FDA to begin regulating electronic cigarettes
The fast-growing “vaping” industry faces a hazy future as the U.S. government said Thursday that it’s taking the “milestone” step of regulating electronic cigarettes and other tobacco products as if they were traditional cigarettes.
The Food and Drug Administration finalized rules extending its oversight of the multibillion-dollar e-cigarette industry, whose products are seen as an alternative to traditional smokes but whose own ingredients and long-term health risks remain murky.
Under the new rules, which go into effect in about three months, e-cigarette sales would be prohibited to anyone under 18, either in person or online. Vending-machine sales, except in adult-only establishments, and the distribution of free samples would be banned.
Manufacturers and importers of e-cigarettes and related products launched since 2007 — which covers the vast majority of the business — also must submit their products for approval so the FDA can evaluate their “ingredients, product design and health risks,” the agency said.
But makers of e-cigarettes and the liquid that goes in them have up to two years to submit their current products for approval, and the FDA’s review is likely to take another year, during which the companies can keep selling the products.
E-cigarette products also will be required to eventually carry health warnings on labels and in advertising.
Until now, all of those products “had gone largely unregulated” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
The new rules also apply to hookah tobacco, pipe tobacco and cigars.
The FDA’s move came one day after Gov. Jerry Brown signed two new major anti-smoking laws in California.
One law raised the smoking age to 21 from 18. The other prohibits e-cigarette use in restaurants, theaters, schools and other public places where smoking already is banned.
E-cigarettes are battery-powered products that typically come in a sleek metal tube the size of a cigarette or somewhat larger. They convert liquids containing nicotine, flavoring and other ingredients into a vapor that the user inhales and exhales, or what’s dubbed “vaping.”
Users refill their e-cigarettes with fresh cartridges or additional liquid, depending on the product, and the liquid can contain varying strengths of nicotine.
Health advocates applauded the FDA’s action. The move was a “long-awaited step to protect public health” and curb growing e-cigarette use among teenagers, American Lung Assn. President Harold Wimmer said in a statement.
The FDA is part of the U.S. Department of Health and Human Services, and HHS Secretary Sylvia Burwell said in a statement that “as cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap.”
E-cigarette use among high-school students “has skyrocketed from 1.5% in 2011 to 16% in 2015,” the FDA said, adding that 3 million middle school and high school students are e-cigarettes users.
But opponents said the FDA’s product-review rules could harm the e-cigarette industry.
Although the FDA contends that the cost of its approval process is less than $1 million per item, other estimates place the cost above $1 million.
Either way, critics said the price would be too onerous for many of the small businesses that manufacture e-cigarettes, the vaping liquids and other related items.
“This gigantic price tag is affordable to Big Tobacco companies but small- and medium-sized businesses will be crushed,” said Gregory Conley, president of the American Vaping Assn.
The e-cigarette brands owned by large tobacco companies include Reynolds American Inc.’s Vuse and Imperial Brands’ Blu.
“If the FDA’s rule is not changed by Congress or the courts, thousands of small businesses will be closed in two to three years” and “tens of thousands of jobs will be lost and consumer choice will be annihilated,” Conley said.
Analysts at Wells Fargo & Co. and other researchers estimate the industry’s annual sales at $2.5 billion to $3.5 billion, and thousands of small “vape” shops have sprung up nationwide in recent years.
The future of those stores would be jeopardized if the FDA’s approval process forces e-cigarette manufacturers to stop making many of their products, Conley said.
“If and when the FDA regulation removes 99% of products from the market, there will be no point in having a vape shop,” he said.
Vape shops often describes themselves as a “vape bar and lounge” where customers can congregate and try out different e-cigarette flavors.
One such shop is Vapor Delight in Santa Monica, where the mingled smell of berries, bananas and other aromas filled the air Thursday as general manager Justin Renken weighed the FDA’s action.
“It’s not fair,” Renken said. “We are trying to create jobs and new opportunities as entrepreneurs.”
One of his customers, Daniel Thang of Venice, said, “It’s good to limit the age of people who buy, but on the other hand, is that where it ends?”
“I’m afraid this could be the start of federal regulations piling up and that concerns me,” said Thang, 31, a longtime smoker who is hoping that e-cigarettes will help him quit.
But Robin Koval, chief executive of the anti-tobacco health group Truth Initiative, said in a statement that “for too long cigars, hookah tobacco and e-cigarettes have proliferated without product standards, sales and consistent age limitations, or controls on claims about health effects.”
“The FDA now has the opportunity to regulate how tobacco products are made, marketed and sold, to make them less toxic and addictive and less appealing to prospective users of all ages,” she said.
There is at least one congressional effort to curb the FDA’s new rules.
Legislation approved by a House committee last month would prevent the FDA from requiring reviews of products already on the market. Newly introduced e-cigarette products would still undergo the reviews.