Yes. Any facility that manufactures, packages, labels, or holds dietary supplements for sale in the US must register with the FDA under 21 CFR Part 1 and comply with GMP regulations in 21 CFR Part 111. If you outsource blending to a co-manufacturer, their facility registration covers the production — but you as the brand owner still hold responsibility for formula compliance and label accuracy.
Read the full guide on small batch supplement powder blending equipment setup →