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FDA clears e-cigarettes to remain on the US market for the first time


The Food and Drug Administration approved the sale of an electronic cigarette in the United States for the first time on Tuesday, a significant turn in one of the most controversial public health debates in decades.

By releasing a tobacco-flavored device and cartridges marketed by RJ Reynolds under the brand name Vuse, the agency signaled that it believes the help certain vaping devices provide to smokers to quit traditional cigarettes is more significant than the risks of enticing a new generation.

“According to the available data, the aerosols of the approved products are significantly less toxic than burned cigarettes,” the FDA said in a statement accompanying the announcement of the decision.

The statement concluded, “The FDA determined that the potential benefits for smokers who completely switch their cigarette consumption or significantly reduce their cigarette consumption would outweigh the risk for adolescents.”

The decision could pave the way for some other electronic cigarettes, including those from the once dominant maker Juul, to be approved to remain in the market. For more than a year, e-cigarette manufacturers have been on hold – most of their products are on the market but awaiting official approval – as the FDA investigated whether they would be of benefit or danger to the public Represent health.

“The importance of having a vaping product approved by the FDA as ‘suitable for public health protection’ should not be underestimated,” said Gregory Conley, president of the American Vaping Association, an industry group. He added, “With the FDA acting, we hope that adult consumers and health communicators begin to understand the benefits of this and other smoke-free harm reduction products.”

In the past few months, the agency has also ordered thousands of vaping products from the market as part of its review, including a brand that Juul has surpassed Juul as a teenage favorite for its fruity and candy-like flavors, Puff Bars. On Tuesday, it also turned down 10 other Vuse-flavored products, but refused to say which ones.

The decision to authorize some products was quickly condemned.

“That throws young people under the bus,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. She said the concern lies with both the broader logic advocating these products and Vuse, which was identified as one of the most popular brands of vape among young people in the latest government survey of teen tobacco use.

Vuse owner RJ Reynolds is one of the largest cigarette manufacturers in the world. Another large cigarette company, Altria, owns 35 percent of the shares in Juul.

Ms. Sward said an industry that lied about tying generations to a deadly product that killed millions is now able to control the next iteration of the nicotine market. “The industry has been waiting for its next big thing and they found it with e-cigarettes,” she said.

Kaelan Hollon, a spokeswoman for Reynolds American, parent company of RJR, said the decision was “an important moment for Reynolds” and shows that the approved products are “useful for protecting public health.”

E-cigarettes first hit the American market in the early 2000s as devices designed to give smokers the nicotine solution they longed for, without the carcinogens produced by burning cigarettes. But about six years ago, with the introduction of Juul’s lean fruit and dessert flavored products, e-cigarette use began to surge among teenagers and public health officials feared a generation of nonsmokers would become addicted to nicotine.

Some public health experts believe that some vaping devices can remain in the market as an alternative to smoking for 400,000 deaths in the United States each year.

After resolving the vapor problem, the FDA’s Tobacco Division will advance a plan to reduce the amount of nicotine in flammable cigarettes. In its tobacco control strategy announced in July 2017, the FDA said it would try to force tobacco companies to lower the nicotine in their products to non-addictive levels. The cigarette industry is against it.

The FDA is also still working on its plan to eliminate menthol cigarettes from the market, a prospect that the tobacco industry is vigorously lobbying against.

Clifford Douglas, director of the University of Michigan’s Tobacco Research Network, said Vuse’s approval was “good first news regarding the agency, which clearly shows its focus on providing well-rated adult harm reduction alternatives.”

“This decision underscores the FDA’s scientific understanding that e-cigarettes are inherently significantly less dangerous than flammable tobacco products,” said Douglas. “And it also makes it clear that these products can be good for public health protection and therefore can potentially help millions of addicted adult smokers to quit.”

The specific products approved by the FDA are the Vuse Solo Power Unit and two replacement tobacco-flavored cartridges, each with around 5 percent nicotine.

In its announcement, the FDA said it was aware of the heavy use of Vuse products by teenagers but was approving “tobacco flavors” that are less attractive to teenagers. The agency also said it is placing restrictions on digital, radio and television marketing, while critics argued that the FDA appears to be leaving plenty of room for other marketing efforts that could affect teenagers.

“They are just inadequate,” said Eric Lindblom, a former FDA Tobacco Policy Officer and senior scientist at the O’Neill Institute for National and Global Health Law by Georgetown Law.

He opposed restrictions on television advertising that only allow commercials on shows with a low percentage of teenage users. Mr Lindblom said teenagers could still see the Vuse commercials, either on TV or if they were copied and put on YouTube, as was the case with Juul.

“They enable marketing by partners, celebrities and brand ambassadors. That’s a real problem, ”said Mr. Lindblom.

One of the major issues that the FDA failed to resolve on Tuesday was what it plans to do regarding menthol-flavored e-cigarettes. The agency said it is “still evaluating” the Vuse application for menthol.

Reynolds said in its own statement that it could “lawfully sell” the products that are still under review.


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