Did Ashwagandha
just change?Not Really!

Find out what all these advisories mean and
what makes a true good Ashwagandha ingredient.

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Root Only ✓
USP Profile
12× AUC
Withanolide AUC
12×
vs comparator branded
Ashwagandha
The Advisory

What FSSAI's advisory actually says
and what it doesn't

MINISTRY OF AYUSH ADVISORY, 2021 · ENFORCED BY FSSAI SCHEDULE IV, APRIL 2026

Ashwagandha leaves in crude or extract or any other form is not permitted.

What is FSSAI?
The Food Safety and Standards Authority of India India's apex food regulatory body under the Ministry of Health. Schedule IV governs nutraceuticals and health supplements.
What is Ministry of AYUSH?
The Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy. Its 2021 advisory confirmed that only root is endorsed for internal therapeutic use.
1
2021
Ministry of AYUSH Advisory
Leaf not endorsed as ASU medicine
2
2026
FSSAI Schedule IV Enforcement
State authorities directed to act
Rule 01
Only root is permitted
FSSAI Schedule IV has always allowed only dried mature root of Withania somnifera in nutraceuticals. The April 2026 advisory is enforcement of an existing rule not new legislation.
Rule 02
Leaf was never permitted
Ashwagandha leaf was never a permitted ingredient under Schedule IV - the April 2026 advisory enforces a rule that always existed. State authorities have been directed to take legal action against non-compliant products.
Rule 03
A label claim is not protection
Brands with a 'root only' label but without independent documentation may be exposed if there is an independent assessment. The label and the Certificate of Analysis must agree. Regulators check both.
The Science

The root and the leaf have different bioactive compositions. Modern science is only validating what Ayurveda always knew.

🌿 3,000+ years - Ayurvedic texts have specified root only for internal therapeutic use. The Ayurvedic Pharmacopoeia of India (API, Part I, Vol. I) confirms it.
Internal consumption
Root and Root derived extracts for Internal Consumption
Bhavaprakash Nighantu, Guduchyadi Varga, Ashwagandha; API Part I, Vol I
Topical application
Leaves for topical Application
Winther et al., Nutrients 2026

The beneficial withanolides that your formulation depends on for its efficacy claims are concentrated in the root. The leaf carries a fundamentally different phytochemical profile.

Ask your supplier for a toxicity profile on their ingredient. If they cannot provide one, that is your answer.

Your Brand

Four things worth checking
for your brand

Not a compliance checklist. Four practical questions a brand professional should be asking their QA and procurement teams.

Supply Chain
Does your Certificate of Analysis explicitly state 'Withania somnifera root' as the botanical source? A supplier's verbal assurance is not independent verification.
→ Ask your QA team: have we reviewed the CoA?
Label Compliance
Do your labels, e-commerce listings, and website accurately describe the plant part? A mismatch between product and label is independently actionable.
→ Check: does every channel say 'root extract'?
Withanolide Claims
Does your withanolide percentage use USP profile by HPLC? A total % may include compounds from not-withanolide material.
→ Ask: is this a USP profile or a generic total?
Science and Dose
Does the dose used in the clinical studies match the dose on your label? A study conducted at a different dose does not validate the efficacy if a different daily dose is recommended on label.
  • Is your Ingredient supported by a published Pharmokinetic Profile?

    • Study of pharmacokinetics is a crucial step in translational research and helps in determination of optimal dose and dosing frequency for getting the best efficacy results.

→ Start the conversation before you need to.
The Standard

Root only is just one of the requirements for Ashwangandha. Here are all the requirements before this regulation was even enforced

One ingredient was designed to meet every level of this framework before this regulation was enforced.

Level 01
✓ Compliant

The root only, confirmed

Your Certificate of Analysis should come from an ISO/IEC accredited third-party or equivalent third-party laboratory
Plant part explicitly stated: Withania somnifera root
No leaf, no stem, no blended extract
Level 02
✓ Verified

The standard verified, not just claimed

Identified 10 withanolides and quantified 8 withanolides as per USP monograph
Adulteration tested by independent lab (HPTLC)
Clean Label Project or equivalent third-party certification
Level 03
✓ Differentiated

The benchmark clinically validated

Published human pharmacokinetic data: AUC, Cmax, and plasma half-life confirmed
Multiple randomised, double-blind, placebo-controlled human clinical trials
Sustained-release format validated at clinical dose, once-daily
The Solution

We were already there.
All requirements met.

✓ Root Only ✓ USP Standardization ✓ 1-A-Day Sustained Release ✓ Clean Label Project Certified ✓ Clinical Package + Tox Pack

Ashwanova™ (Prolanza™) by Nutriventia was designed root-only from its inception - not in response to a regulation, but because Ayurveda was right and modern science was always going to confirm it. Root-only was not our response to FSSAI. It was our starting point.

Root Only
Confirmed by independent CoA
Withania somnifera root. No leaf. No stem. No blended extract. No ambiguity. Every batch independently verified.
USP Withanolides
NLT 4% across all 10 USP compounds
Not a generic total withanolides percentage. Every compound in the USP Withania somnifera Root Monograph individually quantified, from root only.
Clean Label Certified
130+ contaminants independently tested
Third-party certification covering pesticide residues, heavy metals, and plasticisers. Not self-declared. Not a supplier claim.
12× Bioavailability
Published pharmacokinetic evidence
12× higher AUC and 7.1-hour plasma half-life for withanolides vs 2.3 hr for comparator branded Ashwagandha. 300mg SR/150mg SR, once daily. Clinically validated in multiple published randomized controlled trials.
Thanawala S et al., Medicine 2026; Alluri VKR et al., IJBCP 2022; Gopukumar et al., Evid Based Compliment Alt Med 2021
12×
Withanolide AUC vs comparator
7.1hr
Plasma half-life for withanolides
NLT 4%
Quantified as per USP
3,000yr
Ayurvedic root-only tradition
Brand Health Check

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Do you have Ashwagandha in any of your products?
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ASHWAGANDHA HEALTH CHECK

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