Core label requirements to check before U.S. sale

Federal label elements

1. Statement of identity: identify the product as a dietary supplement.
2. Net quantity of contents: state the amount in the package in the required location and format.
3. Supplement Facts: declare serving information and dietary ingredients under the applicable format rules.
4. Other ingredients: list ingredients not declared in Supplement Facts in descending order as applicable.
5. Business details: identify the manufacturer, packer, or distributor and place of business.
6. Claims and warnings: review express and implied claims, required disclaimers, allergens, and product-specific warnings.

Primary sources

• FDA dietary supplements overview
• 21 CFR 101.36 — nutrition labeling of dietary supplements
• FDA structure/function claims

Prepare a release-ready review packet

Collect the finished formulation with ingredient amounts and sources, serving instructions, container count or volume, package dimensions, allergen and safety evidence, manufacturing and distribution roles, and every claim-bearing asset. Include the label, carton, inserts, website, marketplace listing, images, testimonials, and directions. Review the final-size artwork rather than a list of copied fields.

• Assign one version to the formula, package, claims, and artwork.
• Record the source section and access date behind each material check.
• Leave uncertain classification, quantity, identity, or warning facts unresolved.
• Reopen the review after any ingredient, serving, package, claim, or business change.

Detailed labeling guides

Free tools