US gummy launch guide
A practical framework for private-label gummy launches targeting the US market. 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 gummy 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 — the DAT team coordinates the US manufacturing network and the compliance review.
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. DAT's approved US manufacturing network operates under compliant quality systems. The cGMP documentation is available for brand due diligence in the DAT portal project workspace.
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 the project wizard
After reviewing this guide, the next step is the DAT project brief. The brief captures whether you are on the white-label, semi-custom or custom route, your target quantity range, and the US states where you plan to distribute. DAT confirms the US manufacturing network assignment and the claims review timeline against those inputs.
Ready to start a project?
The DAT project wizard takes the brief and routes it through the right manufacturing gate. Pick the route that matches where you are in planning.