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.

"[We] believe that the FDA has carried out is evaluation process in a deliberate manner reflecting sound science," Kessler said in a statement. "We look forward to continuing productive engagement with the agency moving forward."

Previously Kessler has criticized the FDA, telling The Associated Press the FDA was "not exercising common sense" in their approach to authorizing new tobacco products.

"These are cigarettes. They haven't changed in 50 years," Kessler said in an earlier interview with the AP. "I don't think the spirit of the law ever envisioned this type of cumbersome scrutiny."

Electronic or e-cigarettes, which allow users to inhale suspended nicotine through "vapor," are not regulated by the FDA unless the manufacturer claims they have therapeutic benefits.

In 2011, the FDA announced that it would start regulating electronic cigarettes the way it regulates tobacco products but it's in the process of finalizing that proposal.

In addition to the FDA's regulation of new products, Hurt said he hoped the FDA will regulate other cigarette components such as nicotine or menthol to diminish tobacco use.

Hurt added that a cigarette-free country is not out of the realm of possibility. He noted that the modern cigarette is only about 100 years old and that New Zealand aims to be smoke-free by 2025.

"When we talk about a world without cigarettes we talk about a return to a norm," said Hurt. "[Cigarettes were] not a product of note 'til early part of the 20th century."