The single biggest mistake we see when an Indian supplement brand plans a US launch is assuming that FSSAI compliance transfers. It does not. India and the United States regulate supplements under different laws, different definitions, and — crucially — different assumptions about who proves what.
In the US, dietary supplements are governed primarily by the Dietary Supplement Health and Education Act of 1994 (DSHEA), administered by the FDA. Understanding how DSHEA differs from the FSSAI framework tells you exactly what to build before you ship.
Pre-market approval: the fundamental difference
Under FSSAI, many nutraceutical products and novel ingredients require prior approval or must fit within defined schedules before they can be sold. Under DSHEA, dietary supplements do not receive FDA pre-market approval in the same way. Instead, the manufacturer is responsible for ensuring the product is safe and that claims are truthful and not misleading. The FDA generally acts after a product is on the market. This shifts a large compliance burden onto the brand and its documentation.
New ingredients: NDI notifications
A "New Dietary Ingredient" (an ingredient not marketed in the US before 15 October 1994) generally requires a pre-market safety notification to the FDA. This NDI notification, with a safety dossier, is one of the most misunderstood steps for Indian brands introducing a botanical or novel ingredient that is common in India but new to the US market.
Claims: structure/function vs disease claims
DSHEA permits "structure/function" claims (how a nutrient affects the normal structure or function of the body) provided they are substantiated and carry the required FDA disclaimer. Disease claims are not permitted for supplements. The FSSAI claims framework is organised differently, with its own categories and qualifying conditions. A claim that is acceptable on an Indian label may be non-compliant in the US, and vice versa.
- FSSAI: schedule-based ingredients, prior approval routes for novel foods/ingredients, India-specific claim categories.
- DSHEA: manufacturer-responsible safety, NDI notification for new ingredients, structure/function claims with mandatory disclaimer.
- Both: prohibit disease treatment/cure claims on supplements; both require truthful, substantiated labelling.
Manufacturing and facility expectations
US dietary supplements must be produced under FDA 21 CFR Part 111 current Good Manufacturing Practices. Facilities that manufacture or process food for the US market also face facility registration obligations. Indian manufacturers should confirm that their quality system and documentation will withstand these expectations well before a first shipment.
Plan the US regulatory pathway as a distinct project — NDI status, cGMP readiness, label and claim rework, and facility registration — rather than an extension of your FSSAI file.
Frequently Asked Questions
Does FSSAI approval let me sell my supplement in the USA?
No. FSSAI compliance does not transfer to the US market. US dietary supplements are regulated under DSHEA and FDA rules, which have different ingredient, claim, and manufacturing requirements.
What is an NDI notification?
A New Dietary Ingredient notification is a pre-market safety submission to the FDA for ingredients not marketed in the US before 15 October 1994. It is often required for botanicals or novel ingredients new to the US market.
Are disease claims allowed on US supplements?
No. Like FSSAI, DSHEA prohibits disease treatment or cure claims on supplements. Only substantiated structure/function claims with the required FDA disclaimer are permitted.
Tarun Pratap Singh
Founder & CEO, TPS Xperts Group
ISO 22000:2018 FSMS Lead Auditor · FSSAI-empanelled FoSTaC Trainer · 17+ years in food & nutraceutical regulatory affairs