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US FDA programme to tighten food supplement regulatory standards may take toll on Indian nutraceutical exports
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Arun Sreenivasan, New Delhi
February 21 , 2019
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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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