The FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act for the first time to order a manufacturer of currently available tobacco products to stop selling,distributing them, or importing them anywhere in the United States.
The products are all thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string known as bidis, and are popular in India as well as throughout South Asia and parts of the Middle East, where they are cheaper than regular cigarettes. The CDC, however, notes that bidis contain about 3-5 times the amount of nicotine, as well as carbon monoxide, and tar posing an even greater risk for oral cancers as well as lung disease and heart disease.
The banned products, manufactured by Jash International of India, are sold under the brand names Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone.
“Historically, tobacco companies controlled which products came on and off the market without any oversight,” stated 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. If a company fails to provide the necessary information to show that their product is ‘substantially equivalent’ 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,” he continued.
According to authorities, Jash International did not provide the required data.
While current inventories of bidis could be subject to seizure, without further notice, the FDA plans to refrain from taking any action against retails for the next 30 days provided that the tobacco products were purchased prior to the cease and desist order. In the meantime the Food and Drug Administration has issued draft guidance containing more information on the agency’s enforcement policy for certain tobacco products that the FDA finds not substantially equivalent. The guidelines will be open for public comment for 60 days, beginning Tuesday, February 25.