Substantial Moves

Are Zeller’s announcements on substantial equivalence and menthol historic—or more of the same from the FDA?

Melissa Vonder Haar, Freelance Writer

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“I believe the most realistic outcome on the menthol issue is that they possibly lower the levels of menthol over a number of years without banning it,” she says, also admitting that the timing on any regulations is significantly more difficult to predict. “I have no idea when we’re going to get resolution—or if we’re ever going to get full resolution—on the menthol issue.”

A Participatory Process

Whether or not Zeller’s actions so far on substantial equivalence and menthol signify a faster regulatory turnaround for the FDA, it’s crucial for retailers to make their voices heard in the process. The ANPRM on menthol posed many questions and opened the door for comments from any interested party, something Thomas Briant, executive director of NATO, believes it’s imperative for retailers to do.

“The FDA has told us they read every single comment submitted,” says Briant. “We need retailers to submit comments about your everyday sense of what’s going on out there and in the industry because they will take that into account.”

Zeller echoed Briant’s sentiments at the NATO Show. “Some would describe [the rule-making process] as being a participatory sport, not a spectator sport,” he said. “It is extremely important for you to participate in this very public process. If you have a point of view and it’s not submitted to the official docket that we create, legally, we’re not obligated to consider it. If you submit it, legally, we are. We consider all of that when we transition from a proposed rule to considering what—if any—changes should be made to that proposed rule.”

Which is ultimately important for those in the industry to keep in mind as actions on substantial equivalence and menthol are dragged out. The lack of movement may be frustrating, but this slow pace in part stems from the fact that the FDA is literally reviewing every single comment submitted on these issues, which they are legally required to consider when drafting any new tobacco-related regulations.

“The regulatory process is just that: It’s an ongoing process,” Briant says. “We submit our comments, we give our input, and though we may not always agree with the FDA, we know they’re listening.”


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