Supplement Packaging and Label Compliance Checklist

Last reviewed: April 10, 2026 | Next review: October 1, 2026

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 leads 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

Every dietary supplement sold in the United States must include these elements under 21 CFR Part 101 (§§101.3, 101.105, 101.36, 101.4, 101.5) and the Dietary Supplement Health and Education Act (DSHEA). FDA requires a Supplement Facts panel (not Nutrition Facts) with specific formatting rules. Getting it wrong leads 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

Every dietary supplement sold in the United States must include these elements under 21 CFR Part 101 (statement of identity, §101.3; net quantity, §101.105; Supplement Facts panel, §101.36; ingredient list, §101.4; business name and address, §101.5) and the Dietary Supplement Health and Education Act (DSHEA). 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 term 'dietary supplement' must appear on the principal display panel along with the product name. The type of supplement should be identified (e.g., 'Vitamin D3 Dietary Supplement').

Net quantity of contents

The count of capsules, tablets, or gummies, or the net weight for powders and liquids. Must appear on the principal display panel in both metric and US customary units where applicable.

Supplement Facts panel

Lists all dietary ingredients with amounts per serving, percent daily value (%DV) where established, serving size, and servings per container. Must follow the FDA's specific formatting requirements for fonts, lines, and layout.

Other ingredients list

Non-active ingredients (fillers, binders, coatings, flavors) listed in descending order of predominance by weight. Appears below the Supplement Facts panel.

Manufacturer/distributor information

Name and place of business (city, state, ZIP) of the manufacturer, packer, or distributor. If the label names a distributor rather than the manufacturer, it must include 'manufactured for' or 'distributed by' language.

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 is one of the most common areas where brands get into trouble. There are three categories of claims, each with different rules.

Claim Type	Example	FDA Requirement	Risk
Structure/function	"Supports bone health"	Disclaimer + 30-day FDA notification after first use	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"	FDA pre-authorization required (limited approved claims)	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. Words like "treats," "cures," "prevents," or naming specific diseases turn a structure/function claim into a prohibited disease claim. "Supports joint comfort" is acceptable. "Treats arthritis pain" is not.
Incorrect Supplement Facts formatting. The FDA specifies exact formatting: 8-point type minimum, specific line weights, hairline rules between ingredients. Many printers and designers are unfamiliar with these requirements and use standard nutrition label formatting instead.
Missing allergen declarations. Major allergens used as intentional ingredients must be declared in the ingredient list or a Contains statement under FALCPA. The FASTER Act added sesame as the ninth major allergen effective January 1, 2023, so labels created before then may need updating. Cross-contact warnings like 'may contain' are voluntary under FDA guidance and are not a substitute for the required ingredient declarations.
Proprietary blend without total weight. Proprietary blends must list the total combined weight and individual ingredients in descending order of predominance. Listing ingredients without the total blend weight violates FDA requirements.
Using %DV for ingredients without an established daily value. Ingredients like turmeric, ashwagandha, and many botanicals have no FDA-established daily value. These should show a dagger symbol with "Daily Value not established" rather than a percentage.

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): Products that expose California consumers to chemicals on the Proposition 65list above the state's safe-harbor exposure levels must carry a specific warning. Merely containing a listed substance does not automatically trigger the warning; the exposure level does. In practice this catches some common supplement realities, like lead occurring naturally in botanicals, because Prop 65's lead limit is far stricter than FDA's.
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 a Supreme Court petition followed in 2026). Retailers must verify age at the point of sale, and online orders shipped into New York require an adult signature at delivery. If your product is marketed for weight loss or muscle building, build age verification into your New York retail and shipping flows.
Utah: A major supplement-manufacturing hub with a dense cluster of facilities, so FDA inspection activity there is comparatively high. If your manufacturer is Utah-based, ask about their most recent FDA inspection history.
Other states: State requirements vary and change: some states restrict specific ingredients or product categories, and in-state manufacturing facilities typically need state food-establishment licenses. 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" appears 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

Dagger and "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, city, state, ZIP included

Net quantity of contents on principal display panel

Adequate 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?

The FDA requires five core label elements on every dietary supplement: (1) statement of identity (§101.3), (2) net quantity of contents (§101.105), (3) Supplement Facts panel listing all ingredients and amounts (§101.36), (4) ingredient list for non-active ingredients (§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). 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 Dietary Supplement and Nonprescription Drug Consumer Protection Act requires a domestic address or phone number for adverse event reporting on the label.

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 and require FDA authorization (e.g., 'calcium may reduce the risk of osteoporosis'). 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 treat 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, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Allergens must be declared in the ingredient list or in a separate 'Contains' statement. Cross-contact allergen labeling (e.g., 'may contain' or 'manufactured in a facility that processes') is currently voluntary under FDA guidance. However, including cross-contact warnings is considered best practice and may be required by retailers, especially Amazon.

What are common FDA warning letter triggers for supplement labels?

The most common triggers are: (1) disease claims disguised as structure/function claims (using words like 'treats,' 'cures,' 'prevents,' or naming specific diseases), (2) missing or incorrect Supplement Facts panel formatting (21 CFR 101.36), (3) drug-style presentation, such as 'Dosage:' labeling in place of serving-size guidance, which can support a misbranding or unapproved-drug finding when combined with drug-type claims, (4) failing to include the required structure/function claim disclaimer (21 CFR 101.93), and (5) not listing all ingredients or listing them in the wrong order (21 CFR 101.4). The FDA regularly issues warning letters for labeling violations.

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.