FDA has authority to crack down on illicit vapes, but isn't doing it, Stat reveals; study finds increased e-cig use among lesbian girls

Food and Drug Administration photo

Even though the U.S. Food and Drug Administration has ordered hundreds of flavored, nicotine-heavy vaping products off of the market, "a Stat investigation found that vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen," Nicholas Florko and Elissa Welle report for Stat, the medicine-and-science publication of The Boston Globe.  

The authors write that while the FDA has ordered more than 100 vape manufacturers to stop making more than 250 specific flavors and vapes, "We found scores of companies across the country that are defying the FDA's demands." 

And despite having "sweeping legal authorities" to crack down on vape companies that ignore its bans, "ranging from levying seven-figure fines to physically pulling products off shelves," the Stat investigation found that the FDA has never used those powers, according to its own data. And in several cases, "It’s even dropped cases against companies that it knows are still selling illegal products," Florko and Welle write. 

The authors note that the FDA declined Stat’s request for an interview with FDA Commissioner Robert Califf or the head of the FDA’s Center for Tobacco Products, Brian King, but say a spokesperson implied the agency may soon get tougher against companies that ignore its orders,

“The agency is currently working on further enforcement in situations where companies that have [been banned from the market] continue to sell illegal products,” the spokesperson told Stat in an email. “The FDA is currently engaged in discussions with the Department of Justice regarding specific potential enforcement actions.”

Vape shops argued that the FDA’s orders aren’t clear enough, and that until they are more so, they'll keep selling the products.

The shops “are doing their best, despite a complete lack of clarity or transparency from the agency, to piece together what products are still legally able to be sold,” Amanda Wheeler, president of American Vapor Manufacturers, told Stat. “It would be legally and morally irresponsible for us to recommend that companies should voluntarily close down their businesses because FDA cannot sort out their filing systems.”

The authors walk through the FDA's regulation process for vaping products that ultimately requires every company that manufactures a vaping product to get the FDA's permission before selling their products in the United States. After being pushed back from November 2018, the deadline for asking permission was September 2020. And last year, the FDA finally started denying some companies' requests to sell their vaping products, resulting in many companies ignoring the requests. 

As part of the investigation, "Stat reviewed 120 letters issued to vaping companies between August 2021 and May 2022, covering bans on some 274 named products. According to company websites and information provided by vape shops by phone, at least 139 of the products are still being sold — more than 50% of the products named in those warnings." 

“If a large portion of the vaping products FDA has ordered off the market are still being sold, I’m baffled," Bill Schultz, a former deputy FDA commissioner who also served as the federal health department’s top lawyer and represents the Campaign for Tobacco Free Kids, told Stat.  “Congress gave the agency the authority to act decisively and they should be using it.”

The authors note that their investigation is likely an underestimation of the issue, since they only analyzed warning letters sent to companies that formally asked the agency for permission to sell their products, and then had that request denied and did not focus on the hundreds more companies that received warning letters for never asking the FDA for permission at all.

Much of the impetus for the FDA  to crack down on vaping companies' sale of products came from the surge in teenagers' use of these highly addictive devices. From 2019 to 2020, the popularity of disposable electronic-cigarette use among U.S. high school students who currently vaped went up by 1,000 percent, from 2.4% to 26.5%, according to the Centers for Disease Control and Prevention. 

Researchers are beginning to look at which groups of teens vape and the underlying reasons that put them at risk to start with. 

One such study recently published in the American Journal of Preventive Medicine, looked at the prevalence of vaping among high-school students in different sexual orientation, race and ethnicity groups. The study used survey data from more than 38,000 U.S. high-school students from 2015-2019.

The study uncovered significant differences in the prevalence of current electronic-cigarette use between lesbian and heterosexual girls when comparing across racial groups, says a news release from the Annenberg School for Communication at the University of Pennsylvania.  

"Current e-cigarette use was higher in Black girls who identify as lesbian compared to Black girls who identify as heterosexual (18.2% versus 7.1%)." the release says. "The rate was also higher in multiracial girls who identify as lesbian compared to multiracial girls who identify as heterosexual (17.9% versus 11.9%). On the other hand, white girls who identify as lesbian were found to be at lower risk of current vaping compared to white girls who identify as heterosexual (9.1% versus 16.1%)."

The study found that among boys, there were no significant interactions between sexual orientation and race or ethnicity in relation to vaping prevalence.

The authors note, "Previous surveys of gay and lesbian teens suggest that e-cigarette use might be a coping mechanism to deal with the stress of sexual orientation or gender identity-based discrimination or bullying — or a way to bond with others in their social circle." 

They also suggest that a possible reason for finding disparities in e-cig use at the intersection of sexual orientation and race among girls — but not among boys — may be due to higher levels of targeted e-cig marketing toward lesbians of color. 

“For years, the tobacco industry has targeted marketing toward traditionally marginalized groups, whether in clubs, bars, Pride events, or through magazines,” Andy Tan, co-author of the study, said in the release. “Sexual, racial, and ethnic minority youth are more likely to report engaging with online tobacco advertising including e-cigarette ads on social media.”