D.C. Circuit Rejects Challenge to FDA E-Cigarette Regulations

The court was correct to reject most of the arguments, but was too dismissive of the First Amendment concerns.

On Tuesday, the U.S. Court of Appeals for the D.C. Circuit turned away a set of challenges to the Food and Drug Administration's regulation of electronic cigarettes and other vaping devices.  Specifically, in Nicopure Labs v. FDA, a unanimous panel held that the FDA's regulation is neither arbitrary and capricious under the Administrative Procedure Act nor unconstitutional under the First Amendment. These conclusions are not particularly surprising, but it would still be premature to conclude the FDA's current regulatory approach does not raise serious constitutional concerns.

The plaintiffs' APA claims never struck me as particularly strong. Before the D.C. Circuit, Nicopure Labs and the Right to Be Smoke Free Coalition did not challenge the FDA's decision to "deem" e-cigarettes and other vaping products to be "tobacco products." Rather, they argued that the FDA acted arbitrarily and unlawfully in not taking the additional step of adopting an easier way for e-cigarettes to obtain pre-market approval form the FDA.

Under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), tobacco products not on the market prior to 2007 will be required to obtain approval from the FDA before they may be sold. Thus, once e-cigarettes were deemed to be tobacco products, they were subject to this statutory requirement. It would perhaps be a good idea for the FDA to facilitate the rapid approval of e-cigarettes, but it's not a violation of the APA for the agency to fail to adopt this course As the court noted, the plaintiffs' "wholesale objection is to Congress' design, not to any arbitrariness on the FDA's part in carrying it out."

The panel also made quick work of the plaintiffs' claim that it is unconstitutional to prohibit e-cigarette manufacturers from promoting their products through the distribution of free samples. Such a limitation, the plaintiffs' tried to claim, violates the First Amendment. As I noted in my comments on the district court's opinion, this argument is a bit of a stretch. A prohibition on free samples is, in effect, a prohibition on the price at which a product may be sold, and is thus best understood as economic regulation, not the regulation of speech, and I would have been shocked if even a single judge on the panel had concluded otherwise.

The plaintiffs' other First Amendment claims, against the prohibition on making "modified risk" claims about e-cigarettes unless and until such products are approved as "modified risk tobacco products" by the FDA, were more serious, and I am not entirely convinced by the courts' dismissal of these claims.

Under the FDA's current interpretation of the Tobacco Act, it is unlawful for an e-cigarette manufacturer to simply inform consumers of things the FDA has itself said about their products, even with a disclaimer. According to the FDA, "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," yet an e-cigarette maker could not paste this language on their product package or include it in an ad. Nor could they say 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," even thought the FDA has said as much in the Federal Register. And were an e-cigarette maker to say that "there is emerging data that some individual smokers may potentially use ENDS to transition away from combustible tobacco products" (again using the FDA's own words), they would be making a "smoking cessation claim" which, according to the FDA, may only be made once the product in question has been approved as a drug or medical device.

The D.C. Circuit concluded that these prohibitions were fully consistent with the First Amendment. The requirement that e-cigarette makers seek and obtain FDA approval of their products as "modified risk tobacco products" before they can make factually true statements about e-cigarettes and their contents "is reasonably tailored to advance the substantial government interest in protecting the public health and preventing youth addiction." As Judge Pillard explained:

Deliberately selling an e-cigarette as less risky without going through the requisite regulatory review for reduced-risk tobacco products renders the sale-as-labeled unlawful, just as selling saw palmetto extract as a drug without FDA premarket approval was unlawful.

It is true that saw palmetto extract may not be marketed as a drug without prior FDA approval, but prior D.C. Circuit decisions have held that the FDA may not prohibit factual statements about nutritional supplements and the like that fall short of medicinal claims.

In Pearson v. Shalala, for instance (another case concerning the FDA), the court explained that "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." This decision is not distinguished in Nicopure Labs. It is not even mentioned.

It's not just D.C. Circuit precedent that is in tension with the Nicopure Labs holding. In Thompson v. Western States Medical Center, the Supreme Court warned that "We have . . . 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." According to Judge Pillard, however, the Court struck down the limitation on pharmacist speech at issue because the government had failed to identify any basis for its conclusion that warnings or disclaimers would be insufficient to safeguard the government's interest. To me that is an awfully stingy interpretation of that Supreme Court decision.

Congress may have concluded that warning labels or disclaimers are insufficient (though not specifically with regard to e-cigarettes, as they were not on the market at the time the Tobacco Act was adopted. More importantly, is it really the case that a blanket Congressional finding is all it takes to defeat a First Amendment claim?

If restrictions on commercial speech are subject to heightened scrutiny, it would seem that more than a categorical assertion is required to justify the censorship of factually true statements. After all, as the Supreme Court held in Rubin v. Coors Brewing, the government "must demonstrate that harms it recites are real and that its restrictions will alleviate them to a material degree," and no such showing has been made here.  If the FDA had to substantiate the basis for its proposed graphic warning labels for cigarettes, I would think the federal government should have to actually substantiate the claim that indisputably true statements are sufficiently misleading, even when accompanied by warnings or disclaimers, to justify a prior restraint on speech. Apparently not.

The reality is that while the FDA has acknowledged that e-cigarettes are less dangerous than traditional cigarettes, much of the public remains in the dark. And insofar as public perceptions of the relative risks of e-cigarettes affects whether smokers attempt to quit smoking, public misperception as to the relative risk of e-cigarettes cost lives. This does not obligate the FDA to sing the praises of e-cigarettes, or refrain from prudent regulation, but it should counsel against censoring speech that would inform the public – smokers in particular – and potentially save lives.

It is perhaps ironic that this opinion was released the same week as a review essay in Science extolling the potential benefits of e-cigarettes and warning of the dangers of prohibitionist regulatory approaches. In upholding the FDA's actions, Judge Pillard was not content with deferring to the agency's expertise. She instead put the court's imprimatur on specific claims about the relative risks of e-cigarettes that stand in stark contrast to the opinion of some of the nation's foremost health professionals.

From the opening line of the opinion, Nicopure Labs reads like a brief for an e-cigarette prohibitionist group, as if the judges themselves had concluded the e-cigarettes are a threat that must be regulated. To my mind, it would have been better for the court to remain more agnostic on the policy merits of FDA's moves, confining its analysis to the legal merits of the FDA's moves.

I understand the D.C. Circuit's reluctance to invalidate the regulatory scheme for tobacco products Congress created, particularly as such a decision could up-end some aspects of drug regulation as well. But I think it was a mistake to pretend as if public health concerns are indisputably on the side of the FDA's actions and to be so dismissive of the serious First Amendment implications of upholding prior restraints on truthful speech that could save lives.