Puff Bar Continues to Evade the FDA, Rake in Profits, Lawsuit Claims: Civil Suit Adds to FDA Heat on E-cigarette Maker’s Flavored Products

0
    

A class-action lawsuit filed in New York alleges that Puff Bar vape pens last only a few hours, not the 800 puffs the company touts. That’s not an earthshattering consumer complaint, but the suit does make a potentially more explosive claim, i.e., that Puff Bar exploited an FDA ban on flavored e-cigarette pods and cartridges when it launched its product made with a “patented manufacturing process, not from tobacco” earlier this year.

Almost two years ago, the U.S. Food and Drug Administration (FDA) issued a ban on flavored, cartridge-based e-cigarettes, pointing to their increased appeal to teenagers. However, some vaping products, including Puff Bar, have avoided FDA regulation, even though they make e-cigarettes that feature sweet and fruity flavors like Blueberry Ice, Cool Mint, and Watermelon that appeal to teens. Estimates say that at least 40% of U.S. high school students use e-cigarettes.

In July 2020, the FDA ordered 10 e-cigarette companies, including Puff Bar, to remove their flavored, disposable e-cigarettes from the market because they did not have the premarket authorization required of tobacco products. But, not willing to give up easily, Puff Bar relaunched its products in February 2021 with a “tobacco-free nicotine” synthetic formula that does not use tobacco leaves. After the relaunch, Puff Bar quickly sprang to the top of the e-cigarette market, raking in $119 million annually.

According to Puff Bar, synthetic nicotine is actually a better product in terms of the overall vaping experience. But, perhaps most importantly, it also allows them (at least for the time being) to skirt FDA rules and remain on the market.  

In another letter sent March 18, the FDA told the company:

Puff Bar has neither been approved as a drug nor received a premarket tobacco product order. The agency should not allow any perceived regulatory “gap” to enable this company or any other company to market new addictive nicotine products without going through the legally required FDA review by either CDER or CTP. The undersigned organizations believe that these synthetic nicotine products clearly fit within the definition of a drug and must be regulated as such. However, whether regulated as drugs or as tobacco products, these products are on the market illegally and must be removed immediately through enforcement action.

Despite this letter and the fact that the FDA has pulled some 4 million e-cigarette products off shelves in the past few years, Puff Bar’s popular e-cigarettes remain on the market. According to a recent CBS News report, the FDA is investigating and “considering how to address such products.” In addition, North Carolina’s attorney general has launched a statewide investigation into Puff Bar. In June, the state reached a $40 million agreement with JUUL Labs Inc., another e-cigarette maker accused of marketing their products to children and teens. North Carolina is the first state in the nation to hold JUUL accountable for the company’s role in encourage teen use and dependence on e-cigarettes.

Puff Bar CEOs Nick Minas and Patrick Beltran insist that unlike JUUL, their products are intended for adult smokers who want to quit traditional cigarettes. Minas and Beltran say that they are so dedicated to this market that in the face of FDA pressure, they decided to innovate rather than throw in the towel. Loopholes in the FDA rules inspired them to look for alternative ways to offer products, which now contain “fewer byproducts, toxins, and chemicals.” Opponents argue that the tweaks were made by Puff Bar solely to get around FDA regulations. However, the agency has yet to take a stand on synthetic nicotine, writing on its website that that synthetic nicotine may not be regulated as a tobacco product, and regulation would instead take place “on a case-by-case basis.”

Although the e-cigarette industry continues to be mired in controversy and more lawsuits could be on the horizon, the demand for fruity flavored vapes does not appear to be going away any time soon.  “I think there will be a chain effect if flavored vapes don’t exist,” Minas said in a Wall Street Journal report published November 18. “If Puff tomorrow stopped selling flavored vapes, flavored vapes would continue to come onto the market. The more you try to regulate an industry and a product is almost a necessity for people to stop smoking cigarettes, it’s going to go black market. It’s going to cause more problems.”

Print Friendly, PDF & Email
Share This Article

About Author

Leave A Reply