Rules Proposed for Unregulated Tobacco

The FDA has proposed wide-reaching new rules that, if finalized, would ban the sale of e-cigarettes, pipe tobacco, cigars, and other tobacco products to minors. The regulations would also prohibit e-cigarette manufacturers from making claims about health benefits without first presenting supporting scientific evidence.

The measure marks the first time the agency has attempted to regulate e-cigarettes, a multibillion-dollar industry. The products' popularity has grown rapidly in recent years, even among minors. According to data from the Centers for Disease Control and Prevention, the number of middle and high school students who have tried e-cigarettes doubled between 2011 and 2012.

“We're certainly pleased that the FDA is doing this. We've been waiting on this for a long time,” says Lauren Dutra, PhD, an epidemiologist at the Center for Tobacco Control Research and Education at the University of California, San Francisco.

Dutra notes that the new laws would require manufacturers to print warnings about health consequences on the packaging for cigars and loose tobacco used for rolling cigarettes, a regulation applauded by tobacco-control advocates. E-cigarettes will not have to carry such warnings, as little solid evidence exists that they are harmful. However, they may be required to carry warnings about the addictiveness of nicotine.

Even so, Dutra and other tobacco researchers say the proposed measures don't go far enough—and should have been passed years earlier.

“The action that the FDA took is long overdue,” says Dennis Henigan, JD, director of legal and policy analysis at the Campaign for Tobacco-Free Kids in Washington, DC. He notes that the FDA has had the authority to regulate tobacco products since 2009, when Congress passed the Family Smoking Prevention and Tobacco Control Act.

The 2009 act prohibited the use of flavors other than menthol in conventional cigarettes, but the proposed regulations will not extend that ban to e-cigarettes. E-cigarettes are often made with candy or fruit flavors, including mint, chocolate, cherry, and grape. Those flavors make tobacco products especially appealing to minors, say critics, just as they did with cigarettes in the past.

“There's substantial documentation that the industry intentionally flavored cigarettes to attract kids,” says Henigan.

Mitchell Zeller, JD, director of the FDA's Center for Tobacco Products, says that by regulating e-cigarettes and other products, “the FDA, as the science-based, independent gatekeeper, is by law standing between the companies and the users.”

The goal of regulation, Zeller says, is “to reduce the overall disease toll from tobacco use,” and he calls the proposed rules a “critical and essential foundational step.”

The FDA has the authority to ban flavoring or other ingredients for health reasons, Zeller says, if “we have the science to back it up.” Banning flavor would require a separate legal process which, he notes, can only begin once the FDA has jurisdiction over e-cigarettes, as outlined in the proposed rules.

The regulations are outlined in a “deeming” document released in April, available at www.federalregister.gov.

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