FDA clears e-cigarettes to remain in U.S. market for the first time


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

In giving the green light to a tobacco-flavored device and cartridges marketed by RJ Reynolds under the brand name Vuse, the agency said it believes the help that certain vaping devices offer smokers in quitting traditional cigarettes is more important than the risk of trapping a new generation.

“Aerosols from licensed products are significantly less toxic than burnt cigarettes based on available data,” the FDA said in a statement announcing the decision.

The statement concluded, “The FDA determined that the potential benefits for smokers who quit completely or drastically reduce their smoking would outweigh the risks to young people.”

The landmark move could pave the way for some other e-cigarettes, including those from the once-dominant manufacturer Juul, to remain in the market. For more than a year, e-cigarette makers have been on hold – most of their products are on the market but awaiting official clearance – as the FDA investigated whether they had a benefit or a danger to public health.

“The importance of the FDA authorizing a vaping product as ‘appropriate for the protection of public health’ should not be underestimated,” said Gregory Conley, president of the American Vaping Association, an industry group. He added, “Now that the FDA has taken action, we hope that adult consumers and healthy communicators will begin to understand the harm reduction benefits offered by these and other smoke-free products. “

Over the past few months, as part of its review, the agency has also ordered thousands of vaping products on the market, including a brand that has overtaken Juul as a favorite among teens for its fruity and sweet flavors. , Puff Bars. On Tuesday, he also dismissed 10 other Vuse flavored products but declined to say which ones.

The condemnation of the decision to authorize certain products was swift.

“It throws young people under the bus,” said Erika Sward, national assistant vice president for advocacy at the American Lung Association. She said the concern was with both the broader rationale for endorsing these products and Vuse, which in the government’s most recent youth smoking survey turned out to be one of the most popular vaping brands. popular with young people.

Vuse owner RJ Reynolds is one of the largest cigarette companies in the world. Another large cigarette company, Altria, has a 35 percent stake in Juul.

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

Kaelan Hollon, spokesperson for Reynolds American, the parent company of RJR, said the decision “represents an important moment for Reynolds” and shows that the authorized products “are appropriate for the protection of public health.” .

Electronic cigarettes entered the US market in the early 2000s as devices designed to give smokers the dose of nicotine they needed without the carcinogens from burning cigarettes. But about six years ago, with the introduction of Juul’s elegant fruit and dessert flavored products, the use of e-cigarettes among teens began to skyrocket and public health officials feared that a generation of non-smokers won’t become addicted to nicotine.

According to some public health experts, allowing certain vaping devices to remain on the market as an alternative to smoking could make it easier for the government to impose stricter regulations on traditional cigarettes, whose carcinogenic fumes can cause cancer and play a role. role in more than 400,000 deaths in the United States each year.

After resolving the vaping problem, the tobacco division of the FDA will advance a plan to reduce the amount of nicotine in combustible cigarettes. In its tobacco control strategy, announced in July 2017, the FDA said it would try to force tobacco manufacturers to reduce 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 lobbying vigorously.

Clifford Douglas, director of the University of Michigan Tobacco Research Network, said the authorization of Vuse was “good news for the agency which has made it clear its goal of providing good harm reduction alternatives. evaluated for adults “.

“This decision clearly shows the scientific understanding of the FDA that electronic cigarettes are inherently much less dangerous than combustible tobacco products,” said Mr. Douglas. “And it is equally clear that these products can be good for the protection of public health, and therefore potentially help millions of addicted adult smokers to quit.”

Specific products cleared by the FDA are the Vuse Solo Power Unit and two tobacco-flavored replacement cartridges, each containing approximately 5% nicotine.

In its announcement, the FDA said it was aware of the heavy use of Vuse products by young people, but approved “tobacco flavors,” which are less appealing to teenagers. The agency also said it was placing restrictions on digital, radio and TV marketing, while critics argued the FDA appeared to be leaving plenty of room for other marketing that could affect young people.

“They are simply insufficient,” said Eric Lindblom, former FDA Tobacco Policy Officer and Principal Investigator at Georgetown Law’s O’Neill Institute for National and Global Health Law.

He challenged TV advertising restrictions, which only allow ads on shows with a low percentage of teenage users. Mr Lindblom said teens could still see Vuse’s ads, either on TV or if they were copied and shown on YouTube, as happened with Juul.

“They allow marketing through partners, celebrities and brand ambassadors. It’s a real problem, ”said Lindblom.

Among the main issues the FDA did not address on Tuesday was what it was planning to do about menthol-flavored e-cigarettes, which critics say will appeal to young people and e-cigarette advocates will help encourage current smokers to quit. The agency said it is still “evaluating” Vuse’s application for the menthol.

Reynolds, in his own statement, said he could “still legally sell” the products that remain under review.


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