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The Food and Drug Administration on Tuesday authorized the sale of an electronic cigarette in the United States for the first time, making a significant comeback in one of the most contentious public health debates in decades.
The agency greenlighted a device and tobacco-flavored cartridges marketed by RJ Reynolds under the Vuse brand, stating that it believes the help certain vaping devices offer smokers to quit traditional cigarettes is more important than the risks of trapping a new generation.
“Aerosols from authorized 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 has determined that the potential benefit to smokers who reduce their smoking completely or significantly outweighs the risk to young people.”
This landmark decision could pave the way for authorizing several other e-cigarettes to remain on the market, including those from the once-dominant Juul. For more than a year, e-cigarette manufacturers—many of their products are on the market but awaiting official approval—have been on a hold as the FDA is investigating whether it’s a benefit or a danger to public health.
“The importance of the FDA authorizing a vaping product as ‘compliance with public health protection’ should not be underestimated,” said Gregory Conley, president of the American Vaping Association, an industry group. “Now that the FDA has taken action, we hope that adult consumers and health communicators will begin to understand the harm reduction benefits offered by these and other smokeless products.”
Over the past few months, as part of its review, the agency has also ordered thousands of vaping products from the market, including Puff Bars, a brand that has surpassed Juul as a favorite among teenagers for its fruity and sugary flavors. On Tuesday, it also denied 10 other Vuse-flavored products, but declined to say which ones.
The decision to allow certain products was swift to be condemned.
“This is throwing young people under the bus,” said Erika Sward, national vice president of advocacy at the American Lung Association. He said the concern is both with the broader rationale that endorses these products and with Vuse, which was found to be one of the most popular vaping brands among teens in the government’s most recent survey on teen tobacco use.
RJ Reynolds, owner of Vuse, is one of the largest cigarette companies in the world. Another large cigarette company, Altria, owns a 35 percent stake in Juul.
Ms Sward said an industry that has lied about being hooked on a deadly product that has killed millions of people for generations is now positioned to control the next iteration of the nicotine market. “The industry was waiting for the next big thing and they found it with e-cigarettes,” he said.
Kaelan Hollon, spokesperson for RJR’s parent company, Reynolds American, said the decision “represents an important moment for Reynolds” and demonstrates that authorized products are “compliance with public health protection”.
E-cigarettes first came to the American market in the early 2000s as devices designed to give smokers the amount of nicotine they want without the carcinogens that come from burning cigarettes. But about six years ago, with the launch of Juul’s sleek products with fruity and sweet flavors, e-cigarette use began to rise among youth, and public health officials worried that a generation of non-smokers was becoming addicted to nicotine.
Some public health experts believe that allowing certain vaping devices to remain on the market as alternatives to cigarettes could make it easier for the government to impose stricter regulations on traditional cigarettes, whose carcinogenic fumes can cause cancer and play a role in more. 400,000 deaths each year in the United States.
After resolving the vaping issue, the FDA’s tobacco division plans to work with the Biden administration on a plan to reduce the amount of nicotine in combustible cigarettes. In its tobacco control strategy, announced in July 2017, the FDA said it will seek to force tobacco companies to reduce the nicotine in their products to non-addictive levels. The cigarette industry opposes this move.
The FDA is also still working on a plan to remove menthol cigarettes from the market, a possibility the tobacco industry strongly opposes.
Clifford Douglas, director of the University of Michigan Tobacco Research Network, said Vuse’s authorization is “good first news as it clarifies the agency’s focus on providing well-reviewed harm reduction alternatives for adults.”
“This decision clearly demonstrates the FDA’s scientific understanding that e-cigarettes are inherently significantly less dangerous than combustible tobacco products,” said Mr Douglas. “And it makes it equally clear that these products can be good for public health protection and therefore potentially helping millions of addicted adult smokers quit.”
Specific products authorized by the FDA are the Vuse Solo Power Pack and two tobacco-flavored refill cartridges, each containing approximately 5 percent nicotine.
In the FDA announcement, Vuse said it was aware of the heavy use of its products by teens, but had approved “tobacco flavors” that were less appealing to teens. The agency also said it imposes digital, radio and television marketing restrictions, while critics argued that the FDA left plenty of room for other marketing that could affect teens.
“They’re just incompetent,” said Eric Lindblom., a former FDA tobacco policy official and a senior scholar at Georgetown Law’s O’Neill Institute for National and Global Health Law.
It had trouble with restrictions on television advertising that only allowed ads on shows with a low percentage of young users. Mr Lindblom said that as with Juul, teens may continue to see Vuse ads if they’re on TV or copied and put on YouTube.
“They allow marketing through partners, celebrities and brand ambassadors. This is a real problem,” said Mr. Lindblom.
Among the key issues the FDA didn’t resolve Tuesday was what it planned to do about menthol-flavored e-cigarettes, which critics said appealed to youth and that e-cigarette advocates would encourage current smokers to quit. The agency said it is “still evaluating” the Vuse app for menthol.
In his own statement, Reynolds said he could “still legally sell” the products under scrutiny.
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