FDA Steps Up Scrutiny of E-Cigarette Industry

Manufacturers told to submit plans describing how they’ll address the issue of underage e-cigarette use.

October 15, 2018

WASHINGTON – In another round of scrutiny over electronic cigarettes, the U.S. Food and Drug Administration (FDA) has issued letters of inquiry to 21 manufacturers of e-cigarettes following charges that approximately 40 products are being illegally marketed or are not compliant with the agency’s current policy, the FDA announced.

The list of companies contacted includes the manufacturers and importers of more than 97% of closed-system products that range from vapes, vaporizers, vape pens and hookah pens to e-cigarettes and e-pipes.

In the letters, the FDA asked the firms to submit plans within 60 days describing how they will address the issues of youth access and use of its products. The action follows similar steps taken earlier this fall to combat the underage use of e-cigarettes, including warning letters sent to retailers caught selling e-cigs to undercover operatives and letters of inquiry to multiple manufacturers.

“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 Scott Gottlieb, FDA commissioner, on October 12.

The FDA has received complaints that some companies may be marketing new e-cigarette products that fail to meet government regulations and that some were introduced or modified after the FDA deeming rule’s August 8, 2016, effective date, the agency said. Modifications can include the introduction of new product features, formulations or flavors.

The latest letters request information about questionable products, including proof that the product was on the market as of August 8, 2016, and has not been modified since that time.

“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,” said Gottlieb.