The Regulation of Electronic Cigarettes

If you are a fan of Bravo’s “Real Housewives of Beverly Hills” series, you will undoubtedly recall the episode featuring the appearance of psychic Allison DuBois at a dinner party hosted by Camille Grammer. DuBois was quite irksome, but surprisingly, not due to the cigarette she puffed at the dinner table. While DuBois’s cigarette caused little conflict at the party, the product has been at the forefront of some intense litigation and proposed legislation in recent months.

DuBois’s “cigarette” was an electronic cigarette or “e-cigarette.” As such, it was a battery-powered device that allows users to inhale vaporized nicotine, minus the tobacco, tar, and carbon monoxide. E-cigarette advertisements claim that the product is “the smarter and safer alternative to smoking” which looks, tastes, and feels like a real cigarette. If true, the e-cigarette could dramatically impact the nation’s health. Apparently, though, the Food and Drug Administration (“FDA”) has its doubts.

The emergence of the e-cigarette presented the FDA with a new opportunity to extend its regulatory reach. However, over a decade ago, the FDA lost its initial bid to regulate cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act (“the Act”) via the U.S. Supreme Court’s decision in FDA v. Brown & Williamson Tobacco Corp., 539 U.S. 120 (2000) (holding that Congress had not vested the FDA with the power to regulate cigarettes and smokeless tobacco products). Despite that loss, the FDA has made other attempts to regulate e-cigarettes, and we’ve created the handy list below to summarize those attempts:

• In 2009, the FDA warned that e-cigarettes contain carcinogens and toxic chemicals such as diethyline glycol (an ingredient used in antifreeze). According to its statement, the FDA was concerned that e-cigarettes would increase nicotine addiction and tobacco use in young people. The FDA began detaining shipments of e-cigarettes at the border. Following the examination of the seized goods, it determined that the product meets the Act’s definition of a combination drug-device product and, accordingly, was subject to FDA regulation. E-cigarette distributors challenged the FDA’s jurisdiction.

• In January 2010, the U.S. District Court for the District of Columbia granted a preliminary injunction to allow e-cigarette distributors to continue to import their products into the country. Judge Richard Leon agreed with the distributors that Brown prevented the FDA from regulating e-cigarettes. The FDA appealed the ruling, and the D.C. Circuit Court of Appeals issued a stay on Judge Leon’s injunction. (For a more thorough examination of the Court’s decision, see our earlier discussion of that matter here.)

• In September 2010, the FDA notified five e-cigarette distributors that it was taking enforcement actions against the companies for violations of the Act. The list of violations included “violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients like rimonabant and tadalafil.” In addition, the FDA announced its decision to regulate e-cigarettes as combination drug-device products. As a consequence of regulation, e-cigarette manufacturers would be required to comply with the FDA’s drug-approval process.

• On December 7, 2010, the D.C. Court of Appeals affirmed the district court decision and held that the FDA lacked the authority to regulate e-cigarettes under the Act as drugs or devices. In addition, the D.C. Court of Appeals held that the FDA may only regulate the marketing of e-cigarettes pursuant to the Tobacco Act.

While the FDA may have been unsuccessful in its legal battles thus far (the FDA is considering an appeal), several states are considering regulating, or in some instances banning, e-cigarettes. Recently, New York took the first steps to becoming the first state to ban e-cigarettes, passing a proposed bill through the Health Committee of the New York Assembly. The bill’s sponsor, Assemblywoman Linda Rosenthal, indicated she wanted to proscribe e-cigarettes until they undergo more investigation and regulation. Assembly Health Committee Chairman Richard Gottfried has urged e-cigarette manufacturers to prove to the FDA the legitimacy of their “smoking cessation” claims.

Rosenthal and Gottfried may have a point: e-cigarettes may pose some yet-to-be-determined health hazards. It is interesting that the FDA and state legislatures have become so adamant at this stage about banning a cigarette alternative. While we may not know the ill-effects, if any, of vaporized nicotine, we do know the risks associated with tar, tobacco, and carbon monoxide. There is always a risk that e-cigarettes can lead to hazards more significant than cancer and emphysema. However, it seems counter-intuitive to protect consumers by banning a product which may have risks in favor of one we know poses the threat of serious illness.

We can all relate to the fear of the unknown. On the one hand, we may discover in the future that the conservative approach of the FDA and the various state legislatures was proper. On the other hand, we may discover Allison DuBois knew what was safe all along. After all, she is a psychic.