Republican U.S. House leaders last month sent a pointed letter to federal agency heads warning them against finalizing "midnight regulations"—last-minute rules approved during a lame-duck session, without full oversight and hearings. Hastily approved regulations, they wrote, could have "unintended consequences" that "will harm consumers and businesses."
That's a sensible warning, and a precursor to President-elect Donald Trump's promise to roll back counterproductive federal rules. But if the new president and Congress want a good specific place to start, they need not focus on the shady stuff rammed through by federal bureaucrats before the presidential transition. They can begin with a set of Food and Drug Administration (FDA) tobacco rules that have been moving ahead glacially and in full daylight, but which are so fraught with unintended consequences and so harmful to consumers and businesses that it's hard to understand how they got this far.
We're referring to the "deeming" rules the FDA approved last summer and which—barring an act of congressional or Trumpian intervention—will go into effect August 2018.
The final regulation deems some non-tobacco products as tobacco, thus giving the federal government broad authority to regulate and ban them. Those products include e-cigarettes, electronic devices that heat a flavored liquid and allow people to inhale the resulting vapor. The liquids are not made from tobacco, but usually contain nicotine. "Vaping" is proving to be one of the most effective means to break smokers of their dangerous habit, which explains why these rules are so dangerous.
That looming August 2018 date is crucial. E-cigarette companies must have their vaping devices and liquids tested and approved by the FDA by then to be legally allowed to sell them. As harm-reduction expert Christopher Russell argued in an op-ed in The Hill: "Experts have estimated that undertaking this research package to a good standard could cost a manufacturer at least $3 million per product it wishes to keep on the market." Each combination of liquid flavor, device and nicotine strength would require a separate test, and there's no guarantee of approval, he added.
Anti-smoking forces depict the vaping industry as a front for Big Tobacco, but the industry currently is dominated by small companies. These testing costs will put most of them out of business. So, Unintended Consequence number one: Federal rules designed to combat major tobacco companies will end up empowering them, given they are the only players with the kind of cash available to navigate the Rube-Goldberg-like FDA approval process.
The real danger, however, comes from Unintended Consequence number two: As Russell noted, studies show that a large percentage of "vapers" will return to cigarette smoking. Public Health England, the main British health agency, has been out front on this one. Vaping, it argues, is 95 percent safer than smoking combustible cigarettes. Policymakers should promote vaping as a means for "harm reduction." Vaping isn't entirely safe, but sensible public-health policy should focus on promoting safer alternatives rather than myopic abstinence.
Unintended Consequence number three: Devoted e-cigarette users will buy their products from overseas companies, and will deal with products manufactured according to heaven-knows-what standard. This will create black markets and an overall less safe situation.
The FDA's summary of its rulemaking includes this line: "FDA is taking this action to reduce the death and disease from tobacco products." The agency isn't the only group that uses that explanation to justify its attack on vaping products. California Gov. Jerry Brown (D) and the state legislature last session increased the tobacco smoking age to 21, which is designed to make it harder for teens—whose brains are more easily prone to addiction than adults—to get hooked on coffin nails. But the new law also raises the age to 21 for e-cigarettes.
Furthermore, California voters on November 8 approved a $2-a-pack increase in the cigarette tax and a similar increase in other tobacco products, such as cigars, dip, snuff, snus, etc. But the tax hike also applies to e-cigarettes. One can take issue with tobacco tax hikes for a variety of reasons (black markets, personal choice issues, etc.), but at least the intent is clear: raising prices creates a disincentive for buying those dangerous products. But then why increase taxes on a far less dangerous product? It makes no sense from a public-health standpoint.
The FDA approach manages to be even more noxious than California's ill-conceived approach toward e-cigarettes. At least with the California model, those adults trying desperately to quit their cigarette habit can still access vaping products—they just have to pay more for them. FDA's deeming rules could largely destroy the vaping industry, thus leaving vapers without that option—and with a very real need to get a nicotine fix.
It's hard not to see a puritanical bent here. Anti-smoking activists prefer that smokers go cold turkey or turn to a variety of medically approved cessation devices. But smokers often find vaping a satisfactory and enjoyable alternative. It works. Most studies show vaping to be a habit embraced mainly by former cigarette smokers. A study suggesting that vaping leads teens to begin cigarette smoking really just measures the number of teens likely to experiment, and provides little reason to doubt the overall benefits of the e-cigarette alternative.
In one example of sensible federal rulemaking, officials two decades ago abandoned their moralistic pretenses in dealing with the then-insoluble problem of teen pregnancy. They promoted birth control and safe-sex programs instead. Yes, most of us would prefer if teens waited until adulthood to become sexually active, but by focusing on harm reduction, policymakers helped create the latest good news. Teenage pregnancy rates now are at record lows.
Harm reduction has been a successful strategy in dealing with all manner of vice, from heroin addiction to HIV prevention. Yet state and federal officials are stuck in their old ways when it comes to the issue of tobacco use. Instead of treating e-cigarettes like real ones, the FDA should have passed rules that accounted for their potentially life-saving effects. They didn't, so now it's time for Congress and the new president to step in.
If they are looking for an example of federal rules that harm consumers and businesses and have deadly unintended consequences, they need look no further than the FDA deeming rules.
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FDA crackdown should concern other innovative industries
On the FDA's webpage, Commissioner Robert M. Califf asserts "a successful FDA is a critical factor for better public health in this changing world" and that the organization is "committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote public health."
Of course, if the promotion of public health is the mission goal of the agency, one wonders how the regulatory approach delineated in the deeming rules fosters tobacco harm reduction for adult consumers. Indeed, even a cursory read of the nearly 150-page document evinces little to believe the FDA is interested in hewing to a consistent or rational policy of health promotion.
The text informs us the deeming rules were drafted in order to "reduce the death and disease from tobacco products." Excellent. But the FDA's insistence that it classify electronic cigarettes alongside their vastly more harmful cousins is baffling in light of the later claim that the "FDA recognizes that completely switching from combusted cigarettes to [electronic cigarettes] may reduce the risk of tobacco related disease for individuals currently using combusted tobacco products."
Perhaps more shocking, however, is the following statement:
Although FDA is not required to meet a particular public health standard to deem tobacco products, regulation of the newly deemed products will be beneficial to public health… Over time, since the "appropriate for the protection of the public health" standard involves comparison to the general tobacco product market, FDA believes the employment of the premarket authorities could create incentives for producers to develop products that are less dangerous when consumed, less likely to lead to initiation of tobacco use, and/or easier to quit.
If you are rubbing your eyes in disbelief, stop. You read this correctly. The FDA here is claiming they've set no public-health standard when it comes to regulating e-cigarettes, among other things, preemptively. This renders the FDA's equivalency between all tobacco products contradictory. From a public health standpoint, the FDA's purposeful obscurantism is far worse; it's downright harmful.
In the absence of a standard, the crusade against tobacco products continues as long as the FDA wishes. While the tobacco giants and the thousands of small-business vape shops around the country have few public defenders, whenever the government justifies regulatory overreach on such slippery pretenses, it behooves all industries in America to step in and say something. Kicking around tobacco these days is fashionable; and the facility with which imprecise justification is used to strangle the industry is enticing for anyone looking to score easy points. Watch out Silicon Valley, you're next.
This column originally appeared at InsideSources.com.
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