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July 20, 2020

So Much for the Loophole: FDA Orders Puff Bar Off the Market

The best-known U.S. distributor of disposable vape Puff Bar has received a warning letter from the FDA, ordering the products to be removed from the market. The action came after months of news stories incorrectly claimed Puff Bar was exempt from FDA enforcement.

The letter was sent to Umais Abubaker, the owner of Cool Clouds Distribution, Inc., the largest and best known importer of the rectangular-shaped disposable e-cigarette. As we explained in a recent article, multiple Shenzhen, China factories produce Puff Bar products and offer them wholesale on Chinese e-commerce sites. Sending a warning letter to a single distributor may not cut off the flow of Puff Bars to American retail outlets.

The Puff Bar website believed to be run by Cool Clouds Distribution announced last week that it had “ceased all online sales & distribution in the U.S. until further notice,” so the FDA action is probably meaningless. The Puff Bar mogul will likely just move on to selling similar products with different branding.

Puff Bar launched last year, and became popular largely because JUUL had voluntarily removed its non-tobacco and menthol flavors from the market in November 2018. A year later, in January 2020, new FDA guidance prevented sales of all pod- and cartridge-based vaping products in flavors other than tobacco and menthol—except disposable products.

It was after the FDA guidance was issued in January that the news media became aware of Puff Bar, alerted by the Campaign for Tobacco-Free Kids and other tobacco control groups that claimed Puff Bars and other recently introduced disposable products were exempted from enforcement by the FDA.

That was never true. While the guidance did exempt disposable e-cigarettes, the exemption only applied to products that existed on the market before the Aug. 8, 2016 cutoff date set by the FDA Deeming Rule. No product can be introduced after that date without first submitting a Premarket Tobacco Application (PMTA) and receiving FDA marketing approval, which the sellers of Puff Bar certainly did not do.

However, beginning in late January—and ramping up after the FDA guidance took effect in early February—dozens of stories appeared in major news outlets that claimed otherwise. Most used Campaign for Tobacco-Free Kids president Matthew Myers, or another member of his Bloomberg-funded tobacco control cabal, as their “expert” source.

Some of the well-known reporters who wrote about the “Puff Bar loophole” included Sheila Kaplan of the New York Times, Matthew Perrone from Associated Press, Laurie McGinley of the Washington Post, and Allison Aubrey of NPR. (Perrone, in an article written today about the warning letter, repeats his earlier claim that “the flavor restrictions did not apply to disposable vaping products like Puff Bar.”)

All of these articles cited Myers’ contention that the FDA guidance gave a free pass to Puff Bar and similar products, and his claim that only a federal ban on all flavored vaping products would end the “epidemic” of teen vaping. None of the reporters in question bothered to ask the FDA if the “loophole” applied to products that were already on the market illegally.

As it turned out, the FDA warning letter to Puff Bar is based on the products being introduced without first receiving the required marketing approval through the PMTA process. There is simply no FDA guidance loophole that protects an already illegal product from being enforced against by the agency.

The FDA also issued several other warning letters today, including to other disposable vape manufacturers, and to companies selling e-liquid with supposedly child-appealing labels, such as My Little Pony-like images.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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3 years ago

Thank you as always for your articles. Get ready for the crackdown on all disposable pod systems and devices, as this has spread past Puff Bar at this point. All shops in SoCal are now reliant upon pod systems for overhead and revenue, recently and especially disposable pod-esque systems. The vape space is a sh*t show, and its sad to see where it has landed in 2020.

3 years ago
Reply to  Jim McDonald

Unfortunately, as much as I do not want to see it I do agree regarding your view on the potential for flavor bans. I have experienced, and seen too much success with flavors to be okay with such bans. I do have a question for you, as I have been involved in both cessation and cannabis spaces over the years. Do you see this trickling down to cannabis and Terpenes used in some manufacturers blends? Before Covid during the “vape crisis”, Washington was talking about banning terpenes for flavor additives in cannabis. Thoughts?

3 years ago

So what disposable product was the FDA referring to that was important enough to warrant a specific footnote describing it? Obviously they must have been talking about something. . I thought it was odd when they released their guidance. Even more so now.

Johnny hesse
Johnny hesse
3 years ago

You’d think the FDA would have to actually show proof that the flavors are marketed to kids. Is their claim based on the sole fact that they ARE flavored? What’s next, banning fruit flavored vodka? This borders on fascism.