WASHINGTON — For the first time ever, the Food and Drug Administration has fined four businesses that have ignored its orders to stop selling unapproved vapes.
The move is the latest escalation by the agency’s tobacco center, which has been criticized in recent months for allegedly standing by while vape and tobacco companies ignore its rules. The move comes four months after the FDA took six other vape shops to court for selling illegal products.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, the director of the FDA’s Center for Tobacco Products, in a statement. “We are prepared to use the full scope of our authorities to enforce the law — especially against those who have continued to violate the law after being warned by the agency.”
Two of the companies the FDA fined, VapEscape and Great American Vapes, were listed in an October STAT investigation into vape companies ignoring the FDA’s orders. That project found that more than half of the 120 companies that the FDA had already warned about selling illegal vapes were still selling their products. Experts at the time questioned why the FDA had not used its legal powers to fine companies ignoring their rules.
The FDA frequently issues fines when companies are caught selling their products to underage customers, but before today, it had not issued fines for vape manufacturers selling illegal products.
It’s unclear if Wednesday’s announcement will be enough to placate critics who have chastised the FDA’s enforcement in this arena as piecemeal and slow. By STAT’s count it took the agency more than a year since issuing its first warning to VapEscape, Great American Vapes, and 13 Vapor to fine them.
Today’s announcement comes a week after Sen. Dick Durbin (D-Ill.), a vocal critic of the FDA’s enforcement around vapes, sent a letter blasting Commissioner Robert Califf for a “lack of urgency” that “ is creating serious public health harm.” Durbin’s letter also requested that Califf visit a shop selling these products in Washington, D.C.
“Perhaps you would have a greater appreciation for the seriousness and scope of FDA’s failed enforcement if you could see, with your own eyes, the sheer volume of unauthorized and flagrantly kid-friendly e-cigarette products that FDA is allowing to be sold to our children,” the senator wrote.
It’s also unclear whether the fines to these four companies will be enough to persuade the larger industry to begin following the agency’s rules. The fines are being issued to vape shops serving small markets like Norman, Okla., none of which appear to ship products nationwide. The FDA’s fines do not target larger producers like the Chinese disposable vape companies that are now illegally flooding the U.S. market.
“This boneheaded approach by FDA combines failed drug war tactics with appalling indifference to prevailing science that vaping is vastly safer than cigarettes,” the American Vapor Manufacturers, which represents vape shops, wrote in a statement. AVM described the FDA’s action as “crushing tiny domestic manufacturers.”
It’s not immediately clear how much each company will have to pay to regulators, or if they will have to pay a fine at all. Companies have the ability to pay the settlement, enter into a settlement agreement, or request a hearing to challenge the fine. The maximum fine per infraction is $19,192, according to an FDA press release.
STAT’s coverage of the commercial determinants of health is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.