The Thursday, giving the agency authority over e-cigarettes, cigars, little cigars, pipe tobacco, hookah pipes, and other tobacco products.
The action will subject all manufacturers, importers and/or retailers of e-cigarettes and the other newly regulated products to the same regulatory restrictions as traditional cigarettes, and bar sales of these products to minors.
Moreover, starting in 90 days, photo IDs will be required to purchase e-cigarettes, hookahs and the other products, and sale of the products in vending machines and distribution of free samples will be prohibited. Advertising and marketing of the products will be greatly restricted as well.
The regulatory move will require the manufacturers of e-cigarettes and the other newly-regulated products to receive marketing authorization from the FDA, with the exception of products that entered the market before Feb. 15, 2007.
That means that hundreds of e-cigarette products must undergo federal review if they are to remain on the market.
The tobacco product review process will also extend FDA authority over ingredients and product design.
Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to 2 years while they submit a new tobacco product application, and for an additional year while the FDA reviews it.
"As a physician, I've seen first-hand the devastating health effects of tobacco use," FDA Commissioner Robert M. Califf, MD, noted in a written press statement. "At the FDA we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive review."
In a conference call with reporters, Califf said expanding FDA authority to e-cigarettes and other vaping products and restricting the sale of the products to those age 18 and older will help address “the alarming increase in youth use of these products.â€
He noted that use of e-cigarettes by teens and children increased by more than 10-fold in the U.S. from 2011 to 2015, according to findings from the CDC’s National Youth Tobacco Survey.
“Today’s rule is a milestone in consumer protection,†he said. “It represents a new chapter in our efforts to do everything we can under the law to protect Americans from the dangers of tobacco products.â€
As a provision of the final rule, the FDA is giving manufacturers 2 years to submit applications to the agency showing that their product poses no new health risks.
Asked during the press conference if the new regulations on e-cigarettes might discourage their use by cigarette smokers who want to quit, Mitch Zeller, who directs the FDA’s Center for Tobacco Products, said the evidence to date does not show the products to be effective tools to promote smoking cessation.
“While there may be anecdotal reports that e-cigarettes are helping smokers get off cigarettes, the U.S. Preventive Services Task Force and the published literature at this point don’t provide support for e-cigarettes being effective cessation aides,†he said.
He cited recent data suggesting that at least 70% of current adult e-cigarette users continue to smoke cigarettes or use other tobacco products.
Zeller added that it is not yet clear if e-cigarettes are being used as gateway products by youth and adults who have never before smoked cigarettes.
“From a public health perspective, any initiation of e-cigarettes by someone who has never used tobacco products is not good for public health,†he said.
Reaction to the new regulations was swift, with health advocacy group praising the FDA, while vaping industry groups and others continued to argue that e-cigarettes are less harmful than traditional tobacco products and should not be regulated in the same way.
Erika Sward of the American Lung Association told app that the group is pleased that the FDA included all cigars in the final deeming rule, instead of exempting certain cigars from federal oversight as had been proposed.
"The American Lung Association is very pleased to see FDA move forward with these common sense protections for our nation's health," she said. "We urge Congress not to try to delay or weaken these rules." Legislation under consideration in the House would effectively strip the FDA of much of the authority underlying the new rules.
The American Association of Pediatrics also issued a statement applauding the new rules.
"The rule is a welcomed starting point, but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all," it said. "Today's action marks an historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth, and should serve as a foundation for further progress when it comes to keeping children safe from dangerous tobacco products."
But of the National Center for Public Policy Research, which opposes most federal regulations on industry, said the FDA move could end up harming public health by making it harder for smokers to switch to e-cigarettes.
"My concern is that this regulation will stifle necessary innovation," he said, citing a recent report by Britain's Royal College of Physicians finding e-cigarettes to be a much safer alternative to combustible cigarettes and promoting their usefulness as smoking cessation tool.
"If the FDA's regulation in any way stifles regulation, that could undermine the health of those who are using these cigarettes as an alternative to smoking," he said. "It could force them to the black market or force them to go back to smoking."