FDA Issues First Order to Halt Sale of Tobacco Products

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sutra-tobacco-products-recalled-unfitFour types of tobacco products have been ordered off the market, the U.S. Food and Drug Administration (FDA) announced on Friday. This is the first time that the agency has exercised its right to halt tobacco sales under authority from a 2009 law. The products are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone; they are thin, hand-rolled cigarettes manufactured by Jash International.

Under the Family Smoking Prevention and Tobacco Control Act, companies who manufacture regulated tobacco products had to submit an application to the FDA by March 22, 2011 in order to stay on the market. The agency reviews the product applications to see if the products are substantially equivalent to previous products, referred to as predicates. The FDA has the power to stop sales and distribution of a product this is deemed to be not substantially equivalent to a predicate.

According to the FDA’s announcement, the Bidis “were found to be not substantially equivalent to tobacco products commercially marketed as of February 15, 2007.” The agency said “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, “

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, notes that “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.”

The FDA said that existing inventory can be seized, and companies that continue to sell the products could face additional enforcement actions. For retailers that previously bought the products for their inventory, agency will not take enforcement action for 30 days.

Matthew Myers, president of Campaign for Tobacco-Free Kids, noted the significance of the FDA’s move, stating “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,” according to Bloomberg.