FDA Approves Two Lorillard Cigarettes, Rejects Four other Tobacco Products

The U.S. Food and Drug Administration (FDA) has now approved marketing two new cigarettes while rejecting four other tobacco products.

The approved products are manufactured by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box.

 The agency announced that it has approved the products through the substantial equivalence (SE) pathway. Under this law, a tobacco manufacturer can legally sell a commodity if it proves to be equivalent to another approved product in the market (the predicate product). This is the first time that the agency has used its powers to regulate tobacco products. The agency was first authorized to control tobacco-based products in a law passed in 2009.

According to Dr. Margaret A. Hamburg, the F.D.A. commissioner, the agency is the first in the world to have powers to control tobacco products and under the new law, the agency can also control the limit of certain ingredients in the product, such as nicotine, reports The New York Times.

 "Today's decisions are just the first of many forthcoming product review actions to be issued," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products in a statement. "The FDA is committed to making science-based decisions on all product applications and providing the agency's scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law."

The agency claims that approval under the SE Marketing Order doesn't mean the product is safe. Justifying its approval, the agency adds that the product is at par with other goods of its kind that already sell in the market.

"It is important to emphasize that an SE decision does not mean that the agency considers a product to be safe, nor is it FDA-approved. The SE decision only means that a new product does not raise different questions of public health as compared to the predicate product," said Zeller in a blog.

Shares of Lorillard grew by 4.9 percent before dropping again. The shares closed at up 0.3 percent at $43.53, Reuters Health reported.