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| F.D.A. Tightens Rules for E-Cigarettes in a Landmark Move | |
| (35 minutes 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 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 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 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 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.” | |
| 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. | 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. |
| “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. | “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 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 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 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. | “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. |