FDA permits another e-cigarette, pledges decisions soon on big brands

0

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

Logic, owned by Japan Tobacco International, the maker of Camel and Winston cigarettes, accounts for just about 1 percent of e-cigarette sales in the United States, according to some estimates. But the FDA decision seems likely to presage rulings on companies with the biggest 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 widespread that he wants to issue decisions on the big companies before he leaves.

The agency, in a statement, said continued marketing by these major players “has the potential to have a substantial public health impact — either positively or negatively — as they hold an overall large market share and are used by a lot of people.”

The FDA in October issued its first authorization for an e-cigarette — the Vuse Solo vaping device and its tobacco-flavored e-liquid pods, both produced by R.J. Reynolds. But, like the Logic products cited Thursday, Vuse Solo is not a big seller and is not popular among young people.

In 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 the e-cigarettes. He said he was confident the FDA staff was using “the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”

Japan Tobacco International could not be reached immediately for comment.

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

But differences of opinion surfaced immediately after Thursday’s announcement. While Douglas found the FDA’s move encouraging, Erika Sward, assistant vice president of national advocacy for the American Lung Association, said she was frustrated the FDA has not made decisions on some big manufacturers and on whether menthol-flavored vapes, which her organization opposes, will be permitted.

She noted that the FDA missed a September 2021 court-imposed deadline for issuing decisions on whether all e-cigarettes could continue to be sold.

The FDA said it has taken action on about 99 percent of the nearly 6.7 million products submitted for its review, including issuing marketing denial orders for more than 1 million vaping products. But those 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 decision on Logic “thoroughly unimportant and unremarkable.” He said few people use the products. Conley has been highly critical of efforts by anti-tobacco advocates and the FDA to ban sweet and fruity flavored e-cigarettes, saying such flavors are key to helping adults switch from traditional cigarettes to vapes.

In summing up its review of the Logic products, the FDA said data showed that smokers who used the tobacco-flavored items “were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products.” Data also showed that the products produced fewer 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 youth use.

The agency said it denied applications by Logic for other vaping products but declined to identify them. Those product must be removed from the market immediately or face possible enforcement action, the agency said.

The authorizations do not constitute “approvals” in the way the agency approves drugs as safe and effective. Rather, they mean that the products have passed a risk-benefit analysis — helping adult smokers switch to vapes while not encouraging young people to begin vaping — and thus are in the interest of public health.

The reviews are part of a sweeping, 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 small. But the 2015 introduction of Juul Labs’ sleek vaping device and its easy-to-use pre-filled pods, which included sweet and fruity flavors, upended the industry, attracting flocks of teenage users and igniting a battle over 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 permitted to sell only tobacco- and menthol-flavored pods.

In the most recent National Youth Tobacco Survey, 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 middle school students defined as “current users,” followed by Vuse, Smok and Juul. Puff Bar, which sells vapes in a wide range of flavors, had eluded FDA regulation by using synthetic nicotine. But Congress recently gave the FDA authority to regulate laboratory-made nicotine.

FOLLOW US ON GOOGLE NEWS

Source

Leave a comment