�Թϲ�����

The Food and Drug Administration on Wednesday declared that teenage use of electronic cigarettes has reached “an epidemic proportion,” and it put makers of the most popular devices on notice that they have just 60 days to prove they can keep their devices away from minors. The order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes. If Juul Labs and four other major manufacturers fail to halt sales to minors, the agency said, it could remove their flavored products from the market. It also raised the possibility of civil or criminal charges if companies are allowing bulk sales through their websites. (Kaplan and Hoffman, 9/12)

The warning from the Food and Drug Administration on Wednesday cited recent data pointing to a sharp rise in underage use of the devices, including Juul, Vuse and others. It marks a shift in the agency's tone on e-cigarettes. Since 2017, FDA commissioner Scott Gottlieb has discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes, although that benefit hasn't been proven. (Perrone, 9/12)

The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year, compared with 2017. The FDA declined to publicly release the numbers, but people familiar with them said they were preliminary data from the National Youth Tobacco Survey, on which the agency and the Centers for Disease Control and Prevention collaborate. (McGinley, 9/12)

Dr. Gottlieb said he believes that certain flavors make the products appealing to teens. “The availability of e-cigarettes cannot come at the expense of addicting a new generation of youth onto nicotine, and it won’t,” he said in an interview. The announcement marks an about-face for the agency, which in 2016 granted a grace period for e-cigarettes already on the market until the manufacturers submitted products for FDA review. Last year, Dr. Gottlieb extended that grace period to 2022, allowing Juul Labs Inc. and others to continue to sell their existing products. (Maloney, 9/12)

The announcement was immediately hailed by anti-tobacco advocates. "This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes," said an emailed statement from Matthew Myers, president of the Campaign for Tobacco-Free Kids. "Today's announcement will represent a fundamental turning point, if but only if, FDA formally requires all manufactures to comply with these requirements and FDA reverses its policy and requires that all of these products undergo premarket review now, not four years from now." (Stein, 9/12)

The actions were greeted with defiance and derision from the vaping industry. “Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and don't even sell the products being targeted by the FDA with threatening letters,” said Gregory Conley, president of the American Vaping Assn., a nonprofit organization that advocates for what it calls sensible regulation. (Healy, 9/12)

Massachusetts Attorney General Maura Healey raised similar concerns about e-cigarettes in July, when she said her office was investigating one of the biggest makers, San Francisco-based JUUL Labs Inc., for alleged sales to minors. While teen cigarette use has hit a record low, she said, “ ‘juuling’ and vaping have become an epidemic in our schools, with products that seem targeted to get young people hooked on nicotine.” (Saltzman and Freyer, 9/13)