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SILVER SPRING, Md. -- For the first time, the Food and Drug Administration (FDA) has ordered a manufacturer to stop the sale and distribution of tobacco products.
The agency issued the directive against Jash International for four of its products -- Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone. According to the FDA, the products were not substantially equivalent to tobacco products commercially marketed as of Feb. 15, 2007. As a result of the finding, the products can no longer be sold or distributed in interstate commerce or imported into the United States.
The Family Smoking Prevention and Tobacco Control Act gives the FDA the authority to issue such an order.
"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."
Under the Tobacco Control Act, regulated products are allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011. The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products.
According to the agency, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an SE review. Also, the company 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.
"Companies have an obligation to comply with the law -- in this case, by providing evidence to support an SE application," Zeller said. "Because the company failed to meet the requirement of the Tobacco Control Act, the FDA's decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States."
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 agency will not take enforcement action against any retailer for 30 days on previously purchased products that are in its inventory. This policy does not apply to inventory purchased by retailers after the date of the order.