Why Vape? E-Cig Companies Are Not Allowed to Say.
The FDA is suppressing potentially lifesaving information about the health advantages of e-cigarettes.
The e-cigarette regulations that the Food and Drug Administration (FDA) unveiled this month pose a grave threat to products that have the potential to dramatically reduce smoking-related disease and death. The most obvious problem for the e-cigarette industry is that manufacturers of vaping equipment and e-liquids must persuade the FDA that allowing their products to remain on the market is "appropriate for the protection of public health"—a challenge that will be prohibitively expensive for all but the biggest companies and may prove impossible even for them. A lawsuit filed this week by Nicopure Labs, which sells e-liquids and vaping hardware, highlights another troubling aspect of the FDA's regulations: censorship of potentially lifesaving information about e-cigarettes.
Even if a few companies survive the shakeout caused by the FDA's onerous regulations, they will not be allowed to tell consumers the truth about their products. According to the FDA, any intimation that noncombustible, tobacco-free e-cigarettes are safer than the conventional, tobacco-burning kind—which they indisputably are—transforms them into "modified risk tobacco products," which can be marketed only with prior approval. To get the FDA's permission, an applicant must demonstrate that its product will not only "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users" but also "benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products."
The upshot is that any e-cigarette company selling its products as a less hazardous alternative to the real thing would render them "adulterated," inviting FDA seizure. That could happen even if a company truthfully described its product as "smokeless" or "smoke-free." The FDA says it will "evaluate an [e-cigarette] manufacturer's use of 'smokeless' or 'smoke-free' (and similar descriptive terms) on a case-by-case basis." The FDA also looks askance at e-cigarette manufacturers who "advertise that [their products] do not contain tobacco"—a perfectly accurate statement, albeit a potentially confusing one in light of the agency's arbitrary decision to treat e-cigarettes as "tobacco products." The agency's rationale for applying that label to products that contain no tobacco is that the nicotine in e-cigarettes is derived from tobacco, an argument that also turns nicotine gum, patches, lozenges, sprays, and inhalers into tobacco products.
If e-cigarette companies are asking for trouble merely by accurately describing their products, it should go without saying that they are not allowed to talk about the main advantage of vaping: It is something like 95 percent less hazardous than smoking because it exposes consumers to far fewer toxins and carcinogens in far lower doses. Even a straightforward chemical comparison of the aerosol produced by an e-cigarette and the smoke produced by a tobacco cigarette is forbidden, lest it lead consumers to the accurate conclusion that they can dramatically reduce the health risks they face by vaping instead of smoking. In other words, the FDA is actively suppressing truthful information that would encourage people to make healthier choices.
Nicopure's lawsuit argues that the FDA's censorship "violates the First Amendment by prohibiting manufacturers, including Nicopure, from making truthful and nonmisleading statements regarding vaping devices, e-liquids, and related products." Although the FDA dismisses First Amendment concerns about its regulations, it seems to me that Nicopure has a strong case. The Supreme Court has arbitrarily declared that "commercial speech" receives less First Amendment protection than other kinds of expression. But restrictions on what businesses say while trying to sell people stuff still must meet a pretty strict test: As long as the speech is not misleading and concerns legal activity, regulations must be narrowly tailored to directly advance a substantial government interest.
One is hard pressed to identify any legitimate interest that the FDA advances by preventing an e-cigarette company from saying its product does not contain tobacco, does not produce smoke, and generates fewer toxins at lower levels than conventional cigarettes do. When the FDA announced its regulations, it claimed "FDA is taking this action to reduce the death and disease from tobacco products." Its speech restrictions undermine that goal, impeding the success of products that the Royal College of Physicians says have "the potential to prevent almost all the harm from smoking."
In defense of its regulations, the FDA cites a 2012 decision in which the U.S. Court of Appeals for the 6th Circuit rejected a First Amendment challenge to premarket review of "modified risk" claims. That ruling relied heavily on the tobacco industry's history of promoting "light" and "low-tar" cigarettes as healthier alternatives to "full-strength" cigarettes?claims that were misleading because they relied on machine testing and did not take into account humans' tendency to compensate for lower nicotine yields by changing their smoking behavior. There is no comparable history of misleading claims in the e-cigarette market, no question that vaping is less dangerous than smoking, and no doubt that the statements the FDA has forbidden (e.g., "this product does not produce smoke") are true.
Tellingly, the 6th Circuit contradicts itself in discussing the appropriate motives for restricting commercial speech. "A State's paternalistic assumption that the public will use truthful, nonmisleading commercial information unwisely cannot justify a decision to suppress it," the appeals court says, quoting a 1996 Supreme Court ruling that overturned Rhode Island's ban on the advertisement of liquor prices. "This limitation is enforced even where the pervasiveness of such information might persuade the public to make what the government perceives as a bad choice, because 'the First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.'"
Five paragraphs later, the appeals court says censorship of truthful, nonmisleading claims could be justified based on the fear that "the marketing of a product as 'modified risk' [might raise] the aggregate number of people (especially juveniles) who use tobacco because it leads them to believe than an unsafe product is relatively safe, instead of merely affecting the apportionment of current users." That is precisely the sort of fear that the FDA cites to justify its regulations, and it is precisely the sort of motivation that the Supreme Court has rejected. The FDA wants to keep people in the dark for their own good, because they might not use information the way it thinks they should.
This article originally appeared at Forbes.com.
