Tobacco

FDA Ties E-Cigs to Nicotine Replacement Therapies

Agency forms committee to re-evaluate, ‘modernize’ its view on cessation products

SILVER SPRING, Md. -- The U.S. Food and Drug Administration (FDA) will form a new committee to review nicotine replacement-therapy products (NRTs), and with the move, new language is emerging that could potentially place electronic cigarettes into a category typically tied to nicotine gums and patches.

In a joint statement, three FDA officials co-authored an article noting the formation of the Nicotine Steering Committee, saying the group will be “re-evaluating and modernizing the FDA’s approach to development and regulation of nicotine replacement-therapy products that help smokers quit.”

Most NRTs have been approved for more than 20 years, but the statement noted how “novel” forms of nicotine delivery have emerged and may develop into FDA-approved therapies. In the next paragraph, officials wrote that public debate has surrounded “the potential for modified-risk tobacco products like electronic nicotine-delivery systems and e-cigarettes. FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that can be sold as new drugs, typically as over-the-counter pharmaceuticals.”

While not saying directly that it is considering e-cigarettes be deemed an NRT, officials did say that the review process will involve input from multiple stakeholders, including researchers, people from the medical field, tobacco manufacturers and professional organizations.

The authors of the announcement were Scott Gottlieb, commissioner of the FDA; Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research; and Mitch Zeller, director of FDA’s Center for Tobacco Products.

In an article published in The Hill, Neil McKeganey, director at the Center for Substance Use Research in Glasgow, Scotland, said the announcement was welcome news, saying it showed “a growing understanding that safer alternatives, including e-cigarettes, are available to smokers who want to quit.”

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