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FDA Issues First Order to Stop Sale of Tobacco Products

Feb. 21 (Bloomberg) -- Four types of hand-rolled cigarettes were ordered off the market by U.S. regulators, the first time tobacco products have been halted for sale under authority from a 2009 law.

The cigarettes, called bidis, are made by Jash International, the Food and Drug Administration said today in a statement. The company failed to meet the requirements of the Tobacco Control Act, which is designed to reduce addiction among young people, the agency said.

With the law, Congress gave the FDA the authority to oversee tobacco, including the task of clearing new products for sale. The agency has done so primarily by deeming products as substantially equivalent to those on the market prior to Feb. 15, 2007. The Jash International products “were found to be not substantially equivalent,” the agency said today.

“Historically, tobacco companies controlled which products came on and off the market without any oversight,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “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.”

The products are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone cigarettes, the FDA said. They are filled with tobacco, wrapped in leaves from the tendu tree, and tied with string, according to the agency.

Rule Violations

Jash International didn’t identify eligible predicate products, or those marketed as of Feb. 15, 2007, for the agency to do a substantially equivalent review, the FDA said in its statement. The company also failed to provide necessary information to compare the products with older ones and assess questions of public health, the agency said.

Existing inventory can be seized, and companies that continue to sell the products may face enforcement actions, the FDA said. It won’t take action for 30 days against retailers that have previously purchased products in their inventory.

“Today’s action sends a strong message to tobacco companies that the FDA will seriously enforce this critical provision of the law, which is aimed at preventing manufacturers from introducing products that are even more harmful, addictive or appealing to children,” Matthew Myers, president of Campaign for Tobacco-Free Kids, said today in a statement. “We commend the FDA and hope this the first of many actions to stop the marketing and sale of tobacco products that violate the law.”

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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