FDA for the First Time Orders Tobacco Products Pulled Off the Market, Sending Strong Message to Manufacturers about Complying with 2009 Law

WASHINGTON, DC – For the first time since being granted regulatory authority over tobacco products by a 2009 law, the U.S. Food and Drug Administration today ordered a tobacco company to pull several products off the market. The agency acted under a key provision of the law that requires prior FDA review and authorization before tobacco companies can market a new or changed product.

Today’s action sends a strong message to tobacco companies that the FDA will seriously enforce this critical provision of the law, which is aimed at preventing manufacturers from introducing products that are even more harmful, addictive or appealing to children. We commend the FDA and hope this is the first of many actions to stop the marketing and sale of tobacco products that violate the law. The Campaign for Tobacco-Free Kids has brought to the FDA’s attention several products that we believe are being marketed in violation of this provision of the law.

This is one of the most important enforcement actions the FDA has taken under the 2009 Family Smoking Prevention and Tobacco Control Act, the landmark law that gave the agency authority over tobacco products. The law prohibits the introduction of a new or changed tobacco product unless the manufacturer provides evidence to the FDA that the product is either “appropriate for the protection of public health” or at the very least that it is “substantially equivalent” to a product already on the market and “does not pose different questions of public health.” The FDA today ordered the withdrawal of four tobacco products (Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone) that it found were not substantially equivalent to existing products.

The law’s requirement for FDA review of new or changed products is critical because the tobacco companies have a long history of manipulating their products in ways that have made them more harmful, addictive or appealing. As the recently released Surgeon General’s report concluded, these actions have made cigarettes more deadly today than they were 50 years ago. The report found that smokers today have a much higher risk of developing lung cancer than smokers in 1964, despite smoking fewer cigarettes. It concluded that this increase in risk “resulted from changes in the design and composition of cigarettes since the 1950s.”

Before the 2009 law, tobacco companies were free to make these changes in secret, and no government agency had the information or authority to do anything about it. Today, the FDA does have the authority to stop these harmful tobacco industry actions, and the agency’s enforcement action today is a welcome step forward.

Tobacco use is the number one cause of preventable death in the United States, killing 480,000 Americans each year and costing at least $289 billion annually in health care bills and other economic losses. The FDA must continue to vigorously enforce the law in order to reduce tobacco’s terrible toll on America’s families.

More information is available from the FDA’s press release.