CONTENTS INTRODUCTION I. THE LOOPHOLE II. Scope of Regulation III. JUDICIAL CHALLENGES A. Brown & Williamson B. Central Hudson Test C. Zauderer Test D. "Arbitrary and Capricious" Test IV. ISSUES WITH CLOSING THE LOOPHOLE A. Issues with Rulemaking 1. "Tobacco" or "Drug" 2. Administrative Obstacles 3. Congressional Authorization 4. Hard Look 5. Statutory Adherence and Arbitrariness 6. Test Application B. Issues with Legislation 1. Safety Scheme in Brown & Williamson 2. Major Questions Doctrine C. Issues with Anti-Regulation V. MAJOR QUESTIONS RESOLVED FOR LEGISLATION A. Statutory Ambiguity B. Breadth and Limitations of Authority C. Prudential Considerations CONCLUSION
INTRODUCTION
Eighteen-year-old Floridian Chance Ammirata felt like he was having a heart attack. (1) Emergency room physicians discovered his right lung had collapsed, reporting that the hole "could have come from something he'd been inhaling." (2) It turns out that Ammirata began vaping at sixteen years old. (3) In Michigan, seventeen-year-old Daniel Ament needed a double lung transplant due to vaping-related damage thought to be pneumonia. (4) Ament vaped nicotine and tetrahydrocannabinol (THC) starting the winter of his sophomore year of high school; by the fall of his junior year, he was hospitalized. (5) And in Pennsylvania, after only three weeks of vaping, an eighteen-year-old suffered respiratory failure from "wet lung," and required a respirator and tubes to drain fluid from her lungs. (6)
This is not mere anecdotal evidence of a problem with e-cigarette or vaping use-associated lung injury (EVALI). In 2020, the National Youth Tobacco Survey found that 220,000 middle school students and 1.45 million high school students used prefilled e-cigarette cartridges in 2020. (7) As of February 18, 2020, the Centers for Disease Control and Prevention (CDC) confirmed sixty-eight vaping-related deaths in twenty-nine states and the District of Columbia as well as 2,807 EVALI hospitalizations or deaths in all fifty states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. (8) EVALI has not solely affected teens. Thirty-eight-year-old former marathoner Jay Patel developed severe lung disease after vaping for two years and was comatose for two weeks in the ICU, leading to Georgia's first lawsuit against e-cigarette company Juul. (9) Patel's illness is not unusual. Of the 2,668 hospitalized EVALI cases or deaths reported as of January 14, 2020, 15 percent were under eighteen years old, and 48 percent of patients were over twenty-four years of age. (10)
These statistics on tobacco products' age-spanning popularity and effects should not come as a surprise. Studies have long demonstrated that combusted tobacco contributes to deadly cardiovascular disease (11) and cancer. (12) While some researchers claim nicotine itself plays only a minor role in smokers' poor health, others note noncombusted nicotine's harmful effects on various organ systems. (13) Research has suggested that nicotine vaping carries unique health concerns, though long-term health effects have yet to be fully uncovered, given e-cigarettes' relatively recent introduction. (14) New synthetic nicotine e-cigarettes compound these concerns. (15) Besides the ubiquity of disposable electronic nicotine delivery systems (ENDS) like Juul and blu, consumers also use vaping devices with cannabinoid cartridges that include THC and cannabidiol (CBD). In fact, as of January 14, 2020, 82 percent of hospitalized EVALI patients reported using THC-containing products and only 14 percent of those patients reported exclusive use of nicotine-containing products. (16) Therefore, any nicotine-specific government intervention may only address a fraction of vaping health concerns.
Governmental efforts to address the vaping epidemic and regulate the industry have been an ongoing battle. Tobacco and e-cigarette companies have modified their products seemingly in response to the shifting regulatory scope, finding loopholes before they close. (17) As recently as April 2022, Congress passed the Consolidated Appropriations Act (CAA), (18) a small provision of which redefined "tobacco product" to allow the Food and Drug Administration (FDA) to regulate newly marketed synthetic nicotine e-cigarettes as ordinary tobacco-derived nicotine e-cigarettes. (19) Interest groups had spent months lobbying to close the synthetic nicotine loophole via an agency rule that would have folded synthetic nicotine into the FDA's drug regulation authority. (20) Now that Congress has acted, treating synthetic nicotine as a tobacco product, the issue seems resolved.
This Note, however, explores concerns about the new authorization's scope and ability to withstand challenges. Across five Parts, the Note analyzes patterns of tobacco regulation, judicial tests, the advantages of legislation over rulemaking for such regulation, how the major questions doctrine applies to Congress's action, and the implications of regulating synthetic nicotine as a tobacco product for other drug law.
Part I offers background on the regulatory loophole around synthetic nicotine. Part II describes how the CAA alters the Food, Drug & Cosmetics Act (FDCA) (21) to address that loophole. This Part also compares CAA section 111 to past tobacco legislation and rulemaking, which covered combustible cigarettes and eventually e-cigarettes. Then Part III charts historical challenges to tobacco legislation and rules, laying out key judicial tests devised and employed by the courts.
Next, Part IV outlines three standard responses to the synthetic nicotine loophole: support for rulemaking, Congress's actual action, and an anti-regulatory critique based on what is known as the "Baptist/bootlegger theory." Importantly, in evaluating the drawbacks to each option, this Part presents arguments about the legislation's vulnerability to the major questions doctrine. Finally, Part V counters the major questions doctrine argument discussed above. This Part resolves concerns about the legislation's ambiguity or application, the scope of the FDA's authority, the strength of judicial challenges, and related nondelegation doctrine's potential invalidation of the regulation.
The Note's Conclusion further suggests that the redefinition of "tobacco product" to include synthetic nicotine may affect cannabis law specifically and other drug law generally. Folding synthetic nicotine into tobacco-derived nicotine has created a precedent for folding cannabis vape pens into already-regulated ENDS. At the very least, the "tobacco product" redefinition in section 111 of the CAA informs how "cannabis product" could be defined to encompass a range of products. Moreover, since this recent legislation likely withstands constitutional and doctrinal challenges, a similar congressional act related to cannabis may likewise succeed.
I. THE LOOPHOLE
From 1964 to 2019, Congress, the FDA, the Federal Trade Commission (FTC), and the Federal Communications Commission (FCC) increasingly regulated the tobacco industry. Following the landmark 1964 Surgeon General's Advisory Committee Report that revealed smoking's health hazards, (22) the FTC promulgated a rule requiring health warnings on cigarette packaging. (23) In response, Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), (24) mandating a specific health warning that preempted any other. (25) Further, the FCC required radio and television stations to air educational anti-smoking spots counterbalancing tobacco advertisement, a policy upheld in Banzhaf v. Federal Communications Commission. (26) After the favorable Banzhaf decision, the FCC proposed a rule to ban cigarette advertisements on radio and television, (27) a position supported by the FTC. (28) Congress responded by passing the Public Health Cigarette Smoking Act, (29) which amended the FCLAA to enable the FTC to regulate cigarette advertising, required the health warning to demonstrate certainty about smoking's danger, and banned cigarette advertisement in electronic media. (30) Congress then refined the required warnings' content and format, heightening the specificity and restrictions. (31) In addition, Congress applied the cigarette warning requirements and advertisement restrictions to smokeless tobacco products in 1986. (32)
After the Court's decision in FDA v. Brown & Williamson Tobacco Corp. (33) that the FDA did not have authority under the FDCA to regulate cigarettes, (34) Congress expressed the opposite when it enacted the Family Smoking Prevention and Tobacco Control Act (TCA), (35) which amended the FDCA, explicitly empowering the FDA to regulate tobacco products. (36) Expanding on this power in 2016, the FDA issued a rule (known as the Deeming Rule), declaring e-cigarettes as well as cigars and other products to be "tobacco products" under the FDCA. (37) And in 2019, Congress passed a spending bill with a provision that amended the FDCA and raised the federal minimum age for tobacco purchase to twenty-one years old. (38) These laws and rules made up the bulk of tobacco regulation prior to 2021.
However, e-cigarette companies discovered a significant gap in the growing regulatory landscape. Puff Bar, an e-cigarette company that the FDA ordered to remove its products from the market due to regulatory violations in 2020, announced the release of its synthetic nicotine e-cigarettes in early 2021. (39) Puff Bar was not alone. The FDA issued letters to ten top e-cigarette manufacturers regarding their required premarketing authorization, and then their synthetic nicotine products hit the market. (40) This is the core of the loophole: since the new products' nicotine is synthetic, the products are not "made or derived from tobacco," (41) thus falling outside the definition of "tobacco product" and outside the FDA's regulatory reach at the time.
Although the nature of chemically synthesized nicotine, its manufacturing process, and its...
