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F.D.A. Tightens Rules for E-Cigarettes in a Landmark Move F.D.A. Tightens Rules for E-Cigarettes in a Landmark Move
(about 2 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 — 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.
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 people buying them show photo identification to prove their age, measures already mandated in a number of states. The rules also impose regulations on cigars. 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 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. Producing them has taken years. They stem from a major tobacco-control law Congress passed in 2009. They were first proposed in draft form in 2014. 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 process has started, and it has been incredibly difficult,” said Matthew Myers, president of Campaign for Tobacco-Free Kids, a health advocacy group. “This gives the F.D.A. the authority right away to prohibit some of the most outrageous marketing claims. It imposes nationwide rules that make it illegal to sell to kids under 18 with real enforcement authority.” 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.
Perhaps the biggest proposed change would require producers of cigars and e-cigarettes to 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 would also be subject to F.D.A. inspections and would not be able to market their products as “light” or “mild,” unless the F.D.A. allowed them to. Companies would also be prohibited from giving out free samples. 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.
“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. 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 did not include specific bans on flavors, Mr. Myers said. Advocates had been pressing the agency to prohibiting them, arguing that they appealed to young people and got a new generation hooked. “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.
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.
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.
“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.”
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 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.
“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.
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.
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.”
“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.
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.
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.
“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.“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.
“The unfortunate reality is we really don’t know what’s going to happen until we see how F.D.A. interprets that provision,” he said. Still, on the whole the public health community welcomed the rules.
“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.
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.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.