The U.S. Food and Drug Administration (FDA) on Aug. 26 issued marketing denial orders (MDOs) to three manufacturers of e-cigarettes, noting that applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.” The MDOs apply to about 55,000 flavored e-cigarette and electronic tobacco products manufactured by JD Nova Group LLC, Great American Vapes and Vapor Salon.

Products subject to an MDO for a premarket application may not be introduced to the market, and products already on the market must be removed or risk enforcement. In reviewing new tobacco products, the FDA must ensure they meet the standard set by Congress that there is product-specific scientific evidence that demonstrates the benefit to adult smokers is greater than the risk posed to youth.

The MDOs do not include all applications for e-cigarettes and electronic tobacco products for which the three companies submitted applications. The agency will continue to review other applications for flavored electronic nicotine delivery systems. For additional information, read the full FDA press release.

Clinical Topics: Prevention, Smoking

Keywords: Electronic Nicotine Delivery Systems, Vaping, Smokers, Tobacco, Public Health, United States Food and Drug Administration, Tobacco Products, Flavoring Agents, Electronics, ACC Advocacy

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