FDA Gets Tough on Tobacco

June 28, 2013 — -- As the Food and Drug Administration this week announced the rejection of four proposed tobacco products, experts voiced hope that the federal government can diminish tobacco use through regulation.

The FDA's decision Tuesday marked the first time tobacco products were subject to federal oversight. The FDA also authorized two new tobacco products though they are versions of what's already on the market.

The FDA's authorizations come four years after the passage of the Family Smoking Prevention and Tobacco Control Act, which gave the FDA the ability to regulate any new tobacco products put on the market.

"[The] historic announcement marks an important step toward the FDA's goal of reducing preventable disease and death caused by tobacco," FDA commissioner Dr. Margaret Hamburg said in a statement.

According to the Centers for Disease Control, tobacco smoke and secondhand smoke is responsible for the death of 443,000 Americans each year. Experts said the FDA's regulations were just one small step towards diminishing the use of tobacco in the U.S.

Dr. Richard Hurt, founder and director of the Mayo Clinic Nicotine Dependence Center in Minneapolis, said he was pleased the FDA had started to regulate products, although he remained concerned that it took the FDA four years to make a final decision about six products.

"This is just the toe in the water of the FDA's regulation," said Hurt. "All of us in the tobacco field have been waiting for them to do something."

Mitch Zeller, director of the FDA's Center for Tobacco Products, admitted that the process "has taken time," but believed it would become more streamlined in the future.

"As all involved parties continue to gain more experience, FDA expects the process to move much more quickly," Zeller told reporters during a call on Tuesday.

Some 4,000 tobacco products await FDA authorization. Approximately 3,500 of those products are already on the market because they beat a deadline that would have held them off the market pending FDA authorization. They are allowed to remain on the market unless the FDA issues an order saying they do not meet specific standards.

The products that were authorized were two different kinds of Newport non-menthol cigarettes from the Lorillard Tobacco Co. The FDA said they would be allowed on the market because they did not raise different public health questions than comparable products already on the market. By law, the FDA cannot name the four products that were rejected or their manufacturers.

The FDA said there could be a number of reasons new tobacco products do not get authorization, such as if they raise questions of public health, or if there was a lack of data on their impact on public health or incomplete test data.

The FDA's authorization did not mean the products were any healthier than other tobacco products. The FDA authorizes the products on the basis that they will not present more harm to the public health than a comparable product already on the market.

Though the two products passed FDA muster under the guidelines of the Family Smoking Prevention and Tobacco Control Act, that does not allow Lorillard to claim they have FDA approval, because they do not meet the criteria of being "safe and effective" for users.

Lorillard Tobacco CEO Murray Kessler said he was "pleased" with the FDA's ruling.