FDA issued a statement on nicotine replacement therapy for vapes

The US Food and Drug Administration announced other draft guidelines for the agency to support the development of safe and effective new nicotine replacement therapy (NRT) to “help smokers quit smoking”. Part of the plan seems to include a two-step approach - the development of NRT drug products and non-clinical testing of drug products containing oral inhalation, nicotine. These steps are currently not mandatory and are only listed for reference purposes.

In a statement issued by the FDA, especially regarding vapes: "New nicotine delivery routes with different characteristics may provide additional opportunities for healthy smokers who are interested in quitting. This may also include vapes, etc. Products such as nicotine delivery systems, but need to prove that these products are safe and effective for smoking cessation and are regulated as drugs. This will allow them to be sold as prescription or over-the-counter products with medical claims for smoking cessation or related indications, ultimately It reduces the likelihood that smokers will continue to suffer from the clinical consequences of smoking. This is different from our regulation of vapes as a tobacco product."

The FDA continues to describe their nicotine steering committee: “Create a more flexible framework to develop safe and effective innovative products that help smokers quit and improve their health. This includes a public hearing in January 2018. Yes, review the types of safety and efficacy studies we recommend, as well as the use and labeling of these products, and develop guidance to facilitate the development of these products."

The FDA added, “On the basis of these efforts to encourage drug innovation to help more smokers quit, today we have released the second of two draft guidelines designed to support the development of new nicotine replacement therapies that can be used as New FDA-approved drugs are sold, similar to current prescription and over-the-counter NRT drugs."

The draft guide published today in this statement is entitled “Quitting smoking and related indications: developing nicotine replacement therapy drug products”.

In the agency's own words: "The draft guide considers the comments received at the public hearing in January 2018 and aims to be the focus of continued discussions in the FDA, drug sponsors, smoking cessation research community and the public."

The purpose of the guide is to describe new endpoints that are meaningful to help current addictive adult smokers and to promote NRT innovation by outlining broader criteria that can be used as a basis for new approvals.

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