WASHINGTON -- In yet another round of scrutiny over electronic cigarettes, the U.S. Food and Drug Administration (FDA) issued letters of inquiry to 21 manufacturers—including manufacturers and importers of Vuse Alto, myblu, Myle, Rubi and STIG brands—over allegations that about 40 products are being illegally marketed or are not compliant with the agency’s current policy, the FDA announced.
Here’s a full list of the companies that received letters on Oct. 12.
The action follows similar steps taken earlier in the fall to address the issue of underage use of e-cigarettes and the potential role of flavors, especially those that may appeal to minors. Those actions included warning letters to retailers allegedly caught selling e-cigarettes to undercover operatives, as well as 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,” Scott Gottlieb, commissioner of the FDA, said on Oct. 12. “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.”
The FDA had received complaints that some companies may be marketing new products that do not meet the Food, Drug and Cosmetic Act’s premarket requirements and that were introduced or modified after the FDA deeming rule’s Aug. 8, 2016, effective date, the agency said. Such modifications could include the introduction of new product features, formulations or flavors.
The latest letters asked 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.
The agency took similar steps when it approached Juul Labs, San Francisco, with an unannounced on-site inspection of its corporate headquarters, the agency said.
“We are 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,” said Bonnie Herzog, managing director for consumer equity research, Wells Fargo Securities, New York, in a research note. “[More] importantly, the letters do not mean the FDA is considering enforcement action.”
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