Tuesday, October 26, 2021

FDA OKs first e-cigarette, Vuse, and its tobacco-flavored products

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WASHINGTON – The Food and Drug Administration for the first time on Tuesday approved e-cigarettes, saying RJ Reynolds’s evaporator will help smokers reduce their usual cigarettes.

E-cigarettes have been sold in the U.S. for more than a decade with government oversight or research. With the expiration of the trial period, the FDA is reviewing a wide range of vaping products to determine which products should be allowed to remain on the market.

In September, the agency rejected more than a million e-cigarettes and related products, mainly because of the possibility of appealing to minors. But regulators have delayed a decision on major vaping companies, including market leader Juul, which is still to be expected.

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Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-scented nicotine cartridges. According to the company, e-cigarettes have helped smokers significantly reduce their exposure to harmful chemicals in traditional cigarettes.

Although the products can be sold legally in the U.S., the FDA has stated that they are not safe and are not “FDA approved” and that non-smokers will not use them.

Launched in 2013, the Vuse Solo is a rechargeable metal device in the form of a traditional cigarette. The FDA said the company rejected 10 other requests for other fragrant products. The agency is still considering the company’s request to sell a menthol-scented nicotine formula.

“Today’s permits are an important step toward ensuring that all new tobacco products pass the FDA’s robust, scientific market price,” said Mitch Zeller, director of the FDA Tobacco Center. “The manufacturer’s data show that its tobacco-flavored products can pass into smokers, these products — either completely or significantly reduce cigarette consumption.”

E-cigarettes first appeared in the U.S. in 2007 and promised smokers a less harmful alternative to traditional cigarettes. The devices heat the nicotine solution into a breathable vapor.

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But no serious research has been done on whether e-cigarettes really help smokers quit smoking. And the FDA’s crackdown on vaping products and their claims have slowed down several times due to competition from the industry lobby and political interests.

In recent years, the vaping market has been attended by hundreds of companies selling a variety of tools and nicotine solutions with different flavors and strengths. But a large portion of the market is controlled by several companies, including Juul Labs, which is owned by Altria and Vuse.

Behind Vuse Juul is the 2nd vaping brand in the U.S., accounting for nearly a third of retail sales. Its parent company, RJ Reynolds, sells Newport, Camel and other leading cigarettes.

A company spokesman said the FDA decision “confirms that Vuse Solo products are suitable for health, highlighting many years of scientific research and studies.”

To stay in the market, companies need to demonstrate that their products are healthy. In practice, this means proving that smokers who use the product can quit or reduce smoking, and teenagers are less likely to join them.

Kenneth Warner, a tobacco specialist at the University of Michigan School of Public Health, said the news is a positive step to reduce the harm of smoking. But he only regretted that a vaping device backed by Big Tobacco had received FDA approval.

“It is so difficult to meet the FDA’s requirements for companies that submit these applications that only those with large resources and staff – scientists, lawyers and researchers – can successfully submit them,” Warner said.

He said smaller companies and vape stores should have a separate way to get access to their products.

The FDA declared juveniles an “epidemic” in 2018 and took a number of measures to target small-cartridge devices that first caused the problem, including restricting their taste with tobacco and menthol. A separate Congress raised the age of purchase of all tobacco and vape products to 21.

The Department of Health and Science receives support from the Department of Scientific Education at the Howard Hughes Medical Institute. AP is responsible for all content.

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