Amidst New York City, Chicago and Los Angeles implementing citywide indoor bans on e-cigs, the Food and Drug Administration (FDA) released its proposed e-cig regulations last week, more than a year after their originally scheduled release date. In this post, we will provide a broad summary of the much-anticipated e-cig regulations.
New E-Cig Regulations
Currently, under the Federal Food, Drug and Cosmetic Act and Tobacco Control Act, respectively, the FDA has the ability to regulate activities involving “tobacco products.” In September 2009, the FDA conducted a study of the health effects associated with e-cigs and, based on its findings, banned e-cig imports on the grounds that they were unregulated medical devices. However, in December 2010 and amid backlash from the e-cig industry, a federal court of appeals deemed that e-cigs did not come within the definition of tobacco products that may be regulated by the FDA. Under the FDA’s proposed regulations, the definition of “tobacco products” has been expanded to include “dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.” Learning from its past mistakes, the FDA has also included a provision in its proposed regulations that would allow it to regulate future tobacco products that have yet to be invented.
By far the most important aspect of the proposed regulations involves the e-cig registration and approval process. As we previously predicted, the FDA will require that e-cig manufacturers provide the agency with a detailed description of its manufacturing processes and ingredient lists, substantiated with verifiable scientific data. E-cig manufacturing facilities will also be subject to FDA inspections. The good news for e-cig manufacturers is that the FDA will not require substantial equivalence determinations for e-cig products that are currently on the market. To recap an earlier post, the implementation of a substantive equivalence determination would essentially require e-cig companies to remove their products from the market until they demonstrate that they are in compliance with FDA regulations and are substantially equivalent to the other approved products that contain nicotine. There was initially a fear that the FDA would require all e-cig companies that began operating after 2007 to have their products submit to a substantive equivalence determination. Instead, the FDA has decided to allow existing e-cig products to remain on the shelves, so long as e-cig manufacturers apply for FDA approval within two (2) years of the final regulations being enacted. Furthermore, the proposed regulations would allow for new e-cig products to enter the market for the next two (2) years without pre-approval from the FDA.
The draft regulations also propose to establish a nationwide minimum age requirement in order to purchase and use e-cigs. If the draft regulations are passed, no one under the age of 18 will be able to legally purchase e-cigs. Please note that the same age standard would also apply to tobacco accessories, such as filters, rolling papers, tobacco flavorings, hookah coals, etc.
What Is Not Addressed under the Proposed E-Cig Regulations?
While the draft regulations address a number of important aspects of the e-cig industry, the regulations fail to address marketing limitations or restrictions on the availability of flavored e-cigs. However, it is important to remember that if e-cigs are marketed as therapeutic or tobacco alternative products, they must abide by the current marketing regulations enforced by the FDA Center for Drug Evaluation and Research, which govern the marketing practices of nicotine patches and gums.
It should be noted that the announcement of proposed regulations does not necessarily mean that such regulations will be immediately passed into law, without modification. There will be a lengthy public comment period before the final draft of the bill is presented to Congress for a vote. In light of the foregoing, it is a best practice to plan a course of action early and retain experienced counsel to help navigate the murky regulatory climate.
The development of the FDA’s new e-cigarette regulations should be of interest to anyone involved in the e-cigarette industry.
The material contained herein is provided for informational purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney. Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.
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