What ought to happen next at FDA

OPINION:

Scott Gottlieb gave — in a move no one publicly seems to have anticipated — notice on Tuesday he would be stepping down as Food and Drug commissioner. As of this writing, the predictable rumor mill is in full churn. None of this really matters outside of Washington parlor chat, of course; what matters, in the kind of life and death way that FDA decisions tend to matter, is not just what happens next with respect to the policy direction of the agency, but what ought to happen, especially as regards Mr. Gottlieb’s signature issue: Youth vaping.

Recently, the White House Office of Management and Budget received an assessment and path forward from Mr. Gottlieb regarding the so-called youth vaping crisis sweeping the nation. The plan, if agreed to by the administration, calls for the ban of flavored e-cigarettes in convenience stores and, over time, the eradication of menthol cigarettes altogether. The thinking behind both initiatives, it appears, is something like this: Children like tasty things (are you paying attention Smirnoff Sour Lemon Berry?), so we better get them out of the way or kids will saddle up and ride with the Marlboro Man.

But is the science behind Mr. Gottlieb’s initiative sound? And if not, what can the next commissioner do to course-correct for his mistakes?

However popular they may seem, theories that e-cigarettes will lead to smoking later in life have been debunked over and over again. The impulse to come to such a conclusion is understandable, but data purporting strong causality is really (pardon us) just smoke and mirrors. Consider that, in the face of e-cigarette popularity (if you can call a 5 percent rate of regular use “popular”), smoking rates are at an all-time low among adolescents. Or that economic modeling using our country’s favorite surveys shows that e-cigarette use is actually displacing combustible use among high schoolers.

A better explanation in light of the data may be that kids who try stuff, try stuff and move on. Yes, this sounds flippant, but with results from the studies that Commissioner Gottlieb relied on so heavily to push his agenda, one can really come to no other conclusion. Without fail these studies show a stronger trend of cigarette use to e-cigarette use than the other way around.

And, it is worth mentioning here, that the proposed menthol ban is laughable on its face. Does the FDA really suspect that consumers of an addictive product will suddenly stop when their flavor is discontinued? Will we see the proliferation of black markets around menthols and related products or will people simply move to the tobacco-flavored version from their favorite company?

Or will both happen and a subset of smokers view this as unfair punishment for a legal choice? Much like the proposal to limit the nicotine concentration in combustible cigarettes to nearly zero, without a comprehensive framework to ensure access to reduced risk products, the consequences of moving too quickly could undo all the progress we’ve seen.

Irrespective of the debate over whether or not e-cigarettes are a gateway to flavor country, it turns out there is one thing that most reasonable people should agree on: Tobacco products, including e-cigarettes, just like alcohol and R-movies, are not meant for or legally sold to kids.

Surprisingly, in a rare area of consensus between the tobacco industry and public health organizations, many from both sides have gone on record to support increasing the minimum age of purchase to 21 as a way to reduce use through social sourcing of these products — which accounts for most access. Why this is not a sufficient answer to the FDA’s worries is mindboggling.

The next FDA commissioner thus has a rare opportunity to undo the damage of his predecessor before the rot of unintended consequences begins. First, we suggest putting the focus back on serious public health solutions. This means moving away from unfounded claims of youth epidemics or flavor bans and toward practical solutions, like ensuring the success of reduced-risk products as replacements to combustible cigarettes.

Second, if the FDA is serious about alternatives to cigarettes, reduce the regulatory barriers to product development, officially (like the U.K.) recognize reduced-risk products are both safer and the most effective way to help people quit, and increase, not decrease, adult access to e-cigarettes using existing enforcement mechanisms.

Finally, and we save the most difficult piece of advice for last: Perhaps it’s time to do some soul-searching at the FDA and really take to heart that broad, sweeping policy initiatives have negative unintended consequences that can take years to discover. When dealing with public reforms affecting tens of millions of people, and that have the potential to save 480,000 lives a year, incremental tweaks, tested and perfected over time, work best. And sometimes, though this, of course, is unpopular to say out loud, perhaps further government intervention is simply unnecessary.

For many reasons, FDA commissioners tend to want to make a public splash. It feels good and one always has a predecessor to surpass. But we urge Mr. Gottlieb’s replacement to re-evaluate the wisdom of this approach and try the longer, surer path of incremental reform based on hard evidence. Less glamorous, yes, but wiser and better for the Americans on whose behalf they work.

• Carrie Wade is harm reduction policy director, and David Bahr is communications director, both with the R Street Institute.