In previous issues we wrote about the U.S. Food and Drug Administration’s (FDA) regulation of electronic cigarettes promulgated in 2016 that finalized a “deeming rule” that extended the FDAs authority to all tobacco products, including e-cigarettes. The regulations involved several restrictions aimed at preventing youth access. The rule also required manufacturers of all newly regulated products to show that the products met the applicable public health standard set forth in the law and received marketing authorization from the FDA. Certain aspects of the rule were set to become effective on Aug. 8, 2016. However, in May 2017, the U.S. Department of Justice (DOJ) delayed enforcement of the new rule.
As a result of the delay, e-cigarette manufacturers do not have to submit their plans for placing addictiveness warnings on their products. Moreover, e-cigarette manufactures currently do not need to submit ingredient information contained in their e-cigarettes by August 2017, which otherwise would have been required pursuant to the new rule. In addition, the Department of Justice’s move to delay FDA enforcement of e-cigarettes also stops the ban on e-cigarette interstate commerce, including the labeling to identify the types of e-cigarettes for consumer.
Opponents of the new rule cite to the rule’s negative impact on e-cigarette companies. For example, two major e-cigarette companies, NJOY and Electronic Cigarettes International Group Ltd., have gone bankrupt since the rule became effective. Opponents also argue that the new rule requires the companies to perform additional costly user research. On the other hand, supporters of the new rule cite the rapid rise in e-cigarette consumption by youths. Particularly, from 2011 to 2014, the use of e-cigarettes among teens rose from 1.5 to 13.4 percent.
The FDA and the U.S. Department of Health and Human Services have considerable discretion when implementing tobacco policy reform. The future of the FDA’s regulation of e-cigarettes is uncertain, but it seems that e-cigarettes may no longer be classified as tobacco products.
If you need more information on this subject, contact Will Sutton, a lawyer in our firm’s Toxic Tort Section, at 800-898-2034 or email Will.Sutton@beasleyallen.com.
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