D.C. Circuit Upholds FDA’s Authority to Regulate E-Cigarettes
In May 2016, the Food and Drug Administration (FDA) announced a rule declaring that e-cigarettes should be regulated like other tobacco products. Through this rule, the FDA exercised its discretion to deem e-cigarettes to be “tobacco products” subject to the set of federal laws that govern the promotion and marketing of conventional cigarettes. The so-called “Deeming Rule” has been a major point of contention for vaping companies that argue e-cigarettes are not tobacco products and any regulations on e-cigarettes act like a ban that will destroy the industry.
Recently, the U.S. District Court for the District of Columbia upheld the FDA’s authority to issue the rule. In Nicopure Labs, LLC v. FDA, consolidated with Right to Be Smoke-Free Coalition v. FDA, the plaintiffs challenged the rule. Nicopure claimed the rule violates its First Amendment rights because the rule’s restriction on modified-risk statements prohibits manufacturers from making truthful and non-misleading statements about their products. Likewise, Nicopure claimed that the ban on the distribution of free samples violates Nicopure’s right to free speech. Nicopure called for “disclaimers” for e-cigarettes rather than the strict tobacco-like regulations. The court declined that invitation, stating that “Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health.”
While it is true that the costs associated with meeting FDA regulations and securing FDA approval are high, the $7 billion e-cig industry (2016) – projected to grow to $44 Billion by 2024 – can afford to pay a bit to protect public health. Can’t they?
The fact that big tobacco investors have a big interest in the vaping industry provides a clue as to why the industry wants to prevent FDA involvement. Until regulated, tobacco companies did little to prevent risk to public health and in fact hid the detrimental effects of smoking until lawsuits forced them to take responsibility for their predatory manufacturing and advertising practices. Unfortunately, the e-cigarette industry is shaping up to follow in its tobacco investors’ footsteps.
In a note directed toward vapers, the Nicopure court clarified that the FDA rule is not about banning e-cigarettes; it is about instituting the same regulations required for other tobacco products. That statement did not strike accord but rather fueled the fire of the debate over whether e-cigarettes are like conventional cigarettes. One industry publication called the judge’s statement “bizarre.” Such commentary should be recognized for what it is —inflammatory hype in a bid to keep the cash cow flowing without regard to public health.
The FDA recently decided to extend its ruling review period to allow for e-cigarette companies to present more information about how and why they promote their products. This seems like a generous compromise given that e-cigarettes are associated with the same health problems as conventional cigarettes. With a similar risk to health, a marked appeal for teens as a gateway product, and the risk of product explosions, the FDA needs to keep up the pressure to ensure public health is protected and the industry complies with safety and truth in advertising regulations.