US private-label launch guide
A practical framework for private-label launches targeting the US market, across every format DAT Supply manufactures. Covers the FDA dietary supplement framework, claim categories, label requirements and the manufacturing and registration route.
What this guide covers
- DSHEA 1994 — the framework that defines dietary supplements and the ingredient categories that can be used
- 21 CFR Part 111 — current Good Manufacturing Practice requirements for dietary supplements
- Structure-function claims vs. disease claims — the distinction and what is prohibited
- FD&C Act Section 201 — supplement vs. drug, and why the distinction matters at concept
- Supplement Facts label format — required elements, font sizes and placement
- FDA registration and the role of the US agent for foreign manufacturers
Who this is for
- US supplement brands at the early concept stage for a private-label launch
- International operators entering the US market and mapping the FDA compliance route
- Brand managers reviewing structure-function claim wording before artwork sign-off
- Founders assessing the timeline and documentation required for a US private-label launch
This guide is the planning starting point. Final labelling and claims review are confirmed per project.
Planning a US private-label launch?
Drop your work email and a DAT team member will follow up with the specific compliance and claims route for your target market and distribution states.
Key points in the guide
Structure-function vs. disease claims
Dietary supplements may carry structure-function claims ("supports bone health") without prior FDA approval, provided the claim is substantiated and not misleading. Disease claims ("treats osteoporosis") are prohibited and make the product a drug under the FD&C Act. Structure-function claims must include a disclosure statement if FDA has not reviewed the claim. DAT team reviews claim wording per project.
21 CFR Part 111 — GMP requirements
Contract manufacturers producing dietary supplements must comply with 21 CFR Part 111 (cGMP). This covers identity, purity, strength and composition of each component; batch production and control records; and finished product testing. Standard documentation included. Independent lab testing is available on request.
Supplement Facts panel — required elements
US labels must use the Supplement Facts format (not Nutrition Facts). Required: serving size, servings per container, each dietary ingredient with amount per serving, percent Daily Value (%DV) for ingredients with established DRVs. Ingredient list with descending order of predominance. Manufacturer info. Allergen declaration for priority allergens. The guide covers specific rules for gummy formats — including the treatment of gelatin and pectin in the ingredient list.
How this connects to your order
After reading this guide, the next step is starting your order. It captures whether you are on the private-label catalogue or Formula Adaptation, your target quantity range, and the US states where you plan to distribute. DAT confirms the country of manufacture for the products you choose and the claims review timeline against those inputs.
Download the US private-label launch guide (PDF)
A printable summary of DSHEA, 21 CFR Part 111, structure-function claim wording and the Supplement Facts panel — every format DAT Supply manufactures.
Related formats
DSHEA applies across formats. Format hubs cover MOQ, tooling and packaging trade-offs.
Related US state guides
State-level residuals (Prop 65 in California, retail-channel rules in others) sit on top of the federal frame.
Ingredient, dosage or active changes to an existing formula are Formula Adaptation, with the production minimum and timeline confirmed before you commit. A genuinely new formula, R&D, due diligence, compliance and bespoke testing are Custom Projects, reviewed individually.
Related guides
Where to next?
Browse the reviewed catalogue, request samples, or start an order when you're ready — your DAT Supply account routes your brief through the right review step.