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U.S. Department of Health and Human Services

Tobacco Products

This Week in CTP – February 21, 2014

First Orders To Stop Sale, Distribution Of Tobacco Products and An Upcoming TPSAC Meeting

Today, FDA issued orders to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.

The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – were found to be not substantially equivalent because the manufacturer, Jash International, did not identify eligible predicate tobacco products as required for FDA to perform an SE review. This means they can no longer be sold or distributed in interstate commerce or imported into the United States. Companies that continue to sell and distribute these products in the U.S. may be subject to enforcement actions by FDA.

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

Because this is the first time not substantially equivalent (NSE) orders have been issued for marketed products, CTP has released draft guidance explaining the enforcement policy the agency intends to follow with respect to retailers and the products in question.

We have also developed a new webpage, titled Misbranded and Adulterated NSE Tobacco Products, to inform the public about those products that have been on the market but which are now misbranded and adulterated due to the failure of the manufacturer to satisfy the requirements for an SE marketing order. FDA will continue to review tobacco product applications and issue decisions on a regular basis, including for products that are currently on the market.

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Additionally, FDA is announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for April 16-18. This meeting will be held to discuss scientific issues pertaining to dependence and addiction, to receive information on population modeling in the assessment of tobacco product applications, and to discuss possible approaches for evaluating information on the potential risks and benefits of modified risk tobacco products (MRTP).

Interested persons may present data, information, or views, orally or in writing. For more information, including how to get involved, visit the TPSAC webpage.