The regulator said under the Tobacco Control Act, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an substantially equivalent (SE) review. Also, the company did not provide information necessary to determine whether the new products had the same characteristics as that of its previous products, or had different characteristics but did not raise different questions of public health, the basis used by the FDA to review SE applications, it said.
“Companies have an obligation to comply with the law – in this case, by providing evidence to support an SE application,” said Zeller. “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 official said. 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, the statement said. (PTI)