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FDA Issues First Order to Stop Selling Tobacco Products

Feb 25, 2014

Four tobacco products have been deemed unfit for the market by the U.S. Food and Drug Administration (FDA). In an announcement issued Friday, the agency said that the Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone, thin hand-rolled cigarettes manufactured by Jash International, can no longer be sold or distributed in the United States. Any current inventories that carry these products are subject to seizure. For retailers who bought the products prior to the order, the agency will not take action for 30 days.

This is the first time that the agency has exercised its right to stop sales of tobacco products under the Family Smoking Prevention and Tobacco Control Act. 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.”

Under the Tobacco Control Act, companies who manufactured regulated products had to submit an application to the FDA by March 22, 2011. The products are then subject to substantially equivalent review, where the FDA must find that the products have similar characteristics to older products, or have different characteristics but do not raise new health questions, in order for products to remain on the market.

With Jash International, the FDA found that the products “were found to be not substantially equivalent to tobacco products commercially marketed as of February 15, 2007.” The company failed to name an eligible older product to compare the cigarettes to (referred to as a predicate) and did not show that the Bidis were substantially equivalent.

The FDA's decision to stop sales of a tobacco product is significant, says Matthew Myers, president of Campaign for Tobacco-Free Kids. According to Bloomberg, he stated that “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,”

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