Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.
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The FDA is cracking down on a number of tobacco products that were introduced to the U. S. market or changed after Feb. 15, 2007, to ensure these products are substantially equivalent to existing products.
The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.
The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.
The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.
Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.
Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.
"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."
"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."