FDA Proposes Rule to Regulate E-Cigarettes

As an addition to the Family Smoking Prevention and Tobacco Control Act signed by President Obama in 2009, the Food and Drug Administration (FDA) has proposed a new rule that would extend the agency’s tobacco-regulating authority to cover additional tobacco-related products, including electronic cigarettes (e-cigarettes), which over the last several years have grown enormously in popularity.

“The tobacco-product marketplace is evolving at a dizzying pace, with many unanswered questions about the health effects of novel products,” noted FDA Commissioner Margaret Hamburg, M.D., in the blog FDA Voice.

Hamburg stated that in the midst of the “alarming” rise in the number of youth using unregulated products such as e-cigarettes (Psychiatric News, April 15), “it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction.”

Products that are subject to FDA regulation are those that meet the statutory definition of a tobacco product, including e-cigarettes as well as cigars, pipe tobacco, nicotine gels, and waterpipe (hookah) tobacco.

The new proposal, consistent with current regulations governing tobacco products, requires makers of the unregulated products to

In addition, under the new proposal, minimum age and identification restrictions will be implemented to prevent sales to underage youth, as will requirements for health warning labels. Also included is a prohibition against vending-machine sales of the products in facilities that admit youth.

Hamburg predicted that the proposed rule will help to correct misperceptions by consumers that the unregulated tobacco products are safe alternatives to regulated, more traditional tobacco products.

In 2009, after a laboratory analysis of two leading brands of e-cigarette samples, the FDA released a statement reporting that e-cigarettes contained toxic chemicals such as diethylene glycol—an ingredient used in antifreeze—and carcinogens such as nitrosamines, exposure to which can pose a threat to humans.

Moreover, the Centers for Disease Control and Prevention announced that calls related to poisoning from the liquid nicotine used in the electronic devices were being reported at a rate of one per month in 2010, but jumped to 215 in February alone. Of those poisoning calls, 51 percent involved children aged 5 and younger, while 42 percent involved people aged 20 and older.

“This is a very important step by the FDA to extend its authority and oversight of these currently unregulated tobacco and nicotine-delivery products,” said Douglas Ziedonis, M.D., M.P.H., a substance abuse expert and chair of the Department of Psychiatry at the University of Massachusetts Medical School, in an interview with Psychiatric News. “There is so much unknown about the short- and long-term consequences of the use of these products. . . . The public and health care providers would benefit from knowing what’s in these [new] products and from the FDA reviewing product claims.”

While Ziedonis praised the efforts of the FDA to extend tobacco regulation to additional nicotine and tobacco products, he emphasized as well that it is time for the academic community to devote more research efforts toward studying unregulated tobacco products—especially e-cigarettes, which are steadily gaining popularity among youth.

The FDA has made the proposed rule available for public comment until July 8. ■

The FDA announcement regarding the new proposed rule is posted here.