Article

FDA Will Regulate E-Cigarettes, Other Tobacco Products

Author(s):

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.

Related Videos
Yehuda Handelsman, MD: Insulin Resistance in Cardiometabolic Disease and DCRM 2.0 | Image Credit: TMIOA
Nathan D. Wong, MD, PhD: Growing Role of Lp(a) in Cardiovascular Risk Assessment | Image Credit: UC Irvine
Laurence Sperling, MD: Expanding Cardiologists' Role in Obesity Management  | Image Credit: Emory University
Laurence Sperling, MD: Multidisciplinary Strategies to Combat Obesity Epidemic | Image Credit: Emory University
Matthew J. Budoff, MD: Examining the Interplay of Coronary Calcium and Osteoporosis | Image Credit: Lundquist Institute
Orly Vardeny, PharmD: Finerenone for Heart Failure with EF >40% in FINEARTS-HF | Image Credit: JACC Journals
Matthew J. Budoff, MD: Impact of Obesity on Cardiometabolic Health in T1D | Image Credit: The Lundquist Institute
Matthew Weir, MD: Prioritizing Cardiovascular Risk in Chronic Kidney Disease | Image Credit: University of Maryland
Erin Michos, MD: HFpEF in Women and Sex-Specific Therapeutic Approaches | Image Credit: Johns Hopkins
© 2024 MJH Life Sciences

All rights reserved.