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FDA to Announce Public Hearing Concerning its Approach to Evaluating the Safety and Efficacy of Nicotine Replacement Therapy (NRT) Products and Formation of a Nicotine Steering Committee

In tomorrow's Federal Register, the FDA will announce a public hearing concerning FDA's approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should be used and labeled. FDA is holding the public hearing to receive information and comments from a broad group of stakeholders, including the public health community, researchers, health care professionals, manufacturers, interested industry and professional organizations, and the public, on the appropriate study designs and methods for evaluating the safety and efficacy of OTC NRT drug products. FDA is also seeking input on the warnings and directions sections of the Drug Facts labeling (among other aspects) for approved OTC NRT products, specifically regarding the possible impact of current warnings on likelihood of use. 

The advanced Federal Register notice also includes a list of the following six questions for commenters to consider as they prepare their comments or statements:

  1. Might there be ways to improve upon the currently available delivery systems to yield new OTC NRT products that might be more effective? If so, what evidence would be needed to support such changes, and how should they be evaluated?
  2. Are there additional indications or regimens for OTC NRT products that could be explored? Concepts to consider could include relapse prevention, craving reduction, maintenance, reduce to quit, use of short- and long-acting products in combination, or cessation of non-cigarette tobacco products. What evidence would be needed to support each indication or regimen?
  3. What data would be required to demonstrate health benefits of reduction in consumption of combustible tobacco products?
  4. Are there OTC NRT products that could be studied for use in combination that might result in reduced tobacco-related health impacts? What evidence would be needed to support the safety and efficacy of these products when used in combination?
  5. Is there other information that could be added to labeling for currently approved or new dosage forms of OTC NRT products that would maximize their ability to be used to support smoking cessation? Please consider the various sections of the Drug Facts labeling, including the Uses, Warnings, and Directions sections.
  6. Generally, the labeling of OTC NRT products contains a dosing schedule based on duration of use, and FDA has recommended the labeling on OTC NRT products be modified to include the following: "If you feel you need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider." What is the impact of longer term NRT treatment? What is the impact on likelihood of cessation or relapse prevention? What data would support an affirmative recommendation to use approved OTC NRT products for durations that exceed those currently included in the Drug Facts labeling of approved OTC NRT products, or would support a chronic or maintenance drug treatment indication for such products?

The public hearing will be held on Friday, January 26, 2018. Persons seeking to attend or to present at the public hearing must register by Tuesday, January 2, 2018. Electronic or written comments will be accepted after the public hearing until Thursday, February 15, 2018. The advanced Federal Register notice is attached and available here

FDA also announced that the agency is forming a Nicotine Steering Committee to help develop and implement nicotine policy and regulation to address the public health crisis of addiction to tobacco products. The committee, which will include senior leadership from the Center for Tobacco Products, Center for Drug Evaluation and Research, and Office of the Commissioner, will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking. The committee will examine the evolving science behind the agency's evaluation of these NRTs, including the types of safety and efficacy studies FDA requires and how these products are used and labeled. The Committee's first action will be to hold the public hearing described above. Whether and how, if at all, the Committee will consider the impact of recreational nicotine-containing products, such as e-vapor and heat-not-burn products, on promoting tobacco harm reduction among adult cigarette smokers, for example, remains unclear.  


© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 333



About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...