This spring, a number of US tobacco company executives were invited to meet with Mitch Zeller, the newly appointed head of the FDA’s Center for Tobacco Products. The meetings were off the record and were held expressly for the purpose of having Mr. Zeller reintroduce himself to an important part of his regulatory constituency. It was a reintroduction because the industry was familiar with Zeller from his days at the FDA in 1990’s when Zeller was tasked by then FDA head David Aaron Kessler to orchestrate a hostile regulatory takeover of the tobacco industry- a takeover that was effectively thwarted by the US Supreme Court in 2000 in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120. The industry was also familiar with Mr. Zeller from his days at the consultancy Pinney Associates where he worked closely with GlaxoSmithKline, his largest client, on various strategies to introduce, standardize and entrench pharmaceutical nicotine replacement therapies to the US OTC market.
By all accounts the meetings were cordial, but the participants were wary. Zeller, after all, was heading up the FDA’s tobacco oversight, a responsibility provided by Congress via June 2009’s Family Smoking Prevention and Tobacco Control Act. Zeller quickly laid out his near term agenda- an agenda he subsequently made public via numerous speeches and panel participations later in the spring- i.e. NATO and TMA. The agenda had three items and, in order, they were 1) substantial equivalency issues 2) menthol and 3) deeming authority.
After this, according to numerous participants, Zeller asked the attendees questions about, of all things, electronic cigarettes. What did these tobacco executives know about them? What were they hearing about them? What were they planning to do about them- manufacture them, distribute them, sell them? Zeller made clear that the products were of great interest to the FDA and that the FDA was going to analyze and evaluate them carefully and extensively. Zeller noted that the products were “promising” and he encouraged tobacco companies to provide the FDA as much data about the product as possible.
At the conclusion of each meeting Zeller cautioned the participants that the FDA was looking hard at the ways that they could regulate and restrict the industry’s harmful, traditional combustible products, but that they were intrigued by new technologies and, specifically, by e-cigarettes.
One attendee noted, “It’s almost as if we were specifically being told that we should take a close, hard look at e-cigarettes, the technology, begin research and development ASAP and be prepared to educate the FDA ASAP.”
With the recent announcements about Reynolds American “game-changing” Vuse, Altria’s introduction of the “Mark-Ten” in Indiana in August of this year, National Tobacco’s distribution agreement with V2 E-cigs and Lorillard’s continuing success and ongoing investment in their blu cig acquisition, let there be no mistake about what’s going on here- Message Delivered and Message Received!