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
No, dietary supplements don't go through FDA pre-market approval the way drugs do, but that doesn't mean anything goes. Under DSHEA, you're responsible for ensuring your product is safe and properly labelled before it reaches the market, and the FDA can and does take post-market action against non-compliant products. We help clients get the substance and label right upfront, since there's no approval stage to catch mistakes for you.
A New Dietary Ingredient (NDI) notification is required if your product contains a dietary ingredient that wasn't marketed in the US before October 1994, and it involves submitting safety data to the FDA before the ingredient can be sold. Skipping this when it applies is a common and costly mistake. We assess whether your ingredients trigger the NDI requirement early in the formulation stage.
Yes, any facility manufacturing, processing, packing or holding dietary supplements for the US market must register with the FDA and renew that registration every two years, and this applies to overseas manufacturers supplying the US too. Facility registration sits alongside compliance with cGMP requirements under 21 CFR Part 111. We support clients through both the registration and the underlying manufacturing compliance.
A structure/function claim describes how an ingredient supports normal body function, such as 'supports immune health', and is allowed on supplement labels with the required DSHEA disclaimer. A disease claim states or implies your product treats, cures or prevents a disease, which crosses into drug territory and isn't permitted on a supplement. We review claims line by line to keep you on the right side of that boundary.
A Supplement Facts panel must follow the specific format set out in 21 CFR 101.36, including serving size, the dietary ingredients present, and their amounts per serving, and it's formatted differently from a standard Nutrition Facts panel used on regular food. Getting the format wrong is a common reason labels get flagged. We build and review Supplement Facts panels against the exact FDA formatting rules.
Yes, absolutely. Because there's no pre-market approval for supplements, the FDA's oversight happens after your product is already on shelves, through inspections, warning letters, and enforcement action if a product is found unsafe, mislabelled or making illegal disease claims. That's exactly why getting your formulation, cGMP compliance and claims right from day one matters more in the US than in markets with upfront approval.
Still have questions? Contact us and we'll be happy to help.
