September 9, 2020 was the deadline for e-cigarette companies to submit their applications for premarket review to the FDA, a so-called premarket tobacco product application (PMTA). To date, FDA has approved a few PMTAs, most notably for Philip Morris’ IQOS heated tobacco product. The process has not been transparent and health groups and a public comment from the UCSF TCORS have criticized the FDA for not devoting adequate attention to ensuring that new products would not appeal to youth.
Now a bipartisan group of 12 Senators has written FDA a pointed letter raising this issue as well as important specific questions on how FDA will evaluate the new applications.
They also stake out a much stronger position on youth than the FDA has used to date:
“[The “appropriate for the protection] standard prevents FDA from authorizing a PMTA for a new tobacco product unless the manufacturer can prove such product does not lead to youth tobacco initiation and will reduce risk of harm.”
This is not something FDA has done to date. The standard that the senators outline will make it much harder for FDA to accept saccharine assurances that the manufacturers do not want kids to use their products or claim that youth access controls will prevent youth use.
The senators also say that the FDA should not approve any flavored tobacco products, citing the strong evidence that flavors attract kids and the paucity of data showing that flavors help adults quit smoking.
They also stress that FDA should not approve any products that increase the risk of addiction, most notably the nicotine salt formulations pioneered by Juul — and widely adopted by other companies — that increase nicotine delivery.
Then the outline what “harm reduction” would really require: evidence that a particular e-cig has less risk (not exposure) than cigarettes, will be used as a substitute, will only be used by adult smokers, and will not delay or prevent people from stopping altogether, This last point is particularly important given the strong evidence that e-cigarettes as consumer products do not help adults quit smoking.
Finally, they ask for the precise criteria that FDA will use for determining whether a new product is appropriate for the protection of public health.
The letter is worth reading because it is the most succinct summary of what the FDA should be doing to implement the law.