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FDA Shutting Down The Vape Industry

America’s Food and Drug Administration has taken steps to close more vape businesses and put people out of work for doing nothing more than offering harm reduction products

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America’s Food and Drug Administration (FDA) has taken steps to close more vape businesses and put people out of work for doing nothing more than offering harm reduction products. Its letter to ten companies has left them unable to operate online.

Today,” wrote the FDA, “the U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.

These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America. The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.”

In its warning letter to Cool Clouds Distribution, the FDA stated it had “recently reviewed the website” and deemed that the items listed for sale were being made available to Americans.

Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.”

As the products hadn’t been on sale prior to August 8, 2016, the FDA says they constituted a breach of the relevant act.

It also said the company was making the following claims:

  1. the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products
  2. the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance
  3. the products or their smoke do not contain or are free of a substance.

Despite the fact that vape products DO present a fraction of the risk of cigarettes, have demonstrably reduced levels of toxicants, and do not contain tar or emit carbon dioxide.

FDA Commissioner Stephen Hahn said: “The FDA continues to prioritise enforcement against e-cigarette products, specifically those most appealing and accessible to youth. We are concerned about the popularity of these products among youth and want to make clear to all tobacco product manufacturers and retailers that, even during the ongoing pandemic, the FDA is keeping a close watch on the marketplace and will hold companies accountable.”

So, despite having a pandemic to deal with, the FDA is remaining firmly committed to its fictitious ‘teenage epidemic’ and ‘marketing to teens’ tropes.

Anti-vaping Mitch Zeller, director of the FDA’s Centre for Tobacco Products, added: “Despite suspending in-person inspection activities, such as retail compliance checks and vape shop inspections, due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured. These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”

The Puff Bar website now states it has ceased online trading in the United States, but the story is probably far from over according to Vaping 360’s Jim McDonald.


  • FDA warning letter to Cool Clouds Distribution – [link]
  • Puff Bar: A Preview of the Post-PMTA Vaping Industry, Vaping 360 – [link]
  • So Much for the Loophole: FDA Orders Puff Bar Off the Market, Vaping 360 – [link]
Dave Cross avatar

Dave Cross

Journalist at POTV
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Dave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous vape companies to develop content for their websites.

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