FDA proposes rule to include e-cigarettes under its tobacco authority

By Kate Bass, B.Sc.Apr 25 2014

The U.S. Food and Drug Administration (FDA) has recently proposed a new rule to regulate additional tobacco products as part of its implementation of the 2009 Family Smoking Prevention and Tobacco Control Act.

Kathleen Sebelius, Secretary of the U.S Department of Health & Human Services says "This proposed rule is the latest step in our efforts to make the next generation tobacco-free,"

The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Under the new rule additional, currently unregulated, tobacco products, including electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, and waterpipe (or hookah) tobacco, would be subject to FDA regulation. This means that the manufacturers of these products would have to meet a range of requirements, such as:

• Register with the FDA and report product and ingredient listings
• 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
• Not distribute free samples.

In addition, the newly included tobacco products would have to meet minimum age and identification restrictions, have health warnings included on their packaging, and be prohibited from vending machine sales (unless in a facility that never admits youth).

FDA Commissioner Margaret Hamburg commented “Tobacco remains the leading cause of death and disease in this country...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.”

Mitch Zeller, director of the FDA Center for Tobacco Products, explained “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 proposed rule will be available for public comment for 75 days. In particular, since different tobacco products may have varying effects on public health, the FDA is requesting feedback in certain areas, including whether the ruling would apply to all kinds of cigars and how e-cigarettes should be regulated.

Should the rule be passed, the FDA will allow all newly regulated businesses adequate time to comply with the requirements. Products that are marketed for therapeutic purposes will continue to be regulated as medical products.