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F.D.A. Tightens Rules for E-Cigarettes in a Landmark Move F.D.A. Imposes Rules for E-Cigarettes in a Landmark Move
(about 9 hours later)
WASHINGTON — The Food and Drug Administration made final sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, popular nicotine delivery devices that have grown into a multibillion-dollar business with virtually no federal oversight or protections for American consumers. WASHINGTON — After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children.
The 499-page regulatory road map has broad implications for public health, the tobacco industry and the nation’s 40 million smokers. The new regulations would ban the sale of e-cigarettes to Americans under 18 and would require that many people buying them show photo identification to prove their age, measures already mandated in a number of states. The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.
The long-awaited regulations shift the terms of the intense public debate over e-cigarettes, which deliver nicotine without the harmful tar and chemicals that cause cancer. The devices were introduced about a decade ago and have exploded in popularity. There are an estimated 9 million adult e-cigarette users in the United States. The long-awaited regulations, 499 pages of them, shifted the terms of the public debate over e-cigarettes, putting the federal government’s heft behind a more restrictive approach to the devices. Many health experts fear that e-cigarettes will eventually hook a new generation on traditional cigarettes, while others worry that a tougher approach will make it harder for addicted smokers to get access to devices that may be their best hope of quitting.
But they have sharply divided American public health experts. The central question is whether they help people stop smoking — or whether they are a gateway to traditional cigarettes, especially for younger people. Health experts in Britain have decided they are effective in helping people quit, and have urged smokers there to switch to them. American experts have been more cautious, warning that they may eventually result in young people moving from vaping to smoking traditional cigarettes. “We’ve agreed for many years that nicotine does not belong in the hands of children,” Sylvia Mathews Burwell, the secretary of the Department of Health and Human Services, said at a news conference on Thursday. “Progress has been made, but the context has changed so we need to act.”
The answer is important because smoking is still the largest cause of preventable death, with over 480,000 tobacco-related deaths each year in the United States. E-cigarettes were introduced about a decade ago as devices that deliver nicotine without the harmful tar and chemicals that cause cancer. They have since grown into a multibillion-dollar business, with nine million American adults using them, and while most health experts agree that they are less harmful than cigarettes, little is known about their long-term effects.
The regulations, which will take effect in 90 days, establish oversight of what has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance. Finalizing them has taken years. They stem from a major tobacco-control law Congress passed in 2009 and were first proposed in draft form in 2014. The rules, which take effect in 90 days, have broad implications for public health and the tobacco industry. They subject producers to federal regulation for the first time, requiring them to register with the F.D.A. and provide it with a detailed account of their products’ ingredients and their manufacturing processes. Producers will also have to apply to the F.D.A. for permission to sell their products. That includes vape shops that mix their own e-cigarette liquid.
“The process has started, and it has been incredibly difficult,” said Matthew Myers, president of Campaign for Tobacco-Free Kids, a health advocacy group, who generally welcomed the rules. The move was applauded by public health experts who said the industry needed oversight and who had been waiting nearly seven years for the agency to provide it. But it infuriated many e-cigarette companies, which argued that the rules would crush smaller producers that could not afford the time and lawyers to complete an arduous federal applications process. That would have the effect of buoying big tobacco companies, some argued, many of which have gotten into the e-cigarette business.
Perhaps the biggest change is a requirement that producers of cigars and e-cigarettes register with the F.D.A., provide the agency with a detailed accounting of their products’ ingredients, and disclose their manufacturing processes and scientific data. Producers will be subject to F.D.A. inspections and will not be able to market their products as “light” or “mild,” unless the F.D.A. allowed them to. Companies will be prohibited from giving out free samples. “This is not regulation — it is prohibition,” the American Vaping Association, a trade group for the industry, said in a statement. It said that submitting an application to get a product approved would take more than 1,700 hours and cost more than $1 million.
That would also apply to a swath of the many vape shops that have sprung up around the country in recent years. Shops that mix their own e-cigarette liquids would be considered producers under the law. The growing use of e-cigarettes has sharply divided American public health experts. The central question is whether they help people stop smoking — or whether they are a gateway to traditional cigarettes, especially for younger people. Health experts in Britain have decided that they are effective in helping people quit, and have urged smokers there to switch to them. American experts have been more cautious, warning that e-cigarette use may eventually result in young people moving from vaping to traditional cigarettes.
“There are retailers selling these products but in the back room they are also mixing,” said Mitch Zeller, the director of the Center for Tobacco Products at the F.D.A. “That means under the law they are manufacturers.” But smoking rates for youth have declined since the devices were introduced in the mid-2000s, and some experts say that is proof enough that the fears — at least for now — have not come to pass.
One of the central questions about the regulations was whether they would be so tough that it would be hard for smaller producers to remain on the market, and thus bolster large tobacco companies, which have money and big legal departments to navigate the arduous federal application process. “In terms of the health of the public, this action is a disaster,” said Dr. Joel L. Nitzkin, senior fellow for tobacco policy at the R Street Institute, a conservative think tank in Washington. “This will move the debate into a new arena. I wouldn’t be surprised if we started seeing lawsuits.”
The American Vaping Association, a trade group for the industry, seemed to take that view, arguing in a statement on Thursday that the agency had gone too far. Smoking is the largest cause of preventable death, with more than 480,000 tobacco-related deaths each year in the United States. Forty million American adults smoke.
“This is not regulation — it is prohibition,” the group said in a statement. It said the process for submitting an application, in terms of number of hours spent, would exceed a million dollars. The regulations establish oversight of what has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance. Finalizing the rules has taken years. They stem from a major tobacco-control law Congress passed in 2009 and were first proposed in draft form in 2014.
But federal health officials countered that the industry will have ample time to respond to the rules. Companies with products on the market now, including vape shops that mix their own liquids, will have two years to submit an application to the F.D.A. for approval of a product. It can stay on the market for another year while the agency reviews the application. “The process has started, and it has been incredibly difficult,” said Matthew L. Myers, the president of the Campaign for Tobacco-Free Kids, a health advocacy group, who welcomed the rules.
As for the cost, officials and advocates said it was too soon to tell, but added that there was broad agreement — including in federal statute — that the industry needed to be regulated, not unlike the food industry, for example, and that these rules were a thoughtful way to accomplish that. Mr. Zeller. said that until now the industry had been the “wild, wild West.” Producers will be subject to F.D.A. inspections and will not be able to market their products as “light” or “mild” without agency approval. Companies will be prohibited from giving out free samples.
“Today is a first step, a foundational step to bring all these previously unregulated products into the world of being regulated,” he said at a briefing. “There are retailers selling these products, but in the back room, they are also mixing,” said Mitch Zeller, the director of the Center for Tobacco Products at the F.D.A. “That means under the law, they are manufacturers.”
The rules also impose regulations on all tobacco cigars, a tougher move than originally anticipated as the agency was pondering excluding so-called premium cigars. One of the central questions about the regulations was whether they would be so tough that it would be hard for smaller producers to remain on the market and thus bolster large tobacco companies, which have money and big legal departments to navigate the arduous federal application process.
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. Advocates had been pressing the agency to prohibit flavors in all tobacco products, arguing that they appealed to young people and got a new generation hooked, and the omission in Thursday’s regulations was a disappointment. Market analysts and industry groups seemed to be in broad agreement on Thursday that the regulations would have that effect. Some public health experts also expressed that concern.
“The concern is for at least three years, flavored e-cigarette products will remain on the market no matter how many kids are using them,” Mr. Myers said. He added that the F.D.A. left open the possibility of limiting the addition of flavors in the future, but that it would depend on how the agency interpreted today’s rules. “If the vape shops go out of business because they cannot afford to provide the information the F.D.A. needs, then the multinational tobacco companies will have less competition,” said Gary A. Giovino, a professor of health behavior at the State University of New York at Buffalo.
Still, on the whole the public health community welcomed the rules. But federal health officials countered that the industry would have ample time to respond to the rules. Companies with products on the market now, including vape shops that mix their own liquids, will have two years to submit an application to the F.D.A. for approval of a product. It can stay on the market for another year while the agency reviews the application.
“At last, the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah,” Harold P. Wimmer, president of the American Lung Association, said in a statement. Officials and public health experts said there was broad agreement — including in federal statute — that the industry needed to be regulated, not unlike the food industry, and that these rules were a thoughtful way to accomplish that. Mr. Zeller said that until now the industry had been the “wild, wild West.”
The F.D.A. announcement followed a ruling by Europe’s highest court on Wednesday upholding the right of the European Union to place restrictions on the sale of electronic cigarettes. Europe’s rules are to take effect this month. “Today is a first step, a foundational step, to bring all these previously unregulated products into the world of being regulated,” he said at the agency’s briefing.
The rules also impose regulations on hookah and pipe tobacco, as well as all cigars, a tougher move than originally anticipated as the agency was pondering excluding so-called premium cigars.
The rules did not include specific bans on flavors in e-cigarettes, though health officials said they were working on new rules to extend the flavor ban for traditional cigarettes to cigars. Antismoking activists had been pressing the agency to prohibit flavors in all tobacco products, arguing that they appeal to young people, and the omission in the new regulations was a disappointment.
“The concern is for at least three years, flavored e-cigarette products will remain on the market no matter how many kids are using them,” Mr. Myers said. He added that the F.D.A. left open the possibility of limiting the addition of flavors in the future, but that it would depend on how the agency interpreted the rules released Thursday.