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FDA takes action against popular vaping brand

The US Food and Drug Administration is going after vaping company Eonsmoke LLC with...

Posted: Oct 24, 2019 1:10 PM

The US Food and Drug Administration is going after vaping company Eonsmoke LLC with a warning letter seeking to remove roughly 100 flavored vaping products from the market, saying the company "has ignored the law by marketing dozens of unauthorized e-cigarette products," according to a statement by Acting FDA Commissioner Dr. Ned Sharpless.

"Companies are on notice -- the FDA will not allow the proliferation of illegally marketed e-cigarettes or other tobacco products, to come at the expense of our children," Sharpless said in a statement Thursday. "Today's action makes clear that we will continue to keep a close watch on companies and take swift steps when violations are found."

The warning letter also cites claims made by the company that its products are less harmful than other marketed tobacco products -- claims that require FDA review. The company has also advertised online and through social media, including posts "by well-known influencers," that do not contain the required warning statement that nicotine "is an addictive chemical." The company was requested to, but did not provide, the FDA with a list of ingredients in its products.

Eonsmoke LLC sells e-liquids in flavors "such as mango, cotton candy, sour gummy worm and others that are so popular with kids," Sharpless said.

A written response from the company was requested within 15 working days. If the company doesn't comply, the FDA can then take further action such as civil money penalties, seizures or injunctions.

Michael Tolmach, CEO of Eonsmoke, said the company is reviewing the FDA's notice.

"Our company takes this matter and the national vaping crisis very seriously. We will comply will all FDA requests in the time table allotted," Tolmach said in an email. "We've shut down our entire marketing campaign months ago including closing our Instagram, Facebook, and Twitter pages. We look forward to complying and interacting with the FDA over the coming weeks and resolving this crisis. "

The FDA had sent Eonsmoke a letter a year ago asking for more information about whether the company was illegally marketing new tobacco products. The company has also previously been named in probes such as an investigation by Massachusetts Attorney General Maura Healey and a lawsuit by North Carolina Attorney General Josh Stein.

The FDA's latest move comes amid calls by lawmakers such as Rep. Raja Krishnamoorthi and Sen. Dick Durbin for the FDA to issue the compliance policy it announced last month that would clear the market of unauthorized flavored e-cigarettes.

In an email Tuesday, an FDA spokesman said the agency intends to finalize its compliance policy "in the coming weeks" and that the FDA "plans to share more on the specific details of the plan and its implementation soon."‎

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