Photograph of a person holding an e-cigarette in one hand and traditional cigarettes in the other hand.

FDA’s Warning Letter to Juul & the First Amendment

By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

Modified-Risk Tobacco Products: A Brief History

Philip Morris began to realize in the 1950s that a “healthier” cigarette could drive up sales, while also providing ammo for the company to criticize other tobacco companies that did not offer a “light” option. Heavy promotion and advertising of “light” cigarettes ensued ensued. By 1980, filtered cigarettes constituted 45% of the U.S. market, and by 2001 that figure increased to 87%. However, light cigarettes are not safer than normal cigarettes, suggesting that the importance of claiming a product is “light” mainly pertains to marketing. Although a strong opinion, Robert Proctor, professor of the history of science at Stanford, has stated that filters represent the “deadliest fraud in the history of human civilization.”

It was in this context that the Family Smoking Prevention and Tobacco Control Act of 2009 forbade marketing of “light” products or other MRTPs sans FDA approval.

The history of e-cigarette “light” claims is much shorter since e-cigarettes first entered the U.S. market in 2006. E-cigarette manufacturers generally claim their products are safer than combustible cigarettes, rather than asserting their products are “light” compared with other e-cigarettes.

FDA and Juul

FDA claims that Juul needs pre-market approval of its e-cigarettes as MRTPs under Food, Drug, and Cosmetic Act § 911(g) in order for them to be sold as reduced-risk. FDA’s regulatory action lays the groundwork for a possible First Amendment case, in which Juul could argue that it seeks to convey truthful, non-misleading information about its product, and therefore a governmental interest in regulating this speech is minimal. From a legal standpoint, FDA has the 6th Circuit case Discount Tobacco (2012, cert. denied) in its pocket, which held that requiring premarket approval for MRTPs is a valid restriction of speech under Central Hudson. In support of its conclusion, the Court noted a “pattern of deception” in marketing “light” cigarettes warranting government correction. In the Court’s words, “[I]n the context of a deadly and highly addictive product, it would be a virtual impossibility to unring the bell of misinformation after it has been rung.” This strong language is likely a part of FDA’s confidence in its warning letter to Juul. Of course, Discount Tobacco wasn’t a complete victory for FDA, as the agency had hoped to avoid any First Amendment scrutiny of its MRTP pathway by arguing pre-market review was not intended to regulate speech, but to ensure the product worked as advertised. Further, Juul can argue that Discount Tobacco may not be fully translatable to the e-cigarette context.

In any event, if Juul refuses to comply with the warning letter, the stage for a First Amendment challenge to the MRTP approval pathway will be set. This case would have dramatic implications for First Amendment lawyers, public health officials, regulators, and especially our country’s youth. Given the rising scrutiny of regulations on commercial speech, there is a nonzero chance that Discount Tobacco may not be a sufficient bulwark against the historical – and, according to FDA, continuing – practice of capturing new consumers with the assurance of safety.

Daniel Aaron

Dr. Daniel Aaron grew up just outside of Boston. He graduated from Brown University and studied law and medicine between Harvard and Boston University. Dr. Aaron hopes to alleviate health injustice by studying the role of law and policy in creating and perpetuating disease. His research foci include food and drug law, obesity, opioids and related tort litigation, tobacco products, the intersections with racial health inequities, and constitutional health law. His research has been covered by the New York Times, CNN, Time Magazine, and others. Today, he is a Heyman Fellow at Harvard Law School, an attorney at the U.S. Food and Drug Administration, and a member of The Justice Initiative, a collaboration between Harvard Law School and Howard University School of Law aimed at building a community of lawyers and law students around racial justice. Publications: Tobacco Reborn: The Rise of E-Cigarettes and Regulatory Approaches, 25 LEWIS & CLARK L. REV. ___ (forthcoming 2021). Is Obesity a Manifestation of Systemic Racism? A Ten-Point Strategy for Study and Intervention, J. INTERNAL MEDICINE (2021). Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods., CRITICAL REVS. OF FOOD SCIENCE & NUTRITION (2020). Constitutional Cohesion and the Right to Public Health, 53 MICHIGAN J. LAW REFORM 173 (2019). Sponsorship of national health organizations by two soda companies, 52 AM. J. PREVENTIVE MEDICINE 20 (2017). The Landscape of Genetic Variation in Dilated Cardiomyopathy as Surveyed by Clinical DNA Sequencing, 16 GENETICS IN MEDICINE 601 (2014). Nature Publishing Group.

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