FDA clears more e-cigarette products, but still no ruling on menthol and other kid-friendly nicotine products

But public health advocates are frustrated, saying the agency has missed a September deadline set by the US District Court in Maryland to decide which e-cigarette products can stay on the market.

Although e-cigarette products have been allowed to remain on the market for years, in 2020 the FDA required companies to submit applications to keep the products on the market.

The FDA said Thursday that tobacco-flavored Logic Technology products likely benefit adult smokers, serving as an alternative to traditional cigarettes. The likely benefit, according to the agency, outweighs the risk of young people starting to use them, provided the company meets requirements to reduce access and exposure among young people.

However, the agency has rejected some other Logic e-cigarette products and has yet to decide on others, including some with menthol.

The company has submitted information to the FDA showing that the products help adult smokers switch from traditional cigarettes to e-cigarettes, which may reduce a smoker’s risk of exposure to harmful and potentially harmful toxins in traditional cigarettes. like carbon monoxide.

A study that Logic Technology sent to the FDA found that when most people who smoked regular cigarettes switched to e-cigarettes, the number of cigarettes they smoked dropped by 80%, from an average of 13 to 16 cigarettes a day to one or two. , about two months after making the change.

However, another study published this year found that using e-cigarettes did not improve the odds of quitting or prevent relapses. 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 children start with candy, fruit and mint flavors.

Thursday’s FDA clearance does not mean the products are safe, or that they are “FDA approved,” the agency said.

“All tobacco products are harmful and potentially addictive,” the FDA said in a press release. “Those who don’t use tobacco products shouldn’t start.”

“The most important decisions” await

As part of the pre-market tobacco product application process, all e-cigarette manufacturers must demonstrate that marketing a product would be appropriate for the protection of public health. When the FDA makes a decision about an e-cigarette product, it must consider the risks and benefits for the entire population, not just the users of those 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 clearance. It has refused authorization for more than a million products.

If a product is refused authorization, the company must immediately withdraw it from the market.

In October, the FDA gave the green light to several tobacco-flavored products made by RJ Reynolds.
E-cigarettes were less effective than gum and other nicotine replacement aids, study finds
Logic Technology Development only has an 8% market share in dollars, according to a 2020 survey by Statista. The FDA has yet to rule on products from market leader Juul Labs.

“I’m glad they narrowed the decision down to only allowing tobacco-flavored products,” said Rep. Raja Krishnamoorthi, an Illinois Democrat who has pushed for more regulations on cigarette products. electronic.

When he heard about the FDA announcement on Thursday, he said, he had to research the company because it was such a small player.

“It’s still a small step when, unfortunately, our babies who have become young adults are becoming addicted to more and more of these products every day.”

Matt Myers, president of the Campaign for Tobacco-Free Kids, the group whose lawsuit prompted the court-ordered September deadline, said the latest ruling was not enough.

“Today’s ruling authorizing a tobacco-flavored e-cigarette that is not widely used by adults or young people does not set any new precedent,” Myers said. “The most important decisions are always before the FDA.”

Even though the FDA claims to have dealt with almost all of the products that came before it, Myers said those products only accounted for about 25-30% of the market.

The US government is failing on tobacco reduction, according to a report by the American Lung Association

His group filed a motion with the court asking him to intervene because more than six months have passed since the deadline, but the court has not ruled, Myers said.

Krishnamoorthi said he asked the FDA for status updates, but the agency “has not been available.”

Coming soon: menthol and disposables

One outstanding issue concerns products made with menthol, which remain under investigation.

The FDA said in January it was on track to make a decision on menthol products this year.

Adult smoking rates have dropped from 42% to 14% in the past 55 years, according to the FDA, but there are estimated to be nearly 18.6 million current smokers of menthol-flavored cigarettes in the States. -United. Nearly 85% of all non-Hispanic black smokers choose menthol cigarettes.
Studies show that menthol increases the appeal of tobacco products in adults and in newer, younger smokers. Menthol cigarettes are also considered more addictive. One study estimated that if menthol was banned in cigarettes and cigars, it could prevent 650,000 premature tobacco-related deaths.
The FDA also didn’t budge on another group of products known as disposables that became popular with children when the FDA banned the sale of child-friendly fruit-flavored e-cigarette cartridges.
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Disposables were previously exempt from FDA regulations because they use nicotine derived from a lab-made product rather than 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.

Regulations on these products still have a long way to go.

“All of these other products that are being used by many, many more people are still waiting for action from the FDA, and it’s troubling from that perspective,” said Erika Sward, assistant vice president of national advocacy at the American Lung Association. “The FDA may have made all the big decisions easy, but left the ones that would have the greatest impact on public health on its to-do list.”

Sward said the Lung Association is “relieved” the FDA rejected more flavored products with Thursday’s decision.

“But we’re frustrated that it looks like the FDA continues to chase the windmills looking for products that will keep tobacco addiction going,” Sward said.

Inhaling e-cigarette products into the lungs is also dangerous, and since the products are relatively new, the long-term consequences they might have are unclear.

“What’s even more troubling is that it’s the FDA’s job to look at this from a public health perspective,” Sward said. “So far, we appear to be willing to sacrifice a generation of children to use these products and are still not doing what we need to do to help current smokers.”

Rather than encouraging adults to switch to e-cigarettes, Sward said, people should talk to their doctor and use one of seven safe and effective FDA-approved drugs to quit smoking. Studies show that people who use FDA advice or products are much more successful at quitting than those who try to quit cold turkey.

About Donnie R. Losey

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