Supplement manufacturing in the USA
cGMP-certified partner facilities in California, Utah, Texas, and Georgia, coordinated by one team that also handles FDA registration, compliant labels, and packaging.
LumaNutra coordinates US supplement manufacturing through cGMP-certified partner facilities in California, Utah, Texas, and Georgia, all FDA registered and operating under 21 CFR Part 111. Runs start at 2,000 units, every batch ships with an ISO 17025 Certificate of Analysis, and FDA registration and DSHEA-compliant labels are handled inside the same project.
Where we manufacture in the USA
US regulatory context (DSHEA)
Dietary supplements sold in the US are regulated by the FDA under DSHEA. There is no pre-market product approval, but the manufacturing facility must be FDA registered and cGMP compliant under 21 CFR Part 111, and labels and structure/function claims have to meet FDA rules. We confirm facility registration, review claims, and produce compliant labels as part of the project.
Exporting beyond North America? Our export guide covers the documentation and certification path, and our export documentation service prepares the pack during the production run.
Common questions
We coordinate manufacturing through cGMP-certified partner facilities in California, Utah, Texas, and Georgia, all operating under 21 CFR Part 111. You get US-made product with one point of contact for formula, regulatory, packaging, and production, at the pricing our combined client volume earns across the network.
Yes. Every US facility in our network is FDA registered and cGMP certified under 21 CFR Part 111. Every batch ships with a Certificate of Analysis from an ISO 17025 accredited third-party lab.
MOQs start at 2,000 units for capsules, tablets, and liquids, 1,000 units for powders, and 3,000 for softgels and gummies. The exact floor depends on the dosage form and the facility; we confirm it on the discovery call.
Yes, both directions are routine. We run production on whichever side of the border fits your target market, handle FDA registration or the Health Canada NPN as needed, and design bilingual labels when one SKU has to serve both countries.
Tell us what you're making
We match your product to the right facility in the network and come back with one quote and a realistic timeline.