Embracing Harm Reduction, FDA Gives E-Cigarette Industry a Regulatory Reprieve

FDA Commissioner Scott Gottlieb extends a crucial application deadline by four years and promises "a greater awareness" of vaping's health advantages.



Today the Food and Drug Administration (FDA) said it is giving manufacturers of electronic cigarettes until August 8, 2022, to apply for approval of their products under regulations announced last year, which were widely expected to drive most companies out of business. The original deadline was November 8, 2018, and the four-year extension is supposed to provide more time for public comment and industry guidance as part of a "comprehensive regulatory plan" that aims to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."

The agency says "a key piece of the FDA's approach is demonstrating 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." That is music to the ears of harm-reduction advocates who see vaping as a life-saving alternative to smoking and viewed the original FDA rules as misguided, heavy-handed, and potentially deadly meddling that effectively gave conventional cigarettes an advantage over competing sources of nicotine that are much less dangerous.

In addition to providing regulatory relief for the e-cigarette industry, the FDA will be investigating the possibility of mandating a gradual reduction in the nicotine levels of combustible cigarettes. The idea is to make cigarettes less addictive for new smokers, but the policy is apt to hurt current smokers by forcing them to absorb more toxins and carcinogens along with their usual dose of nicotine. The FDA "intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes."

The FDA's new commissioner, Scott Gottlieb, sees a nicotine-reduction mandate as complementing the agency's new receptivity to harm-reducing cigarette alternatives. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," Gottlieb says. "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."

The FDA also seems to be contemplating flavor regulations that might favor e-cigarettes over the real thing. It says it will "seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery." The Family Smoking Prevention and Tobacco Control Act, the law that gave the FDA authority to regulate tobacco products, banned most "characterizing flavors" from cigarettes but made an exception for menthol, by far the most popular one (and, not coincidentally, a big moneymaker for Philip Morris, which supported the law). It sounds like the FDA might be reconsidering that exception, while at the same time recognizing that so-called kid-friendly e-cigarette flavors are in fact very popular with adults who switch from smoking to vaping.

The FDA says it will use the reprieve it is giving e-cigarette companies to clarify what will be required to keep their products on the market. The agency also plans to develop product standards that address battery hazards and help keep e-cigarette liquids away from children.

Over all, it looks like the FDA under Gottlieb will be taking a much more practical approach to e-cigarette regulation that recognizes the realities of the existing market and the relative hazards of different nicotine sources. Instead of wrecking an industry that seems to be accelerating the downward trend in smoking, the agency may actually embrace market-driven harm reduction.

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  1. the policy is apt to hurt current smokers by forcing them to absorb more toxins and carcinogens along with their usual dose of nicotine

    As if they care.

    And banning menthol cigarettes will make for some interesting theater, that’s for sure.

  2. Fucking idiots. If you have ever tried the lower nicotine cigs, you know that you just end up smoking more of them.

    1. If you have ever tried the lower nicotine cigs, you know that you just end up smoking more of them.

      I’m a social or intermittent smoker. I don’t know that I’ve smoked lower nicotine cigarettes. I do know my consumption of tobacco has fuck all to do with nicotine. That I don’t feel like smoking a whole cigar and smoke a pack of cigarettes instead.

      Not to defend them and their pro-regulatory stance or the factual nature of their statement, but that buying into the notion that it’s an all-consuming death drug does little to diminish the premise that it needs to be regulated.

  3. At least it seem the “quit or die” philosophy is being questioned.

    1. Only in fits and starts. Holding off on e-cigs is an encouraging step, but mandating lower nicotine levels is “quit or die harder”.

      1. You are correct that is still is a problem, maybe if they allowed cigarettes to have varying levels of nic, like you find with e-juice, people could use that to wean themselves off cigarettes. I know several people who started vaping with high nicotine, then slowly cut it down to zero and quit altogether. Having the same option for cigarettes seems like a no-brainer.

        1. As an option, sure. I just don’t trust the FDA not make it mandatory.

          If they start forcing manufacturers to reduce nicotine levels, any smokers not trying to wean themselves off are going to be inhaling more tar to get the same fix as before.

          For all the talk of public consultation, the group that carries the most weight in FDA policymaking is tobacco control “experts”, and they tend to be endgamers and prohibitionists.

    2. It’s encouraging. Harm reduction is the realistic way to approach any addiction. Meeting people where they actually are and not where we “think” they should be is the rational and effective way to deal with addiction and other social problems in general.

  4. The good: The FDA is finally admitting there are huge health advantages to e-cigs in which every study supports the idea they are far less harmful than cigarettes.

    The bad: The FDA is reinforcing its paternalistic role in the choices that grown adults make by “cutting nicotine” in cigs. Aside from that, it makes no sense when the most harmful aspects of cigs lie in the smoke itself, not the nicotine. It seems counterproductive as smokers would likely smoke more.

    1. 40 yrs. ago those concerned w this problem wanted development of low tar, high nicotine cigarets, for that reason. Something weird happened a decade later to change the focus to nicotine as the problem. Maybe it went hand in hand w the acceptability of pot, i.e. changing from thinking smoking is bad to focusing on the psychoactives in the vapor, so that now smoking’s OK as long as it’s cannabis.

  5. While it’s encouraging what the FDA has announced on E-Cigs, if they and the Feds really want to support “harm reduction”, then they should stop cities and states from banning their USE everywhere smoking is banned.

    1. Unfortunately they’ve no direct jurisdiction. They’d need some handle by which to compel localities, like withholding $.

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