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

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
September 15, 2015


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 (R.J. Reynolds) to pull a major cigarette brand – Camel Crush Bold – off the market. The agency acted under a key provision of the law that requires prior FDA review and authorization before tobacco companies market new or changed products.

Today’s decision sets an important precedent that almost certainly will apply to other brands. The FDA’s action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful. Tobacco manufacturers have a long history of continually modifying their products to make them more attractive and more addictive and introducing new brands and styles designed to appeal to specific segments of the market, including children. These tactics have been spectacularly successful in attracting new smokers, most of whom are children, and in discouraging current smokers from quitting.

The 2009 law prohibits the introduction of a new or changed tobacco product unless the manufacturer proves to the FDA that the product is either “appropriate for the protection of public health” or that it is “substantially equivalent” to a product already on the market and “does not pose different questions of public health.”

The FDA today issued orders that will stop the further sale and distribution of four cigarette products currently marketed by the R.J. Reynolds Tobacco Company – Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes. The FDA determined that these products were not substantially equivalent to existing products.

The FDA found that R.J. Reynolds had failed to meet its burden of demonstrating that these products do not “raise different questions of public health,” especially because of the higher levels of menthol, the addition of sugars and other sweeteners, the new method of delivering menthol, and increased levels of harmful and potentially harmful constituents.

Camel is one of the three most popular cigarette brands among youth smokers, with 15.1 percent preferring Camel, according to the 2013 National Survey on Drug Use and Health. Camel Crush is an extension of the brand with a capsule in the filter that releases menthol when crushed. Camel Crush has been heavily marketed, including in magazines with large youth readerships.

Before the 2009 law, tobacco companies were free to change their products in secret, and no government agency had the information or authority to do anything about it. The FDA now has the authority to stop these harmful tobacco industry actions, and the agency’s action today is a much-needed step forward.

As the 2014 Surgeon General’s report concluded, changes made by manufacturers 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.”

We commend the FDA and hope this is one 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 the law.

Tobacco use is the number one cause of preventable death in the United States, killing more than 480,000 Americans and costing about $170 billion in health care bills each year. The FDA must continue to vigorously enforce the law in order to reduce tobacco’s terrible toll on America’s families.