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FDA Releases Second Draft Guidance to Support Development of Novel Nicotine Replacement Therapies

On February 21, 2019, FDA released the second of two draft guidance documents related to the development of novel nicotine replacement therapies (NRT).  The first draft guidance document, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry is available here, and the second draft guidance document,  Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products is available here.

The draft guidance documents are one part of FDA’s efforts in reevaluating and modernizing the agency’s approach to the development and regulation of NRT products.  These efforts are particularly relevant for those seeking approval of novel NRT products, including electronic nicotine delivery systems (ENDS), such as e-cigarettes, through FDA’s drug regulatory pathway.

NRT Regulation and E-Cigarettes

Smoking_cessation_draft_GuidanceCurrently, FDA has approved numerous NRT products, as well as other prescription drugs, for smoking cessation.  Specifically, FDA has approved three types of over-the-counter (OTC) NRTs–nicotine gum, transdermal nicotine patch, and nicotine lozenge, as well as two types of prescription NRTs-nicotine nasal spray and nicotine inhaler.  Besides the lozenge formulation, which was approved in 2002, all of these products have been approved for over 20 years.

Currently, there are no electronic nicotine delivery system (ENDS) products approved for use as an NRT for smoking cessation.  ENDSs generally available today, such as e-cigarettes and personal vaporizers are marketed for recreational use and so are regulated by FDA as tobacco products.  Marketing an ENDS as a smoking cessation tool with smoking cessation claims would require FDA premarket approval as a “drug.”

In a February 21, 2019 statement from FDA Commissioner Scott Gottlieb, the Commissioner included ENDS within his characterization of novel NRTs, which could be marketed as prescription or OTC drug products with medical claims for smoking cessation, but noted that they would need to be proven safe and effective for smoking cessation and regulated as drug products.[i]  See our full analysis on the potential OTC pathway for ENDSs here.

Recent Developments on Novel NRTs

As part of FDA’s efforts to support the development of novel nicotine replacement therapies for smoking cessation, in September 2017, FDA announced the establishment of the FDA Nicotine Steering Committee (NSC) as a forum for development and implementing nicotine policy and regulation.[ii]  Moreover, a public hearing on FDA’s approach to evaluating the safety and efficacy of NRT products was held on January 26, 2018.[iii]  Further, on August 3, 2018, FDA issued a draft guidance entitled, “Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products.”[iv] The guidance provides sponsors of NDAs with recommendations on the nonclinical information necessary to support development and approval for orally inhaled nicotine-containing products.  Commissioner Gottlieb noted that this guidance recognizes that while toxicity information is available for nicotine, that information may not be available for other compounds contained in e-liquids, such as flavorings and heat-generated chemicals.[v]

The second draft guidance, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,”[vi]  lays out a framework for the development of appropriate trial designs and new potential clinically relevant endpoints for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term.

Ultimately, FDA’s efforts related to reevaluating the development of novel NRTs for smoking cessation point to the agency’s recognition that e-cigarettes, and other ENDSs, may have a place in the development of novel NRTs sold as new drugs.

[i] U.S. Food and Drug Administration (FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettesFDA. GOV, (Feb. 21, 2019).

[ii] Nicotine Steering Committee, FDA.GOV.

[iii] U.S. Food and Drug Administration (FDA) Website, Public Meeting on FDA Approach to Evaluating Nicotine Replacement Therapies, FDA.GOV (Sept. 13, 2018).

[iv] U.S. Food and Drug Administration (FDA) Draft Guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry, FDA.GOV (Sept. 13, 2018).

[v] U.S. Food and Drug Administration (FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettesFDA. GOV, (Feb. 21, 2019).

[vi] U.S. Food and Drug Administration (FDA) Draft Guidance, Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug ProductsFDA.GOV (March 1, 2019),

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About this Author

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

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...

202.434.4230
Samuel Jockel, Keller Heckman Law Firm, Corporate and Food Law Attorney, Washington DC
Associate

Sam Jockel practices in the area of food and drug law. Mr. Jockel advises both domestic and international corporations on product compliance issues involving the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). In particular, he assists clients with regulatory matters related to food, food ingredients, processing aids, food packaging, and labeling issues.

Prior to joining Keller and Heckman, Mr. Jockel served as a trial attorney in the USDA’s Office of the General Counsel. While at USDA, Mr. Jockel was counsel for the implementation of the National Bioengineered Food Disclosure Standard, where he played a key role in providing legal advice to senior USDA and Agricultural Marketing Service (AMS) officials, drafting the proposed rulemaking, and defending USDA in a challenge under the Administrative Procedure Act.

At USDA, Mr. Jockel also represented AMS, the Food Safety and Inspection Service, and the Animal and Plant Health Inspection Service in administrative enforcement proceedings before USDA’s Administrative Law Judges. Mr. Jockel has particular expertise in enforcement matters arising under the Animal Welfare Act, where he successfully tried and resolved major compliance actions brought against animal research institutions, drug and biological product development companies, and animal dealers and exhibitors.

Mr. Jockel also served as an Oak Ridge Institute for Science and Education (ORISE) Fellow in FDA’s Office of International Programs during and following law school. At FDA, Mr. Jockel drafted and negotiated numerous international arrangements to share regulatory information between FDA product centers and foreign regulatory counterparts and multilateral organizations. Mr. Jockel also worked on medical product safety and regulatory harmonization initiatives, including representing FDA before the World Health Organization and the Pan American Health Organization.

202-434-4224