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US FDA programme to tighten food supplement regulatory standards may take toll on Indian nutraceutical exports

Arun Sreenivasan, New Delhi
Wednesday, February 20, 2019, 08:00 Hrs  [IST]

Indian nutraceutical manufacturers who set their sights on the US market or seek to expand their presence there face a tougher road ahead as the US Food and Drug Administration (FDA) has decided to tighten the regulatory oversight of the dietary supplement sector. The US watchdog has started sending warning letters and online advisories to companies whose products are marketed as food supplements, as many are “intended for use as drugs.”

Since most of the pharmaceutical firms in India have a dedicated nutraceutical and dietary supplement portfolio, the move is expected to take a toll on many. The US is the largest market for nutraceuticals in the world, followed by Asia-Pacific and the European Union, with functional food as the fastest growing segment. The dietary supplements include vitamins, minerals, amino acids and botanicals. They come in many forms including tablets, capsules, powders, energy bars and liquids.

According to the FDA, “there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk”. The agency is developing a new "rapid-response tool" to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients.

The FDA crackdown has sparked concerns among Indian food supplement manufacturers who bet big on exports to boost bottom line. As the US agency gets ready to implement new measures in the coming months “to move the dietary supplement programme forward”, a few cases of wrongdoing could taint the reputation of the entire industry, they worry. “We are currently exporting mainly to South East Asia. But the US is a major market for dietary supplements and we have been planning to make a foray into that country,” a senior official at Zeon lifesciences, Uttar Pradesh-based neutraceutical and food supplement exporter, says.

But the FDA statement allays these fears, saying genuine companies have nothing to worry about. “Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality,” the agency said in its statement.

Many Indian industry experts also echo this view. “We already have very strong regulations for nutraceuticals, health and protein supplements under the Food Safety and Standards Authority of India. The FDA measure won’t have much impact on us,” Sandeep Gupta, vice-chairman of nutraceutical committee, Indian Drug Manufacturers’ Association, told Pharmabiz.

According to industry estimates, India's nutraceutical industry is set to double in size to Rs.26,764 crore by 2020. However, a recent study conducted by Assocham and market research firm RNCOS has revealed that almost 70 per cent of dietary supplements sold in the domestic market are fake, counterfeit, unregistered and unapproved.

 

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