FDA Dragged its Feet on Vaping for a Decade: NYT

A 10/14 New York Times article examines FDA’s and the federal government’s alleged foot-dragging over the last decade that allowed e-cigarette use and marketing to explode to the detriment of teenagers. “In dozens of interviews, federal officials and public health experts described a lost decade of inaction, blaming an intense lobbying effort by the e-cigarette and tobacco industries, fears of a political backlash in tobacco-friendly states, bureaucratic delays, and a late reprieve by an FDA commissioner who had previously served on the board of a chain of vaping lounges,” according to the article.

One turning point came in the president Obama’s last year in office when his administration rejected a proposal to ban flavored e-cigarettes. “It came in the face of fierce lobbying over the tobacco regulations, including by a former senator and by a onetime White House analyst who had represented the Obama administration in the same discussions a year earlier,” the article says.

In 2017, recently departed FDA commissioner Scott Gottlieb granted e-cigarette companies a reprieve of four years before they would have to prove that the public health benefits of their products outweighed the risks in order to stay on the market. That extension, an interviewee told the New York Times, “left the door wide open for the surge in popularity of devices such as those made by Juul Labs, the troubled company that now dominates the market. Meanwhile, the federal government has largely ignored the explosion in vaping THC, the psychoactive ingredient in marijuana, which coincided with either recreational or medicinal legalization in many states. That regulatory dead zone has left public health officials scrambling to track the cause of the vaping-related lung illnesses that have led to at least 29 deaths.”

The public and Capitol Hill are losing patience due to FDA’s inaction, particularly with regard to the unexplained increasing vape-related illnesses and deaths. Last month at a Congressional hearing, a parent told a House panel: “If this was romaine lettuce, the shelves would be empty.” FDA acting commissioner Ned Sharpless told the hearing that the agency should have acted sooner. “We’re going to catch up,” he promised.

Meanwhile, the Trump administration said last month that it would soon announce a flavor ban for e-cigarettes. But the ban has yet to materialize, and industry groups have been fighting it, especially any limits on menthol and mint, according to the article.

In addition, the Gottlieb-endorsed four-year enforcement delay has been shrunk by a judge who ordered the agency to require e-cigarette makers to submit marketing applications by 05/2020. The article says that last week Reynolds American filed such an application for VUSE, the company’s cartridge-based vaping system that features flavors such as mixed berry, tropical, menthol and others.