A line of hand-rolled, leaf-wrapped tobacco cigarettes got the ax on Friday, as the Food and Drug Administration (FDA) announced its first orders to stop the sale and distribution of Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone cigarettes.
In January 2011, the FDA announced it would no longer be approving products that didn’t already have a market equivalent sold before Feb. 5, 2007. The move was designed as part of the Tobacco Control Act, instituted in March of 2011, which gave the FDA total oversight over tobacco products and allowed them to reject products that would raise new public health concerns. Jash International, the manufacturer of the axed products, is the first company to see the FDA’s new power in action.
“Historically, tobacco companies controlled which products came on and off the market without any oversight,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in an agency release. “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.”
Companies may submit an application to the FDA for approval in order to establish their products as “substantially equivalent” (SE) to pre-existing products in the market. If companies submitted their applications before March 22, 2011, their products were allowed to stay in the market while the FDA reviewed whether they met the criteria. In this case, Jash International failed to prove their products were SE to products already on the market, or, alternatively, that their products are different from what’s currently on the market yet do not raise additional health concerns.
“Because the company failed to meet the requirement of the Tobacco Control Act,” Zeller said, “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.”
According to the FDA, the agency will not take enforcement action on the policy for 30 days on inventory that retailers had already purchased. However, “this policy does not apply to inventory purchased by retailers after the date of the order,” the statement said.