Four Tobacco Products Deemed Unfit for Sale by FDA

tobacco-products-recalled-unfitFor the first time, U.S. Food and Drug Administration (FDA) has stopped sales of 4 tobacco products on the market. In an announcement issued today, the agency said that Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone failed to meet certain requirements mandated by a 2009 law.

The FDA has the authority to stop the sales and distribution of tobacco products under the Family Smoking Prevention and Tobacco Control Act. In order for regulated products to stay on the market, companies had to submit an application to the FDA by March 22, 2011. The agency then determines whether or not the tobacco products are substantially equivalent to previous products, known as predicates. Those that are not deemed substantially equivalent can no longer be sold or distributed.

This was the case with the Bidis, which are thin, hand-rolled cigarettes manufactured by Jash International. These products “were found to be not substantially equivalent to tobacco products commercially marketed as of February 15, 2007.” the FDA said in its announcement. Jash International failed to identify a predicate product as required by the substantially equivalent review. In order for the products to stay on the market, the company was supposed to demonstrate that their products had the same characteristics as older products, or show that the products were different but did not raise new health issues. Jash  failed to do this, the agency said.

Existing inventory can be seized, the FDA said. Any companies that continue to sell the products could face further action. The agency will not take action against retailers who bought the products previously for 30 days.

“Historically, tobacco companies controlled which products came on and off the market without any oversight,” said Mitch Zeller, J.D., 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.”

Matthew Myers, president of Campaign for Tobacco-Free Kids, advocated the FDA’s decision, stating 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,” according to Bloomberg.

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