Confession: In the weeks and months I spent working on this year’s Tobacco Supplement, my life was lled with all kinds of uncertainties. I’m not talking about deeming; I’m talking about real estate.
While I was writing this year’s cover story on Mitch Zeller, director of the U.S. Food and Drug Administration’s Center for Tobacco Products, my husband and I also found what might just be our dream home in Brooklyn, N.Y.
And just as I have no clue whether those pesky deeming regulations will have been published by time this column goes to print, I’m equally uncertain about whether I will be a homeowner by time I walk the NATO Show floor.
As Tom Petty wisely sang, “The waiting is the hardest part.”
My husband constantly hummed this song as we waited to see if our offer would be accepted, waited to see if the bank would approve this massive loan, and waited for our lawyer to hammer out any number of contract concerns I couldn’t even begin to comprehend.
I love Tom Petty, but I have to disagree. The waiting most definitely was not the hardest part of this process. Compared to actually getting our offer accepted in an uber-competitive market, putting together the down payment and filling out the seemingly endless piles of paperwork to secure a mortgage, the waiting has been a breeze.
I also suspect the “waiting” part of deeming will seem like a walk in the park for retailers and manufacturers. Actually having to comply with the FDA regulations on cigars, pipe tobacco, hookah and vape—that’s the hardest part.
Sympathy for the Director
It’s not exactly shocking that I’d relate to manufacturers and retailers living in this “wait-and-see” zone for the deeming regulations. It was, however, surprising that I found myself understanding—and maybe even feeling a little sympathy for the other side.
This year’s cover story started out with a question: Is Zeller really interested in harm reduction, or is he seeking to enforce a regulatory prohibition?
It’s a compelling question, a debate I’ve heard many times in off-the-record conversations. But is it a fair question? Zeller is one man—a solitary man in an appointed position, working for a government agency and required to work within the legal framework of the Tobacco Control Act.
I’m not saying Zeller would be pro-vaping if only the law allowed. Publicly, he hasn’t said enough one way or another to indicate his true feelings. That in and of itself says something.
And for most of us, I think we’d much prefer Zeller’s public ambiguity over that of another health-related agency head. Just look at Thomas Frieden, another man in an appointed position at a government agency. The director of the U.S. Centers for Disease
Control and Prevention (CDC) has repeatedly made less-than-flattering comments about electronic cigarettes.
“This is a really bad thing,” Frieden said in a recent New York Times article about a study that showed teenagers may be using electronic cigarettes to quit smoking. “This is another generation being hooked by the tobacco industry. It makes me angry.”
Say what you want about Zeller, but he does not regulate based on emotion.
The Wait Continues
Theoretically, we should almost certainly have the FDA’s fiinal deeming regulations by April’s NATO Show. The FDA’s final draft of regulations was submitted to the White House Office of Management and Budget late last October, feasibly the last step before the FDA announces the final regs.
But I’m not sure having the final regulations by April would be a good thing. Not if the premarket tobacco product application (PMTA) requirement in the original proposed rule stands to bring vaping (and cigar, pipe, hookah, etc.) innovation to a screeching halt.
On the other hand, if we’re still waiting on the final deeming announcement come April, it might indicate the White House asked the FDA to rewrite certain aspects of the law. That’s what happened with the proposed deeming regulations: The White House spent seven months reviewing the proposal and, according to former White House policy analyst Andrew Perrault, the rule came out of the process “fundamentally different.”
So we wait. And just as I’m currently sitting back and enjoying the wait on my (hopeful) closing date, I’d encourage retailers and manufacturers to sit back and enjoy the wait on these regulations.
Whatever the outcome, we’re all in for a hectic post-wait period.
Melissa Vonder Haar is senior editor of CSP and covers tobacco. Reach her at mvonderhaar@winsightmedia.com.
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