US: FDA clears first e-cigarettes
Cigarette smoking is the leading cause of preventable death in the United States.
Health officials in the United States authorized on Tuesday the first cigarette electronic, saying that RJ Reynolds products can benefit adult smokers.
The Food and Drug Administration (FDA) said the company's data showed that its Vuse e-cigarettes helped cigarette smokers to quit or significantly reduce the habit, the leading cause of preventable deaths in the United States.
Tuesday's decision is part of a vast effort by the FDA to subject the multi-billion dollar e-cigarette industry to scientific scrutiny after years of delay.
In September, the agency said it had rejected permit applications for more than one million e-cigarettes and related products, mainly because of the potential for them to attract teenagers. But regulators deferred decisions on most of the industry's top companies, including market leader Juul.
The FDA's decision only applies to Vuse's refillable device, Solo Power, and its tobacco flavored nicotine cartridges. The agency said it rejected 10 other requests from the company for other flavored products, although it did not release details. The FDA continues to review the company's application to sell a menthol-flavored nicotine formula.
"Today's authorizations are an important step in ensuring that all new tobacco products undergo a robust and rigorous scientific evaluation by the FDA," said Mitch Zeller, director of the agency's tobacco center.
"The manufacturer's data shows that its tobacco-flavored products can benefit adult smokers who switch to those products - either completely or with a significant reduction in cigarette use."
E-cigarettes first appeared in the United States more than a decade ago, with promises to provide smokers with a less harmful alternative to traditional cigarettes. Cigarettes heat a nicotine solution in vapor that is inhaled.
But there have been very few rigorous studies on whether e-cigarettes actually help quit smoking. And the FDA's efforts to review the products and what they offer were repeatedly hampered by lobbying from industry and political interests.
SOURCE: Associated Press
The Food and Drug Administration (FDA) said the company's data showed that its Vuse e-cigarettes helped cigarette smokers to quit or significantly reduce the habit, the leading cause of preventable deaths in the United States.
Tuesday's decision is part of a vast effort by the FDA to subject the multi-billion dollar e-cigarette industry to scientific scrutiny after years of delay.
In September, the agency said it had rejected permit applications for more than one million e-cigarettes and related products, mainly because of the potential for them to attract teenagers. But regulators deferred decisions on most of the industry's top companies, including market leader Juul.
The FDA's decision only applies to Vuse's refillable device, Solo Power, and its tobacco flavored nicotine cartridges. The agency said it rejected 10 other requests from the company for other flavored products, although it did not release details. The FDA continues to review the company's application to sell a menthol-flavored nicotine formula.
"Today's authorizations are an important step in ensuring that all new tobacco products undergo a robust and rigorous scientific evaluation by the FDA," said Mitch Zeller, director of the agency's tobacco center.
"The manufacturer's data shows that its tobacco-flavored products can benefit adult smokers who switch to those products - either completely or with a significant reduction in cigarette use."
E-cigarettes first appeared in the United States more than a decade ago, with promises to provide smokers with a less harmful alternative to traditional cigarettes. Cigarettes heat a nicotine solution in vapor that is inhaled.
But there have been very few rigorous studies on whether e-cigarettes actually help quit smoking. And the FDA's efforts to review the products and what they offer were repeatedly hampered by lobbying from industry and political interests.
SOURCE: Associated Press
