Just months into his tenure as CTP director, Mitch Zeller told attendees of the 2013 NATO Show that his top three priorities would be menthol, deeming and substantial equivalence (SE). Though major regulations take time, Zeller made good on that vow by passing the final deeming regulations in May 2016. The deeming rule granted the FDA authority to regulate cigars, electronic cigarettes and other previously unregulated tobacco products. It was easily the most landmark regulatory action of Zeller’s time at the CTP so far.
While many convenience retailers expressed relief that these regulations were not more onerous—they did not, for example, include a ban on flavored products—many in the vaping industry likened the costly premarket tobacco product application (PMTA) requirement for any products introduced after the Feb. 15, 2007, grandfather date as an effective ban for the majority of vaping manufacturers.
“We believe our approach in this final rule is both reasonable and balanced,” Zeller said in a public statement. “This historic rule allows the FDA to use a variety of regulatory tools to improve public health and protect future generations from the dangers of tobacco use.”
Other notable regulatory actions credited to Zeller include:
—The FDA’s first SE and PMTA approvals.
—The FDA’s first Not Substantially Equivalent (NSE) orders removing products from the market.
—The FDA’s first No Tobacco Sale Orders to tobacco retailers failing multiple inspections.