FDA Approves Two New Tobacco Products; Denies Four Others

The U.S. Food and Drug Administration has authorized the marketing of two new tobacco products through substantial equivalence pathway, and at the same time rejected four other new tobacco products.

The two products that have received the marketing orders from FDA are Lorillard Tobacco Company's Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box.

Since the 2009 Family Smoking Prevention and Tobacco Control Act, this is the first time that FDA gained the authority to regulate tobacco products.

According to the new law, a tobacco manufacturer can legally sell a new tobacco product if it establishes that its product is substantially equivalent to an approved one already in the market. The FDA's task is to see that the new tobacco product approved through the substantial equivalence pathway does not cause more damage to public health than a similar product already in the market.

FDA Commissioner Margaret A. Hamburg, M.D was quoted in Medical Daily stating, "This decision was the first step in the FDA's push toward reducing preventable disease and death related to tobacco use. Any new tobacco product cannot enter the market without the FDA review.  The agency can also limit the ingredients in the new tobacco products."

FDA gives the new product a SE Marketing order not only when the new product is substantially equivalent to an existing product in the market but also confirms to the requirements of the Federal Food, Drug & Cosmetic Act (FD&C Act).   

"Today's decisions are just the first of many forthcoming product review actions to be issued," Mitch Zeller, J.D., director of FDA's Center for Tobacco Products, said in a press 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 four products faced rejection by FDA as they were not found substantially equivalent. Apart from this, there was a lack of evidence to prove that the additional use of specific ingredients did not cause public health issues and they also did not have adequate information about the design of the product and its test data.

After gaining approval from FDA, shares of Lorillard increased by 4.9 percent. The shares closed at 0.3 percent at $43.53, reports Reuters Health.