Makers of e-cigarettes have 3 months to get FDA license

MANILA, Philippines — Manufacturers of electronic cigarettes have been given three months to register and comply with the regulations set by the Food and Drug Administration (FDA) or they run the risk of their products being confiscated.

Health Undersecretary Rolando Enrique Domingo said manufacturers, importers and retailers of e-cigarettes should secure during this three-month period a license to operate as well as be issued a certificate of product registration for them to sell their products to the public legally.

“After three months, when we see unregistered products, we will come up with an advisory to remind the public that such products have not been tested and for the companies to recall them from the market,” said Domingo, currently the officer in charge of FDA.

Last month, the Department of Health (DOH) issued Administrative Order No. 2019-0007, which seeks to regulate the manufacture and sale of nicotine and non-nicotine delivery systems, popularly known as e-cigarettes, which are being marketed as safer alternatives to combustible cigarettes.

Heat-not-burn products

Manufactures must submit to the FDA the list of all the ingredients used for the product.

Health Secretary Francisco Duque III, however, warned the public to steer clear of these products, saying they are “not completely without harm.”

“While there is a lack of conclusive data regarding the long-term effects of using e-cigarettes, its health risks cannot be set aside,” Duque said.

Aside from e-cigarettes, heat-not-burn tobacco products are also being marketed as safer alternatives to smokers.

Non-combustible tobacco products such as heat-not-burn devices offer the best way to end the smoking epidemic that kills 20,000 people a day, according to health experts.

27% drop in sales

Japan saw cigarette sales fall 27 percent in two years with the introduction of heat-not-burn products, according to Prof. Gerry Stimson of the London School of Hygiene and Tropical Medicine.

Around 17 percent of the Japan cigarette market have switched to IQOS, the heated tobacco system of Philip Morris International.

David Sweanor, a lawyer and chair of the advisory board of the Centre for Health Law, Policy & Ethics at the University of Ottawa, said this was because electronic nicotine delivery systems such as heat-not-burn products, e-cigarettes and Swedish snus are much safer alternatives to cigarette smoking.

“We have seen examples around the world that many smokers will move to these products,” Sweanor said.

The Global State of Tobacco Harm Reduction Report estimates that by 2021, over 55 million people will be using e-cigarettes or heat-not-burn tobacco products and that the global market will be worth $35 billion.

Sweanor said tobacco companies are now forced to offer safer nicotine products because of the rising demand from consumers.

“Companies are constantly looking at where the market is going. If you miss the change, you will go broke,” he said. “The people could now get what they want from cigarettes in a far less hazardous way.”