The US Food and Drug Administration gave the official green light Thursday to several tobacco-flavored e-cigarette products from Logic Technology Development LLC. The FDA said it is also “close” to additional decisions about products that make up a larger share of the market.
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.
In October, 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.”
Even though the FDA says it has addressed almost all of the products that have come before it, Myers said those products involve only about 25% to 30% of the market.
His group has filed a petition with the court asking it to intervene because it has been more than six months since the deadline, but the court has not ruled, Myers said.
Krishnamoorthi said he has been asking the FDA for status updates, but the agency has “not been forthcoming.”
Still to come: menthol and disposables
One outstanding issue is products made with menthol, which remain under review.
The FDA said in January that it is on track to make a decision about menthol products this year.
According to the FDA, adult smoking rates declined from 42% to 14% over the past 55 years, but it’s estimated that there are nearly 18.6 million current smokers of menthol-flavored cigarettes in the US. Nearly 85% of all non-HIspanic Black smokers choose menthol cigarettes.
Studies show that menthol increases the appeal of tobacco products among adults and among newer and younger smokers. Menthol cigarettes are also considered more addictive. One study estimated that if menthol was prohibited in cigarettes and cigars, it could prevent 650,000 premature tobacco-related deaths.
The FDA also hasn’t moved on an alternate group of products known as disposables that became popular with kids when the FDA prohibited the sale of kid-friendly fruit-flavored e-cigarette cartridges.
Disposables were previously exempt from FDA regulation because they use nicotine derived from a laboratory-made product rather than from tobacco. Krishnamoorthi helped create bipartisan legislation that closed that loophole, part of the omnibus bill that was signed into law by President Biden last week.
Regulation on those products still has a ways to go.
“All of these other products that are being used by many, many more people are still sitting out there waiting for FDA action, and that’s troubling from that perspective,” said Erika Sward, assistant vice president of national advocacy at the American Lung Association. “The FDA had made perhaps all of the big easy decisions but left the ones that would be most impactful for the public health on their to-do list.”
Sward said the Lung Association is “relieved” that the FDA rejected more flavored products with Thursday’s decision.
“But we are frustrated that it seems FDA is continuing to chase windmills by looking for products that will sustain addiction to tobacco,” Sward said.
Inhaling e-cigarette products into the lungs is also dangerous, and because the products are relatively new, it’s not clear what long-term consequences they might have.
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“What’s even more troubling is that it’s the FDA’s job to consider this from a public health perspective,” Sward said. “So far, we seem to be willing to sacrifice a generation of kids to using these products and still not do what we need to do to help current smokers.”
Rather than encourage adults to switch to e-cigarettes, Sward said, people should talk to their doctor and use one of the seven safe, effective FDA-approved medications aimed at quitting. Studies show that people who use counseling or the FDA products have much more success quitting than those who try to stop cold turkey.