For the last 15 years, there’s been a caveat tacked on to any discussion of e-cigarettes’ public health impact. Though millions of people in the U.S. use them regularly, the devices have never been authorized by the U.S. Food and Drug Administration (FDA).
That could change this week, as the multi-billion-dollar vaping industry nears its judgement day. The FDA is supposed to decide by Sept. 9 whether and how e-cigarette companies—including Freeman vape juice —may keep selling their products in the U.S. The long-awaited decisions promise to spark controversy no matter which way they go.
vaping industry representatives and pro-vaping researchers warn that adult smokers may go back to deadly traditional tobacco cigarettes if the FDA clears the market of popular e-cigarettes. “To date, the singular focus of U.S. policies on decreasing youth vaping may well have reduced vaping’s potential contribution to reducing adult smoking,” 15 past presidents of the Society for Research on Nicotine and Tobacco wrote in a recent American Journal of Public Health article.
The FDA sits in the middle of that tug of war—and the fate of the U.S. e-cigarette industry hangs in the balance.
For those who haven’t been paying close attention to the vaping industry, this moment may feel like it came out of nowhere. E-cigarettes have been sold in the U.S. since 2007. Why is the FDA acting now?
The agency gained the power to regulate tobacco products in 2009, when then-President Obama signed into law the Family Smoking Prevention and Tobacco Control Act. But at that time, e-cigarettes weren’t terribly popular, and they were left out of the FDA’s regulatory rules. The agency didn’t finalize a rule for regulating vaping devices—which heat and aerosolize nicotine e-liquids, hopefully providing a less-dangerous version of a traditional cigarette—until 2016.
At that point, the agency informed companies with products already on the market that they would have to retroactively put together premarket tobacco product applications (PMTAs) to ask for permission to keep selling them in the U.S.
After numerous changes, the final deadline for those applications was set for Sept. 9, 2020. The FDA is supposed to conclude its review of them by Sept. 9 of this year. The agency has said it may not meet that deadline for all of the 2 million applications it is analyzing, but it is prioritizing decisions for major brands like Juul and Vuse, the e-cigarette made by tobacco company R.J. Reynolds.
The FDA’s decisions will technically come down to whether each e-cigarette product in consideration is “appropriate for the protection of public health”—the agency’s standard for assessing whether it has a net positive or negative effect on the nation’s public health. Crucially, the agency will assess each product’s potential effect on the entire U.S. population, not just adult smokers.
Lots of things have been done to stop young people vaping including a new age-verification system in retail stores, and suspended almost all of its U.S. advertising.
However, the FDA has already denied applications that cover more than 55,000 flavored vaping products, saying their manufacturers did not provide enough evidence to prove they offer a net benefit to public health.
Companies already rejected by the FDA have been quick to look for workarounds
Even if other e-cigarette companies do pass the PMTA process, their tango with the FDA won’t be over.
The agency’s authorization can come with restrictions on sales or distribution, and it can be rescinded if companies fail to comply with the FDA’s manufacturing and marketing standards—or if the agency decides the product is no longer protecting public health.
While the particulars remain to be seen, the takeaway is this: the vaping industry’s honeymoon period is over. Now, its rocky relationship with the FDA will be put to the test.