But public health advocates are frustrated, saying the agency has blown past a September deadline set by US District Court in Maryland to decide what e-cigarette products may remain on the market.
Though e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA asked the companies to submit applications to keep products on the market.
The FDA said Thursday that the tobacco-flavored Logic Technology products probably benefit adult smokers, serving as an alternative to traditional cigarettes. The likely benefit, the agency said, outweighs the risk that young people would start using them, provided that the company follows requirements to reduce access and exposure to them among youth.
However, the agency rejected some other Logic e-cigarette products and has yet to decide about others, including some with menthol.
The company submitted information to the FDA showing that the products helped adult smokers move away from traditional cigarettes to e-cigarettes, which can reduce a smoker’s risk of exposure to harmful and potentially harmful toxins in traditional cigarettes like carbon monoxide.
One study that Logic Technology sent to the FDA found that when most of the people who smoked regular cigarettes switched to e-cigarettes, the number of cigarettes they smoked dropped 80%, from an average of 13 to 16 cigarettes a day to one or two, by about two months after they made the switch.
However, another study published this year
found that using e-cigarettes did not improve a person’s chance of quitting, nor did it prevent relapse. It was also found to be less effective than gum and other nicotine-replacement aids. Other research has shown that young people are less likely to start using tobacco-flavored e-cigarettes. Most kids start with candy, fruit and mint flavors.
Thursday’s FDA authorization does not mean the products are safe, nor are they “FDA approved,” the agency said. “All tobacco products are harmful and potentially addictive,” the FDA said in a news release. “Those who do not use tobacco products shouldn’t start.”
‘The most important decisions’ await
Under the Premarket Tobacco Product Application pathway, all e-cigarette makers must demonstrate that the marketing of a product would be appropriate for the protection of public health. When the FDA makes a decision about an e-cigarette product, it has to take into consideration the risk and benefit to the entire population, not just users of these products.
The FDA says it has taken action on 99% of the nearly 6.7 million e-cigarette products that have been submitted for premarket authorization. It has denied authorization to more than 1 million products. If a product is denied authorization, the company must remove it from the market immediately.
, the FDA gave the green light to several tobacco-flavored products made by R.J. Reynolds. Logic Technology Development holds only an 8% dollar share of the market, according to a 2020 survey by Statista.
The FDA has yet to rule on products from market leader Juul Labs. “I’m glad that they limited the ruling to allowing only tobacco-flavored product,” said Rep. Raja Krishnamoorthi, an Illinois Democrat who has been working to get more regulations on e-cigarette products.
When he heard about Thursday’s FDA announcement, he said, he had to look up the company because it was such a small player. “This is yet another baby step when, unfortunately, our babies which have become young adults are getting addicted every day to more and more of these products.”
Matt Myers, president of the Campaign for Tobacco-Free Kids, the group whose lawsuit prompted the court-ordered September deadline, said the latest move is not enough.
“Today’s decision authorizing a tobacco-flavored e-cigarette that is not widely used by either adults or youth doesn’t set any new precedent,” Myers said. “The most important decisions are still sitting in front of the FDA.”
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Jen Christensen – CNN – 2022-03-25.