In First, F.D.A. Rejects Tobacco Products
By SABRINA TAVERNISE
Published: June 25, 2013



The Food and Drug Administration announced on Tuesday that for the first time it had begun exercising its power to regulate cigarettes and other tobacco products, an authority it was given under a 2009 law supported by President Obama.

The Food and Drug Administration gained authority over cigarettes and related products through a 2009 law.

Agency officials said they had authorized the sale of two new products — both of them Newport cigarettes made by the Lorillard Tobacco Company — and rejected four others. The law forbade them to name the rejected products, they said.

Before the law, cigarettes were manufactured without any federal regulation. Instead, states decided where and how tobacco products would be sold, but had no authority over the ingredients they contained. Now, the F.D.A. is deciding which new products can be sold. In addition to cigarettes, the agency’s authority covers loose rolling tobacco, chewing tobacco and snuff.

The agency can reject cigarettes and other tobacco products that its scientists believe pose public health risks above and beyond comparable products already on the market, a sharp departure from past practice, when tobacco companies could change existing products and introduce new ones at will.

Advocates said the F.D.A.’s use of this authority was a milestone.

“This is the first time in history that a federal agency has told tobacco companies that they could not market a new or modified cigarette because of the public health problems they pose,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group.

Dr. Margaret A. Hamburg, the F.D.A. commissioner, called the development “historic,” and said that the F.D.A. was the only agency in the world that possessed such powers. Under the law, the agency can also limit ingredients in tobacco products like nicotine. Federal officials say they are currently studying how to exercise this authority.

Still, the tobacco industry has scored some recent successes against federal regulators. An attempt to require companies to put graphic images on their labels, another power granted by the 2009 law, has been challenged in court, so far successfully. Regulators in other countries including Australia and Uruguay have so far prevailed against the industry in requiring such images.

Mitchell Zeller, director of the Center for Tobacco Products at the agency, said some of the rejected products presented new public health risks by including, for example, more added chemicals than a similar product currently being sold. Some products were rejected because their makers had not provided enough information.

Researchers said that it remained to be seen just how effective the agency would be over time in the face of the industry’s formidable legal firepower. Mr. Myers cautioned that the announcement left out some important details.

“There’s a lot they don’t say about how they did the evaluation,” Mr. Myers said, including information that is critical to knowing what level of risk officials consider unacceptable.

Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor, said the ruling might be an indication of the agency’s thinking on menthol. Newport cigarettes are traditionally menthol flavored, but the two types the agency approved did not contain the menthol additive. The agency is expected to rule on whether to ban menthol, but the timing is not known.