The FDA has begun enforcing a major provision of its Deeming Rule, more than two years after the rule went into effect. The Deeming Rule prohibits products from being introduced to the market after Aug. 8, 2016 without first going through premarket review by the agency. No product has yet been submitted for review.
The agency has sent letters to 21 vaping importers and sellers asking for evidence that some of their products were on the market before the 2016 deadline. Some of the named products almost certainly did not meet that deadline, which makes them in violation of the federal Food, Drug, and Cosmetic Act (FDCA). This is a full list of the cited products:
Most of the devices are pod and mini vapes, which have been the subject of attacks from the Campaign for Tobacco-Free Kids and other tobacco control groups. Anti-vaping activists believe all pod vapes are attempts to copy the JUUL, which has been the subject of a coordinated campaign of misinformation in an attempt to portray vaping in general and JUUL specifically as deliberately trying to lure teenagers into nicotine use.
FDA Commissioner Scott Gottlieb is portraying what should be understood as routine regulatory enforcement action as an extraordinary step that will somehow affect what he calls the “epidemic” of teen vaping. Luckily for Gottlieb, the mainstream press has virtually no understanding of the issues, so his pronouncements are largely repeated without critical questioning. Some of the products named in this action were on the market before the cutoff date, and some weren’t. But removing any or all of them will only force people to buy other similar products.
Anti-vaping groups were behind the recent spate of stories accusing manufacturers of introducing products after the Aug. 8, 2016 deadline. Those articles, combined with JUUL Labs’ own legal actions against other pod manufacturers, probably prompted the FDA to act — although the agency certainly must be aware that there are thousands of non-compliant products on the market. Most nicotine salt e-liquids, for example, were introduced after the deadline.
The enforcement action is just the latest event in a topsy-turvy year following Commissioner Gottlieb’s July 2017 announcement that the FDA would postpone the deadline for vaping manufacturers to submit premarket tobacco applications (PMTA’s) for all existing products until 2022. Last month, Gottlieb threatened to rescind that decision and immediately pull products off the market until PMTA’s are submitted. He has also suggested the FDA might ban online sales of vapor products.
The agency is also in the process of making rules that will regulate e-liquid flavors. Most observers believe the FDA will restrict fruit, candy and dessert flavors, which are the flavors preferred by most vapers. There is also bipartisan legislation in the Senate that would effectively ban all non-tobacco flavors.
In the last year, the FDA has swung wildly from seeming to show some understanding for the millions of vapers who have used e-cigarettes to avoid the dangers of smoking cigarettes to enthusiastically joining hands with the anti-vaping organizations that have applied pressure on the agency to ban vaping products, and have even sued the FDA to reinstate the 2018 PMTA deadline.
The FDA would like the tobacco control groups, vape-denouncing politicians, and politically active parents that are hyping the supposed teen juuling epidemic to think that the action against these pod sellers will somehow address some of their concerns. And the agency wants the public to believe that pointless sanctions on fringe elements of the Chinese vaping industry represent meangingful enforcement actions.
“Companies are on notice – the FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency’s compliance policy, and we will take swift action when companies are skirting the law,” said Commissioner Gottlieb. His boss, HHS Secretary Alex Azar, is on board with the FDA’s new stance too, and that means the upper echelons of the Trump administration won’t get in Gottlieb’s way.
Now the FDA commissioner claims that the agency will learn exactly how many teens are using each kind of vaping product. That’s quite a promise to make, considering it took the massive federal agency two years to take any enforcement action to support its regulations, and that it never seems to do anything at all without being motivated by extreme political pressure.