FDA Will Regulate E-Cigarettes, Other Tobacco Products

April 25, 2014
Rachel Lutz

Among other tobacco products, e-cigarettes, cigars, nicotine gels, and hookah tobacco will be regulated by the US Food and Drug Administration, the agency announced Thursday.

The US Food and Drug Administration (FDA) has announced plans to increase regulation over tobacco products, including electronic cigarettes, or e-cigarettes, in part due to the introduction of President Barack Obama’s 2009 Family Smoking Prevention and Tobacco Control Act.

Previously, the FDA had authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but the Tobacco Control Act extends the agency’s authority to regulate any product that meets the statutory definition of tobacco products, including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe or hookah tobacco, and dissolvables not already under the FDA’s control.

Additional regulations will apply to tobacco products newly placed under the federal parameters, such as:

  • Minimum age and identification restrictions to prevent underage sales
  • Health warning requirements
  • Prohibiting sale through vending machines, unless in a facility that never admits youth

Makers of these products will also be required to adhere to the FDA’s existing rules surrounding tobacco products, including:

  • Register with the FDA
  • Report product and ingredient listings
  • Only market new products after FDA review
  • Only make direct and implied claims of reduced risk if facts have been substantiated by the FDA
  • Not distribute free samples

“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said 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.”

The FDA’s proposition will be open for public comment for 75 days, and the agency is specifically requesting comments from certain areas, including cigar coverage and e-cigarette regulation, although comments, data, research, and other information will also be considered.

Therapeutic products will continue to be regulated as medical products under the Food, Drug, & Cosmetic Act, the FDA noted in a statement.

Kathleen Sebelius, Department of Health and Human Services Secretary, called this move the latest step in the FDA’s efforts to make the next generation tobacco-free.