The US Food and Drug Administration says it has sent letters to electronic-cigarette companies seeking to discover if 40 such products are being marketed illegally.
In a note issued through its Center for Tobacco Products, the FDA said the 21 letters that had been sent included those to the manufacturers and importers of the brands Vuse Alto, myblu, Myle, Rubi and STIG.
It said it was ‘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,’ the note said.
“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,” FDA Commissioner Scott Gottlieb, M.D, was quoted as saying. “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.”
‘The FDA has received complaints that some companies may be marketing new products that do not meet the Food Drug and Cosmetic Act’s (FD&C Act) premarket requirements and that were introduced or modified after the deeming rule’s Aug. 8, 2016, effective date,’ the note said. ‘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 Aug. 8, 2016 and has not been modified since that date.
‘Any product that does not comply with the premarket requirements of the FD&C Act is adulterated and misbranded and may not be marketed without authorization from the FDA. The agency has several tools to enforce these requirements and its regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.’
There is more information here.
E-cig epidemic crackdown
