Guest Post: Where Is FDA Going with Nicotine and Tobacco?

At the end of July, FDA Commissioner, Scott Gottlieb, and his Center for Tobacco Products (CTP) Director, Mitch Zeller, announced a commitment and vision to dramatically change the impact of tobacco in the US. To understand how far-reaching this plan is, consider the following basics on the state of nicotine policy and science.

1. As a result of the 2009 Tobacco Control Act, the FDA (through the CTP) regulated cigarettes and smokeless tobacco. With a formal rule-making completed in 2016, CTP secured jurisdiction over all other tobacco products (such as cigars and e-cigarettes).

2. The 2009 law provides CTP with substantial resources and authority, but there are limits. For example, FDA cannot require that tobacco products be sold by prescription nor are they allowed to reduce nicotine levels to zero.

3. While you might be forgiven for thinking that smoking and tobacco have been “taken care of” as health issues, given the progress that has been made since the 1964 Surgeon General’s Report, you would be wrong. Smoking remains the leading cause of preventable premature death and disease, costing over 480,000 Americans their lives every year. And this staggering total is projected to continue into the foreseeable future.

4. And, finally, the harms from tobacco use arise almost entirely from the inhalation of combustion products, not from nicotine. Yes, nicotine appears to be critical for cigarettes to be addictive, but it is not viewed as a substantial contributor to other health problems.

Armed with these powers and information, Gottlieb and Zeller described a future where nicotine may still used by those who want or need it, but where the smoking of tobacco would be very rare. The two pillars of the plan are to foster innovation for noncombustible products while also setting a product standard to reduce nicotine levels in combustible products below a level able to create or sustain addiction. Thus, continuing users would consume nicotine through noncombustible sources, ranging from medications (patches, gums, lozenges), to smokeless tobacco, to vaping devices, and to future, novel forms.

The FDA faces many challenges to realize this future. But perhaps the greatest obstacle, based on FDA’s own data, is that upwards of 80% of smokers believe that nicotine itself is the primary ingredient that causes cancer.

We hope that FDA uses its bully pulpit and other communication channels to correct the record; its bold plan will be even harder to execute if they do not.

For more on the FDA’s new plan from FDA, click here. For some more detailed, and more critical, analysis, see these two posts from Clive Bates (here and here). For more on the underlying science of nicotine, click here. And for a useful summary of nicotine misperceptions (as well as other info in the other slides), click here for Dr. Sarah Johnson’s slides. Finally, for an op-ed that ran in The Hill yesterday on many of these issues, click here.

Today’s post comes from our friend Joe Gitchell, who has devoted his career to behavioral health and especially nicotine and tobacco policy. By way of disclosures, he tells us:

My employer, PinneyAssociates, provides consulting services on tobacco harm minimization (including nicotine replacement therapy and vapor products) to Niconovum USA, RJ Reynolds Vapor Company, and RAI Services Company, all subsidiaries of Reynolds American Inc. In the past three years, PinneyAssociates has consulted to NJOY on electronic cigarettes. I also own an interest in intellectual property for a novel nicotine medication.

Young Tobacco, photograph © Melinda Young Stuart / flickr

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November 14, 2017