FDA Announces New Nicotine-Focused Plans for Tobacco Regulation

The US Food and Drug Administration (FDA) has announced a new comprehensive plan for tobacco and nicotine regulations that aims to significantly reduce tobacco-related diseases and death, and address concerns regarding nicotine exposure in children. This new approach is designed to ensure the FDA has the proper scientific and regulatory foundation to implement the Family Smoking Prevention and Tobacco Control Act, and to balance the regulation of tobacco products with the development of innovative products that may be less dangerous than cigarettes.

Currently, the FDA plans to begin a public dialogue on lowering nicotine levels in combustible cigarettes to non-addiction levels in order to gather input on potential public health benefits and possible adverse effects. The lowering of nicotine is intended to reduce the risk of addition in youths and help long-term users quit. Likewise, the FDA is seeking input from the public on regulating kid-appealing flavors in e-cigarettes and cigars, as well as increase access to FDA-approved medicinal nicotine products intended to help people who smoke quit.

In addition, the FDA is extending timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of August 8, 2016 to encourage innovations that would make a difference in public health, help smokers quit, and protect children. This will allow the agency to explore options that reduce the toxicity of tobacco products, as well as make the products less appealing and addictive.

The agency intends to issue new guidance that describes the new enforcement policy soon. This new enforcement policy will only affect newly-regulated tobacco products, and will not affect any current requirements for cigarettes or smokeless tobacco products.

—Melissa Weiss

Reference:

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death [press release]. FDA. July 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm. Accessed July 31, 2017.