Consumer group calls Appeals Court decision against FDA a great victory for public health.
The U.S. Court of Appeals (DC Circuit) has affirmed that the FDA cannot regulate or ban e-cigarettes as drug devices as long as the manufacturer makes no therapeutic claims for their product.
“This is a great victory for public health,” stated Theresa Whitt, M.D., medical director of the Consumer Advocates for Smoke-free Alternatives Association (CASAA). The appeals court upheld an injunction against the U.S. Food and Drug Administration (FDA) seizing product imports, claiming they were unapproved drug delivery devices.
“We estimate that over a million smokers have switched to electronic cigarettes,” stated Dr. Whitt. “As a result of avoiding the toxins, carcinogens, and particulates in smoke they are reporting their health has improved. Regulating electronic cigarettes under FDCA would result in these life-saving products being removed from the market, pending lengthy and expensive clinical trials.”
The appeals court decision agreed with the arguments CASAA and others put forth in an amicus brief to the court, that the FDA cannot regulate electronic cigarettes under the Food Drug and Cosmetics Act (FDCA) unless the products are advertised as therapeutic or medicinal. However, the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) passed in 2009 gives the FDA authority to regulate electronic cigarettes as tobacco products. CASAA’s legal director, Yolanda Villa, called upon the FDA to immediately announce that it will regulate electronic cigarettes as tobacco products.
“The FDA’s remaining legal options are limited,” stated Villa. “The opinions issued by the lower court and by the U.S. Court of Appeals make it clear that the FDA has little chance of winning the case.”
Media Contact:
Elaine D. Keller
703-244-8692
ekeller@casaa.org
http://www.casaa.org
Press release courtesy of Online PR Media: http://bit.ly/h6QGv8
