What changed in FSSAI's nutraceutical licensing rules

The two-part licensing reality

Nutraceuticals and health supplements are regulated in India under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 — a framework that has been re-operationalized and amended more than once since, most recently through further amendments in 2026. Two things often get conflated but are legally separate:

• A facility licence — a Central Licence, required for every nutraceutical or health supplement business (manufacturer, importer, or marketer) regardless of turnover. This is one of the few FSSAI categories where the licensing tier doesn't scale down for smaller operations the way it does for ordinary food businesses.
• Product approval — a separate, per-product step required whenever a formulation contains an ingredient not already on FSSAI's permitted list, or carries a health or disease-risk-reduction claim. Holding a valid facility licence does not, by itself, mean a specific product is cleared to sell.

What actually changed

The detail most worth flagging for planning purposes: an amendment to Regulation 2.1.7 changed how long a licence stays valid. Historically, businesses budgeted for a fixed licence term requiring renewal. Under the amended provision, a licence now remains valid and subsisting unless and until it is suspended, cancelled, or voluntarily surrendered — rather than expiring automatically on a fixed multi-year schedule.

Separately, further 2026 amendments to the food business licensing rules eased some operational record-keeping obligations for non-manufacturing businesses — specifically around daily production and raw-material utilisation records, and clarified that FIFO/FEFO inventory management requirements don't apply to retailers.

What this means for you

• If you've been tracking a fixed renewal date based on older guidance, it's worth confirming your licence's actual current status rather than assuming an expiry date that may no longer apply the way it used to.
• "No fixed expiry" doesn't mean "no risk" — a licence can still be suspended or cancelled for non-compliance, so the ongoing obligations (accurate labelling, permitted ingredient levels, NABL-accredited lab testing where required) still apply continuously, not just at renewal time.
• This doesn't change the separate product-approval requirement — a longer-lived facility licence is not a shortcut around getting a specific new formulation cleared.

The part that still catches people out

Regardless of licence validity mechanics, the two most common reasons a nutraceutical product approval stalls haven't changed: an ingredient that isn't on the permitted list (or isn't within its permitted dosage range), and a health claim on the label that isn't backed by the kind of credible scientific substantiation FSSAI expects. Both are formulation-stage problems, not paperwork-stage problems — which is why we review the product itself before we touch the filing.