The Supplement Facts panel
Dietary supplements use a Supplement Facts panel, not the standard Nutrition Facts panel used by conventional foods. It lists each dietary ingredient, the amount per serving, and — where established — the percent daily value. Proprietary blends must disclose the total blend weight, and botanical ingredients need the part of the plant used identified.
Three claim types, three different obligations
| Structure/function claim | NDI notification | Disease claim | |
|---|---|---|---|
| Example | "Supports immune health" | A botanical not marketed in the US food supply before Oct. 1994 | "Treats seasonal allergies" |
| Deadline | Notify FDA within 30 days after first marketing | Notify at least 75 days before marketing | Not permitted on a supplement label at all |
| Required disclaimer | Standard FDA-not-evaluated disclaimer, prominently displayed | Not applicable | N/A — making the claim reclassifies the product |
Why the NDI notification matters more than it looks
A "new dietary ingredient" is any dietary ingredient not marketed in the US food supply, in the form used, before October 15, 1994. For imported botanicals and Ayurvedic-tradition ingredients, this comes up more often than importers expect — a plant with a long traditional-use history elsewhere can still be an NDI if it wasn't part of the US market before that date. Marketing a supplement with an unnotified NDI makes the product adulterated, independent of whether the ingredient is actually safe.
A structure/function claim that implies a disease link crosses the line
"Supports healthy blood sugar already in the normal range" is a permitted structure/function claim. "Helps manage diabetes" is a disease claim. The distinction turns on whether the claim references a recognized disease or its symptoms — not on how the marketing team intends the phrase to be read. This is one of the more common ways an Ayurvedic-tradition product ends up reclassified as an unapproved drug, even when the manufacturer considered it a supplement claim.
Frequently asked
What's the deadline for a structure/function claim notification?
No later than 30 days after the product is first marketed with that claim.
What's the deadline for a new dietary ingredient notification?
At least 75 days before the product containing the new ingredient enters interstate commerce.