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FDA’s Tobacco Policy Pivot, Five Months Later

FDA’s Tobacco Policy Pivot, Five Months Later

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In late July, FDA Commissioner Scott Gottlieb, MD, announced a major pivot in tobacco policy aimed at shifting the federal government’s regulatory focus from nicotine to combustible tobacco products. Click here to read MedPage Today‘s original report on the announcement. In this follow-up story, we review what has transpired in tobacco regulation since then.

In that announcement, Gottlieb outlined a multi-pronged strategy:

  • Reducing the nicotine in traditional cigarettes to non-addictive levels
  • Increasing the number of approved nicotine replacement therapies (NRT)
  • Acknowledging the potential of other, non-combustible nicotine-delivery products to help smokers quit — recognizing a “continuum of risk for nicotine-containing products,” as Gottlieb put it

“The regulatory framework for reducing harm from tobacco must include nicotine — as a centerpiece,” Gottlieb wrote in an editorial explaining the policy shift published in the New England Journal of Medicine.

“Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year,” he wrote. “The FDA’s approach to reducing the devastating toll of tobacco use must be rooted in this foundational understanding: other chemical compounds in tobacco, and in the smoke created by combustion, are primarily to blame for such health harms.”

Specific actions outlined by the agency in the late July announcement included a plan to formally seek input on dramatically lowering nicotine levels for combustible cigarettes under an Advanced Notice of Proposed Rule Making, and the delay of key regulatory actions on electronic cigarettes, cigars, and previously unregulated tobacco products.

Movement ‘Slower than Promised’

The comprehensive tobacco policy was generally praised by anti-tobacco groups at the time as a potentially positive step forward for reducing tobacco-related death and disease in the United States, while they uniformly criticized the plan to delay key deadlines for the regulation of electronic cigarettes and other tobacco products that came under the FDA’s authority in 2016.

In a press release issued in response to the FDA’s shift in tobacco policy, Robin Koval of the anti-tobacco group Truth Initiative agreed with Gottlieb’s conclusion that reducing the addictive ability and appeal of combustible tobacco products “is a cornerstone of protecting the public health.”

“Ultimately, while we are strongly supportive of the goals set forth by Commissioner Gottlieb today, our optimism is tempered by the ongoing delays in implementing measure that will have an impact on the death and disease caused by tobacco.”

Campaign Tobacco-Free Kids’ (CTFK) president Matthew Myers called Gottlieb’s sweeping tobacco regulatory agenda “a bold and comprehensive vision with the potential to accelerate progress” in reducing tobacco-related disease and death.

But, in a press release, Myers also noted that with regard to implementing the vision, “the devil is in the details.”

Five months later, Myers says that, while there are signs the FDA moving forward with key areas of the agenda, it’s been slower than promised.

“I would now say the devil is in the follow-up,” Myers told MedPage Today in a Dec. 27 telephone interview.

He said the FDA had promised to issue an Advanced Notice of Proposed Rule Making (ANPRM) by the end of the year to formally begin the dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.

Other proposed ANPRMs include seeking public comment about whether FDA should eliminate flavors, including menthol, from little cigars and other tobacco products and seeking comment on whether the agency should reconsider its jurisdiction over certain forms of cigars.

Myers said CTFK received notice about a week ago that the ANPRM proposals have been sent to the Office of Management and Budget, but they have not been published yet.

“The public hasn’t seen them, so it is impossible to know how effectively they will move the ball forward,” Myers said.

“Whether Dr. Gottlieb’s July announcement turns into a significant and meaningful step forward depends on what happens in 2018 — not what he said in 2017,” Myers added.

NRT Steering Committee Appointed

One step forward came late last month. Gottlieb, along with Mitchell Zeller, JD, and Janet Woodcock, MD — heads of the FDA’s tobacco and drugs divisions, respectively — announced formation of a Nicotine Steering Committee with the aim of increasing the number of nicotine replacement therapies (NRTs) available for smokers who want to quit.

The FDA officials noted that while around 70% of adult smokers in the U.S. report wanting to quit and nearly half try to quit each year, only a small percentage succeed.

Myers said the goal of streamlining the reviewing process for NRTs regulated under Woodcock’s Center for Drug Evaluation and Research is a good one.

“We have over 36 million smokers, yet during the last 15 years there have only been three products approved to help smokers quit,” he said. “FDA has to do more to encourage innovation for smoking cessation.”

But he added that any effort to recognize electronic cigarettes or other recreational, non-combustible devices as nicotine delivery therapies for smoking cessation would be premature.

The studies examining the potential of e-cigarettes to help smokers quit have been contradictory and, Myers said, largely poor in quality.

“The bias of the researcher going in is the biggest predictor of what they will find,” he said. “It’s the FDA’s job to be the independent arbiter and demand good science. So far, it has been slow to do that.”

Tobacco researcher Stanton Glantz, PhD, told MedPage Today that while the research conducted to date suggests e-cigarettes can help a subset of smokers quit, they also have been shown to suppress smoking cessation among a larger group of adult smokers and promote the initiation of cigarette smoking among teens.

Glantz, who has long been critical of nicotine products, directs the Center for Tobacco Control Research and Education at the University of California San Francisco.

“If the FDA comes to the conclusion that smokers should be encouraged to shift to these less dangerous forms of nicotine, that would be inconsistent with what the evidence shows,” he said.

Considering Approval of ‘Heat-not-Burn’ Products

The FDA is currently reviewing tobacco giant Philip Morris’ proposal to sell its ‘heat-not-burn’ product IQOS in the U.S., and to market it as a reduced-harm device for nicotine delivery.

While news reports suggest that approval could come as early as February, both Myers and Glantz indicated that this timeline is wildly optimistic, given that the application is not complete and has not been considered by the FDA’s tobacco science advisory committee.

“Anyone who makes that prediction is shilling for the company,” Myers said. “Philip Morris International is spending literally millions of dollars to promote the notion that [IQOS] should and will be approved. There is no objective evidence that FDA has a point of view on this product yet.”

Earlier this month, Reuters published an investigative report detailing Philip Morris’ efforts to promote IQOS to health officials around the world as a safe alternative to combustible cigarettes.

Reuters said it “identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials that underpin the tobacco giant’s application to the FDA.”

Glantz recently sent a letter to the agency’s Tobacco Products Scientific Advisory Committee (TPSAC) urging it to delay action on the application until all public comments have been submitted and the application process is complete.

The TPSAC is scheduled to meet late next month to consider the IQOS application.


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