FDA Serving Notice to E-Cigarette Manufacturers

Illegal marketing activities receiving increased scrutiny

The FDA sent 21 letters to e-cigarette companies, 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.” said FDA Commissioner Scott Gottlieb, MD.

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. 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.


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