FDA Commissioner Gottlieb Discusses Proposed Tobacco Regulations

During a Tuesday event hosted by Politico, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb was asked about the agency’s recent efforts to increase regulation of the tobacco industry, including an Advance Notice of Proposed Rulemaking (ANPRM) on nicotine in cigarettes. CDA has submitted comments on the ANPR on nicotine levels as well as another pending ANPRM on flavors. The nicotine level comment deadline was July 16, 2018, and the tobacco product flavors comment deadline is July 19, 2018.

The Commissioner said that the proposal is intended to consider ways to make cigarettes less addictive and to “embrace” the use of modified risk products to migrate adults from combustible products more quickly. Commissioner Gottlieb also said that it could be possible to bring e-cigarettes and similar non-combustible products to market as drugs meant to be smoking cessation products, and that he wants to use the Tobacco Control Act to open the market to products that have lower levels of risk than combustible cigarettes.

Commissioner Gottlieb closed his comments by stating that the FDA was “very concerned” about the use of e-cigarettes by underage youth, and he expected the agency to take “aggressive action” against manufacturers that sell and market these products to children.