FSSAI's October 2026 botanicals advisory: what it covers, and what it means for fruit and herb preparations
On 15 October 2026 FSSAI issued an advisory on warning statements for products containing botanicals. Headlines summarised it as "herbal products must carry warnings", which made some fruit and herb suppliers ask whether their hibiscus, papaya or coffee preparations are now caught. This page reads the advisory itself: who it covers, what the label must say, the botanicals it lists, and where ordinary fruit and herb preparations stand. It is not legal advice.
📄 What the advisory is
The document is FSSAI's advisory dated 15 October 2026 on warning statements for botanicals, file F. No. RCD-02004/7/2025-Regulatory-FSSAI. BusinessLine reported it on 20 October 2026 as a direction to nutraceutical makers to put mandatory warnings on products with herbal extracts.
🎯 Who it applies to
The advisory is addressed to food business operators making products 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, that contain botanicals listed in Schedule IV of those regulations. In practice that means:
| In scope | Outside this advisory |
|---|---|
| Health supplements with botanical ingredients | Fruit preparations for ice cream, yoghurt and bakery |
| Nutraceuticals using Schedule IV plants | Fruit juices, nectars and RTS drinks under the product standards |
| Foods for special dietary use (FSDU) | Ice cream, frozen desserts and sorbets |
| Foods for special medical purpose (FSMP) | Herbal teas and spices sold as ordinary foods |
The right-hand column follows the general Labelling and Display Regulations, which is where ingredient lists, the ingoing percentage of a named fruit and allergen declarations come from.
🏷️ What the label must carry
For in-scope products the advisory requires:
- The plant part used, for example fruit, leaf, seed or flower.
- The caution statement in Annexure I for that botanical. FSSAI says the annexure was prepared in consultation with the Ministry of Ayush.
- Compliance with the listed clauses of Schedule IV.
Non-compliance is treated as a contravention of section 23 of the Food Safety and Standards Act, 2006, and can attract action under section 52, including suspension or cancellation of the licence. For imports, the advisory asks the Executive Director (Trade and International Cooperation Division) to ensure implementation.
🌿 Annexure I: the botanicals a fruit or herb supplier will recognise
Annexure I lists 16 botanicals. These are the ones closest to fruit and flavour work, with the caution group the annexure names:
| Botanical (part) | Caution group in Annexure I |
|---|---|
| 🍈 Papaya (unripe fruit; leaf) | Not for use during pregnancy |
| 🌺 Hibiscus (flower) | Not for use during pregnancy |
| ☕ Coffee (dry green seed) | Not for children under 5 |
| 🍃 Betel (leaf) | Not for children under 5 |
| 🥕 Carrot (seed) | Not for use during pregnancy |
| 🌱 Garden cress (seed) | Not for use during pregnancy |
| 🌳 Neem (leaf; fruit) | Not for those planning to conceive; fruit also not for children under 5 |
Annexure I also gives a daily amount range for each entry, for example 1 to 3 g of hibiscus flower powder and 3 to 5 g of green coffee seed. Read the full annexure for the exact wording.
Not in Annexure I: amla, ginger, tulsi, rose and kokum. None of these appears among the 16 listed botanicals.
🍓 What this means for fruit and herb preparations
- Ask which regulation the finished product is made under. If a dairy, café or bakery buys a hibiscus, papaya or coffee preparation for an ice cream, drink or filling under the general product standards, this advisory is not the governing text.
- Watch the "supplement" pivot. If the buyer's product is licensed as a health supplement or nutraceutical, the advisory applies to that product, and your spec should state the plant part so the buyer can label it.
- State the plant part anyway. "Hibiscus flower extract" or "papaya fruit pulp" on a spec costs nothing and answers the first question a regulatory team will ask.
- Keep health claims off. Fruit preparations sold as ordinary food ingredients should not carry botanical health claims; that is a different regulatory door. See Labelling fruit preparations.
FSSAI's 15 October 2026 botanicals advisory is for nutraceuticals, health supplements, FSDU and FSMP under the 2016 regulations: name the plant part and print the Ayush-backed caution for 16 listed botanicals. Ordinary fruit preparations, juices and frozen desserts stay under the general labelling rules, but stating the plant part on the spec is good practice.
This page is a reading of public documents, not legal advice.
Sources
- FSSAI, 15 October 2026: Advisory on warning statements for products containing botanicals
- BusinessLine, 20 October 2026: FSSAI directs nutraceutical makers to ensure mandatory warning statements on products with herbal extracts
- FSSAI: Labelling and Display Regulations, 2020, compendium
- FSSAI: Advisories list
Hero photo: "Red hibiscus (Hibiscus rosa-sinensis)" by Francis Chung from Utara Subang Jaya, Malaysia, Wikimedia Commons, CC BY 2.0. See Credits.
Questions
Which products does the advisory apply to?
Food business operators manufacturing health supplements, nutraceuticals, foods for special dietary use (FSDU) and foods for special medical purpose (FSMP) 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, that contain botanical ingredients listed in Schedule IV. BusinessLine's 20 October 2026 report describes it the same way, as a direction to nutraceutical makers using herbal extracts.
What must the label carry?
The plant part used, for example leaf, fruit, seed or flower, and the caution statement given for that botanical in Annexure I. The annexure was prepared with the Ministry of Ayush. The advisory also tells operators to comply with the listed clauses of Schedule IV.
Are amla, ginger, tulsi, rose or kokum in Annexure I?
No. None of them appears among the 16 botanicals in Annexure I of the advisory. The botanicals listed include papaya (unripe fruit and leaf), coffee (dry green seed), hibiscus (flower), betel (leaf), neem (leaf and fruit), carrot (seed) and garden cress (seed), among others.
Does a hibiscus or papaya fruit preparation for ice cream need the caution?
Not under this advisory, which is limited to products under the 2016 nutraceutical regulations. A fruit preparation, ice cream or beverage made under the general product standards follows the Labelling and Display Regulations instead. If a buyer positions a finished product as a health supplement or nutraceutical, the advisory then applies to that product, so ask which regulation it is made under.
Who enforces it for imports?
The advisory asks FSSAI's Executive Director (Trade and International Cooperation Division) to ensure implementation for imported products. Domestic enforcement sits with licensing authorities and food safety officers.
Is this legal advice?
No. It is a reading of the advisory, one news report and the labelling compendium. Your regulatory advisor applies it to your product and the regulation it is licensed under.