Do Supplements Need FDA Approval? What’s Actually Required (and What Isn’t)
Summary (Key takeaways)
No premarket “FDA approval.” Dietary supplements don’t go through an FDA approval process before sale.
You still have FDA obligations. You must follow GMPs (21 CFR 111), label correctly, use only legal ingredients, and keep claims truthful and substantiated.
Some things must be notified to FDA:
Structure/Function claims (the ones with the asterisk disclaimer) require a notification to FDA shortly after you first market the product.
New Dietary Ingredients (NDIs) require a pre-market NDI notification if your ingredient wasn’t marketed in the U.S. before Oct 15, 1994.
Facility registration & safety reporting apply. Your manufacturer must be FDA-registered, and serious adverse events must be reported.
The short answer
No—supplements are not “FDA approved.” There’s no premarket approval pathway for dietary supplements. You can go to market without an approval letter—but you’re responsible for complying with FDA and FTC rules. If you don’t, FDA (and sometimes retailers, platforms, and litigators) can take action.
What you still must do (non-negotiables)
Manufacturing controls (GMPs). Your product must be made under dietary supplement Good Manufacturing Practices (21 CFR 111), with proper specifications, testing, and documentation.
Accurate, compliant labeling. Required statements, Supplement Facts formatting, contact info, lot codes, etc.
Truthful, substantiated claims. No disease/drug claims. Structure/Function claims need solid evidence and the “These statements have not been evaluated by the FDA…” disclaimer.
Structure/Function claim notification. If you use S/F claims, submit a notification to FDA with your label and claim info (timing is tied to first marketing).
New Dietary Ingredient (NDI) check. If any active is “new,” submit an NDI notification to FDA beforemarketing—or reformulate with an old (pre-1994) ingredient.
Facility registration & AERs. The manufacturing site must be FDA-registered (not “approved”), and you must file serious adverse event reports when they occur.
Quick sanity check: If your label says or implies it treats, cures, or prevents a disease, you’ve crossed into drug territory—that would require FDA approval.
“FDA approved facility” vs. “FDA registered”
FDA does not “approve” supplement facilities. Legit language is “FDA registered.” (And registration is required.) Avoid flags like FDA logos or “FDA approved” on your labels or product pages.
Could this change?
FDA has pushed for ideas like mandatory product listing for supplements. It’s not required today, but keep an ear out—requirements evolve, and retailers often adopt their own gatekeeping rules ahead of regulation.
Next steps (work with us)
Signature 1-on-1 Consultations — Get practical guidance on your specific product, label/claims, and what notifications or testing you actually need.
SSET: Supplement Startup Essentials Training — Learn which rules apply to your concept, how to build a focused market brief, and how to find and vet co-manufacturers and labs with confidence.