structure or function of the body (21 CFR 101.93(f)). A claim to diagnose, treat, cure, mitigate or prevent disease is a disease claim under 101.93(g). It makes the product subject to regulation as a drug, unless it is an authorized health claim.

The disclaimer for one claim reads (21 CFR 101.93(c)(1)):

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

With several claims, the plural "These statements have not been evaluated…" may be used (101.93(c)(2)).

The 30-day notification

The manufacturer, packer or distributor must notify FDA no later than 30 days after first marketing a supplement that carries the claim (21 CFR 101.93(a)(1); FD&C Act § 403(r)(6)).

The notice gives the firm, the claim text, the ingredient and the product name. A responsible individual signs it and certifies that the firm has substantiation (101.93(a)(2)–(3)). FDA accepts it electronically, through the Centralized Online Submission Module (COSM), or on paper by mail (an original and two copies, under 101.93(a)(1)). It is a filing, not a label element.

The domestic adverse-event contact

A supplement is misbranded unless its label includes a domestic address or domestic phone number through which the responsible person can receive serious adverse event reports (FD&C Act § 403(y)).

FDA's 2009 guidance on this requirement spells it out:

• The address must be a full US mailing address: street address or P.O. box, city, state and ZIP code.
• The phone number must include its area code.
• An email address or website may appear only in addition to the address or phone number. A website alone is not enough.

Cosmetics differ: under MoCRA, a website can serve as the contact.

The 403(y) contact is also separate from the name and place of business under 21 CFR 101.5. An imported supplement can show its foreign manufacturer under 101.5. It still needs a US address or US phone number, usually the US distributor's.

Allergens

According to FDA, FALCPA's allergen labeling applies to dietary supplements. The nine major food allergens are milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame (FD&C Act § 201(qq)). Sesame applies to food introduced into interstate commerce on or after 1 January 2023.

They are declared in a "Contains" statement immediately after or adjacent to the ingredient list (or, if there is none, the Supplement Facts panel), or in parentheses in the ingredient list or within the Supplement Facts panel (FD&C Act § 403(w)(1); FDA allergen guidance, Edition 5, E.1–E.7). A "Contains" statement, if used, must name every major allergen. For fish, Crustacean shellfish and tree nuts, the species or nut must be named, so a fish oil from anchovy that is not exempt as a highly refined oil declares "anchovy" (403(w)(2); 201(qq)(2)(A)).

Common mistakes

How RegaaS checks this

RegaaS treats 21 CFR 101.36 as its own regime. On a supplement label it checks:

• whether a Supplement Facts panel is used in place of Nutrition Facts;
• the separate basis for the ingredient declaration;
• "supplement" in the statement of identity;
• whether botanicals name the plant part;
• the structure/function disclaimer, including its placement, framing and type size;
• the domestic address or phone number for adverse events, where a website alone is not enough.

It also applies Part 101 (name and place of business, net quantity, claims) and FD&C Act § 403(w) on allergens. Each finding cites its provision, is marked on the label image and comes with suggested 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 these as out of scope:

• advertising substantiation under FTC jurisdiction;
• new dietary ingredient (NDI) notifications;
• current good manufacturing practice under 21 CFR Part 111;
• state rules such as California Proposition 65;
• OTC drugs;
• EU food supplements, Great Britain and Switzerland.

The 30-day claim notification, a claim's substantiation, and lab verification of declared amounts (21 CFR 101.36(f)) cannot be confirmed from a label.

Frequently asked questions

Which regulation sets Supplement Facts panel requirements? 21 CFR 101.36. Under 101.9(j)(6), supplements are exempt from the Nutrition Facts rules and are labeled under 101.36 instead.

What is the exact structure/function claim disclaimer? "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." It must be in bold type, at least 1/16 inch high (21 CFR 101.93(c), (e)).

Do I have to notify FDA about a structure/function claim? Yes, no later than 30 days after first marketing the product with the claim (21 CFR 101.93(a)(1)).

Is a website enough for the adverse-event contact? No. FD&C Act § 403(y) requires a domestic address or domestic phone number, and FDA's guidance allows a website only in addition to one of them.

Must botanicals name the part of the plant? Yes, in English, for example "Garlic (bulb)". Algae are the only exception (21 CFR 101.4(h)(1)).

What does "†Daily Value not established" mean? It marks ingredients with no RDI or DRV. 21 CFR 101.36(b)(3)(iv) requires a symbol and that statement, and the dagger (†) is a common choice of symbol.

Primary sources

• 21 CFR 101.36 (eCFR)
• 21 CFR 101.3 (eCFR)
• 21 CFR 101.4 (eCFR)
• 21 CFR 101.93 (eCFR)
• 21 CFR 101.2, 101.5, 101.7, 101.9 and 101.12 (eCFR, Part 101)
• 21 U.S.C. 343, FD&C Act § 403 (govinfo)
• 21 U.S.C. 321, FD&C Act § 201 (govinfo)
• FDA guidance: labeling of dietary supplements under the DSNDCPA
• FDA: structure/function claim notifications
• FDA: food allergies
• FDA Letter to Industry on the DSHEA disclaimer (11 December 2025)
• FDA guidance: questions and answers on food allergens, Edition 5 (January 2025)

A RegaaS report is a documented review against the provisions above. It is not legal advice, and it does not replace sign-off by a qualified regulatory professional.