FDA Will Regulate E-Cigarettes As Tobacco Products

On Monday the Food and Drug Administration said it will not challenge a federal appeals court ruling that prevents it from banning electronic cigarettes as unapproved pharmaceutical products. In December a panel of the U.S. Court of Appeals for the D.C. Circuit agreed with U.S. District Judge Richard Leon that e-cigarettes are properly regulated as tobacco products, since the nicotine in the vapor they produce is derived from tobacco. The FDA unsuccessfully sought review of that decision by the full court, and now it says it is ready to comply rather than appeal to the Supreme Court. In a "stakeholder" letter dated April 25 (the deadline for appealing the D.C. Circuit's ruling), the FDA says e-cigarettes will be "subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for 'new tobacco products' and 'modified risk tobacco products.'"

Although it should be easier for e-cigarettes to stay on the market as tobacco products than as "drug/device combination products," the practical implications of the FDA's new policy are not completely clear. Under the Family Smoking Prevention and Tobacco Control Act, which Congress enacted in 2009, tobacco products that were on the market in the U.S. prior to February 15, 2007, are grandfathered and cannot be banned by the FDA. That provision also covers "substantially equivalent" products. Judging from a Nexis search, e-cigarettes were first sold to Americans in 2007, but there are no references to them as a product available in the United States as early as February of that year. Assuming e-cigarettes don't qualify for the grandfather clause, they would have to be approved by the FDA as "new tobacco products" or as "modified risk tobacco products." In either case, the FDA has substantial leeway to bar their sale.

The FDA can approve a "new tobacco product" only if it determines that doing so "would be appropriate for the protection of the public health." It is supposed to make that determination "with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

A "modified risk tobacco product"—one that is "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products"—has to meet the same standard. The FDA also has to decide, based on evidence presented by the manufacturer, whether the product would "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users." But the latter determination is not decisive, since a product could be safer (as e-cigarettes clearly are) but still be deemed bad for public health based on predictions of how consumers will respond to it. If, for example, a new cigarette is half as hazardous as existing cigarettes but the FDA thinks that fact will encourage every American to start smoking, it might decide that the net result of allowing the product on the market will be more smoking-related disease, even though the risk for any given smoker is a lot lower. Given the enormous difference between the health hazards posed by conventional cigarettes and the health hazards posed by e-cigarettes, which deliver nicotine without tobacco or combustion products, it is exceedingly hard to argue that e-cigarettes fail this collectivist calculus. But that does not mean the FDA won't try.

More on e-cigarettes here.

[Thanks to Russell Wishtart for the tip.]