FDA Authorizes Sale of Two New Cigarette Products; Rejects Four Others
The Food and Drug Administration (FDA) on Tuesday announced it had authorized the sale of two new cigarette products and rejected four others. It is the first time the agency has exercised its power to regulate cigarettes and other tobacco products since it was given that authority under the Family Smoking Prevention and Tobacco Control Act of 2009.
The law allows tobacco manufacturers to legally sell new a tobacco product if they establish it is substantially equivalent to a product already on the market. The FDA is charged with ensuring the new tobacco product will not present more harm to public health than the product with which it was compared.
The two new authorized products are Newport cigarettes made by the Lorillard Tobacco Company, The New York Times reports. The law forbids the FDA from naming the products it rejected.
Until the 2009 law was passed, cigarette manufacturing was not subject to federal regulation, the article notes. States decided where and how tobacco products were sold.
“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” FDA Commissioner Margaret A. Hamburg, MD, said in a news release. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”
The decisions are the first of many product review actions the agency will issue, according to Mitch Zeller, Director of the FDA’s Center for Tobacco Products. He noted some of the rejected products included more added chemicals than similar products on the market. In other cases, products were rejected because the manufacturer did not provide enough information.