Regulatory review: India’s ashwagandha leaf ban, FTA with New Zealand and more

Find out the latest regulatory updates regarding Asia-Pacific's nutraceutical industry.
Find out the latest regulatory updates regarding Asia-Pacific's nutraceutical industry. (Getty Images)

India’s ban on ashwagandha leaf use in food products and its free trade agreement (FTA) on manuka honey and bulk infant formulas with New Zealand are some of the latest updates in this regulatory news round-up.

Indian high court grants interim stay on ashwagandha leaf ban

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The supplementation of ashwagandha leaf and root extracts has been shown to stimulate the immune system. ©Getty Images

The Karnataka High Court in Bangalore has temporarily stayed the Indian government’s restriction on the use of ashwagandha leaves issued last month after industry stakeholders challenged the rationale behind the blanket ban.

The interim order responds to an over 600-page petition with supporting documentation submitted on May 8 by a group of dietary supplement manufacturers objecting to an April 16 advisory issued by the Food Safety and Standards Authority of India (FSSAI).

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The advisory was directed against the use of ashwagandha leaves in crude or extract or any other form in food products.

India-New Zealand FTA: NZ health product firms on opportunities, challenges

India and New Zealand have signed a FTA on April 27.
India and New Zealand have signed a FTA on April 27. (studiocasper/Getty Images/iStockphoto)

India and New Zealand recently inked a FTA that allows nutritional products such as manuka honey and bulk infant formula from New Zealand to be imported at lower tariff rates.

At the moment, there is a 66% tariff on New Zealand’s manuka honey exported into India, but will be reduced to to 16.5% in five years’ time.

“The FTA is a great opportunity. I applaud the two governments for coming together to find a path forward,” Karl Gradon, CEO of New Zealand-based manuka honey maker Comvita, told NutraIngredients.

HMO infant formulas: Regulatory developments to drive NPD and affordability

Infant formulas across Asia-Pacific markets are starting to contain a greater range and variety of human milk oligosaccharides (HMOs) following regulatory approvals.
Infant formulas across Asia-Pacific markets are starting to contain a greater range and variety of human milk oligosaccharides (HMOs) following regulatory approvals. (Olga Yastremska/Getty Images)

The growing number of regulatory approvals for human milk oligosaccharides (HMOs) in infant formulas is set to fuel product innovation and drive more affordable pricing in the long run.

Regulatory approvals of HMOs have been the driver of new launches in infant nutrition products, said Annette Lau – Global Regulatory Affairs Senior Manager ELN & MN at dsm-firmenich.

She pointed out that in 2024, regulatory approvals of HMOs have accounted for up to 28% of new formulas entering the global market.

India bans ashwagandha leaf use in any form, industry reacts

A person cutting or chopping ashwagandha roots on the ground. Withania somnifera, Indian ginseng, poison gooseberry, or winter cherry. Process of making ashwagandha powder, dry in sunlight at home
The new study evaluated the bioavailability of four commercially available, standardized ashwagandha extracts with varying compositions, in 16 healthy human volunteers. (Azay photography/Getty Images)

On April 16, the Indian government issued an advisory restricting the use of ashwagandha leaves in crude or extract or any other form in food products, catching many industry stakeholders by surprise.

This follows a letter published by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (Ayush), directing product manufacturers to use root only—not leaf—and requiring that all plants parts used be identified on product labels.

It cites a 2024 updated ashwagandha safety dossier and its reports, which categorically recommends root use for health benefit, as well as two studies shared by the ministry identifying “possible safety concerns for ashwagandha leaves due to higher concentrations of reactive withanolides, particularly withaferin A.”

South Korea’s MFDS reiterates ban on Gymnema sylvestre, Bacopa in supplements

Gymnema sylvestre, a climbing medicinal plant traditionally used in Ayurveda, is banned for use in health supplements in South Korea.
Gymnema sylvestre, a climbing medicinal plant traditionally used in Ayurveda, is banned for use in health supplements in South Korea. (sulhanul khoir/Getty Images)

South Korea’s Ministry of Food and Drug Safety (MFDS) has reiterated its ban on some of the commonly used ingredients in health supplements, including Gymnema sylvestre and Bacopa, due to concerns around side effects such as hepatitis and abdominal pain.

The MFDS said that these banned ingredients were discovered in its recent inspection of overseas-made health supplements sold into South Korea via e-commerce platforms like Amazon and eBay.

In South Korea, these ingredients are subject to an import ban under Article 25-3 of the Special Act on the Safety Management of Imported Food and are said to pose a risk to public health.