The complete guide to FDA-compliant supplement labels in 2026

If you sell dietary supplements in the United States, your labels are governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA), updated and enforced by the FDA. The rules are detailed but not arbitrary — most exist to protect consumers from misleading claims and undisclosed ingredients.

This guide covers what your label must include, what it can't say, and the most common mistakes that get small brands a warning letter.

Required elements on every label

Every dietary supplement sold in the US must include five things on its label:

1. A statement of identity (e.g. "Ashwagandha Capsules" or "Vitamin D3 Dietary Supplement").
2. A net quantity of contents declaration (count, weight, or volume).
3. A nutrition labeling panel — formally called the Supplement Facts panel.
4. An ingredient list, including all "Other Ingredients" used in manufacturing.
5. The name and place of business of the manufacturer, packer, or distributor.

The Supplement Facts panel

This is the most regulated part of the label. The format is prescribed in 21 CFR 101.36 and includes serving size, servings per container, each nutrient with its quantity per serving, and the percent Daily Value where one has been established.

Proprietary blends are allowed but the total weight must be disclosed. Ingredients within the blend are listed in descending order by weight without specifying individual quantities. This is legal but increasingly distrusted by informed consumers.

What you can and can't claim

Claims are where most merchants get into trouble. Three claim categories are permitted:

• Health claims — describe a relationship between a substance and a disease (requires FDA pre-approval).
• Nutrient content claims — characterize the level of a nutrient ("high in", "good source of") and follow strict definitions.
• Structure/function claims — describe how a nutrient affects normal body structure or function ("supports healthy immune function"). These do not require pre-approval but require the 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."

Claims about diagnosing, treating, curing, or preventing disease are reserved for drugs and will get your product reclassified. "Reduces inflammation" is borderline. "Treats arthritis" is illegal.

Most common compliance mistakes

• Disease claims dressed up as structure/function claims. The FDA pays attention to your full marketing context — your label, your website, your ads.
• Missing or hidden disclaimer. The structure/function disclaimer must be on the label or labeling, in close proximity to the claim, in a prominent type size.
• Inaccurate Supplement Facts. The FDA tests products. Mislabeled potency is a frequent source of warning letters.
• Allergen disclosure failures. The Big 9 allergens (now including sesame as of 2023) must be disclosed if present.

State-level rules to know

California Prop 65 affects any product sold to California residents. The required warning depends on what's in your product and is enforced by private bounty hunters as well as the state.

New York has had a more aggressive supplement enforcement posture since 2015. Several large retailers were forced to remove products that didn't match label claims.

When to bring in a regulatory consultant

If you're selling at meaningful volume (say, more than $50K/month) or making any claims that approach disease territory, hire a regulatory consultant for a label review. The cost is a few hundred dollars and may save you a warning letter that costs tens of thousands.

For most merchants launching their first product, the auto-generated labels in Productifi handle the baseline requirements. But the legal responsibility for your label always rests with you, the marketer of record.