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E-cigarette companies avoid FDA regulation

Time: 2022-01-03

Views: 559

CBS: How does the e-cigarette company Puff Bar avoid FDA regulation

According to foreign news reports, nearly two years ago, the U.S. Food and Drug Administration banned flavored e-cigarettes such as JUUL as popular among young people. However, even if some e-cigarette products are becoming more and more popular among children, they have managed to avoid FDA supervision.


Nick Minas and Patrick Beltran are the two businessmen and CEOs behind PUFF Bar. Puff Bar is the largest company in the United States that still sells fruit-flavored nicotine products.


The company produces a series of sweet e-cigarette products.


"People always say, for example, you are trying to avoid or evade, you know, there is a bit of law. And we are not. You know, I mean, if there is a law tomorrow that requires us to withdraw from the market, we will take us tomorrow. The product goes out of the market.” Beltran told Tony Dokupil, co-host of CBS Morning.


The FDA has challenged Puff Bar before. In a warning letter last year, it told the company that it did not require all new tobacco products to obtain marketing authorization from the FDA. But in February, they relaunched what they said was a tobacco-free nicotine formula that is not subject to FDA regulations.


"I think it will eventually become a better choice," Beltran said. Synthetic nicotine is produced through a chemical process that does not involve tobacco leaves.


Since the beginning of 2020, Illinois Rep. Raja KRIShnAMOorthi has criticized Puff Bar directly.


"The FDA is only slow and tentative, and now they have been beaten by two 27-year-olds." KrishnAMOorthi said. "When I visited their website, I saw strawberry banana, raspberry ice and banana ice flavors on sale. I knew exactly who they were attracting. It was mainly children."


Beltran and Minas say their products are designed for adult smokers who want to quit smoking - they believe that they are very committed to serving this market and they must innovate.


"These loopholes prompted us to find alternative ways to still provide our consumers and customers with the products they need." Minas said.


"We now see more enjoyment of our products." Beltran said.


Minas said that now their products "have fewer by-products, toxins, and chemicals. He said they are now smoother and cleaner."


But researchers believe that adjustments to the Puff Bar formula allow them to bypass regulations and create loopholes.


"This is a land boom in Oklahoma, and it is passing a very big loophole," said Dr. Robert Jackler, a doctor at Stanford University who has turned into a tobacco researcher.


Jackler sees the switch to synthetic nicotine as part of the tobacco industry’s decades of efforts to evade regulations.


Every time the government issues regulations, the industry can innovate around it. They have the smartest people to come up with ways to bypass and undermine regulatory intent," he said.


Both Minas and Beltran said they believe the FDA's concerns are wrong.


Traditional cigarettes on the market now have FDA approval stamps. But those are not safe. So why the American people or people, you know, believe that the FDA will stamp the approval for the safety of the product, when the FDA knows that it allows cigarettes to be marketed, it causes 480,000 deaths every year," Beltran said.


The FDA does not approve tobacco products, but it does determine whether they meet legal requirements.


The agency has not yet taken a position on synthetic nicotine. The FDA wrote on its website that it is possible that synthetic nicotine will not be regulated as a tobacco product, adding that it plans to make decisions based on specific circumstances.


Congressman Krishnamoorthi said that he is enacting legislation to clarify the government's role in regulating synthetic nicotine.


Krishnamoorthi said: I will ensure that the law clearly stipulates that they should and can supervise in this regard.


But Jackler said the FDA's choice is very clear. "The FDA has the right to remove these products from the market. If they are not tobacco products, and this is what these companies claim, then they are a drug. They should be removed before they are approved," Jackler Say.


The FDA rejected CBS News’ request for an interview, but in a statement, Mitch Zeller, director of the FDA’s Tobacco Products Center, said that the agency is actively investigating and considering how to resolve such product issues.


Zeller said the agency looks forward to working with Congress to resolve potential problems. In the past few years, the FDA has removed about 5 million e-cigarette products, and each of them can be rewarded by loopholes in synthetic nicotine.



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