Last Thursday, Alex Azar, Secretary of Health and Human Services (HHS), and Dr. Scott Gottlieb, U.S. Food and Drug Administration (FDA) Commissioner, penned a joint op-ed in the Washington Post, expressing deep concern about the risks e-cigarettes pose to children. They described the federal government’s steps to “crack down” on the sales of e-cigarette products to minors. Importantly, they have come to the conclusion that HHS and FDA have not gone far enough in their attempts to curb e-cigarette use among children, and are “actively” considering a range of policy options, including curbing the use of flavored e-cigarette products.

This was followed by an announcement from the FDA on Friday that the agency was stepping up its efforts to determine whether e-cigarette companies are illegally marketing their products to children. The agency is requesting information from manufacturers on 40 specific products as part of its Youth Tobacco Prevention Plan, which combines “cracking down” on sales and marketing to children and a targeted education campaign on the dangers of e-cigarette use.

On Monday, the FDA took an additional step in announcing a public comment period on its guidance to the industry on how to establish that a tobacco product was commercially marketed in the US prior to Feb. 15, 2007. As we have shared previously, the FDA refers to tobacco products that were commercially marketed in the US as of Feb. 15, 2007, as “grandfathered” tobacco products, which are not considered new tobacco products and are not subject to the premarket requirements of section 910 of the Food, Drug and Cosmetic Act. The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the US as of Feb. 15, 2007. As a reminder, the House fiscal year (FY) 2019 Agriculture funding bill includes language supported by CDA, which streamlines and clarifies the regulatory process for vaping products. However, the Senate FY 2019 Agriculture bill is silent on the issue. CDA will continue to lobby for the final FY19 Agriculture funding bill to include the House language which creates some certainty for the regulation of vaping products.