E-cigarettes may soon be regulated by FDA

May 5, 2014

The sale of electronic or e-cigarettes may soon be regulated by FDA. Last week the agency proposed a new rule that would extend its authority to cover additional tobacco products, including e-cigarettes.

The sale of electronic or e-cigarettes may soon be regulated by FDA. Last week the agency proposed a new rule that would extend its authority to cover additional tobacco products, including e-cigarettes.

The proposal would ban the sale of e-cigarettes to minors, and require health-warning labels on the product. Vending machine sales also would be prohibited, unless they are located in a facility that never admits persons under the age of 18 years.

In addition, the proposed regulation would require manufacturers to register with FDA and disclose the ingredients of their product to the agency.

Under the Family Smoking Prevention and Tobacco Control Act, which was signed into law in 2009, FDA was given the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The proposed rule would extend their reach to cover additional items that meet the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables, as well as future tobacco products.

“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of FDA’s Center for Tobacco Products, in a press release. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”

Technically, e-cigarettes are not actually a tobacco product as they do not contain tobacco. Instead, they are designed to deliver nicotine or other substances to a user in the form of a vapor. According to FDA, these products have not been fully studied, so the potential risks and benefits are unknown. But once the proposal is enacted, FDA will be able to regulate their use.

The proposed rule will be available for public comment for 75 days, until July 9, and the agency seeks comment in this proposed rule as to how these products should be regulated.