FDA Releases Final Regulation Extending Authority Over E-Cigarettes, Other Tobacco Products

More than two years after the U.S. Food and Drug Administration (FDA) proposed a rule to extend its authority to cover unregulated tobacco products, including e-cigarettes, the Agency has released a final regulation. Under the Final Tobacco "Deeming" Rule, an extension of the Family Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), the FDA now has control over all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, and will ban sales of these products to anyone under 18 years of age. The FDA will also "evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users" for all products in these categories commercially marketed after Feb. 15, 2007.

"Marketing tobacco products, especially e-cigarettes, to children would slow the progress we’ve made in reducing heart disease brought about by the decline of smoking in the U.S.," said ACC President-Elect Mary Norine Walsh, MD, FACC. "The FDA's decision to restrict the sale of all tobacco products is a significant step forward."

According to the Agency, smoking, which is responsible for 480,000 deaths each year, is the number one cause of preventable disease and death in the U.S. Under the Tobacco Control Act, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco were automatically "deemed" subject to FDA authority. Until now, there was no federal oversight of the manufacture, distribution or marketing of e-cigarettes, cigars and other tobacco products, and no restrictions in place to protect public health against the risks of these products. "The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks," said the FDA in a statement.

"As a physician, I’ve seen first-hand the devastating health effects of tobacco use," said FDA Commissioner Robert M. Califf, MD, MACC. "At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review."

In April 2015, the ACC joined numerous health care organizations [PDF] to urge President Barack Obama to take action and finalize the regulation. The College submitted comments [PDF] to the FDA on its proposed rule in August 2014.

ACC Advocacy is reviewing the final regulation and will work with the College’s coalition partners to address any deficiencies.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Prevention, CHD & Pediatrics and Prevention, Smoking

Keywords: Adolescent, Electronic Cigarettes, Public Health, Smoking, Tobacco, Tobacco Use, Tobacco Products, Tobacco, Smokeless, United States Food and Drug Administration

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