FDA Approves Vuse Tobacco Flavored E-Cigarettes, Blocking Fruit Flavored Refills
WASHINGTON (AP) – Heath officials on Tuesday approved the first US electronic cigarettes, saying RJ Reynolds’ vaping products could benefit adult smokers.
The Food and Drug Administration said data submitted by the company showed that its Vuse e-cigarettes helped smokers either quit smoking or significantly reduce their use of cigarettes, the leading preventable killer in the United States
The first decision on Tuesday is part of a sweeping effort by the FDA to scientifically scrutinize the multi-billion dollar steam industry after years of delays.
In September, the agency announced that it had turned down applications for more than a million e-cigarettes and related products, largely due to their potential appeal to underage teens. However, regulators delayed decisions on most of the major vaping companies, including market leader Juul.
The FDA’s decision only applies to Vuse’s Solo Power refillable device and its tobacco-flavored nicotine cartridges. The FDA said it declined 10 more requests from the company for other flavored products but did not provide details. The agency is still considering the company’s request to sell a menthol-flavored nicotine formula.
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“Today’s approvals are an important step in ensuring that all new tobacco products undergo robust, pre-market FDA scientific evaluation,” Mitch Zeller, director of the FDA’s Tobacco Center, said in a statement.
“The manufacturer’s data shows that its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either entirely or with a significant reduction in cigarette consumption.”
E-cigarettes first appeared in the US more than a decade ago with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution in an inhaled vapor.
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However, little research has been done on whether e-cigarettes actually help smokers quit smoking. And the FDA’s efforts to review vapor products and their claims have been repeatedly hampered by industry lobbying and competing political interests.
Over the past few years, the vape market has grown by hundreds of companies selling a range of devices and nicotine solutions in a variety of flavors and strengths. However, the vast majority of the market is controlled by a few companies, including Juul Labs, which is partially owned by Altria, and Vuse.
To stay in the market, companies need to demonstrate that their products are good for public health. In practice, this means proving that adult smokers using the products are likely to quit or cut down on smoking, while teenagers are unlikely to become addicted.