Blue cotton candy, bubblegum, blackberry ice, cherry bomb. While this list might sound like the contents of a particularly eclectic bag of lollipops, these are also the names of real varieties of e-cigarettes, or vapes, sold online and in smoke shops across the United States.
Although vapes — battery-powered devices that dispense nicotine — are supposed to be restricted to those over the age of 21, the similarity of some flavors to candy is no accident, say experts like Daniel G. Aaron ’20, an associate professor at the University of Utah College of Law and a Harvard Law School alumnus.
Indeed, says Aaron, with many products featuring brightly colored packaging, cutesy names, and sweet flavors, e-cigarette companies are hoping to tap into a hot market composed largely of young people. “It’s common sense, and it’s also visible in the data we see,” says Aaron, who holds an M.D. and was also a Heyman Fellow at Harvard Law School.
Although the number of Americans who smoke traditional tobacco products has sharply declined in recent decades, use of e-cigarettes has risen dramatically. Particularly alarming, Aaron says, is consumption by minors, who risk nicotine addiction and lung damage, among other negative health outcomes posed by e-cigarettes. Flavored vapes may be a significant contributor to the increase in youth usage, he adds. According to recent FDA data, of the more than 1.6 million middle and high school students who regularly consume e-cigarettes, nearly 88% prefer flavored e-cigarettes.
Curiously, such products are already illegal in the U.S., Aaron adds. A new tobacco product can only come onto the market if the FDA gives its approval, and “it has not authorized any flavored e-cigarettes other than tobacco and menthol flavored e-cigarettes,” he says.
The FDA’s denial of approval for these products is at the heart of Food and Drug Administration v. Wages and White Lion Investments, which the U.S. Supreme Court will hear on December 2. In the case, the nine justices will consider whether the FDA’s refusal to authorize a company’s flavored e-cigarette products was “arbitrary and capricious,” as held by the Fifth Circuit Court of Appeals.
And while the case hasn’t attracted a lot of media attention, Aaron says the Court’s decision could not only impact the health of millions of young Americans — it could also stymie the FDA’s ability to regulate thousands of other everyday goods.
Harvard Law Today: Why might flavored e-cigarettes pose a particular risk to young people?
Daniel Aaron: Flavored e-cigarettes are marketed seemingly with youth in mind. You can see this in some of the really strange flavor names, such as “OMG,” which is orange mango guava, I believe. There’s one called “kiwi strawberry puff bunny,” there are flavors like bubblegum. These are flavors that do not seem to be meant to appeal to adults. We also know the majority of youth e-cigarette users use flavored e-cigarettes. So, it seems like common sense, and it’s also visible in the data.
HLT: Even though these types of products are illegal, it’s not difficult to find places online — or even in vape shops — where you can buy them easily. Why is that?
Aaron: The Food and Drug Administration has the authority to authorize or deny authorization to e-cigarette products, and it has not authorized any flavored e-cigarettes other than tobacco and menthol flavored e-cigarettes — meaning all the flavors I just mentioned are illegal.
But it’s also true that companies are selling these products relatively freely, and that’s largely because there’s a gap between the law and the FDA’s enforcement of the law. In other words, to actually make the law matter, the FDA has to go to either an administrative law judge or to a federal court and say “the law is being broken and we need to enforce it,” and try to get a court order — maybe a court judgment, maybe an administrative fine — something that forces that company to stop selling the product. Barring that, these products are very profitable, and so online stores, convenience stores, and vape shops are unlikely to stop selling them voluntarily.
HLT: Has the FDA tried to enforce the law?
Aaron: The FDA has tried to do some enforcement, particularly with regard to Elf Bar, which is a very popular flavored e-cigarette brand among youth. But my understanding is that that product is derived from China and often is shipped through illicit channels into the U.S., and has therefore been hard to enforce against. So, there’s also the problem of dodging FDA authority.
Why is the FDA not enforcing the law more rigorously? There are likely a couple factors behind that, but the biggest factor appears to be interference by the Department of Justice. The FDA is one of a number of agencies that can’t enforce the law on their own. They generally have to turn to the Department of Justice, which is the main legal organ of the federal government. And so, if the Department of Justice doesn’t want to enforce the law, then the FDA is out of luck. The DOJ has largely vetoed FDA enforcement efforts and that has been an immense source of frustration for the FDA Center for Tobacco Products.
“The FDA is one of a number of agencies that can’t enforce the law on their own. … [but the Department of Justice] has largely vetoed FDA enforcement efforts and that has been an immense source of frustration for the FDA Center for Tobacco Products.”
HLT: Is the DOJ’s reluctance to enforce this tied to a particular administration, or is this a consistent policy over the last few presidencies?
Aaron: This has largely been a consistent policy across administrations. I think that there are some reasons why one might be sympathetic to the DOJ here, in the sense that we do have a Supreme Court that is increasingly skeptical of federal agencies and is trying to curtail their power. If the FDA does enforce the law proactively, then perhaps it risks losing some of its legal authority. On the other hand, legal authority not exercised might as well not exist, right? Furthermore, why obey a Supreme Court ruling before it’s even been issued? The Supreme Court should take the fall, not the administration.
Part of the strategy may have been to delay the enforcement of tobacco law until scientific review by the FDA has been done. The FDA/DOJ have been largely hands-off with products that have a pending application before the FDA. In part, DOJ may have thought that it would be better to enforce the law after doing the scientific review, so that there isn’t the argument that the FDA is being derelict and too slow, and scientific decisions may be harder for courts to question. Unfortunately, the FDA has not been able to expeditiously handle millions of applications for what is a new e-cigarette review regime. In fact, the FDA gained jurisdictional authority over e-cigarettes in 2016, so officials were trying to set up this new regulatory system while actively receiving applications. During these time-consuming reviews, e-cigarette companies have been flouting the law and selling their products often without enforcement by FDA/DOJ.
HLT: Could you tell us more about the law that allows the FDA to regulate tobacco products?
Aaron: The FDA obtained authority over tobacco products via the Family Smoking Prevention and Tobacco Control Act of 2009, which was a landmark act that was actually supported by the tobacco industry and gave the FDA this pretty broad authority to regulate tobacco products. This was also in the wake of the Supreme Court decision that ended FDA tobacco authority previously. The law actually didn’t apply to e-cigarettes, but allowed the FDA to “apply” the law to additional types of tobacco products. In 2016, the FDA finalized a rule giving it authority over e-cigarettes.
The statute lays out a framework for the review of new tobacco products. These new products have to be “appropriate for the protection of the public health,” taking into consideration whether we’re going to experience a rise in youth addiction from new tobacco products, versus whether these new tobacco products could ameliorate the risk of cigarette smoking by shifting people to a less harmful product.
HLT: The FDA ultimately decided not to approve these new flavored e-cigarette products — at least not yet. Subsequently, several courts of appeals around the country have upheld the law, but not the Fifth Circuit Court of Appeals, which called the FDA’s denial “arbitrary and capricious.” Can you explain the court’s rationale?
Aaron: The Fifth Circuit departed from almost all of its sister circuits. They said that the FDA’s scientific decisions were arbitrary and capricious, and in doing so intruded on the agency’s expertise. First, they accused the agency of flip-flopping in its guidance for the application process, and second, they said that the FDA didn’t consider companies’ marketing plans as an antidote to an otherwise harmful product. In other words, if the product’s harmful, maybe a company can try to market it responsibly so that youth don’t buy it.
As to the first issue about flip-flopping, it is likely true that the FDA’s guidance for applicants was not entirely consistent. You had an agency that was trying to set up a new regulatory regime from scratch amidst an e-cigarette epidemic among our youth. And in addition, we did have a change in administration. During this time, the FDA was often giving informal guidance to industry so that the contents of a tobacco application weren’t a mystery. The FDA warned companies that they need to submit pretty good evidence for flavored products. The Fifth Circuit said the FDA should be required to turn square corners and be clear with what information it expects. But I think that’s setting a pretty high bar for the agency, and it could discourage the FDA’s informal disclosure of information that streamlines the process.
HLT: How did the FDA respond to the argument that a responsible marketing plan might ameliorate a product’s health risk?
Aaron: The FDA said that it thought that marketing plans couldn’t make a dangerous product appropriate for the protection of public health. In this case, they said that flavored vapes were too risky, and that, in the agency’s experience, a company promising to market responsibly is not going to make the product safe. I think that is a scientific decision that necessitates deference, and it did not receive it from the Fifth Circuit. Furthermore, I think the FDA may also be concerned about whether these marketing plans can even be enforced, because they’re largely governing industry communications, which are protected by the First Amendment as a matter of corporate free speech. Given that companies could simply renege on any restrictions that they claim they’ll place on their marketing activity, you can see why the FDA was reluctant to place much credit on these plans.
HLT: How will the Supreme Court think through this case?
Aaron: I think the Court is going to think about whether it wants to shore back the power of administrative agencies. Just last term, the FDA had its scientific decision-making questioned over mifepristone, and the Supreme Court dodged that question in the election year. I think tobacco is not as contentious of an issue for many members of the public, and so the Court can overrule the FDA without as much public anger as might be expected if it were impinging on abortion. And I think now that we have something much less salient to the public, there’s an opportunity to shore back administrative power, and I worry that is how the Court is going to think about this case, rather than in a principled manner.
“I think the Court is going to think about whether it wants to shore back the power of administrative agencies.”
HLT: What happens if the Court finds for the e-cigarette company? Does the FDA lose the ability to regulate vapes completely?
Aaron: The case would likely be remanded back to the lower courts, and the agency would have another chance to review the applications, and this time, they would probably have to look at the marketing plans. It might have to give more guidance to the industry and more time to meet the obligations that the Fifth Circuit thought that it did not meet. That could mean that the FDA has to communicate new expectations, and companies may be given more time to complete their studies, during which time the FDA likely is not going to enforce the law, since it hasn’t been doing so anyway.
So, you’re going to have the continued marketing of all these products. Essentially, the Supreme Court right now has the authority to allow 55,000 e-cigarette products onto the market. There’s a huge public health impact potential of this case, as well as buying a lot of time for industry to continue selling their products while the FDA jumps through hoops that have been created by the courts.
HLT: There is another e-cigarette case, which also emerged out of the Fifth Circuit, that the Supreme Court will hear in January. It involves whether a tobacco manufacturer can challenge FDA actions in the Fifth Circuit, as opposed to where the company is based. Can you tell me more about why that suit is important?
Aaron: The Tobacco Control Act requires companies to challenge denials in a court of appeals — either in the D.C. Circuit or “the circuit in which such person resides or has their principal place of business.” Despite this provision, the Fifth Circuit is now allowing tobacco companies to sue in the Fifth Circuit as long as they join with a convenience or vape shop in the Fifth Circuit. The case is essentially about the Fifth Circuit inviting litigants from the tobacco industry around the country to litigate in its circuit. The model the Fifth Circuit has created for tobacco is a little bit genius, but not in a good way. I could imagine the Supreme Court signing off on that in order to give the Fifth Circuit more authority over administrative agencies. On the other hand, there are at least a couple members of the Court that are skeptical of national oversight through a single court. I would point to Justice Gorsuch and Justice Jackson as critics of the nationwide injunction.
The other dynamic I want to point out is that, when the Fifth Circuit creates a decision that damages agencies or other aspects of the public interest, the Supreme Court doesn’t have to take the case. Even just by denying certiorari, the Court can bless the case. By delegating this authority to the Fifth Circuit, by signing off on procedural loopholes, the Supreme Court can achieve some of the similar ends without spending political capital. Here, the Supreme Court granted review, so at least four members of the Court may be questioning the loophole.
HLT: Finally, what might the impact of these cases be on the FDA itself?
Aaron: We’re at a moment in time where there is increasing skepticism of science and of agencies’ authority to govern based on science. We’ve seen the Supreme Court being willing to wade into really challenging scientific and factual disputes in a way that it would not have done 10 or 20 years ago, and so I am very concerned about the FDA’s continuing authority and its ability to make scientific decisions in this climate. Under the Supreme Court’s heightened scrutiny of agency science, all categories of the FDA’s scientific judgments are likely to come into question, and I think the FDA and its authorities are potentially at risk over the next few years.
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