FDA Likely to Start Regulating E-Cigarettes

Electronic cigarettes included in FDA proposal for tobacco product regulation expansion

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) E-cigarettes have been getting plenty of attention lately, and the debate surrounding them has grown. Now rules governing the products may become stricter.

The US Food and Drug Administration (FDA) has proposed a change that would make e-cigarettes and other tobacco products fall under their regulation.

The rules would require that these products include health warnings and only make health claims confirmed by the FDA, among other requirements.

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The FDA currently regulates certain tobacco products, including cigarettes, roll-your-own tobacco and smokeless tobacco, but not others. The proposed change would extend this regulatory authority to include additional products.

"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 electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority," explained FDA.

The new rule would require that the makers of these products register with the FDA, have FDA approval before marketing new tobacco products, not distribute free samples of the products, have minimum age requirements and include health warnings, among some other steps and requirements.

The makers of the products would also only be able to make claims about reduced risk if the claims were supported by scientific evidence, confirmed by the FDA and deemed beneficial to public health.

According to the Centers for Disease Control and Prevention (CDC), tobacco leads to over 5 million deaths per year around the world, and it is estimated that it will lead to over 8 million deaths per year by 2030. CDC also noted that the tobacco industry spent an estimated $8.4 billion on advertising and promotions in 2011.

In a press release from the FDA, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the proposed rules are important as the landscape of tobacco products changes.

“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Zeller. “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 changes are open to public comment for 75 days and, if approved, FDA reported that the producers of these products would have "adequate time" to fall into accordance with the changes.

Review Date: 
April 24, 2014
Last Updated:
April 26, 2014