The U.S. Food and Drug Administration has sent 21 letters to vapor companies seeking information about whether more than 40 products are being illegally marketed 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. The products include including the manufacturers and importers of Vuse Alto, myblu, Myle, Rubi and STIG,
“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,” said FDA Commissioner Scott Gottlieb. “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.”
Wells Fargo Managing Director Bonnie Herzog stated that her organization was not surprised by the FDA’s action as it attempts to get a better understanding of e-cig marketing tactics and rein in potential violators of the current deeming regs. “Importantly, the letters do not mean the FDA is considering enforcement action. We expect tobacco stocks to remain weak today on the news and would be buyers of MO as it trades down in sympathy,” she stated in an email.
The FDA stated that it had received complaints that some companies may be marketing new products that do not meet the Food Drug and Cosmetic Act’s (the Act) premarket requirements and that were introduced or modified after the deeming rule’s Aug. 8, 2016, effective date. Such modifications could include the introduction of new product features, formulations or flavors. These letters ask companies to provide information about the products in question, including evidence that the product is a deemed product that was on the market as of the Aug. 2016 deadline and has not been modified since that date.
Any product that does not comply with the premarket requirements of the Act is considered adulterated and misbranded by the FDA and may not be marketed without authorization.
