May 17, 2019

Stanton A. Glantz, PhD

Federal court has created an opportunity for FDA to stop protecting the tobacco companies and start protecting kids from ecigs

Earlier this week, in a case brought by the American Academy of Pediatrics, the Campaign for Tobacco Free Kids, and a broad coalition of health groups, a federal court in Maryland ruled that the FDA must enforce the Family Smoking Prevention and Tobacco Control Act as it applies to e-cigarettes.

When the FDA finally issued is “deeming” rule in August 2016 taking jurisdiction over e-cigarettes all e-cigarettes on the market instantly became illegal because they did not have an order from the FDA allowing them to be marketed.  FDA dealt with this situation by saying they would exercise “enforcement  discretion” and allowed the companies selling the newly deemed products one year (through August 2017) to submit the needed applications for authorization to sell these products.  The FDA gave itself another year, until August 2018 to complete these reviews.  Any product without a premarket order could not be sold.

When Scott Gottlieb became commissioner, he extended the time for companies to file their applications until August 2022 and also allowed the products to stay on the market until FDA finished its review of the application with no end date.

Federal Judge Paul Grimm ruled that the FDA delay was “so extreme as to amount to an abdication of its statutory responsibilities.”  He gave the FDA and health groups two weeks to submit briefs on what the judge should order the FDA to do. 

Thanks in large part to FDA ignoring its responsibilities on e-cigarettes, youth use has exploded, which has led to a lot of strong statements from Gottlieb and others at the FDA, but no meaningful action.

Everyone expects that the FDA will appeal the decision, dragging out the process and allowing Juul and the other e-cigarette companies to continue to run wild, solidifying the FDA’s reputation as enablers rather than regulators of the tobacco companies.

The ruling does, however, give the agency a chance to rescue its reputation:  It could announce that it will be complying with the order rather than appealing it and present a sensible rapid plan to get e-cigarettes off the market unless the manufacturers can meet the legal requirement that allowing their sale is “appropriate for public health.”

The recent decision on Philip Morris’ IQOS does not generate a lot of confidence in the FDA’s judgment in this area, where their definition of “appropriate for public health” seems to be “not worse than a cigarette.”  That’s why, even though the FDA is not required to put premarket applications out for public comment, they should do that with all the premarket applications to make it harder for the companies to slide through. 

The full decision is here.  An AP story on the decision is here.

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