The FDA cited various reasons for the violations in its press release. As an example, the agency cited that the filter on the Camel Crush Bold cigarettes contain a capsule that when crushed, releases additional menthol flavoring. The agency found that the feature creates a significant difference from products that existed prior to the law. The Campaign for Tobacco-Free Kids president Matthew Myers praised the decision, believing that the Camel Crush cigarettes “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.” According to Myers, Camel is the most popular cigarette brand among young smokers.
The U.S. Food and Drug Administration (FDA) has used its authority granted to it by the 2009 Federal Food, Drug, and Cosmetic Act (FD&CA) to order four types of cigarettes off the market from America’s Second-largest tobacco supplier, R.J. Reynolds. The company’s major sellers include Camel, Newport, and Pall Mall brands. The four types of cigarettes that have been pulled are: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. The 2009 law gives the FDA authority to cite a violation if it can demonstrate that the health effects of new products are “not substantially equivalent (NSE) to their respective ‘predicate’ products,” which are essentially products that have been on the market prior to February 15th, 2007. None of the four types of cigarettes existed prior to then. Instead, the four brands were introduced to the market during the FDA’s grace period regarding the law, which ended in 2011. According to Mitch Zeller, the director of FDA’s Center for Tobacco Products, “These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use.”
The FDA cited various reasons for the violations in its press release. As an example, the agency cited that the filter on the Camel Crush Bold cigarettes contain a capsule that when crushed, releases additional menthol flavoring. The agency found that the feature creates a significant difference from products that existed prior to the law. The Campaign for Tobacco-Free Kids president Matthew Myers praised the decision, believing that the Camel Crush cigarettes “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.” According to Myers, Camel is the most popular cigarette brand among young smokers. In addition to concerns about the added menthol, FDA scientists were also skeptical whether or not the products were more addictive than their predecessors. The FDA first rejected products due to the FD&CA in February 2014 when it ordered four types of hand-rolled cigarettes from Jash International off the market. The FDA has rejected 78 out of 240 product submissions this year under the guidelines of the Act, but Tuesday’s announcement was the first involving a major U.S. tobacco manufacturer.
R.J. Reynolds executive vice-president for operations and the company’s chief scientific officer Jeffery S. Gentry said he was “deeply disappointed” by the decision. Gentry did not commit to pulling the products off the market, saying “Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence,” and that company management was “examining all of our options at this time.” RBC analyst Nick Modi does not see the recall to be of major financial consequence to the company, saying “We estimate these brands to be 1 percent or less of total cigarette volumes for Reynolds.” Still, Gentry indicated that the company would likely file for an injunction to halt the ruling, or it would pull the products and then contest the recall in court. The FDA stated in its release that it will give R.J. Reynolds a 30-day window before it begins enforcing the law in order to sort out the logistics involved with pulling the product nationwide.
Sources:
Bloomberg Business – Jennifer Kaplan and Anna Edney
New York Times – Sabrina Tavernise
Washington Post –Brady Dennis
Join the conversation!