CASAA Call to Action: A couple of days ago Mitch Zeller of the FDA and the Director, Center for Tobacco Products spoke at the National Association of Tobacco Outlets (NATO) conference. I admit that I am very skeptical of anything he says and in reality from a regulatory standpoint, all that matters is the text of the final rule. However, their may be some clues for the future of vaping in what he said. Here are the relavent points and my thoughts on them below each quote:
1. Though Zeller would not give any indication on how close the agency was to finalizing the rule (or what changes might be made to it), he referenced that the FDA’s unified agenda states a goal of having deeming finalized by June of 2015.
“I can’t reveal non-public information on where we are in the rulemaking process,” he said. “But June is still our goal, and we’re working very hard to meet that goal.”
My thoughts: Not a chance in Hell the final rule will be issued by June of 2015. The FDA has never met a stated deadline on vaping issues, so why should the final rule release be any different. The end (last quarter) of 2015 is my best guess.
2. Substantial equivalence (SE) – The CTP (Center for Tobacco Products) made its first-ever SE rulings last year, but it’s been somewhat slow-going ever since. In fact, the Government Accountability Office (GAO) issued a rather scathing report on the FDA’s lack of movement on SE, instructing the agency to set up performance measures for how it processes SE applications. Zeller was proud to report that the agency has since set up these performance measures and reviews, telling the audience “as of March, we have no backlog. When a new application comes in, it’s reviewed immediately.”
My thoughts: A half truth spin. He is only referring to “regular” SE applications. The FDA is still about 4 years behind ruling on SE applications. With a total of 4700 SE applications, the FDA still hasn’t set up performance measures or ruled on the majority of the 3,600 “provisional” applications. Talk about slow motion and a backhanded way to stifle an industry.
3. The nicotine issue.”It shouldn’t be a debate about e-cigs,” he said. “It should be a debate about nicotine with e-cigs as the poster child of that debate.” “People have said we should treat nicotine like caffeine,” said Zeller. “I’m not there yet, but I do agree we have to think about it differently.” Which may lead to discussion across multiple FDA centers on defining which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic and an easier application process for products on the safer end of the risk continuum. “Armed with more science, yes, future regulations should take into consideration a products’ place on the continuum of risk,” Zeller promised.
My thoughts: Confusing isn’t it? Maybe Desk Killer Zeller has realized that the “push back” from trying to regulate ecigs as a “tobacco product” does not provide enough traction to win the battle so lets continue to talk out of both sides of our mouth and introduce nicotine into the regulatory argument. Two talking points is better than one. The FDA has approved a variety of smoking cessation products which are all nicotine delivery. These include prescription medicines (Chantix) as well as over-the-counter products such as skin patches, lozenges, and gum. These cessation products are regulated through FDA’s Center for Drug Evaluation and Research. Double speak continues as Zeller chooses the words “future regulations” so the deeming becomes the law of the land first. In totality, I take these thoughts with a grain of salt.