Does FDA approve dietary supplements before sale?

No. Supplements are not approved before marketing. The responsibility sits with the firm to ensure the product is safe, properly labeled and lawfully claimed — which is why the consequences arrive after launch rather than before it.

What makes a claim a drug claim?

Language that names a disease or implies treatment, prevention or cure of one. The line is about what the claim asserts, not how carefully it is phrased.

Do we need to register our manufacturing facility?

Facilities manufacturing, processing, packing or holding food, including supplements, for U.S. consumption generally register with FDA and renew on a schedule. Foreign facilities also need a U.S. agent on file.

Is this legal advice?

No. These guides are educational and reflect how the requirements work in practice. Specific products and claims should be reviewed by qualified regulatory counsel, and we work alongside counsel rather than in place of it.

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FDA compliance.

Registration, labeling, claims and imports for supplements, food, beverage and personal care entering the United States — the work that decides whether a container clears or sits.

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The pillar

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Pillar guide · 16 min · Updated Aug 2026

FDA compliance

Registration, the U.S. agent requirement, panel construction, claims classification, prior notice and the import pathway, for each of the main product categories.

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Questions

Frequently asked.

Does FDA approve dietary supplements before sale?: No. Supplements are not approved before marketing. The responsibility sits with the firm to ensure the product is safe, properly labeled and lawfully claimed — which is why the consequences arrive after launch rather than before it.
What makes a claim a drug claim?: Language that names a disease or implies treatment, prevention or cure of one. The line is about what the claim asserts, not how carefully it is phrased.
Do we need to register our manufacturing facility?: Facilities manufacturing, processing, packing or holding food, including supplements, for U.S. consumption generally register with FDA and renew on a schedule. Foreign facilities also need a U.S. agent on file.
Is this legal advice?: No. These guides are educational and reflect how the requirements work in practice. Specific products and claims should be reviewed by qualified regulatory counsel, and we work alongside counsel rather than in place of it.

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