In April, the Food and Drug Administration (FDA) missed its deadline to submit proposed tobacco and e-cigarette regulations. The FDA has now set a new deadline of October 31st to release the promised e-cig regulations. In an effort to ensure that the new deadline is met, Attorneys General from 40 states have jointly submitted a letter urging the FDA to regulate electronic cigarettes in the same way that it regulates tobacco products. However, it is unclear whether the recent federal government shutdown will have an impact on the FDA’s ability to reach its October 31st goal.
Current E-Cig Regulations
To recap another recent post, the following statements from the FDA provide us with insight as to the FDA’s opinion regarding the highly unregulated e-cigarette industry:
- As the safety and efficacy of e-cigs have not been fully studied, consumers of e-cigarette products currently have no way of knowing whether e-cigarettes are safe for their intended use, how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there are any benefits associated with using these products.
- Currently, e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research (CDER). The FDA Center for Tobacco Products (CTP) . . . intends to regulate other nicotine-containing products, including electronic cigarette products that do not make a therapeutic claim, in the future.
FDA E-Cig Regulations Are Imminent
While electronic cigarettes, have been available for almost a decade, the industry has faced little marketing, labeling or other regulations. In September 2009, the FDA banned e-cigarette imports on the grounds that they were unregulated medical devices. Amid backlash from the e-cigarette industry, the FDA was found to have exceeded its authority and forced by a federal court to reverse the import restrictions and find another way to regulate the devices. Since the court’s ruling, the FDA has faced problems regulating the e-cigarette industry mainly due to the difficulty in classifying the product. For example, if e-cigarettes are not marketed as therapeutic products, such as for help quitting smoking, the FDA does not currently have the power to regulate them, leading to several undesirable results addressed by the Attorneys General letter. The most pressing need for regulations addressed by the Attorneys General letter are the ease with which e-cigarettes can be sold to minors. Furthermore, unlike traditional tobacco products, there are no federal advertising restrictions on e-cigarettes, resulting in major advertising campaigns across the country that mimic, in many ways, cigarette advertising from years past.
A study by the Center for Disease Control has found that the advertising campaigns are working, indicating that 21% of adults who smoke tobacco have also used e-cigarettes. Given the exponential growth of the e-cigarette consumer base and the amount of pressure the FDA is receiving from state legislatures demanding regulation, e-cigarette regulations are imminent and those engaged in the industry should prepare for dramatic changes in the way they conduct their operations.
The development of the FDA’s new e-cigarette regulations should be of interest to anyone involved in the e-cigarette industry and those interested in product marketing in general. If you are interested in learning more about this topic or pursuing a venture in this area, please e-mail us atinfo@kleinmoynihan.com, or call us at (212) 246-0900.
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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