The nation’s top cigarette manufacturer must stop selling four products after federal regulators determined RJ Reynolds failed to show the brands did not pose increased health risks compared to items already on the market.

The Food & Drug Administration ordered RJ Reynolds to cease the sale, distribution and marketing of Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 after finding the company’s submissions for the products did not meet requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The order to cease the sale of the products was handed down after investigators for the FDA found that the four products were not substantially equivalent (NSE) to comparable products marketed as of Feb. 17, 2007.

Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has the ability to reject cigarettes and other tobacco products that its scientists believe pose greater public health risks than comparable products.

In the case of RJ Reynolds’ Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 products, the company was allowed to begin selling the cigarettes on the basis that they were comparable to products already on the market.

To be considered substantially equivalent, tobacco products must be proven to have the same characteristics of previous products, or to different ones that don’t raise new questions for public health.

However, the FDA determined that the products were not the same as their predecessor brands. Specifically, the agency found that the products in question had higher amounts of harmful ingredients, higher levels of menthol, and the addition of new ingredients raised new questions for public health.

In the case of Camel Crush Bold, RJR also failed to show the addition of a menthol capsule in the filter did not affect consumer perception and use.

“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.”

Under the NSE orders, RJ Reynolds must stop selling the products immediately and to dispose of them within 30 days or face financial penalties or criminal prosecution.

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