Big Tobacco Has Gotten the Message!

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!

9 comments ↓

#1 TobaccoToxDoc on 06.28.13 at 10:14 AM

The major tobacco companies here and their overseas allies have been into alternate delivery devices for decades. There are even patents, a few of which, are cited in the Ruyan patents. The e-cig only companies would rather spend money on TV advertising than on serious product stewardship (e.g., chemistry & Toxicology) studies and on QA work to make sure that their devices and e-liquids are consistently meeting consumer expectations of good tobacco (or menthol) taste.

#2 asd@asd.com on 06.29.13 at 8:52 AM

Cynical, probably true in part — but equally applicable to pharma or food industries. You think Pfizer wants to spend money on DTC or on post approval tox surveillance?

#3 sexyvaper on 07.01.13 at 12:27 AM

Yeah and folks are still waiting to see the Altria offering
Might have wanted to call it Ghost 10
Sort of proves the posts point.
Will be very interesting.

#4 Ed on 07.01.13 at 7:16 AM

It will be interesting to see what the FDA does with e-cigs. We all know at the end of the day it’s about revenue. If e-cigs are growing and hurting the tax revenue the Feds are getting well I think you know where this is going. Hate to see it happen as nothing will kill that segment quicker than a big tax increase.

#5 Candy Girl on 07.01.13 at 7:58 AM

I think the point of the post is that the FDA has sent the tobacco industry the clear signal that it is not going to be inflexible or irrational when it comes to e-cigs. The counterpoint is that the FDA is going to appear irrational and inflexible when it comes to traditional smoking products and menthol. Really does explain the rush of tobacco companies to e-cig technology. Many rushing to the technology without fully understanding or appreciating the inherent challenges. At the end of the day it’s going to be a lot more difficult to thrive or survive in this market than by simply importing and distributing another “me-too” product from China.

#6 Copenhagen Man on 07.11.13 at 1:34 PM

Must say I agree with candy girl

#7 Sambo Eciger on 07.19.13 at 12:19 PM

FDA Plans to Issue Proposed Regulations on Other Tobacco Products by October 2013. See article ” http://www.cspnet.com/news/tobacco/articles/fda-plans-issue-proposed-regulations-other-tobacco-products-october-2013

#8 Candy Girl on 07.19.13 at 12:38 PM

The FDA’s notice of its plans to issue a deeming regulation through the recent updating of its “Unified Agenda” is simply proforma at this juncture. While I think it could come before year end or in Q1 of 2014, nobody should bet the farm that we will see “Proposed Regulations on Other Tobacco Products” by October 13, 2013. Depending on how you count- this is the fourth or fifth such “targeted date” they have published since April of 2011!

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