FDA News

FDA issues order to stop sale of 4 R.J. Reynolds cigarette brands

The FDA has issued orders to stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products, according to an agency press release.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in the release. “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.”

Mitch Zeller

Mitch Zeller

The company’s Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 brands did not meet requirements set in the Federal Food, Drug and Cosmetic Act – which states that products must be substantially equivalent to respective “predicate” models.

The agency determined the products have different characteristics than previous products and that the manufacturer failed to identify that the new products do not raise different questions of public health compared with the old products.

The order prohibits these products from being sold, distributed, imported or marketed in interstate commerce.

However, the FDA does not intend on enforcing the ban for 30 days on previously purchased products any retailer has in its inventory.

The FDA has issued orders to stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products, according to an agency press release.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in the release. “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.”

Mitch Zeller

Mitch Zeller

The company’s Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 brands did not meet requirements set in the Federal Food, Drug and Cosmetic Act – which states that products must be substantially equivalent to respective “predicate” models.

The agency determined the products have different characteristics than previous products and that the manufacturer failed to identify that the new products do not raise different questions of public health compared with the old products.

The order prohibits these products from being sold, distributed, imported or marketed in interstate commerce.

However, the FDA does not intend on enforcing the ban for 30 days on previously purchased products any retailer has in its inventory.