9/5/2014 FSSAIs Product Approval Scheme Is Impacting Health And Nutraceutical Industry Of India | E-Retailing Laws And Regulations In India

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Regulations In India

FSSAIs Product Approval Scheme Is ImpactingHealth And Nutraceutical Industry Of India

The dietary and health supplement, functional food and nutraceutical legal and regulatory compliances in

India have taken a totally dierent meaning in the contemporary information and communication

technology era. Use of e-commerce model has not only expanded the horizons and territories of these

businesses but it has also imposed techno legal compliance requirements upon them.

As on date the requisite techno legal regulatory framework for dietary and health supplement, functional

food and nutraceutical segments is missing. Till now the Indian Parliament has not been able to integrate the

techno legal compliance requirements of these elds through dedicated laws. As a result multiple laws are

applicable to these businesses especially if they explore the e-commerce method.

Recently the Bombay High Court stayed the scheme of product approval by FSSAI for six months after

considering it as ambiguous. However, this stay is causing inconvenience and losses for the dietary

supplement, health supplement, functional food and nutraceutical industry of India.

The stay on product approval process would continue until August 2014, but port authorities have been

demanding product approvals from importers of dietary supplements and nutraceuticals. The authorities

refused to send the landed products for testing without the product approval. As a result, no clearance

would be made for the import of goods in India. Further, even applications made for product approvals are

pending approval or rejection for years. These conditions have aected the business of these segments.

9/5/2014 FSSAIs Product Approval Scheme Is Impacting Health And Nutraceutical Industry Of India | E-Retailing Laws And Regulations In India

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A large number of food business operators (FBO) are also exporting nutraceuticals and dietary supplements

to developed markets like the United States and Europe, where there is no such product approval system.

However, there are adversely aected by the uncertain regulatory regime in India. Most of these FBO are not

at all aware of the techno legal requirements that they have to comply with while selling their products

through websites and e-commerce portals.

The impugned product approval scheme by FSSAI initially limited the requirement of product approval for

novel foods that contain ingredients which are introduced for the rst time in the country or which do not

have a history of safe use. However, the scope of scheme was extended to cover all categories of products

which are not standardised, even if they were old and established in the market.

As a result a writ petition was led in the Bombay High Court against such scheme. Till now FSSAI has not

been able to justify its power to issue regulations/scheme by showing that Indian Parliament approved the

same. In the interim stay on January 31, 2014, the Bombay High Court stayed the product approval advisory

dated May 11, 2013 for a period of four weeks from February 4, 2014. While the High Court extended the

period for conversion of old licences by a period of eight weeks in an advisory issued recently, FSSAI

extended the same by six months until August 2014.

This entry was posted in Uncategorized on April 10, 2014 [http://ptlb.in/ecommerce/?p=284] by PTLB.