The FDA's plan to crack down on e-cigarettes in 2020 was meant to be a comprehensive, aggressive strategy.
Two years later, sales of disposable e-cigarettes have increased. Some companies have moved beyond the reach of the F.D.A. They circumvented federal oversight by using an unregulated synthetic nicotine.
The agency almost wiped out the use of flavors in devices like Juul, which were once popular among teenagers. The teen favorite Puff Bar is selling disposable devices filled with candy flavors and tobacco-free or synthetic nicotine.
Scientists are just beginning to study the unknown health effects of synthetic nicotine, even as research is expanding into the harm caused by vaping and flavor ingredients alongside continuing cases of devastating vaping-related lung injury. The F.D.A.'s efforts to protect a new generation from nicotine addiction are being hampered by new trends in the vaping industry.
The founder of Parents Against Vaping E-Cigs said that companies like Puff Bar and others are deliberately driving their trucks of poison through this huge loophole. She hosted a seminar about synthetic nicotine attended by 700 people.
The F.D.A. has authority to regulate synthetic nicotine, but it is unclear if the issue will be included in the final bill.
The provision would be a public health victory over bad actors who circumvented the F.D.A.
The bill will close the loophole and clarify F.D.A.'s authority to regulate all tobacco products, including those containing synthetic nicotine.
Market research shows that sales of tobacco-free nicotine went from zero in 2020 to two-thirds of US shops in 2021. According to ECigIntelligence, those stores said such products accounted for 20% of their sales. The company projected that the U.S. market would be $6 billion this year.
Some e-cigarette makers have been in a fight with federal officials. The F.D.A. forced thousands of e-cigarette companies, including Juul, to apply in 2020 for authorization to remain on the market. Makers of disposable vape pens in flavors like gummy bear and candy cane flooded the market after the agency focused on the most popular devices. The agency responded with a stern warning and even product seizures for some of the companies.
More than a million applications for tobacco sales were denied last year. Applications to remain on the market are pending.
By early 2021, the market for synthetic nicotine that didn't fall under F.D.A. oversight would be available. Other companies imported similar devices containing synthetic or tobacco-free nicotine from factories in Shenzhen, China.
The man who identified himself in news reports as one of the executives of Puff Bar did not respond to requests for comment.
The C.D.C. Foundation shows that disposable fruit- and candy-flavored devices have increased in sales since the F.D.A. stepped up e-cigarette enforcement in February 2020. Sales of the F.D.A.- targeted devices have almost stopped.
According to Information Resources, the sales of e-cigarettes have increased by nearly 50 percent since early 2020. According to the National Youth Tobacco Survey, about 11 percent of high school students used e-cigarettes.
A senior counsel supervising e-cigarette enforcement for the Massachusetts attorney general said that new e-cigarette suppliers can go into business quickly if they contract with a manufacturer in China, set up a website and get space in a warehouse to store and ship devices. If they face scrutiny, they can quickly withdraw their profits.
It's a whack-a-mole situation, said Ms. Shusterman, whose state banned all flavors of e-cigarettes.
The Center for Tobacco Products of the F.D.A. recognized the problem.
Mr. Zeller said in an email that disposable e-cigarettes made with synthetic nicotine pose a particular challenge for the F.D.A.
Vaping is popular among teenagers. In her high school in the Detroit suburbs, Rani said it is very visible in the bathroom and stairwell.
The stress and loneliness of the Pandemic may have triggered some teenagers to start. She pointed out that it was portrayed glamorously in a popular series about a teenager kicking drug addiction.
It's hard to do anything about people in the bathroom using e-liquid.
The F.D.A.'s efforts to limit teenagers' access to flavoured e-liquids had little effect on the ability to get them in the Indianapolis suburbs. She said she was addicted to nicotine within weeks of starting to use it. She said there was always a gas station that sold e-cigarettes in flavors like banana ice cream or sour apple.
She said she was using a device that had as much nicotine as two packs of cigarettes every two to three days. She said that she fell ill with a cold, which quickly turned into a breathing problem, and felt exhausted. By the time she went to the emergency room, her oxygen saturation was 67, far below the normal range of 95 or higher. Ms. Burgess had a lung injury and was in the I.C.U.
She is down to two cigarettes a day because of her nicotine addiction.
I think the F.D.A. should take it all off the market. It is so large and there are so many companies.
Some industry experts are questioning whether a device label for synthetic nicotine is accurate because it is more expensive than tobacco.
The president of the American Vaping Association said that the unregulated market is a problem. The problem was caused by the agency overregulating a product used by millions of adults who find it a safer alternative to smoking.
The country should learn from the past failures of prohibition.
Major tobacco retailers are entering the synthetic nicotine market with flavoured gum called pouches, according to Dr. Robert Jackler, who studies tobacco company advertising.
There is no age gating when we buy them, according to Dr. Jackler.
He said that the loopholes allow the products to avoid hefty tobacco taxes and remain affordable, and that they can be used to evade online retailers' efforts to weed out underaged sales of tobacco products. Dr. Jackler said that the ease of purchasing was concerning, given how little is known about the health effects of nicotine.
The chemicals used to make butter are linked to lung damage and are associated with birth defects.
Dr. Jordt is an associate professor at Duke University and has studied synthetic nicotine.
He said that 99 percent of tobacco-derived nicotine is a psychoactive molecule. 50 percent of most types of synthetic nicotine are made up of a mirror-image molecule. He said that little research has been done on the R-nicotine molecule in humans or animals.
Dr. Jordt said that it could alter nerve transmission in the brain in different ways.
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