FDA issues first orders to stop sale, distribution of tobacco products
Yesterday the U.S Food and Drug Administration ordered that sale of four tobacco products that are currently available be stopped immediately. This is the first time the FDA has used its authority on the Family Smoking Prevention and Tobacco Control Act to order a manufacturer to stop selling or distributing a product. The products are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone and they were found to not be “substantially equivalent to tobacco products commercially marketed as of February 15, 2007.”(FDA press release, www.fda.gov)
Bidis are hand-rolled cigarettes that are filled with tobacco and wrapped in leaves from tendu tree that are tied with a string. Jash International did not provide information necessary to determine whether the new products had the same characteristics as a predicate product, or had different characteristics, but did not raise different questions of public health, the basis used by the FDA to review SE applications for tobacco products. (FDA press, release www.fda.gov)
The Tobacco Control act regulates products and allowed those to stay in the market if the companies submitted an application to the FDA by March 22, 2011. The FDA then reviews the product applications so the agency can decide whether the products are “substantially equivalent “(FDA) to valid predicate products. If the correct information is not provided the FDA then declares that the product cannot be sold or distributed.
According to the statement by the FDA, “"Historically, tobacco companies controlled which products came on and off the market without any oversight. But the Tobacco Control Act gave the FDA, a science-based regulatory agency, the authority to review applications and determine which new tobacco products may be sold and distributed under the law in order to protect public health," said Mitch Zeller, director of the FDA's Center for Tobacco Products.”
Existing inventory may be subject to enforcement action, including seizure, without further notice. Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by the FDA, the statement said.(www.fda.gov)