Supplement Packaging and Label Compliance Checklist

Recorded sources last checked between October 1, 2026 and October 5, 2026. 26 of 37 recorded claims have no open issue recorded. Source check due January 1, 2027.

By Greg Huang, founder since 2009 in the dietary supplement and nutrition industry

Reviewed by Dr. James Pendleton, ND, licensed primary care physician, 20+ years in naturopathic medicine

Your supplement label is a regulated document. Getting it wrong can lead to FDA warning letters, retail rejection, and product recalls. This guide covers what the FDA requires, what to watch for, and the most common mistakes brands make.

The short answer

A dietary supplement sold in the United States generally needs five core label elements under 21 CFR Part 101 (§§101.3, 101.7, 101.36, 101.4, 101.5) and the Dietary Supplement Health and Education Act (DSHEA), with narrow exceptions: no separate ingredient list when every ingredient is declared in the Supplement Facts panel, and a Supplement Facts exemption for some small businesses and low-volume products. FDA requires a Supplement Facts panel (not Nutrition Facts) with specific formatting rules. Getting it wrong can lead to FDA warning letters, retail rejection, and product recalls.

Dietary supplement manufacturers must comply with 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements). This includes requirements for personnel, facilities, equipment, production, laboratory operations, and record-keeping.

Required Label Elements

A dietary supplement sold in the United States must generally include these elements under 21 CFR Part 101 (statement of identity, §101.3; net quantity, §101.7; Supplement Facts panel, §101.36; ingredient list, §101.4; business name and address, §101.5) and the Dietary Supplement Health and Education Act (DSHEA), with two exceptions: no separate ingredient list is needed when every ingredient is declared in the Supplement Facts panel (§101.4(a)(1)), and some small businesses and low-volume products are exempt from the Supplement Facts panel if they meet the conditions in §101.36(h), which include a label that gives no nutrition information and makes no nutrient content or health claim. Directions for use appear in the table below as a customary element: FDA rules do not expressly mandate them, but serving directions drive the Supplement Facts serving size.

Statement of identity

The statement of identity on the principal display panel must include the term 'dietary supplement', though the word 'dietary' may be replaced by the name of the dietary ingredients (e.g., 'calcium supplement') or a term describing the type of ingredients (e.g., 'herbal supplement with vitamins'), per 21 CFR 101.3(g).

Net quantity of contents

The count of capsules, tablets, or gummies, the net weight for powders, or the fluid measure for liquids (21 CFR 101.7(a)). It goes on the principal display panel, and a weight or measure must be stated in both metric and US customary units (15 U.S.C. 1453(a)(2)), except that the metric statement is optional on random-weight packages and not required for foods packaged at the retail store level (1453(a)(3)(A)(ii) and (a)(6)).

Supplement Facts panel

Lists the dietary ingredients with amounts per serving, percent Daily Value (%DV) where one is established, serving size, and servings per container (which may be left off when the net quantity statement already gives it). Must follow the formatting rules in 21 CFR 101.36(e): a single easy-to-read type style, minimum type sizes, hairlines, and a prescribed layout.

Other ingredients list

Every ingredient not already declared in the Supplement Facts panel, in descending order of predominance by weight: source ingredients the panel does not name, and ingredients that are not dietary ingredients, such as excipients, fillers, binders, flavors, and artificial colors (21 CFR 101.4(a)(1) and (g); 21 CFR 101.36(d)). It goes immediately below the Supplement Facts panel, or to its right if there is not enough room below, and is headed 'Other ingredients' when some sources are named in the panel.

Manufacturer/distributor information

Name and place of business of the manufacturer, packer, or distributor: street address, city, state, and ZIP code, though the street address may be left off if it is listed in a current city or telephone directory (21 CFR 101.5(d)). If the firm named did not make the product, its name must be qualified by a phrase showing the connection, such as 'Manufactured for' or 'Distributed by' (21 CFR 101.5(c)).

Directions for use (customary, not expressly required)

Suggested serving size and how to take the product. No FDA rule expressly mandates directions on supplements, but they are functionally necessary because they determine the serving size used in Supplement Facts. Avoid drug-like dosage language. Say 'Take one capsule daily with food' rather than 'Dosage: 1 capsule twice daily.'

Understanding Claims

What you can and cannot say on your label depends on the type of claim. FDA groups label claims into three categories (health claims, nutrient content claims, and structure/function claims), each with different rules, and a supplement may not make a disease claim.

Claim Type	Example	FDA Requirement	Risk
Structure/function	"Supports bone health"	Disclaimer + FDA notification within 30 days of first marketing	Low (if done correctly)
Nutrient content	"High in calcium"	Must meet FDA-defined thresholds (21 CFR 101.54)	Medium
Health claim	"May reduce risk of osteoporosis"	An FDA authorizing regulation, or an FDA enforcement-discretion letter for a qualified claim	High (most brands should avoid)
Disease claim (prohibited)	"Treats arthritis" or "Cures insomnia"	Not permitted for supplements	Warning letter or product seizure

Required disclaimer for structure/function claims: “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.”

Common Labeling Mistakes

Disease claims disguised as structure/function claims. A statement that the product diagnoses, mitigates, treats, cures, or prevents a specific disease, or affects its characteristic signs or symptoms, is a disease claim rather than a structure/function claim (21 CFR 101.93(g)). "Treats arthritis pain" is a disease claim.
Incorrect Supplement Facts formatting. 21 CFR 101.36(e) sets the formatting, and the type-size rule is narrower than it sounds: information other than the title, headings, and footnotes must be no smaller than 8 point, while column headings and footnotes may be as small as 6 point, and small and intermediate-sized packages have their own separate provisions. The panel must also use a single easy-to-read type style, be enclosed in a box by hairlines, and carry a hairline rule between each listed dietary ingredient.
Missing allergen declarations. Major allergens used as intentional ingredients must be declared under FALCPA; on a supplement that can be within the Supplement Facts panel (FDA's example is 'bovine colostrum (milk)'), in the ingredient list, or in a 'Contains' statement. The FASTER Act added sesame as the ninth major allergen effective January 1, 2023, so labels created before then may need updating. Advisory statements like 'may contain' are not required by law; FDA says they must be truthful and not misleading and are not a substitute for following current good manufacturing practices.
Proprietary blend without total weight. A proprietary blend must show the total weight of its other dietary ingredients on the same line as the blend name, with those ingredients listed beneath it in descending order of predominance by weight; vitamins and minerals in the blend are still declared with their own amounts (21 CFR 101.36(c)). Listing the ingredients without the blend's total weight does not meet that rule.
Using %DV for ingredients without an established daily value. Ingredients like turmeric, ashwagandha, and many botanicals have no FDA-established daily value. In place of a percentage, they take a symbol (the regulation's example is an asterisk) that refers to the footnote "Daily Value not established": in the % Daily Value column, or, when the panel has no "% Daily Value" heading, right after each ingredient's amount (21 CFR 101.36(b)(3)(iv)).

State-Level Requirements

Federal FDA requirements are the baseline. Several states add their own rules that apply if you sell or distribute in those states.

California (Prop 65): A business may not knowingly and intentionally expose anyone to a chemical on the Proposition 65 list without first giving a clear and reasonable warning (Health and Safety Code 25249.6). The statute does not count a business employing fewer than 10 employees as a person "in the course of doing business," so the rule does not apply to it (25249.11(b)). The warning is also not required for an exposure the business can show poses no significant risk (cancer-causing chemicals) or has no observable effect at 1,000 times the level (reproductive toxicants), and the business carries that burden (25249.10(c)). So the exposure level matters, not merely whether a listed substance is present. Lead is on the list, and the level the regulations set for it as a reproductive toxicant is 0.5 micrograms per day (27 CCR 25805).
New York: Bans selling over-the-counter diet pills and dietary supplements marketed for weight loss or muscle building to anyone under 18 (NY General Business Law Section 391-oo, effective April 2024; the Second Circuit affirmed the denial of a preliminary injunction against it on November 13, 2025, and the U.S. Supreme Court denied a petition to review that ruling on October 5, 2026). The law's definition "shall not include protein powders, protein drinks and foods marketed as containing protein" unless the product contains another ingredient that, considered alone, would make it a dietary supplement for weight loss or muscle building (391-oo(1)(a)). The statute sets separate age-verification rules for in-store sales and for orders that are mailed or shipped. If your product falls within that definition, build age verification into your New York retail and shipping flows.
Other states: State requirements vary and change. California enacted a similar under-18 sales restriction on September 28, 2026 (AB 2030, Chapter 720, Statutes of 2026), which takes effect January 1, 2027. Verify current requirements with the food and drug authority in each state where you manufacture or sell.

Pre-Print Review Checklist

Before sending your label to print, verify each of these items. Reprinting labels after a compliance issue is expensive and delays your launch.

"Dietary supplement" (or, e.g., "calcium supplement") appears in the statement of identity on the principal display panel

Supplement Facts panel follows 21 CFR 101.36 formatting

All dietary ingredients listed with amounts per serving

%DV shown for ingredients with established daily values

A symbol and the footnote "Daily Value not established" for others

Other ingredients listed in descending order by weight

Allergen declarations present and complete (including sesame)

Structure/function claims include required disclaimer

No disease claims anywhere on label or packaging

Manufacturer/distributor name and place of business (street address unless listed in a directory, city, state, ZIP)

Domestic address or phone number for serious adverse event reports

Net quantity of contents on principal display panel

Directions for use

Lot number and expiration date placement designated

Barcode (UPC) present if selling through retail

Prop 65 warning if selling in California (if applicable)

Check the claims on your label

Panel formatting is only half of label compliance; the claims on the front are the other half. Our free substantiation checker flags claim phrasings that tend to draw FDA and FTC attention. Try the substantiation check →

Frequently Asked Questions

What is required on a dietary supplement label?

FDA requires five core label elements on dietary supplements, subject to two exceptions noted below: (1) statement of identity (§101.3), (2) net quantity of contents (§101.7), (3) Supplement Facts panel listing the dietary ingredients and their amounts (§101.36), (4) ingredient list for ingredients not already declared in the Supplement Facts panel (§101.4), and (5) name and place of business of the manufacturer, packer, or distributor (§101.5). These requirements come from 21 CFR Part 101 and the Dietary Supplement Health and Education Act (DSHEA). The exceptions: no separate ingredient list is needed when every ingredient is declared in the Supplement Facts panel (§101.4(a)(1)), and some small businesses and low-volume products are exempt from the Supplement Facts panel under the conditions in §101.36(h), which include a label that gives no nutrition information and makes no nutrient content or health claim. Directions for use are not explicitly mandated by rule but are customary and functionally important because they determine the serving size used in Supplement Facts. Additionally, the label must include a domestic address or domestic phone number through which the responsible person can receive reports of serious adverse events (21 U.S.C. 343(y), added by the Dietary Supplement and Nonprescription Drug Consumer Protection Act).

What is the difference between a health claim and a structure/function claim?

Health claims describe a relationship between a substance and a disease or health condition (e.g., 'calcium may reduce the risk of osteoporosis'). On a dietary supplement, a health claim must be authorized by an FDA regulation or, for a qualified health claim, covered by an FDA letter of enforcement discretion; FDA says the notification route for claims based on authoritative statements cannot be used for dietary supplements. Structure/function claims describe how a nutrient affects the body's structure or function without referencing disease (e.g., 'supports bone health'). Structure/function claims require a disclaimer stating the claim has not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease. You must also notify the FDA within 30 days of first marketing with a structure/function claim (21 CFR 101.93(a)).

Do supplement labels need to list allergens?

Yes, for intentional ingredients. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA) and the FASTER Act, supplements must declare the presence of major allergens used as intentional ingredients: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. On a supplement, an allergen can be declared within the Supplement Facts panel, in the ingredient list, or in a separate 'Contains' statement. FDA says no separate 'Contains' statement is needed when every major allergen is declared in the panel or the ingredient list, but a 'Contains' statement that is used must list them all. Advisory statements such as 'may contain' or 'produced in a facility that also uses' are not required by law; FDA says they must be truthful and not misleading and are not a substitute for following current good manufacturing practices.

Which supplement label mistakes break FDA rules?

Five to check for: (1) disease claims, meaning statements that the product diagnoses, mitigates, treats, cures, or prevents a specific disease or its characteristic signs or symptoms (21 CFR 101.93(g)); unless it is an authorized health claim the product qualifies for, a product whose label makes one is subject to regulation as a drug (21 CFR 101.93(f)), (2) a Supplement Facts panel that does not follow 21 CFR 101.36, (3) a structure/function claim without the required disclaimer (21 CFR 101.93(c)), (4) ingredients missing from the ingredient list or listed out of order (21 CFR 101.4), and (5) a major food allergen that is not declared (21 U.S.C. 343(w)).

Greg Huang, founder since 2009 in the dietary supplement and nutrition industry

Founder of Inventory Ready. Previously founded and operated multiple consumer brands in the dietary supplement and nutrition industry since summer 2009.

Concepts Covered

Supplement Packaging Structure/Function Claims Proposition 65 (California)DSHEA (Dietary Supplement Health and Education Act)

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Disclaimer: This guide is educational content, not legal or regulatory advice. Label compliance decisions should involve a qualified regulatory consultant or attorney. FDA regulations change; always verify current requirements at FDA.gov. See our Terms of Service for details.

Primary sources

The sourced claims in this guide are grounded in the following primary references. The guide's source manifest maps each claim to its source and verification date.