The Food and Drug Administration is threatening to pull new e-cigarette products from shelves if the companies don’t prove they’re selling the items legally.
The FDA sent letters on Friday to 21 e-cigarette manufacturers requesting information to investigate whether they illegally introduced more than 40 new devices and nicotine liquids to the market without receiving agency approval.
Business units of Big Tobacco companies British American Tobacco, Imperial Brands and Japan Tobacco are among the manufacturers that received letters. Juul, the clear market leader, did not receive a letter because regulators already obtained the information during a recent surprise inspection of the company’s San Francisco headquarters.
Via press release from the FDA:
The agency also recently issued letters to five major e-cigarette manufacturers whose products – JUUL, Vuse, MarkTen, blu e-cigs and Logic – comprise more than 97 percent of the market share for closed system ENDS products. These letters asked the firms to submit to the FDA within 60 days plans describing how each firm will address the widespread youth access and use of its products.
In addition, the FDA also recently stated it will consider whether it would be appropriate to revisit the current policy that results in certain deemed products remaining on the market without a marketing order from the agency. This could mean requiring companies to remove some or all of their flavored products, which may be contributing to the rise in youth use, from the market, until they receive premarket authorization and otherwise meet all of their obligations under the law.