What Does Gottlieb's Resignation Mean for FDA Initiatives?

Future of flavors in vaping, tobacco face uncertain times with departure of agency’s commissioner
Photography: Shutterstock

WASHINGTON The U.S. Food and Drug Administration’s (FDA) hard line on flavors in electronic cigarettes and other tobacco products now comes into question as the champion of those measures and other agency efforts, Commissioner Scott Gottlieb, announced his resignation effective in early April.

While the FDA has yet to issue official word, Gottlieb confirmed his decision in a tweet on March 5, with subsequent confirmations and statements of support coming from other government officials, including President Donald Trump.

In his own tweet, Gottlieb said he was “immensely grateful” for the opportunity to lead the agency since May 2017, adding “this has been a wonderful journey and parting is very hard.”

Among the wide-ranging issues that Gottlieb oversaw during his almost two-year tenure included a crackdown on the ability of young people to purchase electronic cigarettes and an effort to make generic drugs more accessible.

Trump in his tweet said, “Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things.”

For tobacco retailers, Gottlieb’s departure calls into question the fervor with which he delivered most of his recent public announcements surrounding nicotine, and the continuing tenacity the agency will have on tobacco issues. These announcements included the naming of 15 retailers as having a concerning number of violations regarding the sale of tobacco product to minors, as well as a general call for more restrictions on flavored vaping products and cigars and the complete ban of menthol-flavored cigarettes.

“It’s to be determined what effect his resignation will have,” said Lyle Beckwith, senior vice president of government relations for NACS, Alexandria, Va. “But there’s no reason to believe his vape agenda will not continue.”

Saying she was surprised by Gottlieb’s decision, Bonnie Herzog, managing director of consumer equity research for Wells Fargo Securities, New York, said it was a “positive” for the tobacco industry, even though it also would mean uncertainty.

“We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cigarette usage and access, cigarette nicotine limits and a cigarette menthol ban given he was the champion behind those initiatives,” Herzog said in a statement she released soon after initial reports surfaced on March 5. “We also believe his resignation could have implications—positive, we hope—for the FDA’s approvals of the premarket and modified-risk applications for the [heat-not-burn device] iQOS.”

About two years in, she said FDA approval for the New York-based Philip Morris International’s (PMI) iQOS device is long overdue, without any clear explanation as to why the agency is taking so long.

Reiterating concern over the future of the FDA’s initiatives, a spokesperson for the Campaign for Tobacco-Free Kids said Gottlieb’s proposals had the potential to save more lives from tobacco use than the actions of any previous administration; however, Matthew Myers, president of the Washington, D.C.-based advocacy group, said in a statement, “To date, none of his proposals have been adopted, and there are no rules in place to prohibit the sale of the flavored, high-nicotine products that have led to the skyrocketing use of e-cigarettes by our kids. Commissioner Gottlieb’s legacy will depend on whether his many proposals are implemented and, in the case of the youth e-cigarette epidemic, strengthened going forward.”

Other comments about Gottlieb’s departure focused on his achievements and leadership style. The Grocery Manufacturers Association, Washington, D.C., issued a statement on behalf of Geoff Freeman, its president and CEO: “Under the leadership of Commissioner Scott Gottlieb, the Food and Drug Administration was a strong and effective champion of public health. The consumer-packaged goods industry believes in smart, uniform regulation and a strong FDA is a critical partner in building trust in the products Americans use every day.”

Similarly, Health and Human Services (HHS) Secretary Alex Azar said in a statement: “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease and more.”

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