Food Supplements
Selling dietary supplements in the US means working under DSHEA 1994 and the FD&C Act, overseen by the FDA. There's no pre-market approval, but you must register your facility, follow cGMP under 21 CFR Part 111, notify new dietary ingredients, and keep your claims to structure/function - never disease.
At Taylored Consultancy Ltd, we make supplement compliance clear and stress-free. We help you get your facility, formulation, labelling and claims right so you can sell with confidence.
Clearing the path to market -
regulatory and quality expertise that gets your food supplements compliant, safe, and ready for market.
We help you register your facility with the FDA as a food facility, as required before you manufacture or distribute.
We help you build and audit a quality system that meets the dietary supplement cGMP requirements - a frequent source of FDA inspection findings.
For ingredients not marketed before October 1994, we help you prepare and file the required NDI notification.
We review your formulation against FDA requirements and flag ingredients that need extra substantiation.
We review your Supplement Facts panel and labelling against 21 CFR 101.36, including the DSHEA disclaimer.
We make sure your claims stay within permitted structure/function territory and avoid prohibited disease claims.
We help you align with HACCP, ISO 22000 or GFSI-recognised schemes where retailers require them.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 22000 - Food safety management
HACCP - Hazard Analysis and Critical Control Points
GFSI-recognised certifications (usually BRCGS, FSSC 22000, IFS)
ISO 9001 - General quality management
Get our instant-download US Food Supplements Regulations cheat sheet — classification, route to market and labelling essentials in one clear guide, for £15.
