FDA authorizes another e-cigarette and promises decisions soon on major brands

The FDA said Logic may continue to market certain e-cigarette devices and pre-filled cartridges because the benefits — in helping adult smokers move away from traditional cigarettes — outweigh the risk of young people starting to use cigarettes. electronics. The agency noted that tobacco is not a popular vaping flavor among young people. The FDA has yet to rule on Logic’s application to sell menthol-flavored cartridges.

Logic, owned by Japan Tobacco International, the maker of Camel and Winston cigarettes, accounts for only about 1% of e-cigarette sales in the United States, according to some estimates. But the FDA’s decision seems to bode well decisions on which companies hold the largest market shares, including Juul, blu, Vuse and NJoy. Mitch Zeller, director of the FDA’s Center for Tobacco Products, is retiring in early April, and speculation is rife that he wants to make big business decisions before he leaves.

The agency, in a statement, said continued marketing by these major players “has the potential to have a substantial impact on public health – positively or negatively – as they hold a significant overall market share and are used by many people”.

The FDA in October issued its first approval for an e-cigarette – the Vuse Solo vaping device and its tobacco-flavored e-liquid pods, both produced by RJ Reynolds. But, like the Logic products listed on Thursday, Vuse Solo isn’t a big seller and isn’t popular with young people.

Announcing the decision on Logic, FDA Commissioner Robert M. Califf said in a statement that the agency’s career scientists balanced the risks and benefits of e-cigarettes. He said he was confident FDA staff were using “the best available evidence with the most robust methods to ensure that the products that continue to be marketed are appropriate for the protection of public health.”

Japan Tobacco International could not immediately be reached for comment.

Clifford E. Douglas, director of the University of Michigan Tobacco Research Network, said he hopes the FDA’s vaping efforts are approaching a point “where we move from polarized warfare over these issues. complexes to a regulated market that carefully provides more support and alternatives for addicted adult smokers” while protecting young people.

But differences of opinion emerged immediately after Thursday’s announcement. While Douglas found the FDA’s decision encouraging, Erika Sward, assistant vice president of national advocacy for the American Lung Association, said she was frustrated that the FDA hadn’t made decisions on some major manufacturers. and on whether menthol-flavored vapes, which his organization opposes, will be allowed.

She noted that the FDA missed a court-mandated September 2021 deadline to issue rulings on whether all e-cigarettes can continue to be sold.

The FDA said it has taken action on about 99% of the nearly 6.7 million products under its review, including issuing marketing denial orders for more than 1 million vaping products. But these products represent a small fraction of total sales.

Gregory Conley, president of the American Vaping Association, a nonprofit pro-vaping advocacy organization, called the FDA’s decision on Logic “completely unimportant and trivial.” He said few people use the products. Conley has been a vocal critic of efforts by tobacco control advocates and the FDA to ban e-cigarettes with sweet and fruity flavors, saying these flavors are key to helping adults switch from traditional cigarettes to vapes.

Summarizing its review of Logic’s products, the FDA said the data showed that smokers who used the tobacco-flavored items “were more likely to significantly reduce their use of burnt cigarettes and those who did not smoke were unlikely to begin to smoke.” use them. products.” The data also showed the products produced less or lower levels of toxins such as carbon monoxide than traditional cigarettes, the agency said. The FDA also imposed marketing restrictions on Logic to discourage use by young people.

The agency said it denied Logic’s requests for other vaping products, but declined to identify them. These products must be removed from the market immediately or face possible enforcement action, the agency said.

Authorizations are not “approvals” in the sense that the agency approves drugs as safe and effective. Rather, they mean the products have passed a risk-benefit analysis – helping adult smokers switch to vaping without encouraging young people to start vaping – and are therefore in the interest of public health.

The reviews are part of a broad, years-long effort by the FDA to expand its regulation of tobacco products beyond cigarettes. For many years, e-cigarette sales in the United States were relatively low. But the 2015 introduction of Juul Labs’ sleek vaping device and its easy-to-use prefilled pods, which included sweet and fruity flavors, shook up the industry, attracting herds of teenage users and sparking a battle. about vaping that continues, though transformed in many ways, to this day.

Amid the uproar over youth use, Juul pulled its sweet and fruity flavors from the market a few years ago and promised to work more closely with the FDA. Juul, like other cartridge-based vaping companies, is licensed to sell only tobacco and menthol flavored pods.

In the most recent National Survey of Youth Smoking, conducted by the FDA and the Centers for Disease Control and Prevention, Puff Bar, which makes disposable e-cigarettes, was by far the most popular vape among high school and college students. college students defined as “current”. users”, followed by Vuse, Smok and Juul. Puff Bar, which sells vapes in a wide range of flavors, had evaded FDA regulations by using synthetic nicotine. But Congress recently gave the FDA authority to regulate lab-made nicotine.

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