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How companies like Puff Bar have avoided FDA regulation: "The industry can innovate around it"

Flavored vaping "loophole"
How Puff Bar has avoided FDA regulation 06:53

Nearly two years ago, the Food and Drug Administration banned flavored e-cigarettes, like Juul, citing their popularity among teens.  But some vaping products have managed to avoid regulation by the FDA even as they grow increasingly popular among kids. 

Nick Minas and Patrick Beltran are the two of the businessmen and CEOs behind Puff Bar, the biggest company in America still selling fruit-flavored nicotine products. 

The company makes a range of vaping products with sweet flavors. 

"People always say, like, 'You guys are trying to sidestep or side skirt, you know, kind of laws.' And we're not. You know, I mean, if there's a law that would order us off the market tomorrow, we would pull our products off the market tomorrow," Beltran told "CBS Mornings" co-host Tony Dokoupil. 

The FDA has challenged Puff Bar before. In a warning letter last year, it told the company it did not have FDA "marketing authorization" required of all new tobacco products. But in February, they re-launched with what they say is a "tobacco-free nicotine" formula that doesn't fall under FDA rules. 

"I think it ended up being the better alternative," Beltran said. Synthetic nicotine is created through a chemical process that does not involve tobacco leaves.  

Illinois Congressman Raja Krishnamoorthi has been critical of Puff Bar since early 2020. 

"The FDA has just been slow and tentative, and now they're getting punked by two 27-year-olds," Krishnamoorthi said. "When I go to their website and I see strawberry banana and raspberry ice and banana ice flavors being sold, I know exactly who they're appealing to. It's mainly kids." 

Beltran and Minas say their products are intended exclusively for adult smokers hoping to switch off cigarettes—a market they are so dedicated to serving, they argue, they had to innovate. 

"These loopholes have caused us to look for alternative ways to still provide to our consumers and customers with the products that they need," Minas said.  

"We see more enjoyment with our product now," Beltran said. 

Minas said that there are fewer "byproducts, less toxins, less chemicals" in their products now, which he says are now "smoother and cleaner." 

But researchers believe the tweak to Puff Bar's formula has allowed them to get around regulations and create a "loophole." 

"It is an Oklahoma land rush going through a very wide loophole," said Dr. Robert Jackler, a physician turned tobacco researcher at Stanford University.

Jackler sees the turn to synthetic nicotine as part of a decades-long effort by the tobacco industry to evade regulations. 
"Every time the government brings in regulations, the industry can innovate around it. They have the smartest people to think up ways of skirting and undermining the intent of regulation," he said.  

Minas and Beltran both say they think the FDA's worries are misplaced. 

"Traditional cigarettes on the market right now have the FDA stamp of approval. But those are not safe. So why should the U.S. people or the people, you know, trust the FDA to be stamping approvals for the safety of products, when the FDA knowingly is allowing cigarettes to be on the market that are killing 480,000 people a year," Beltran said. 

The FDA doesn't "approve" tobacco products, but it does determine whether they meet legal requirements.  

The agency hasn't yet taken a stand on synthetic nicotine. On its website, the FDA writes that "it's possible" synthetic nicotine "would not be regulated" ... "as a tobacco product" adding it plans to decide "on a case-by-case basis."  

Congressman Krishnamoorthi said he's working on legislation to clarify the government's role in regulating synthetic nicotine. 
"I will make sure that it's crystal clear in the law that they should and can regulate in this area," Krishnamoorthi said. 
But Jackler says the FDA's options are already perfectly clear. "The FDA has authority to take these products off the market. If they're not tobacco products, and that's what these companies assert, then they're a drug. And they should be taken off until approved," Jackler said. 

The FDA declined CBS News' request for an interview, but in a statement, the FDA Center for Tobacco Products Director Mitch Zeller said the agency is "actively investigating" and considering "how to address such products."  

Zeller said the agency looks "forward to working with Congress" on a potential fix. The FDA has pulled some 5 million e-cigarette products off the shelves in the past couple of years, and every one of them could make a return through the synthetic nicotine loophole.

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