FDA Misses Deadline for E-Cig Regulations

Following up on our post from last Thursday, the Food and Drug Administration (FDA) has announced that it will not meet its midnight deadline to submit proposed tobacco regulations.  The FDA will also miss deadlines to publish a consumer-friendly list of dangerous chemicals found in electronic cigarettes (e-cigarettes or e-cigs) and testing / reporting requirements for tobacco ingredients and additives.  Unfortunately, the FDA is not required to abide by the deadlines that it sets for itself, nor is it assessed any penalty for missing such deadlines.

Current E-Cig Regulations

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Notwithstanding the foregoing, based on this morning’s press release, the proposed regulations, which will likely target the e-cig industry, are near completion and can be expected for public comment and scrutiny in the near future.

To recap another recent post, the following statements from the FDA’s website 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-Cigarette Regulations Are Imminent

The fact that the proposed e-cigarette regulations were not handed down today should not be interpreted as the FDA backing down from regulating the industry, as it did in 2010.  Given the 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 online or digital marketing in general.

If you are interested in learning more about this topic or pursuing a venture in this area, please e-mail us at info@kleinmoynihan.com, or call us at (212) 246-0900.

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David Klein

David Klein is one of the most recognized attorneys in the technology, Internet marketing, sweepstakes, and telecommunications fields. Skilled at counseling clients on a broad range of technology-related matters, David Klein has substantial experience in negotiating and drafting complex licensing, marketing and Internet agreements.

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