Health products: FDA toothless after SC order

Nagpur: Putting aside all speculations of activists and complainants about the quality of nutraceuticals, food and health supplements available in the market, the Food and Drug Administration (FDA) has stopped the process of asking nutraceutical companies for withdrawal of controversial products from the market. It is only picking samples and sending them for testing as per the recent directives of the Food Safety and Standards Authority of India (FSSAI).

Three nutraceutical companies — Herbalife International India Pvt Ltd, Vestige Marketing Pvt Ltd and Sami Direct Marketing Pvt Ltd — were in news for quite some time due to various issues related to their products based on which there were directives from the FSSAI to withdraw these products from the market.

Activists and certain complainants were pressuring the local FDA to ask the respective companies to follow the FSSAI directives. Apparently, these companies had neither withdrawn the rejected products nor obtained the required NOC or obtained product approval from FSSAI.

But somehow, the FDA kept postponing any action. And luckily for the companies, the Supreme Court issued directives that there was no need for product approval by the manufacturer as FSSAI was just issuing these directives as an advisory body and was actually not empowered to do so.

Following this, the FSSAI has now issued an order dated March 30, 2016 saying that looking at the numerous representations received by FSSAI from Food Business Operators (FBOs) engaged in manufacture and distribution of nutraceuticals, food and health supplements regarding large scale enforcement activities being undertaken by state food safety departments, it has been decided that until 'standards' of nutraceuticals and supplements are notified enforcement agencies against FBOs may be restricted to just testing of products with respect to requirements given in the draft notification on such products uploaded on FSSAI website on September 9, 2015.

However, it goes with the rider that these products were available in market prior to FSSAI Act, FBOs had applied for product approval and decision was pending as on August 2015 and such products are explicitly covered under the draft notification. "We are bound by the FSSAI order dated March 30, 2016," said Shivaji Desai, the joint FDA Commissioner (food).

However, activist Sachin Khobrgade of Sangharsh Vahini says that though Section 22 of FSS Act 2006 has been discontinued until a new regulation regarding product approval comes, the Scientific Committee ordered the FBOs to stop manufacturing, sale and distribution of the products. He insists FBOs should share details of recalled products as per the same section.