3 Big Changes FDA Could Make in Tobacco

Angel Abcede, Senior Editor/Tobacco, CSP

Dr. Scott Gottlieb

WASHINGTON -- With the recent Senate confirmation of Dr. Scott Gottlieb to lead the U.S. Food and Drug Administration (FDA), tobacco retailers are hopeful that federal regulation and oversight of the category could ease.

Gottlieb, 44, has ties to electronic cigarettes, having invested in Kure Corp., an e-cigarette company based in Charlotte, N.C. Because of those ties, he has recused himself from commenting on vaping regulation for a year. Still, articles he has written for Forbes and other publications show an openness to harm-reduction arguments presented by vaping proponents.

This would potentially conflict with the views of the current head of FDA’s Center for Tobacco Products (CTP), Mitch Zeller, who has taken many antitobacco viewpoints since the FDA gained oversight of the category last year.

Here are some ways Gottlieb could reshape the FDA's position on tobacco products …

1. A stronger harm-reduction stance

Man vaping

The FDA could take a more open position on the harm-reduction potential of alternative nicotine-delivery devices like electronic cigarettes. While e-cigarettes still pose health concerns such as cardiovascular risk, studies have shown vaping to be of less harm than combustible cigarettes.

2. An easing of product-development rules


Current regulations mandate that virtually all e-cigarettes go through a rigorous and expensive application process by the FDA. Pending proposals at the federal level could ease those requirements, but any reversal from within the FDA could also quickly remedy the matter.

In general, the severity of the FDA approval process affects virtually all new tobacco products, so manufacturers and retailers are hopeful that a more pro-business perspective would reduce the challenges of new-product development.

3. Letting Zeller go

Mitch Zeller

Some industry watchers suggest that a removal of Zeller as head of the CTP will resolve several regulatory issues the tobacco industry has, but whether Gottlieb will go in that direction remains to be seen.