The United States regulates dietary supplements under a completely different framework from India: DSHEA (the Dietary Supplement Health and Education Act, 1994). There is no pre-market product approval — but that freedom comes with strict rules on ingredients, claims, labels and notifications, enforced after the fact by the FDA and FTC. Indian brands routinely stumble here by applying FSSAI instincts to a US problem.
We prepare Indian supplement brands for US entry: verifying ingredient status, structuring compliant claims, formatting Supplement Facts panels and handling the notifications DSHEA actually requires.
Who is this service for?
- Indian supplement brands launching on Amazon.com or US retail
- Exporters whose US distributors demand label compliance sign-off
- Brands using ingredients that may require New Dietary Ingredient (NDI) notification
What is included?
- US-format label and Supplement Facts panel review
- Structure/function claim drafting and the required FDA notification
- Ingredient status assessment — old dietary ingredient vs NDI
- NDI notification preparation where required
- cGMP (21 CFR Part 111) readiness guidance for manufacturers
How does the process work?
- 1Product and claims audit against DSHEA requirements
- 2Ingredient-by-ingredient US status check
- 3Compliant label build with claim wording
- 4Notifications filed; launch checklist issued
Which documents will you need?
- Current label and formulation
- Intended claims and marketing copy
- Ingredient specifications and supplier documentation
How long does it take?
A label-and-claims package is typically completed in 2–3 weeks. NDI notifications add FDA’s statutory 75-day pre-market window plus dossier preparation time.
Common mistakes we correct
- Disease claims ("treats", "cures", "prevents") that instantly make a supplement an unapproved drug
- Structure/function claims used without the mandatory FDA notification and disclaimer
- Assuming an FSSAI-permitted ingredient is automatically marketable in the US
- Supplement Facts panels formatted like Indian nutrition tables
Frequently Asked Questions
Does the FDA approve supplements before sale?
No. Under DSHEA there is no pre-market approval — but the FDA enforces ingredient rules, claim rules, labelling formats and manufacturing standards after products reach the market, and the FTC pursues unsubstantiated advertising. Compliance is your burden from day one.
What is an NDI notification and do I need one?
A New Dietary Ingredient notification is required for dietary ingredients not marketed in the US before 15 October 1994, unless an exemption applies. It must be filed at least 75 days before marketing and must contain safety evidence. Whether your ingredient needs one is a factual, documentable question — we make that determination as step one.
Can I use my Indian label in the US with a sticker?
Practically never. US labels require a Supplement Facts panel with specific formatting, US measure units, FDA disclaimer text for claims, and US-party contact details. A compliant US label is a rebuild, not a patch.
Regulations that apply
- DSHEA 1994 — Dietary Supplement Health and Education Act
- 21 CFR Part 101 (labelling) and Part 111 (cGMP)
- FDA structure/function claim notification requirements