Question 1

Does FDA approve dietary supplements?

Accepted Answer

No. There is no FDA pre-approval for supplements. But facilities must register, labels must comply, claims must be substantiated and notified, and genuinely new dietary ingredients may require an NDI notification before you can sell.

Question 2

Do supplement facilities have to renew registration?

Accepted Answer

Yes, biennially, between 1 October and 31 December of every even-numbered year. 2026 is a renewal year. An unrenewed registration is treated as expired at 11:59pm on 31 December.

Question 3

What claims can I make on the label?

Accepted Answer

Structure-function claims are permitted with the DSHEA disclaimer, and must be notified to FDA within 30 days of first marketing the claim under 21 CFR 101.93. Claims that a product treats, cures or prevents a disease are drug claims and are not permitted on a supplement.

Question 4

Who needs an FSVP?

Accepted Answer

The U.S. importer of record for foreign-made supplements. It is a separate obligation from your U.S. Agent appointment: different party, different rulebook.

FDA Compliance for Dietary Supplement Manufacturers & Importers

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