The FDA’s just-unveiled Draconian restrictions on vaping products are an example of good PR but bad public-health policy. And regulators know better.
When he headed the FDA, Dr. Frank Young used to admonish his minions that there were times when common sense should modulate established policies and rules. That can be done in federal agencies via “enforcement discretion,” a tool that regulators use to carry out their mandate in light of sometimes ambiguous laws and regulations.
Other officials have not been so wise.
Take Young’s successor at the FDA, David Kessler, who chose a ludicrous case calculated to get him on the evening news in a virile demonstration that he was tough at enforcing the law.
Was the issue defective heart valves, a contaminated vaccine or perhaps pathogenic bacteria in lettuce? No — Kessler directed armed federal marshals to confiscate and dump 15,000 gallons of Citrus Hill orange juice — solely because it was labeled “fresh.” It was reconstituted from concentrated juice, you see, and the FDA asserted that it is inaccurate to call orange juice “fresh” when made from concentrate.
On CBS’ “60 Minutes,” Kessler expressed his indignation: “[The juice] was made from concentrate. My grandmother could have told you, I mean, it wasn’t fresh. It wasn’t very hard [to tell the difference].” Duh. If it was so obvious, why not simply let consumers decide whether they like the product enough to buy it again?
The FDA’s failure of common sense is evident again in newly announced sweeping restrictions on e-cigarettes, popular not only among teenagers but adult smokers who use them as an invaluable tool for quitting tobacco-containing cigarettes.
The crackdown, which FDA Commissioner Scott Gottlieb says is intended to prevent a new generation of nicotine addicts, means that only tobacco, mint and menthol e-cigarette flavors can be sold at most traditional retail outlets, such as convenience stores and gas stations. Other sweet- or fruit-flavored varieties — all favorites of former adult smokers — can now only be sold at age-restricted stores or through online merchants that use age-verification checks.
Like the dumping of perfectly good, wholesome orange juice, the Gottlieb Plan doesn’t make much sense.
First, let’s stipulate that e-cigarettes are not entirely safe and that in a perfect world, they would not be used by kids. At the same time, as Commissioner Gottlieb himself has conceded, conventional cigarettes that expose mucous membranes and the lungs to combustion products are vastly more dangerous than e-cigarettes.
Many adults who have not been able to quit smoking using methods such as nicotine-containing gum or patches have been able to stop, with the help of a wide variety of these far less harmful, non-combustible vaping alternatives.
The FDA should concentrate on two primary goals: Enforce already-existing rules that ban the sale of e-cigarettes to minors, and, as conseillé by the American Cancer Society, support adult smokers who attempt to quit with e-cigarettes.
Unfortunately, the new restrictions represent a dramatic and surprising reversal from July 2017, when the FDA announced a new “comprehensive regulatory plan” for “tobacco products,” including e-cigarettes, which embraced the idea of tobacco harm-reduction.
Commissioner Gottlieb said at the time that the plan demonstrated “a greater awareness that nicotine — while highly addictive — is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”
In other words, we should be more concerned about the smoke delivery system than we are about nicotine itself, even though, ideally, kids should never use nicotine of any kind.
Gottlieb continued, “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground.”
But capitulating to intense pressure from activists who seek nothing other than complete nicotine abstinence from adults, that cornerstone has crumbled. Instead, Gottlieb is now pitting the proper goal of preventing youth use against the other proper goal of helping adult smokers quit. But these objectives are not and should not be seen as mutually exclusive.
The news reports and the public opinion the FDA is largely relying upon to justify this about-face have been generated by puritanical pressure groups who want non-medicinal nicotine products off the market entirely.
Neither evidence nor common sense seems to influence those groups that are hell-bent on removing e-cigarettes from the market. Consider, for example, the latest creepy video from a mysterious group that calls itself “The Truth,” which features puppets, and which seems targeted at kids, journalists, and politicians
The text under the video states that vaping “makes you 4x more likely to start smoking cigarettes.” But the latest étude, conducted by Rand, concludes otherwise: “EC use among youth is prospectively associated with progression toward greater cigarette use.”
There’s less to that statement than meets the eye. Are kids who engage in risky behaviors such as vaping also more likely to start smoking? Absolutely. Does vaping “make,” or cause, young people to start smoking? That’s not what the evidence says, but The Truth presents it that way.
It turns out that reporters were the real puppets, uncritically responding to and repeating activists’ unsupported assertions. This, in turn, has led to distorted public opinion which, the FDA now concedes, contributed to the just-announced Gottlieb Plan.
The FDA often touts itself as a science-based agency, immune to pressure from the public, politicians, and special interests. Maybe this is the Gottlieb Exception.
When Congress gave the FDA authority to regulate recreational lower-risk nicotine products, it was with the expectation that the FDA would be able to both discourage youth use and help adults quit smoking. Sadly, to date, the FDA has accomplished little on either front.
These failures don’t justify a misplaced “crackdown” on e-cigarettes and responsible sellers. They require an aggressive effort to stop the bad actors. Accomplishing that now will require a new FDA policy. And clearly, a new commissioner.
Jeff Stier (@JeffaStier) is a policy adviser to the Heartland Institute and a senior fellow at the Centre de choix des consommateurs. Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the Office of Biotechnology at the FDA.