Nutraceuticals and dietary supplements are FDA-regulated under DSHEA, with mandatory GMP compliance under 21 CFR Part 111. PMG's partner facilities are cGMP-compliant, and our regulatory team understands the difference between a defensible structure-function claim and an FDA Warning Letter waiting to happen.
Every dosage format, every demanding active, every clean-label claim. We build supplements that pass identity testing, potency verification, and the consumer's read of the label.
21 CFR Part 111 requires rigorous identity testing, contaminant testing, and potency verification for every production run. Our facilities operate to this standard for every client, not just the ones who ask.
The line between a defensible structure-function claim and an impermissible disease claim is exactly where most supplement brands get into regulatory trouble. Our regulatory team reviews your draft claims against FDA guidance and case precedent before anything goes to print.
Gummies are technically demanding. Softgels require specialized equipment. Certain actives require coatings for stability or taste masking. We don't upsell format complexity; we tell you honestly what your product needs to perform as claimed.
Dietary supplements are regulated under DSHEA (1994) and the 2007 cGMP Final Rule (21 CFR Part 111). Every supplement must have a New Dietary Ingredient notification if the ingredient wasn't marketed before October 15, 1994. Structure-function claims must be truthful, substantiated, and include the required disclaimer. The FTC also regulates advertising claims separately from FDA — meaning a claim that passes the label review can still draw an FTC enforcement action. Our regulatory team navigates both.
Supplement brands live or die on trust — and trust starts with cGMP-compliant manufacturing, defensible claims, and a partner who understands the regulatory landscape.