FDA Issues First Order to Stop Sale and Distribution of Four Tobacco Products

In a latest announcement, the U.S. Food and Drug Administration issued a first order to halt the sale and distribution of four tobacco products, called bidis, which are thin, short hand-rolled cigarettes.

The four tobacco products whose sale and distribution has been stopped by the FDA include Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone. These four tobacco products were not found equivalent to the predicate tobacco products that were commercially marketed prior to February 15. 2007.

The manufacturer, Jash International, failed to meet the requirements of the Tobacco Control Act due to which it cannot continue its sale and distribution of Bidi products. Bidis are the thin hand rolled cigarettes that are stuffed with tobacco and wrapped in tendu or temburni leaves and tied with a string.

"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."

According to the Tobacco Control Act, regulated products were allowed to sell in the market only if they submitted the application to the FDA by March 22, 2011. The law demands FDA  review the product application in order to decide whether or not the product is substantially equivalent (SE) to the products already in the market. When a company breaks this rule and fails to show how their product is SE to the earlier products, the agency has the authority to delist the product. With this title the product cannot continue its sale and distribution of the products within the state.

The reason why the agency stopped Jash International for selling and distributing its tobacco products is because it failed to put the predicate tobacco products for the SE review. Apart from this, the company failed to provide the data needed to determine whether the new product has  similar characteristics as the earlier products.

"Companies have an obligation to comply with the law - in this case, by providing evidence to support an SE application," said Zeller in a statement. "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."

The present inventory may be liable to enforcement action that includes seizure without any notice.

This is the first time that the FDA has employed its power under the Family Smoking Prevention and Tobacco Control Act to order a tobacco manufacturer of currently available products to stop the sale and distribution in market.