New FDA Regulations on E-Cigarettes Set to Take Effect

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On May 3, 2016, the Food and Drug Administration expanded their reach to include the regulation of, among others, e-cigarettes and hookah tobacco.  The FDA regulates “tobacco products,” defined to be any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product, including, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.  Until now, e-cigarettes were not considered a part of that definition.

According to the FDA, it will be able to review new e-cigarettes not yet on the market, help prevent misleading claims by e-cigarette manufacturers, evaluate the ingredients of the majority of e-cigarettes and how they are made and make mandatory warning labels on products.  This also means that e-cigarettes cannot be sold to minors, cannot be given away as free sampling and must meet federal warning label requirements.  In addition, all e-cigarettes that were not on the market prior to February 15, 2007, must either show the product is substantially equivalent to something on the market on or before February 15, 2007, or go through an approval process.

While the new rules go into effect on August 8, 2016, litigation over this new rule is already ongoing.  Nicopure Labs LLC filed a lawsuit in the Federal District Court of Washington, D.C. a week after the FDA’s announcement challenging the new rules (1:16-cv-0088-ABJ).  Assuming, the new rules survive  any legal challenges, one possible impact is that e-cigarette manufactures who comply with the new regulations may try to use their compliance as a defense to any lawsuits against it.  What seems certain is that the new rules will have an impact on litigation against e-cigarette manufactures, the extent of which will be seen over the next couple of years.


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