FDA Approves 2 New Cigarettes, Despite Not Being Any 'Safer' Than Other Products On Market

In its first decision on new tobacco products since being given authority over all tobacco product regulation, the U.S. Food and Drug Administration (FDA) has approved two new types of cigarette while denying four others.
FDA officials issued a press release stating that although these products are not considered safe, they are no more hazardous than current tobacco products on the market, Reuters reported.
"While the new products have different characteristics than the predicate products, the new products do not raise different questions of public health," the release stated.
The FDA was granted authority over regulating tobacco products in 2009 through the Family Smoking Prevention and Tobacco Control Act. Products receive approval through a substantially equivalent (SE) Marketing Order, which means that only the FDA has approved the product's use.
"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.
"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 two products, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, were both submitted by Lorillard Tobacco Company. The administration also found that four tobacco product recommendations were not substantially equivalent (NSE), meaning they did not include "a lack of evidence to support that the addition of specific ingredients did not raise different questions of public health, a lack of information about the design of the product, and incomplete test data."
FDA Commissioner Margaret A. Hamburg, M.D., said this decision was the first step in the FDA's push toward reducing preventable disease and death related to tobacco use.
"The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA's authority to come to market without FDA review," Hamburg added.