A Pending FDA Showdown: Gottlieb vs. Zeller

WASHINGTON -- As President Trump's nominee for head of the U.S. Food and Drug Administration (FDA)—Dr. Scott Gottlieb—continues to make his way through Congress' review process, several differences between him and Mitch Zeller, the FDA’s current director of the Center for Tobacco Products, have become clear.

Indications are that Gottlieb (above) will most likely take a pro-business approach to current and future regulation, standing in stark contrast to the more constrictive bent that Zeller has taken. While generally good news for tobacco retailers, Gottlieb’s initial impact may be muted as he decided to recuse himself in mid-April from judgment over electronic cigarettes for at least a year. His business ties to the vaping industry have drawn scrutiny, potentially curbing any relief Gottlieb could provide to e-cigarette regulation.

Through various reports, public statements and an article penned by Gottlieb and published in Forbes magazine in 2013, here’s how he and Zeller stack up on key issues …

The issue of tobacco control vs. harm reduction is the battle line between anti-tobacco activists and the tobacco industry. “Control” is often synonymous with “anti-tobacco,” while harm-reduction proponents typically focus on the benefits of alternatives to traditional, combustible cigarettes.

In a 2013 article in Forbes, Gottlieb reviewed the pros and cons of the tobacco debate, essentially questioning the anti-tobacco stance of refuting harm-reduction alternatives. “Would [tobacco] critics accept the proposition that any tobacco-based product could pose less risk, even if it were formulated into a nonsmoked consumable?” Gottlieb wrote.

Zeller (above) has a history with anti-smoking campaigns and has been quoted as saying, “We will marshal the science to support new policies to help combat the leading cause of preventable disease and death in the United States.”

During his confirmation hearings, Gottlieb was noncommittal regarding flavored electronic cigarettes. When Sen. Patty Murray (D-Wash.) asked, “Gummy bears? Cookies and cream?” regarding their appeal to children, Gottlieb said: “I recognize there is a line here somewhere, and I don’t know where that line gets drawn. I think that line needs to get drawn by people who are experts in evaluating that science, and I want to support that.”

Observers say science exists to support arguments both for and against flavor bans.

Under Zeller’s watch, the deeming regulations avoided bans on flavor, advertising and self-service displays, a move largely viewed as positive for retailers.

Vaping-industry representatives cautiously welcomed Gottlieb’s nomination, pointing to his appreciation of the harm-reduction concept, according to a report in Vape.com. With those credentials, he would appear predisposed to favoring changing the predicate date in the FDA’s deeming rules. Such a move would “grandfather” in many vaping products currently needing to meet stringent reviews and regulation.

In a media briefing, Zeller said such a change in the predicate date would have “an enormously adverse impact on public health and the ability of the FDA to do its job. It will exempt all of these products from any premarket review. Worse, those unreviewed products will be able to serve as predicates for new products coming down the road.”

Zeller’s position may stand, at least for the near term, as Gottlieb recused himself from oversight of any issue involving electronic cigarettes for at least a year. Gottlieb was a major financial investor in the Kure e-cigarette company, Charlotte, N.C.