New Dietary Ingredients (NDI) and cGMP

The NDI 75-day notification and cGMP manufacturing standards (21 CFR 111) that define a compliant supplement — and how to spot a reputable brand to promote.

Two more parts of the DSHEA framework shape what a compliant supplement looks like: the rules for new dietary ingredients and the manufacturing standards known as cGMP. Affiliates do not file these themselves, but understanding them helps you choose reputable products and recognize red-flag brands.

New dietary ingredients (NDI)

A “new dietary ingredient” is one that was not marketed in the United States in a dietary supplement before October 15, 1994. Under DSHEA, unless the ingredient has been present in the food supply in an unaltered form, the manufacturer or distributor must submit an NDI notification to the FDA — with evidence of safety — at least 75 days before marketing the product. The NDI process is the closest thing to a pre-market safety check in the supplement world.

Current Good Manufacturing Practices (cGMP)

Supplement manufacturing is governed by cGMP regulations at 21 CFR Part 111. These require controls over identity, purity, strength, and composition — that a product actually contains what the label says, in the stated amount, without harmful contamination. FDA inspects for cGMP compliance, and failures are a common basis for warning letters and recalls.

Signals of a compliant supplement brand

• Uses accurate structure/function language and shows the DSHEA disclaimer, without disease claims.
• Manufactures under cGMP (21 CFR Part 111), often with third-party testing or certification.
• Handles new ingredients through the NDI process rather than quietly introducing novel compounds.
• Makes claims backed by real evidence, consistent with the FTC standard.

For the disclosure you should add when promoting supplements, see the DSHEA disclaimer and supplement affiliate disclosures.

Last reviewed July 2026. This page is general educational information, not legal or tax advice.