The dietary and health supplement, functional food and nutraceutical legal and regulatory compliances in India have taken a totally different 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 fields 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 affected the business of these segments.
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 affected 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 first 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 filed 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.