Agency seeks more information from companies as it continues to pursue its Youth Tobacco Prevention Plan amid evidence of sharply rising e-cigarette use among kids.
Today, the U.S. Food and Drug Administration sent letters to 21 e-cigarette companies, including the manufacturers and importers of Vuse Alto, myblu, Myle, Rubi and STIG, seeking information about whether more than 40 products – including some flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy. These new actions build on those taken by the FDA in recent weeks as part of its Youth Tobacco Prevention Plan to address the epidemic of youth e-cigarette use, including cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.
“Companies are on notice – the FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency’s compliance policy, and we will take swift action when companies are skirting the law. Given the explosive growth of e-cigarette use by kids, we’re committed to taking whatever measures are appropriate to stem these troubling use trends. We’re going to address issues related to the access kids have to e-cigarettes, as well as the youth appeal of these products. If products are being unlawfully marketed and outside the FDA’s compliance policy, we’ll act to remove them. This includes revisiting our compliance policy that has resulted in certain e-cigarettes, including flavored e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorization. Further, many of these products pose particular concerns given their use of flavors. We know flavors are one of the principal drivers of the youth appeal of e-cigarettes and we’re looking carefully at this,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA remains committed to the potential opportunity for e-cigarettes to help adult smokers transition away from combustible cigarettes. But we cannot allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine. We’ll take forceful steps to stem the youth use, even if our actions have the unwelcome effect of impeding some opportunities for adults. These are the hard tradeoffs we now need to make. We’ve been warning the e-cigarette manufacturers for more than a year that they need to do more to stem the youth use. No reasonable person wants to see these products reaching epidemic use among kids. Retailers and manufacturers of e-cigarettes know that the FDA is aggressively enforcing the law to ensure they are complying with prohibitions against marketing and selling to kids. Through these actions – and with more to come in the weeks and months ahead – we’re committed to doing all we can to reverse the disturbing trends of youth tobacco use, especially e-cigarettes. I’ll do everything I can to curb the epidemic of youth use.”
As part of the FDA’s comprehensive plan on tobacco and nicotine regulation, the agency implemented a new compliance policy related to the deadline for companies to submit tobacco product review applications for “deemed” tobacco products that were on the market as of Aug. 8, 2016 – the effective date of the final deeming rule that extended the FDA’s authority to additional tobacco products such as e-cigarettes. The compliance policy provided manufacturers additional time to develop higher quality, more complete applications. The extension of the compliance date also aimed to give the agency more time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. These measures, which will focus on protecting youth, could include an examination of flavors/designs that appeal to children, child-resistant packaging and product labeling to prevent accidental child exposure to e-liquid nicotine.
Read more at https://www.fda.gov