The FDA issued orders to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the 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 to tobacco products commercially marketed as of February 15, 2007, also known as predicate products. This means they can no longer be sold or distributed in interstate commerce or imported into the United States.
Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string. The manufacturer, Jash International, did not meet the requirements of the Tobacco Control Act to be able to continue selling these products.
Under the Tobacco Control Act, regulated products were allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011. The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products. If a company fails to provide the necessary information to show that their product is SE to a predicate product, the FDA has the authority to declare a product not substantially equivalent, which means that it can no longer be sold or distributed in interstate commerce.
In this case, 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, the basis used by the FDA to review SE applications for tobacco products.
“Companies have an obligation to comply with the law – in this case, by providing evidence to support an SE application,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “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.”
Existing inventory may be subject to enforcement action, including seizure, without further notice. Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by the FDA.
With regard to retailers, the FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory. This policy does not apply to inventory purchased by retailers after the date of the order. The FDA has issued draft guidance containing more information on the agency’s enforcement policy for certain tobacco products that the FDA finds not substantially equivalent.
See the FDA Announcement