Federal Court Deals Blow to Public Health in Ruling FDA Cannot Regulate E-Cigarettes As Drugs or Medical Devices

Washington, D.C. — In ruling today that the U.S. Food and Drug Administration may not regulate electronic cigarettes as drugs or medical devices, U.S. District Judge Richard Leon has ignored decades of precedent and put America's consumers at unnecessary risk. If upheld, Judge Leon’s decision opens a gaping loophole in the protection FDA has provided against the sale and distribution of non-tobacco products that a manufacturer laces with unregulated quantities of nicotine. For years, the FDA has stringently regulated all products containing nicotine when sold to consumers in any form other than a traditional tobacco product because of nicotine's dangerous and addictive impact.

Judge Leon's decision also ignores the common sense distinction that FDA has long drawn between traditional tobacco products that contain nicotine, such as cigarettes, smokeless tobacco, cigars and pipes, and a host of non-tobacco products, ranging from toothpaste to lollipops to water, in which manufacturers have added nicotine, a highly addictive substance.

We urge the government to appeal this ruling in order to protect public health. It is important to note that even if today's ruling is upheld, this ruling leaves open the possibility that the FDA can regulate electronic cigarettes under the new law granting the agency the power to regulate tobacco products. Like other consumer products, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.

Judge Leon's decision came in response to a lawsuit filed by two e-cigarette manufacturers that challenged the FDA's jurisdiction over these products and the agency's attempt to prohibit their importation under the Federal Food, Drug and Cosmetic Act. Electronic cigarettes have not been tested for safety or approved by any government agency for sale in the United States, yet manufacturers have been marketing and selling these products in stores and shopping mall kiosks throughout the U.S., as well as on the Internet.

Electronic cigarettes, which are manufactured primarily in China, pose several serious potential risks to public health. First, there is no credible scientific evidence that these products are safe for human consumption or that they are effective at helping smokers or other tobacco users quit, as some manufacturers have claimed. In contrast to tobacco cessation products that have been approved by the FDA, there are no controls on the amount or potency of the nicotine or other substances in electronic cigarettes. Last year, the FDA announced that a laboratory analysis of electronic cigarette samples found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze

Second, these products risk deterring current smokers from quitting by providing an alternative source of nicotine in places where smoking is not allowed. They also provide an unproven and unapproved alternative to smoking cessation therapies that have been approved by the FDA as safe and effective. Smokers concerned about their health should utilize approved smoking cessation medications and counseling rather than unapproved products. As the World Health Organization has concluded, until electronic cigarette manufacturers have conducted the necessary scientific studies and gone through the appropriate regulatory process, 'WHO does not consider it to be a legitimate therapy for smokers trying to quit.'

Third, these products could serve as a pathway to nicotine addiction for children, leading them to smoke cigarettes and use other tobacco products. Electronic cigarettes have been marketed in youth-friendly candy and fruit flavors including bubblegum, cookies and cream, and cola. These products are also readily accessible to youth because they are widely sold in shopping malls and over the Internet and, because they are not traditional tobacco products, they are not subject to age verification laws.