Lawrence is the Chair for Obermayer’s Health Care Law Department and Election Law Practice Group. Lawrence’s Health Care Law legal experience includes the representation of physician group practices (single and multi-specialty), hospitals,...Read More by Author
Where There’s Smoke, There’s Proposed Regulation: FDA Seeks to Bring E-Cigarettes Within Its Regulatory Authority
On April 24, 2014, the Food and Drug Administration (“FDA”) released a proposed rule (the “Proposed Rule”) that will expand its authority to regulate items like electronic cigarettes (“e-cigarettes”). The Proposed Rule essentially makes currently unregulated tobacco products subject to FDA regulation under the Federal Food, Drug and Cosmetic Act. In other words, the FDA will “deem” subject to FDA oversight e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah tobacco, and other dissolvable products that meet the definition of a tobacco product.
Under the Proposed Rule, makers of these tobacco products that are deemed to be subject to FDA oversight will be required to report to the FDA and also only market products after FDA review, among other provisions. In addition, the Proposed Rule will implement a minimum age of 18 for purchasing these tobacco products and will require such products to carry health warning labels.
This governmental action comes at a time when some private employers are considering and implementing new policies to curtail employees’ use of tobacco products. Thomas Jefferson University (“Jefferson”) in Philadelphia, for example, has moved to a smoke-free campus policy, which includes prohibiting the use of tobacco products, like cigarettes, e-cigarettes, cigars, pipes, and hookahs, anywhere on its campus. Moreover, beginning July 1, 2014, job applicants at Jefferson will need to attest to the fact that they are non-smokers as part of Jefferson’s nicotine-free hiring policy, according to a Jefferson FAQ. Other notable Philadelphia employers have also implemented such policies, like the University of Pennsylvania Health System, which stopped hiring tobacco users in July of 2013.
The Proposed Rule is subject to a public comment period before it will be published in its final form. Mitch Zeller, the director of the Center for Tobacco Products, stated that, “The proposed rule would give the FDA additional tools to protect public health in today’s rapidly evolving tobacco marketplace.”
To read the FDA press release, click here.
To read the Proposed Rule, click here.