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Professor Jordan Paradise of Seton Hall Law School Issues Paper on e-Cigarettes and the Law

Paper Warns Against ‘Nonexistent Safety Data’ and Charts a Course for FDA Oversight

Seton Hall Law Professor Jordan Paradise has released her newest paper, “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” scheduled to be published this Spring in Volume 13 of the Yale Journal of Health Policy, Law, and Ethics.

A report issued in February 2013 by the Centers for Disease Control and Prevention (CDC) estimates that as of 2011 “about one in five U.S. adult cigarette smokers have tried an electronic cigarette,” nearly twice as many as in 2010. CDC’s director, Tom Frieden, MD, MPH, remarked that “E-cigarette use is growing rapidly” but also noted that “there is still a lot we don’t know about these products….”

In “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” Professor Paradise investigates the rise of the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), the tumultuous history of attempts at tobacco regulation— through Congress, the FDA and the courts— and suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. These measures would facilitate oversight and the compilation of a safety profile for e-cigarettes; such a profile is conspicuously absent at present.

In the paper, Professor Paradise explains that because e-cigarettes contain nicotine, and are “derived from tobacco,” they have been found to fall under the designation of “tobacco products” under the TCA. Any product designated a Tobacco Product may not be considered a drug or medical device for FDA oversight purposes. Although e-cigarettes have been found to be a tobacco product, they are neither “cigarettes” nor “smokeless tobacco” under the statutory definitions. This leaves their regulation unclear as neither drug-devices absent blatant health claims (which would subject them to rigorous preapproval clinical trials) nor cigarettes (subjecting them to flavor additive bans, advertising restrictions, and graphic warnings). These perceived statutory gaps have thus far allowed the manufacturers, marketers and distributors of e-cigarettes to sell their product to the public, largely unregulated and unsupervised.

Professor Paradise notes, “E-cigarettes are one of those products for which the technology has seemingly outpaced the law. In fact, most of the core provisions of the TCA aimed at restricting youth access to smoking apply only to cigarettes and smokeless tobacco. But there is sufficient foundation under the TCA for oversight of e-cigarettes, and that oversight can be used to inform consumers of the potential risks to health as well as any benefits.” She continued, “Although there seems to be a great many people who have benefitted from e-cigarettes to quit or drastically reduce their smoking, there is currently a dearth scientific testing, comparative data, manufacturing and quality controls, limits on nicotine levels, product standards, or labeling requirements. This results in vials of the addictive drug nicotine being distributed for public consumption unchecked. We don’t necessarily know what’s in e-cigarettes, we don’t know how much, nor do we know what e-cigarettes will ultimately do, health wise, to those who use them or those who are exposed to them second hand.”

As an example of potential for oversight of e-cigarettes under the existing statutory framework, Professor Paradise points out that the statute provides for heightened requirements for what are known as “modified risk tobacco products,” defined as “any tobacco product that is sold or distributed for use to reduce the harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” The FDA has clarified the definition to say that what constitutes a “modified risk tobacco product” may be found through a product’s label, and it’s advertising—either explicit or implicit— and through any type of media. Products which meet this definition are subject to satisfying the scientific data and comparative study requirements set out by the FDA.

In addition, Professor Paradise notes that “products which make ‘therapeutic claims,’ such as signaling that a product is intended for use as an aid in smoking cessation, reduction, or as a healthy alternative to smoking, will trigger the drug or medical device provisions under the Food Drug and Cosmetics Act as a threshold matter—bringing with it, again, the need for scientific data and comparative studies. The intent in ‘Intended use’ may be determined through explicit claims or ‘expressions’ by the original manufacturer or subsequent marketer or affiliates, or, according to the FDA, ‘be shown by the circumstances surrounding the distribution of the article.’”

A good look at the advertising for e-cigarettes and the circumstances surrounding their distribution is compelling, she said.” Recommendations:

  1. Scrutinize claims and representations of e-cigarette manufacturers and distributors and identify those that trigger drug-medical device requirements. These representations can be found on the labeling, packaging, advertising, and all printed promotional materials; television, internet, radio, and other communications; and statements in public documents, including patents and SEC filings.
  2. Examine the actual consumer use of e-cigarette products to support enforcement based on drug-device requirements because of the widespread intended use of the products for smoking cessation or reduction.
  3. Utilize the “new tobacco product” and “modified risk tobacco product” provisions contained in the TCA to implement heightened requirements for e-cigarettes.
  4. Provide clarity on the application of universal tobacco product requirements contained within the TCA and FDA regulations regarding manufacturer registration, disclosure to FDA of ingredients, and manufacturing practice requirements.
  5. Promulgate e-cigarette regulations and issue guidance documents for standardization, reporting, and labeling, including:
    1. Product standards
    2. Good manufacturing practices and quality control mechanisms
    3. Uniform labeling and listing of ingredients on the label Prominent and uniform display of nicotine levels
  6. Congressional amendment of the TCA to include e-cigarettes in the flavor additive ban, advertising and marketing restrictions, and other provisions to protect adolescents and youth.
  7. Proactive assessment by states and localities of the scope of laws covering access to tobacco products and public smoking bans. Many are drafted in a manner that does not encompass e-cigarettes and “vaping”; states and localities should determine whether they should amend them to include e-cigarettes.

The paper, “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” may be found here on SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2118802

The Seton Hall Law Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues that emerge within pharmaceutical and health law. Additionally, the Center is a leader in providing compliance training on the wide-ranging state, national and international mandates that apply to the safety, promotion and sale of drugs and devices. Seton Hall University School of Law, New Jersey's only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching with a strong focus on experiential learning. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.