FDA allows two new cigarettes to market after "historic" review

The Food and Drug Administration in a first has authorized the release of two new types of cigarettes while rejecting four others, using for the first time a regulatory rule established about five years ago by the Obama administration.

That's not to say the two new products -- Lorillard Tobacco's Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box -- are less harmful than other cigarettes or that the makers can even call the products "FDA-approved," Mitchell Zeller, director of the FDA's Center for Tobacco Products, emphasized to reporters on a conference call Tuesday.

"All it means is we've conducted a current scientific review, and concluded the...products are not more harmful than existing products," Zeller told reporters.

FDA commissioner Dr. Margaret Hamburg called the new tobacco announcement "historic."

Fewer U.S. adults are smoking these days, according to June report from the Centers for Disease Control and Prevention (CDC) that found about 18 percent of U.S. adults smoke cigarettes, down from 19 percent the previous year.

Still, tobacco kills more than 400,000 Americans each year, according to Hamburg, and about 3,600 children under the age of 18 try their first cigarette each day.

Because there's no such thing as a safe tobacco product in the FDA's eyes, the new regulations are based on whether the product poses a greater risk to public health than products already on the market.

The FDA's regulation stems from the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the health agency regulatory authority over tobacco products. Under the law, the tobacco product's manufacturer must show the FDA that the new product is "substantially equivalent" to a product already available on the market, and won't cause more harm to public health than the comparable product.

In addition to authorizing the two Lorillard products, the FDA rejected four more products because they were found "not substantially equivalent." The agency would not name the products, but said reasons included a lack of evidence to support that the addition of new ingredients did not raise different questions of public health, a lack of information about the design of the product and incomplete data on product tests.

"This is historic because we went through a thorough, extensive, pre-market scientific review," said Zeller.

The Associated Press conducted a review last December that found that the FDA hadn't ruled on 4,000 of these product applications for more than a year despite the expectation of a 90-day review process.

Nearly every application completed to date, however, has been insufficient in some way, said Zeller, who said the new regulations are still a learning process.

The agency also created a website that tracks the progress of substantial equivalence applications.

At any point a manufacturer can withdraw a submission: The FDA thus far has formally withdrawn 136 reports at applicants' requests. Some manufacturers can also request an exemption for a new product if there is only a minor modification being made such as including a new additive. The FDA said it has refused 20 exemption requests so far.

Electronic cigarettes will still not be regulated by the FDA, Zeller said, as long as they don't make health claims.

Zeller explains more on the new tobacco rulings in a blog on the FDA's website.