New FDA Regulations Coming Soon for E-Cigarettes?


While electronic cigarettes, or E-cigarettes, have been available for almost a decade, the industry has faced little marketing, labeling or other regulations.  According to a Food and Drug Administration (FDA) spokesperson, that may change in April.

In September 2009, the FDA conducted a study of the health effects associated with E-cigarettes and based on its findings, banned E-cigarette imports on the grounds that they were unregulated medical devices.  Amid backlash from the E-cigarette industry, the FDA was forced by a federal court to reverse the import restrictions and regulate the devices as tobacco products.  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 explicitly marketed as a tobacco alternative product, then they’re not required to face the same regulations as nicotine patches or gum.  Likewise, some E-cigarettes are advertised to contain 0 milligrams of nicotine and thereby avoid regulations targeted at tobacco and tobacco alternative products.

In the past several months, E-cigarettes have again come under fire for needing more regulation by the FDA, due to a documented increase in the number of users.  A study by the Center for Disease Control has found that about 21 percent of adults who smoke tobacco have also used E-cigarettes.  On the heels of the CDC study, several organizations, including the American Cancer Society Cancer Action Network, have called for tighter FDA regulations.

In response, the FDA spokesperson has indicated that the agency wants to place E-cigarettes in a new subcategory of tobacco products, which will allow the FDA to apply new regulatory rules. The FDA may issue a new proposal for public commentary as soon as April of this year.

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, 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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