FDA orders R.J. Reynolds to pull major brand off the market

The U.S. Food and Drug Administration (FDA) has ordered tobacco giant R.J. Reynolds to pull their Camel Crush Bold cigarette brand off the market. The FDA acted under a key provision of the 2009 law that requires prior FDA review and authorization before tobacco companies are permitted to market new or changed products.

The decision, which was announced on Sept. 15, marks the first time the agency has ordered a tobacco company to remove a major cigarette brand from the market since it was granted regulatory authority over tobacco products by the 2009 law. This move sets an important precedent that could apply to other brands as the FDA works to prevent the introduction of tobacco products to the market that may be more appealing to youth, more addictive or more harmful.

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 “substantially equivalent” to a product already on the market. Manufacturers must also prove that the product “does not pose different questions of public health.”

In addition to Camel Crush Bold, the FDA also issued orders that will stop the further sale and distribution of three other cigarette products currently marketed by R.J. Reynolds: 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 failed to demonstrate that these products do not “raise different questions of public health,” particularly because of the higher levels of menthol, the addition of sugars and other sweeteners, a 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.