E-cigarettes not drug, traders can resume sale, says Bombay high court
The FDA had on July 6 issued a show cause notice to GPI asking them why legal action should not be initiated against them for selling e-cigarettes and violating provisions of the Drugs and Cosmetics Act and the Cigarettes and Other Tobacco Products Act.
In a reprieve for e-cigarette manufacturers and distributors, the Bombay high court (HC) on Friday allowed them to resume sale of the product as it is not a drug. Observing that the action taken against them by the Food and Drugs Administration (FDA) was not sustainable, the HC directed it to release the seized stock of e-cigarettes.
A bench of justices Ranjit More and Bharati Dangre was hearing two separate petitions — filed by Godfrey Phillips India Limited (GPI), and local e-cigarette stockist, Hamida Manwani — seeking directions to the FDA to release their seized goods and restrain it from taking any further action against them. Acting on a Ministry of Health and Family Welfare advisory instructing all states to ban production, storage, distribution and sale of e-cigarettes, the FDA had on July 6 issued show cause notices to GPI and subsequently seized their stock.
“Prima facie, ENDS [Electronic Nicotine Delivery System, popularly known as e-cigarette] does not fall within the definition of drugs, as contemplated under provisions of the Drugs and Cosmetics Act, 1940,” said the bench on Friday. “And, therefore, we are of the view that the action of search and seizures, issuance of show cause notices [by FDA] and directions not to dispose of the stock cannot be sustained,” the judges said, allowing manufacturers and stockists to sell the product. The bench’s order was issued primarily in view of the fact that though tobacco and other tobacco products are regulated, nicotine or nicotine preparations, including e-cigarettes, are not covered under the Drugs and Cosmetics Act or the Cigarettes and Other Tobacco Products Act, 2003.
The FDA had on July 6 issued a show cause notice to GPI asking them why legal action should not be initiated against them for selling e-cigarettes and violating provisions of the Drugs and Cosmetics Act and the Cigarettes and Other Tobacco Products Act. The notice was followed by inspection of GPI’s Lalbaug office and seizure of the entire stock of e-cigarettes at its warehouses in Andheri and Vakola on June 25.
Senior advocate Amit Desai, representing GPI, pointed out that the Delhi HC had stayed the advisory by the Union ministry, and therefore, the FDA should not have taken action on its basis. “They have seized our entire stock and stopped our operations completely,” Desai had submitted. Additional public prosecutor Aruna Pai opposed the plea, claiming the Delhi HC had taken into consideration only the report of 44th meeting of the Drugs Consultation Committee (DCC) and did not look into the recommendations made by the DCC —to include ENDS within the definition of drugs — on June 1.
The bench, however, rejected the argument. It said the recommendation has not yet been acted upon by the Centre and “as of today FDA had no powers to take the action”.