Last week, two House Committees held hearings on e-cigarettes.
Democrats want e-cigarettes to be banned until approved by the Food and Drug Administration (FDA) through the FDA’s premarket tobacco product application (PMTA) pathway. By May of next year, all manufacturers will have to apply for new product approval and FDA could grant approval for
manufacturer’s flavored products to come back on to the market. Specifically, Acting FDA Commissioner, Ned Sharpless, wants to ban e-cigarettes not only from convenience and other non-adult only retail, but also from the Internet.
On September 11, the Trump Administration announced that the FDA plans “to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements” for flavored e-cigarettes other than tobacco-flavored e-cigarettes. Click
to view a copy of the FDA news release.
The announcement appears to reference the FDA’s March proposed draft Guidance “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” A guidance document explains how a federal agency intends to administer and enforce current law and how those being regulated can comply with current regulations.
The March draft Guidance would apply to certain flavored electronic nicotine delivery systems (ENDS), but not tobacco-flavored, mint-flavored or menthol-flavored electronic products. The FDA explained in the March 2019 Guidance that its prioritized enforcement will focus on flavored ENDS products (other than tobacco-flavored, mint-flavored, and menthol-flavored ENDS products) “that are offered for sale in ways that pose a greater risk for minors to access such products.”
However, the announcement on September 11 indicates that the FDA will prioritize its enforcement on all flavored e-cigarettes except tobacco-flavored electronic nicotine delivery systems. This enforcement prioritization would likely include mint-flavored and menthol-flavored e-cigarettes because the announcement references preliminary results from the National Youth Tobacco Survey that “the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.”
It is important to understand that the final compliance policy that will be issued by the FDA will need to be analyzed to determine exactly what enforcement actions the agency intends to take and to which electronic nicotine products the policy will apply. PMAA will update members once the FDA issues the final compliance policy.
In addition, last week, Representatives Pete King (R-NY) and Tom Suozzi (D-NY) introduced H.R. 4425, the "Quell Underage Inhaling of Toxic Substances Act" or QUITS Act. The bill would ban flavored ecigarettes, raise tobacco taxes, establish equivalent tax on e-cigarettes, increase resources available to those who want to quit smoking, and more than double funding for the Centers for Disease Control and Prevention (CDC)'s Office on Smoking and Health from $210 million to $500 million.