OAKBROOK TERRACE, Ill. -- For every issue Mitch Zeller, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) director, was willing to discuss at last week’s NATO Show, there seemed to be at least five topics that were off-limits.
While I understand and respect that there are many areas on which Zeller is legally not allowed to comment, here are four areas on which I wish he could have gone on the record:
How the FDA Will Address Social Sources
Though Zeller admitted social sources are a big problem when it comes to underage tobacco use, he neglected to elaborate on what the FDA will do about it. Yes, he said the agency was open to suggestions, and yes, it’s certainly easier to impose regulations on tobacco manufacturers and retailers than it is to regulate adult behavior.
Still, the agency has taken on tobacco retailers and manufacturers in its “The Real Cost” marketing campaign. Would it be that difficult to also single out social sources in a similar manner?
Elaborate on the Smokeless Campaign
Speaking of “The Real Cost” campaign, Zeller spoke about the most recent round of ads, which target smokeless-tobacco use on a regional basis.
“Our data showed 32% of rural, white males ages 12 to 17 are currently experimenting with or susceptible to using smokeless tobacco,” Zeller said, describing that statistic as “staggering.”
What Zeller didn’t say was just how the FDA went about defining “susceptible” to smokeless use (which seems a vague metric to measure).
Where E-Cigs Fall on the Spectrum of Risk
When discussing the nicotine spectrum of risk, Zeller put cigarettes at one end and nicotine replacement therapies (NRTs) at the other. As for electronic cigarettes, he said the category belongs on the risk spectrum but not until the FDA has regulatory authority over the products.
Given the wide range of claims about e-cigs’ potential harm and potential to reduce harm, it would be nice for the FDA to weigh on what the data suggests. Are e-cigs as harmful—if not more harmful—than combustible cigarettes, as numerous anti-tobacco groups have claimed? Or is the U.K. correct in its finding that e-cigs are 95% safer than cigarettes? Even the slightest acknowledgement from the FDA would go a long way.
How the FDA Can Facilitate Harm Reduction
Somewhat related, this NATO Show marked the most I’ve heard Zeller refer to the concept (and need for) harm reduction. Repeatedly, he called out the e-cig debate as being “emotional and divisive,” urging the vaping and public health communities to find common ground in the form of harm reduction.
As with the spectrum of risk, it seems the FDA could play a vital role in bridging this gap. Zeller said tobacco control groups have a “historic distrust” of the tobacco industry, dating back to the days of “light” cigarette claims. It’s going to take more than tobacco and e-cig manufacturers presenting data that vaping presents a reduced-harm tobacco option. Were the FDA to acknowledge vaping could be a good thing for public health, perhaps common ground would be easier to find.
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