Editorial: Deeming Regs Look Promising … For Now
Potentially good for retailers, less positive for smaller players, innovation
As such, the application process most likely benefits Big Tobacco, which has the legal infrastructure, experience and cash flow to handle it, while hampering smaller players, who have offered more flexibility and better margins to retailers.
It's also crucial to remember that these deeming regulations represent the first steps toward regulations. As the FDA's Center for Tobacco Products' head Mitch Zeller said in a media briefing, "You have to walk before you run; before we can restrict advertising or flavors, we have to have jurisdiction (via deeming regulations) over the segment."
In other words, the door is still wide open for further, stricter regulations.
Besides the uncertainties of the regulations themselves, there are several questions for retailers to ponder in the upcoming months. Among them:
- What will Congress do? Though the FDA did not limit the e-cig industry's ability to advertise, Herzog pointed out that only Congress could enact a television ban. With many Democrats in both Houses calling for stricter regulations, will they now take such action?
- Will this slow down local battles?New York, Chicago, Los Angeles and others have all adopted strict e-cig regulations, often with little scientific support and often citing the lack of FDA oversight and a desire to tame the "wild-west" segment. Will these proposed regulations calm these concerns or fuel the fire?
- How will the FDA handle product applications?The FDA is already under scrutiny for its lack of movement on substantial equivalence: A House subcommittee has called for closer oversight, and the FDA recently released a new monitoring program (hopefully) to speed up the process. With more than 200 e-cig companies on the market, the FDA is looking at hundreds of thousands of new applications. Will they be able to get this under control by time the e-cig deeming regulations go into place?
- How long will the commenting process take?With the proposed regulations striking something of a middle-ground, who will come out against these regulations? Anti-tobacco groups could lobby for stricter regulations, while smaller e-cig players and public-health advocates like Siegel could argue that the proposal stifles innovation.
With (at least) 75 days in the commenting period, followed by a revisal period that could take months--if not years--the most pressing question on my mind (and I'm sure the minds of many others) is what will these regulations actually look like when they finally come to fruition?
Today marked an important first step. But we still have a long way to go.
What's your take on the FDA's proposed deeming regulations? Are they good or bad for your business? Email your thoughts to [email protected].
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