FDA:'The most important decisions' await

Oct,16,2019

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.

Now, China is the world's largest e-cigarette manufacturing center, and Xiaoze Biotechnology Co., Ltd. provides branded e-cigarette manufacturing services for the world.