FDA cracks down on big tobacco

The Obama administration is cracking down on big tobacco.

The Food and Drug Administration (FDA) has ordered R.J. Reynolds Tobacco Co. to stop selling or distributing four of their cigarette products — Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The agency said it evaluated the products and found that they are not substantially equivalent to products marketed before Feb. 15, 2007, as the manufacturer had claimed. Not only were the products’ characteristics different, the FDA said R.J. Reynolds failed to show that the new products would not raise different public health concerns.

The FDA said the four brands, which entered the market under a provision established by the Family Smoking Prevention and Tobacco Control Act of 2009, can no longer be sold, distributed, imported or marketed in interstate commerce.

As part of that provisional period, R.J. Reynolds was required to submit a substantial equivalence application to the FDA in order for the products to remain on the market.

The FDA determined that the products were not substantially equivalent to a valid product already on the market. Because the agency recognizes that retailers have limited options for disposing of products in their inventories, FDA said it does not intend to take enforcement action for 30 days on previously purchased products.

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

In a press release, R.J. Reynolds said it ‘strongly disagrees’ with the FDA’s ruling. 

“We believe that our substantial equivalent applications fully satisfied the guidance the agency provided,” Jeffery Gentry, the company’s executive vice president of operations and chief scientific officer, said.

“We supplied the agency with extensive information on each of the products and responded to all of the agency’s questions. Our product stewardship process is rigorous and ensures that we are producing the highest quality products that meet regulatory requirements.”

This story was updated at 5:12 p.m.