FDA unveils new regulations on tobacco, vaping industry
WASHINGTON – The U.S. Food and Drug Administration announced Thursday that it will regulate all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.
Until now, the FDA could only regulate cigarettes and cigarette-related products and smokeless tobacco.
“This action is a milestone in consumer protection — going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products,” the FDA said in announcing the changes.
The rules will forbid the sale of e-cigarettes to people under the age of 18 and will allow the government to regulate the contents of the products.
According to The Hill, the rule also prohibits products from being sold in vending machines, distributed as free samples or marketed as “light,” “low” or “mile” unless authorized by the FDA.
It also puts more of a spotlight on manufacturers, who must submit applications to the FDA to show that their products do not post any new health risks beyond products that were already on the market.
The FDA said it will also control the “parts” and “components” of tobacco. For e-cigarettes, that would include e-liquids, atomizers, batteries, flavors, vials that contain e-liquids and programmable software.
Tobacco and e-cigarette manufacturers must register their facilities and give the FDA a list of products, ingredients and must have the products reviewed and approved.
The regulations came with much concern to the e-cigarette industry, but the FDA said it is staggering the compliance date for new products to meet the regulations.
The FDA admits that many vape shops will close their doors, but it claims many will still be able to operate, despite massive costs that are expected to reach over $1 million the first year.
The Vapor Technology Association said the FDA’s regulations will put a roadblock in the way of an industry that has helped people stop smoking.
“Despite an overabundance of distorted and misleading information propagated by some in the public health community, the science is clear- responsibly manufactured vapor products are not only a safe alternative to traditional combustible products, but also provide smokers with a viable path to reducing their tobacco consumption and quitting altogether. Today’s action by the FDA will do nothing to improve our nations’ public health objectives. To the contrary, today’s action will yank responsibly manufactured vapor products from the hands of adult smokers and replace them with the tobacco cigarettes they had been trying to give up. Moreover, by simple dumping vapor technology products into an already antiquated federal regulatory scheme, the FDA will, in one stroke, kill almost a decade of innovation in the vapor technology industry and, at the same time, kill the many thousands of small and mid-size businesses in communities across this country who have invested in establishing retail stores and developing new technologies that sit outside of the influence of Big Tobacco. If enforced, the unreasonable and excessive regulations proposed by the FDA will only serve to put these innovators out of business, their employees out of work and hand deliver a monopoly on vapor products to Big Tobacco,” Tony Abboud, the association’s National Legislative Director, said in a statement.
The FDA attempted to ban the sale of e-cigarettes following a 2009 study that found detectable levels of carcinogens and toxic chemicals in e-cigarette samples. But a court ruled in 2010 that the FDA had not cited evidence of harm.