Why FDA regulations limiting e-cigarette marketing may cost lives and violate the Constitution

Earlier this year, Food and Drug Administration Commissioner Scott Gottlieb announced that the FDA would reevaluate and reorient its tobacco policies. Recognizing that the primary health threat from tobacco products comes not from nicotine, but from combustion, Gottlieb noted the role that “less harmful tobacco products” could play in reducing the death toll from cigarettes. He elaborated on the FDA’s new approach in an article for the New England Journal of Medicine.

Gottlieb’s comments were welcome — yet more is needed. Even with recently announced reforms, the FDA’s regulation of cigarette alternatives, such as electronic cigarettes, threatens to do more to harm than to help public health. It is likely unconstitutional to boot.

Despite reductions in smoking, cigarettes remain one of the leading causes of preventable death in the United States. Though many smoke for the nicotine, it’s not the nicotine that kills. Rather, it is the combustion of tobacco that is primarily responsible for smoking’s risk. E-cigarettes (and smokeless tobacco products) have the potential to satisfy smokers’ craving for nicotine at far lower risk. The available evidence suggests that e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible tobacco. Yet as I discuss at length in this forthcoming paper, the harm reduction potential of e-cigarettes is hampered by federal regulation and the not-so-subtle suggestion from government officials that e-cigarettes are as dangerous as tobacco cigarettes. Federal regulatory measures and health pronouncements that discourage current smokers from trying e-cigarettes and other less-dangerous alternatives may hamper efforts to safe smokers’ lives.

FDA regulation of e-cigarettes is not only bad for public health but also is likely unconstitutional. Insofar as the federal Tobacco Act, and the FDA’s implementing regulation, prohibit product makers and sellers from making factually true statements about their products, they likely violate the First Amendment.

It is well-established that advertising, product labels and other forms of commercial speech are protected by the First Amendment. “The fact that speech is in aid of a commercial purpose does not deprive responded of all First Amendment Protection,” explained the Supreme Court in United States v. United Foods. Commercial speech may not receive quite the same level of protection as political speech, but the protection it receives is significant.

Under current law, restrictions on commercial speech are evaluated under the “Central Hudson” test. Under this test, commercial speech is protected provided it concerns a lawful product and is not misleading. Restrictions on such commercial speech must be justified by a substantial governmental interest. In addition, such restrictions must directly advance the government interest asserted and cannot be more extensive than necessary to serve that interest.

In May 2016, the FDA deemed e-cigarettes to be regulated “tobacco products” under the Family Smoking Prevention and Tobacco Control Act of 2009 (a.k.a. the Tobacco Act). As a consequence, e-cigarette manufacturers and retailers are prohibited from informing consumers that e-cigarettes are less dangerous than combustible cigarettes. Such claims may be made only with the FDA’s approval, after submitting to a lengthy and costly approval process. In the meantime, straightforward factual claims — even claims that do no more than repeat public statements made by the FDA — are prohibited.

The Tobacco Act’s prohibition on the ability of producers to make factual statements about cigarette alternatives are quite sweeping. Under the act’s provisions concerning “Modified Risk Tobacco Products” (MRTP), producers of deemed products may not make commercial statements that “explicitly or implicitly” indicate that the product or its “smoke” “presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products”; “contains a reduced level of a substance or presents a reduced exposure to a substance”; or “does not contain or is free of a substance.”

As interpreted by the FDA, a manufacturer’s claim that an e-cigarette “contains less nicotine” or is a “healthier alternative to smoking” is prohibited, unless the manufacturer first submits to a lengthy and costly process to be approved as an MRTP. Although several such applications have been submitted to the FDA, as of this writing, none have been approved. (The FDA keeps track of applications and orders here.)

To be clear, unless and until a manufacturer obtains approval to market a specific e-cigarettes as an MRTP, it cannot even repeat FDA statements about the relative risks of e-cigarettes in its advertising, such as that “the inhalation of nicotine (i.e. nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products” or that “several studies support the notion that the quantity of toxicants [in e-cig vapor] is significantly less than those in tobacco cigarettes and tobacco smoke and similar to those contained in recognized nicotine-replacement therapies.”

The Tobacco Act’s MRTP provisions are not the only way in which tobacco regulation stifles truthful claims. According to the FDA, manufacturers of e-cigarettes and other tobacco cigarette alternatives may not make “therapeutic” claims about their products unless and until they obtain FDA approval as medical drugs or devices. Here again, the prohibition is construed broadly.

According to the FDA, were an e-cigarette manufacturer to inform consumers that its products are an alternative (and less dangerous) way for smokers to satisfy their nicotine cravings, this would be a “therapeutic” claim. As the FDA explained in a recent Federal Register notice, “statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose.” Therefore such claims cannot be made without FDA approval. Here again, producers and vendors are prohibited from repeating the FDA’s own language. While the FDA has admitted “there is emerging data that some individual smokers may potentially use ENDS to transition away from combustible tobacco products,” e-cigarette manufacturers may not tell this to consumers of their products.

The FDA’s position — and the implicit premise of the relevant Tobacco Act provisions — is that producers must be barred from making statements that might mislead consumers. Should an e-cigarette maker proclaim that vaping is less dangerous than smoking, for example, consumers might mistakenly believe that e-cigarettes are completely safe. Under existing First Amendment jurisprudence, however, such potential for consumer confusion is insufficient to justify restrictions on truthful speech.

In Thompson v. Western States Medical Center the Supreme Court expressly “rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.” Instead of suppressing such speech, the court explained, the government must pursue alternatives, such as mandating curative statements or disclaimers. The problem of potentially harmful or misleading speech is to be cured by more speech. As the U.S. Court of Appeals for the D.C. Circuit explained in Pearson v. Shalala, “when government chooses a policy of suppression over disclosure — at least where there is no showing that disclosure would not suffice to cure misleadingness — government disregards a ‘far less restrictive’ means.”  Only if the government can show that such disclaimers are insufficient may limitations on truthful claims be considered.

As the court further explained in Rubin v. Coors Brewing Co., claims that truthful speech is inherently and incurably harmful or misleading require more than “mere speculation or conjecture.” To justify limitations on factual claims, the government “must demonstrate that harms it recites are real and that its restrictions will alleviate them to a material degree.” So, for instance, the FDA would have to be able to “demonstrate” that limiting truthful claims about the relative risks of e-cigarettes is likely to harm public health. Given that consumers are more likely to overestimate, than to underestimate, the relative risks of e-cigarettes, this is a burden the FDA would have a hard time meeting. Nonetheless, a federal district court was dismissive of e-cigarette makers’ First Amendment claims in a recent decision rejecting challenges to the FDA’s deeming rule.

The government has a significant interest in ensuring that producers do not misrepresent their products or make unsubstantiated product claims. But under current First Amendment jurisprudence, this does not allow the government to prohibit truthful claims about otherwise legal products. If the FDA is concerned that e-cigarette manufacturers might oversell their products’ benefits or mislead consumers, it can require disclaimers and qualifications, much as is done with nutritional supplements. What the FDA cannot do is simply require manufacturers to be silent. Such a position is contrary to the First Amendment — and risks undermining public health.