FDA Exercises Its Authority to Regulate Tobacco Products

The U.S. Food and Drug Administration (FDA) gave the go-ahead for the sale of two new cigarettes—both nonmenthol versions of Newport cigarettes, from Lorillard Tobacco Company—in late June.

This was the agency's first such decision since it received authority to regulate certain tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the law, tobacco companies can legally sell a new product by proving that the product is no more detrimental to public health than other products currently on the market.

“But what a conundrum, since we know that there's no safe level for any of these products,” says Roy Herbst, MD, PhD, chief of medical oncology at Yale Comprehensive Cancer Center in New Haven, CT, and chair of the American Association for Cancer Research's Tobacco and Cancer Subcommittee. “The whole premise for the FDA's authorization starts on such a slippery slope.”

However, Mitch Zeller, JD, director of the FDA's Center for Tobacco Products (CTP), stresses that the recent authorizations do not mean the agency has approved the products (as it does for drugs and devices) or that it considers them safe.

Why the long gap between the law's passage and the first authorization? The review process has been a learning curve for both manufacturers and the agency, says Zeller. He adds that of the thousands of submitted applications, nearly all lacked sufficient information for the FDA to render a decision.

The FDA's attainment of some regulatory power is progress, concedes Benjamin Toll, PhD, an associate professor of psychiatry and program director of the Smoking Cessation Service at Yale Comprehensive Cancer Center. “But I don't think this change will affect smoking or cancer rates,” he adds.

One change that could affect smoking rates is the FDA's intention to regulate electronic cigarettes, battery-operated products that turn nicotine into a vapor inhaled by the user.

Currently, the FDA's regulatory authority through the CTP applies only to cigarettes, cigarette tobacco, roll-your-own, and smokeless tobacco. E-cigarettes were not included in the 2009 legislation because they weren't considered tobacco products. But in 2010, the U.S. Court of Appeals for the DC Circuit ruled that e-cigarettes should be regulated by the FDA because they contain nicotine derived from tobacco. The agency tentatively plans to issue proposed regulations in October that would cover e-cigarettes and other novel tobacco products, says FDA spokesperson Jennifer Haliski.

Some former smokers claim that e-cigarettes helped them quit using tobacco. However, e-cigarettes haven't been marketed for therapeutic purposes, such as smoking cessation, because doing so would subject them to FDA approval. That would require clinical trials comparing e-cigarettes to currently approved smoking-cessation products, and no such trials have been done, explains Toll.

E-cigarettes provide “a way to get your nicotine high without really smoking,” says Herbst. “But no one knows what the long-term consequences of that practice are.”

It's also unclear whether e-cigarettes might help smokers quit smoking or, conversely, encourage young people to try other tobacco products. “We clearly need more research and FDA guidance on how e-cigarettes are formulated and used,” says Herbst.