FDA Proposes to Extend Authority to Cover E-Cigarettes and Additional Tobacco Products

The U.S. Food and Drug Administration (FDA) has proposed a new rule that would extend its authority to cover electronic cigarettes (e-cigarettes) and additional tobacco products, according to an announcement made April 24.

The extension is part of the Family Smoking Prevention and Tobacco Control Act passed in 2009, which granted the FDA authority to regulate tobacco products, such as cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. It also restricted tobacco marketing and sales to youth; required detailed disclosure of ingredients; allowed the FDA to require changes to tobacco products; and required larger, more specific health warnings.

According to the announcement, the additional tobacco products that would be "deemed" to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA's authority.

Further, under the proposed rule, makers of newly "deemed" tobacco products would, among other requirements: only market new tobacco products after FDA review; only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and not distribute free samples.

In addition, under the proposed rule, the following provisions would apply to newly "deemed" tobacco products: minimum age and identification restrictions to prevent sales to underage youth; requirements to include health warnings; and prohibition of vending machine sales, unless in a facility that never admits youth.

"Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products," said FDA Commissioner Margaret A. Hamburg, MD. "Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."

"Restricting the sale of harmful substances and limiting the tobacco industry's marketing tactics reflects an understanding of just how harmful all types of tobacco products are to the human body," commented ACC president Patrick T. O'Gara, MD, FACC. "As we all know, tobacco use remains the leading preventable cause of heart disease, disability and death in the United States. We congratulate the FDA on taking this first step to protect the public health through the policies proposed in this regulation. We look forward to working with the FDA and our partners in the medical and public health communities to strengthen the proposed regulations as needed and complete this important work."

The College intends to submit a public comment in support of this proposed rule.

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

Keywords: Adolescent, Cause of Death, Cost of Illness, Heart Diseases, Marketing, Nicotine, Public Health, Risk Reduction Behavior, Tobacco Industry, Tobacco Use Disorder, Tobacco, Smokeless, United States Food and Drug Administration


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