FDA Acts to Protect Public Health from Electronic Cigarettes

Washington, D.C. — The U.S. Food and Drug Administration has acted to protect public health from so-called electronic cigarettes by seeking to block importation of these products and, during a press briefing today, informing the public about the potential health risks of these products. The FDA announced today 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. We look forward to the FDA taking additional action to stop the marketing and sale of these unapproved products.

The FDA appropriately has asserted the authority to regulate these products, which deliver the powerfully addictive drug nicotine, as combination drug-device products under the Federal Food, Drug and Cosmetic Act. Electronic cigarettes have not been tested for safety or approved by the FDA 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. Manufacturers have refused to submit these products to the FDA for regulatory review and in fact have filed a lawsuit challenging the FDA’s authority over their products. Some have gone so far as to claim that electronic cigarettes should not be subject to any regulation to protect public health. We disagree.

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 to satisfy their addiction. 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.

No one is suggesting that these products should never be allowed on the market; rather, like other consumer products, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.