RJR Responds to FDA ‘NSE’ Decision

“Examining options” on ruling requiring tobacco company to stop selling four brands

R.J. Reynolds

WINSTON-SALEM, N.C. -- R.J. Reynolds Tobacco Co. said it “strongly disagrees” with the ruling by the U.S. Food & Drug Administration (FDA) that four of the company’s brands—Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13—are “not substantially equivalent” (NSE) to their respective “predicate” products (defined as products that were commercially marketed as of Feb. 15, 2007).

The U.S. Food & Drug Administration (FDA) issued orders on September 15 to stop the sale and distribution of the four R.J. Reynolds cigarette products because the company’s submissions for these products did not meet requirements set forth in the federal Food, Drug & Cosmetic Act (FD&C Act), the agency said.

As reported in a 21st Century/CSP Daily News Flash, the FDA’s evaluation found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were "not substantially equivalent" (NSE) to their respective predicate products as identified by the manufacturer.

The agency concluded that the products have different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them.

Consequently, at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce, the FDA said.

“We believe that our substantial equivalent applications fully satisfied the guidance the agency provided, and we respectfully disagree with their evaluations of the products in question,” said Jeffery S. Gentry, Ph.D., executive vice president of operations and chief scientific officer for R.J. Reynolds in a statement the company issued to respond to the ruling. “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.”

All of the brands included in the order represent a very small portion of R.J. Reynolds’ business, less than 0.4 share of market, the company said.

“Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence. We’re examining all of our options at this time,” Gentry said.

Cowen & Co. analyst Vivien Azer said she expects Reynolds American Inc. “will either file for a preliminary injunction to suspend this action or pull the products and then contest these findings legally,” according to a report by StreetInsider.com.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “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 products receiving NSE orders entered the market during a provisional period established by the Family Smoking Prevention & Tobacco Control Act of 2009. As part of the provisional period, the company had to submit a substantial equivalence (SE) application to the FDA for review by March 22, 2011, in order for the products to remain on the market.

The scientific basis for these four decisions include the company’s failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol or the addition of new ingredients in the currently marketed products, when compared to the predicate products, do not raise different questions of public health.

Click here to read Brief Summary of “Not Substantially Equivalent” Determinations.

In the case of Camel Crush Bold, a failure 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 FDA said.

R.J. Reynolds Tobacco, an indirect subsidiary of Reynolds American Inc., Winston-Salem-N.C., is the second-largest tobacco company in the United States. Its brands include Newport, Camel and Pall Mall. These brands, and its other brands, including Doral, Misty and Capri, are manufactured in a variety of styles and marketed in the United States.