The rules did not include specific bans on flavors in e-cigarettes, though health officials said they would produce a new rule that would extend the flavor ban in traditional cigarettes to cigars.
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Industry spokespeople call the rules Draconian.
Others fear the devices will addict nonsmokers to nicotine and eventually lead to more people smoking.
Research has showed that e-cigarettes have become a problem for children.
“Use of these products has risen dramatically – especially among youth – so it is imperative the FDA have authority over these previously unregulated tobacco products”, said Kevin Walker, regional vice president of advocacy for the American Heart Association in Kansas, Missouri and Iowa. What we know is absence of federal restriction means that enforcement is uneven and at times nonexistent, HHS Secretary Sylvia Burwell said during a news conference.
Since e-cigarettes appeared on the market, they have been touted as a safer alternative to traditional cigarettes, but consumers didn’t have any way to validate or refute that claim without government oversight.
The FDA held three public workshops to gather information about the devices and the potential impact on public health.
Though changes won’t happen tomorrow, regulating e-cigarettes was much needed.
They say numerous small businesses that make their products would go out of business once the rules are in place.
Electronic cigarettes, like traditional ones, will be banned in public spaces across the state.
“As a physician, I’ve seen first-hand the devastating health effects of tobacco use”, said FDA Commissioner Robert M. Califf, M.D.
Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The devices will no longer be sold to anyone under 18 and hundreds of brands will now have to get FDA approval.
“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated”, said Mitch Zeller, director of the FDA’s center for tobacco products.
The rules go into effect in 90 days.
The new rules also apply to premium cigars and hookah. “We want them to be defined as a tobacco product”.
But Chris Hansen, president of the American Cancer Society Cancer Action Network, praised the FDA for including a wide range of cigars, including premium cigars, saying “these products pose no less a health risk than other cigars”. It warned e-cigarette users that they were inhaling “toxic” and “harmful” chemicals. Legislation in Congress would move that to a later date, since there were few if any e-cigarettes on the market prior to 2007.
But many anti-smoking advocates disagree. They lack the chemicals and tars of burning tobacco, but the cigarettes have not been extensively studied, and there’s no scientific consensus on the risks or advantages of “vaping”. “In the interests of public health it is important to promote the use of e-cigarettes”, the group said in a statement released April 28. Industry officials said the regulations could hurt smaller companies and cripple a their job-creating business due to the expense of the regulatory process.
The FDA’s regulation had been highly anticipated after the agency issued a proposed rule two years ago on how to oversee the $3 billion e-cigarette industry and these other products.
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41 states have already banned the sale of E-cigarettes to minors.
