It’s understandable if people are confused by the Food and Drug Administration’s announcement on September 9. The agency’s statements on that day discuss the ongoing process of reviewing marketing applications for e-cigarettes and the FDA’s enforcement against products that haven’t received authorization to be sold in the U.S. Little is mentioned about the significance of September 9 and what it is that is required of manufacturers and of the FDA going forward.
The FDA’s struggles with premarket review date back to the very beginning of the agency’s regulation of tobacco products. Regarding e-cigarettes in particular, the FDA has had a difficult time picking a direction and sticking with it. In general, the agency has been reactive rather than proactive and not just slow, but glacial, in its response to unique threats like Juul. The terrible irony is that premarket review was intended to prevent harm before it happens, and the youth e-cigarette epidemic is a perfect example of something that would never have happened if the FDA had been an effective regulator.
In fact, the FDA was so derelict in its duties that public health groups actually sued the FDA so it would start implementing premarket review for e-cigarettes. Those groups won and the court imposed two deadlines for premarket review. First, by September 9, 2020, e-cigarette manufacturers were required to submit marketing applications to the FDA in order to continue selling their products for up to one more year. By September 9, 2021, e-cigarette manufacturers were required to secure marketing authorization from the FDA in order to keep their products on the market after that date.
If you’ve been attempting to follow what’s going on, you’ve probably heard a lot of noise about the FDA missing the deadline to authorize products. No such deadline exists. The deadline of September 9 was for manufacturers to have received authorization, not for the FDA to have finished review. What is required of the FDA is enforcement. In this case, that means removing products from the market that haven’t received authorization. Any e-cigarettes that are sold without authorization are sold illegally. On September 9, no products had received marketing authorizations which means every e-cigarette was being sold illegally.
A lot about this process is unknown, but here’s what we know so far:
The FDA received about 6,500,000 premarket tobacco product applications for e-cigarettes. The vast majority were so defective that the FDA could not even begin to review the scientific merits of the applications and so the applications were denied without even being reviewed. The FDA has also issued denials for several hundred thousand applications, mostly for flavored e-cigarettes. However, despite indicating that it would use market-share as a factor in prioritizing applications for review, the FDA has yet to announce decisions on applications from companies like Juul, NJOY, and Reynolds that control the majority of the e-cigarette market.
We will continue to monitor the FDA’s progress and update the public health community on what happens in the coming weeks and months.
By Desmond Jenson, Lead Senior Staff Attorney for Federal Regulation, Commercial Tobacco Control Programs
September 21, 2021