R.J. Reynolds Cigarettes Banned By FDA For Failing To Meet Safety Requirements

R.J. Reynolds Cigarettes Banned By FDA For Failing To Meet Safety Requirements

R.J. Reynolds cigarettes have been banned after failing to meet the safety requirements set forth by the FDA’s Federal Food, Drug, and Cosmetic Act (FD&C Act).

The U.S. Food and Drug Administration made an announcement on Tuesday, September 15, saying that they were banning “further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products.” The four products are the Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol, and Vantage Tech 13 cigarettes.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in a statement. “The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.”

The press release explained that the four brands are not similar enough to their respective “predicate products (i.e., products that were commercially marketed as of February 15, 2007),” and the manufacturer failed to show that the new products do not raise public health concerns when compared to the tested products. Because of this, they can no longer be sold, distributed, imported, or marketed in “interstate commerce.” In the case of the Camel Crush Bold, they failed to demonstrate that the “addition of a menthol capsule in the filter did not affect consumer perception and use also contributed to the decision.”

The scientists discovered that the four brands had higher levels of menthol and other ingredients, causing questions of public health to be raised. In 2009, a provisional period was created by the Family Smoking Prevention Tobacco Control Act, allowing the FDA to regulate some aspects of cigarettes and other tobacco products. R.J. Reynolds had to submit a substantial equivalence (SE) application to the FDA by March 22, 2011, in order for the products to remain on the market.

Per the press release, “When the FDA issues an NSE order, the tobacco product in inventory, including at a retail location, becomes adulterated and misbranded. As a result, it is illegal to sell or distribute the product in interstate commerce, or sell or distribute the product received from interstate commerce. Doing so may result in the FDA initiating enforcement action, including seizure, without further notice.”

[Photo by defotoberg / Shutterstock.com]

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