India bans wellness wonder ashwagandha's leaf products on health risk

The move could disrupt formulations in India’s $38.77 billion nutraceuticals industry, where ashwagandha is a key product with its market estimated at $928.5 million in 2026. It has seen a surge in overseas popularity, particularly in North America and Europe, where it is a leading adaptogenic herb sold in diverse formats such as gummies, capsules, tea blends and fortified beverages.

The FSSAI, in a 16 April communication to state food safety commissioners and licensing authorities reviewed by Mint, instructed states and Union Territories to maintain "strict vigilance" and initiate legal action against any food business operators (FBOs) found using unauthorized leaf-based ingredients. Manufacturers have also been asked to comply with labeling rules that mandate clear declaration of the specific plant parts used in the product.

“It has been brought to the notice of FSSAI that certain manufacturers of these products are using ashwagandha leaves and its extracts in their products. In this regard, it is clarified that the use of ashwagandha leaves in crude or extract or any other form is not permitted under the said regulations, the FSSAI said. "Further, the Ministry of Ayush, has also directed Ayush drug/product manufacturers to use only ashwagandha roots and their extracts and not the leaves, in any form.”

Scientific studies have identified high concentrations of reactive withanolides, notably withaferin-A, in the leaves, which may pose health risks including liver damage (hepatotoxicity), gastrointestinal distress such as vomiting and diarrhea, and potential neurotoxicity

“In view of the above, all food business operators (FBOs) are hereby advised to ensure strict compliance with the aforementioned provisions. Any deviation shall attract action under the Food Safety and Standards Act, 2006 and regulations made thereunder," the food regulator said in its communication.

"Appropriate action shall be initiated against any noncompliance observed under the Food Safety and Standards Act, 2006, and regulations made thereunder,” it said.

Queries on the development emailed to an FSSAI spokesperson remained unanswered until press time.

Primarily grown in dry, sub-tropical regions, ashwagandha is cultivated across Madhya Pradesh, Rajasthan, Gujarat, Maharashtra, Uttar Pradesh, Punjab, and Haryana, with nearly 10,780 hectares area under cultivation. Hub Madhya Pradesh has over 5,000 hectares dedicated to the crop.

The intervention assumes significance when India’s nutraceutical industry is experiencing exponential growth. According to Grand View Research, which tracks industry trends and market size, India's nutraceuticals market was valued at $38.77 billion in 2025 and is projected to reach $84.99 billion by 2033, growing at a compound annual growth rate of 10.3%.

Major industry players offering ashwagandha products include Himalaya Wellness, Dabur India, Patanjali Ayurved, Baidyanath, and Zandu (Emami).

The nutraceuticals industry has promised compliance. “We support measures that enhance consumer safety and regulatory clarity. As a marketer, we work with licensed manufacturing partners and ensure that our products are developed in line with applicable regulations. Ashwagandha used in our formulations is intended to be derived from permitted plant parts, in accordance with current guidelines," said Manish Chowdhary, co-founder of WOW Life Science that manufactures wellness supplements including Himalayan Shilajit with ashwagandha resin.

"We also ensure that product labels and disclosures align with applicable requirements, including Rule 161 of the Drugs Rules, 1945. We remain committed to maintaining high standards of quality, transparency, and compliance,” he said.

FSSAI has specified standards for health supplements, nutraceuticals, food for special dietary use, food for special medical purpose 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. Schedule IV of these regulations provides the list of plants or botanicals permitted for use in such products.

As per schedule IV of the aforesaid regulations, only the roots and their extracts of ashwagandha are permitted for use in the above-mentioned categories of products, subject to compliance with the prescribed limits.