Harm reduction — opting for a product or activity that is not harmless but is better than the existing alternative — is a common and obvious strategy that we employ almost unthinkingly. For example, many drugs used for chemotherapy to treat cancer are highly toxic and cause a variety of serious side effects, but taking them is better than leaving the cancer untreated.
Another example is the substitution of lower-risk nicotine products, such as electronic “cigarettes” that deliver nicotine in vapor form, for tobacco cigarettes. Because there is no combustion, using these devices (“vaping”) is intrinsically less dangerous than cigarettes — 95 percent less harmful, according to Public Health England — and they can help adults to quit smoking.
Yet in the United States, FDA regulations are denying smokers the opportunity to use e-cigarettes to quit. Further complicating the landscape, leading public-health groups, including the American Heart Association, the American Lung Association, and the American Cancer Society, are actively lobbying against e-cigarettes and misrepresenting the science about both the safety of e-cigarettes and how they can help cigarette smokers significantly reduce their risk. Local governments are behaving just as badly. Consider this outrageously unscientific ad campaign that the New York State Department of Health is sponsoring in U.S. News and World Report.
Although anti-e-cigarette activists claim that it will take decades to know whether e-cigarettes are less harmful than smoking, we already know a great deal about why cigarette smoking is so devastatingly dangerous: It is primarily due to the combustion of tobacco.
Earlier this month, partisan politics in the Senate blocked an effort to rein in the FDA’s retroactive de facto ban on e-cigarettes, known as the “deeming” regulation. The legislative fix, as outlined in the bipartisan Cole-Bishop rider to the budget bill, was a modest but urgent effort to fix part of the Obama administration’s ban. The amendment would have restricted the FDA’s new “deeming” regulations and its ill-conceived “pre-market tobacco application” process to e-cigarette products that first went on sale on or after August 8, 2016 (the date the deeming rule took effect), with those introduced before that date (which includes almost all e-cigarette products) being allowed to remain on the market under the preexisting regulations.
The Cole-Bishop amendment was approved by the House Agriculture Appropriations Committee, and was on its way to becoming law via the budget bill. But Senate Democrats threatened a government shutdown if this and a range of other legislative riders were included in the legislation.
The same day the budget was unveiled, the FDA announced an extension to deadlines related to the deeming regulations. In an e-mail to stakeholders, the agency said the extensions “will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.”
Newly confirmed FDA commissioner Dr. Scott Gottlieb and the Justice Department can now consider the prospects and policy implications of defending the Obama FDA’s flawed regulatory process, which is facing six different lawsuits at various stages, with more in the offing.
What are the government’s chances of defeating all the increasingly expensive and expansive challenges? It’s certainly not even close to being a sure thing.
Consider just one example. Does Attorney General Jeff Sessions propose, in good faith, to defend the many absurdities put forth in the rule, as laid out in Obama-era court filings? For instance, the Obama administration contended that vaping devices alone, which don’t even contain consumable liquid (it’s sold separately) and are widely used by former smokers who vape with zero-nicotine liquid, are in fact “tobacco products” under the Tobacco Control Act. Surely AG Sessions doesn’t believe this contorted approach necessary to justify the rule. He shouldn’t think the courts will either.
The policy implications of “winning” in court are even more clear. There would be a retroactive and innovation-stifling regulation that would decimate an entire class of life-saving products.
Taking all this into account, the Trump administration now has a unique opportunity to make good on its promise to roll back the worst of the Obama-era regulations, by undoing one that won’t only kill American jobs but will kill Americans.
How would it do so?
The Trump administration has a unique opportunity to make good on its promise to roll back the worst of the Obama-era regulations, by undoing one that won’t only kill American jobs but will kill Americans.
There’s one approach to reversing the rule that would obviate the need for ponderous rulemaking or the uncertain legislative process: The Justice Department could decline to continue to defend the deeming regulation in court. If the department ceased to defend it against the many viable legal challenges, the rule would either be nullified by a court or else be scaled back by way of a broad-based consent decree. A judicially approved consent decree could leave in place certain aspects of the rule, such as the ban on sales to minors, that are not a matter of dispute.
Gottlieb might be tempted to simply refrain from enforcing the rule, but this approach would be perilous not only because of political considerations, but because it would leave the rule in place for a future administrator to enforce. The innovative and young vaping industry, already under misguided attacks, urgently needs predictability.
Rolling back the regulation through a new rule-making process would also be a major step in the right direction, but that course would entail unnecessary political risks by nakedly second-guessing a rule already in place. The administration will be on firmer political, legal, and practical footing if it exercises its discretion to evaluate the current status and merits of the legal cases it is being asked to defend. Critics will howl, but they’ll be criticizing an approach that Obama deftly used as a tactic when his Justice Department decided not to defend duly passed legislation it determined not to be legally defensible (the Defense of Marriage Act). In fact, declining to defend a law that an administration considers indefensible, and that was enacted by a different branch of the government, should be held to a higher standard than an executive-branch decision not to defend a rule enacted by the executive branch, albeit in a previous administration. This is especially so when there is a legitimate question whether the rule was in fact duly enacted, as is the case here, and when many of the legal challenges center on whether the enactment of the rule complied with administrative law.
In his Senate confirmation hearing, Gottlieb alluded to this, perhaps prophetically, in response to questions about how to balance the benefit of e-cigarettes against any risk. “I think a properly constructed and overseen regulatory process [emphasis added] should have the capacity under the authorities Congress gave the agency to make these determinations,” he said.
The Obama FDA’s process was improperly constructed and lacked effective oversight. Declining to defend the process by which the rule was created would also give Congress time to rethink the underlying 2009 Tobacco Control Act, which did not even contemplate e-cigarettes, a class of disruptive-technology products that was in an early stage of development at the time.
Gottlieb also stated, “We need to make sure we’re getting the most bang for our regulatory buck.” Spending the Justice Department’s and the FDA’s already stretched resources on defending the indefensible is hardly a good investment.
Attorney General Sessions, in consultation with Commissioner Gottlieb, can act right now by announcing the administration’s decision not to further defend the myriad cases. Not only would doing so remove a politically charged issue from Gottlieb’s already very full plate, but it would help to restore the FDA’s credibility. It would also prevent DOJ from being forced to make untenable legal arguments. Most important of all, it would save the lives of smokers who would like to quit, today and in the future.
— Jeff Stier is a senior fellow at the National Center for Public Policy Research in Washington, D.C., and heads its Risk Analysis Division. Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the FDA’s Office of Biotechnology.