The FDA has announced a change in strategy for regulating nicotine replacement therapy (NRT) products, with the aim of ushering in new products that can help cigarette smokers quit.
In a blog post published on the agency’s site on Wednesday afternoon, FDA Commissioner Scott Gottlieb, MD, and two other agency officials announced the formation of a Nicotine Steering Committee charged with “re-evaluating and modernizing” FDA’s approach to NRTs.
The post noted that a primary focus of the committee will be existing nicotine delivery treatments, including prescription products and those currently sold over-the-counter in the form of gums, patches, and lozenges.
“This reflects the need to critically examine the evolving science behind FDA’s evaluation of the safety and efficacy of NRTs. Key topics will be the types of safety and efficacy studies we require and the way these products are used and labeled,” wrote Gottlieb, along with Center for Drug Evaluation and Research Director Janet Woodcock, MD, and Center for Tobacco Products Director Mitch Zeller, JD.
Last summer, FDA officials announced a dramatic shift in tobacco policy, with the goal of slashing nicotine levels in combustible cigarettes to non-addictive levels and exploring the potential of new nicotine delivery products like e-cigarettes and heat-not-burn devices as nicotine replacement therapies.
The FDA is currently reviewing Philip Morris International’s application to allow its heat-not-burn product IQOS to be marketed in the U.S. as a modified risk tobacco product. The agency is expected to rule on the application by early next year.
In Wednesday’s blog post, the officials reaffirmed the commitment to, “rendering combustible cigarettes minimally — or non-addictive,” as well as the commitment to offering reduced-harm products to replace them.
“If there are new kinds of NRTs — with different characteristics or routes of delivery — that can offer additional opportunities for smokers to quit combustible tobacco, we want to explore what steps we can take using our own regulatory policies to enable these opportunities, while making sure these products are demonstrated to be safe and effective for their intended use.”
The FDA blog noted that while nearly half of smokers try to quit combustible cigarettes each year, only a small percentage are successful.
In a study published this week in the BMJ journal Tobacco Control, researchers with Georgia State University’s Tobacco Center of Regulatory Science in Atlanta found that the vast majority of smokers they surveyed wanted to quit smoking and wished they had never picked up the habit.
The nationally representative survey of close to 1,300 adult smokers found that more than 80% reported high (22.5%) or very high (59.8%) discontent regarding their inability to quit smoking, their perceived addiction, and their decision to start smoking.
High levels of discontent did not vary significantly by sex, age, race/ethnicity, education, or income.
Compared with smokers expressing low (5.9%) or very low (3.6%) discontent regarding their smoking status, smokers expressing higher levels of discontent were more than twice as likely to perceive their health status as fair or poor (adjusted OR 2.3), more than four times as likely to worry about lung cancer (adjusted OR 4.6), and more than five times as likely to feel that they might develop lung cancer in the future (adjusted OR 5.1).
In an interview with MedPage Today, the lead researcher, Terry Frank Pechacek, PhD, said the findings have implications for federal regulators as they consider moving forward in the regulation of tobacco products and nicotine-delivery devices.
Pechacek said FDA officials and others should recognize that most smokers do want to quit. In addition, regulators should not put much emphasis on the “lost pleasure” aspect of quitting smoking, he said.
The FDA is required to perform an economic cost-benefit analysis of proposed regulations, and the agency has included the lost pleasure measure in its analysis of cigarette regulations.
Pechacek said there is significant debate about how the benefit-cost analysis of tobacco regulation should be conducted. He said federal regulators should focus on estimating net welfare gains from quitting smoking rather than emphasizing any lost pleasure in policy analyses.
“Our study found that most smokers express regret about starting smoking and they wish they could quit. These people are not continuing to smoke because they derive pleasure from the habit.”
Grant support for the research was provided by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products.
The researchers reported having no relevant relationships with industry.
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner