6/26/2013

The FDA on Tuesday used its regulatory power over tobacco products for the first time when it issued substantial equivalence orders allowing Lorillard Tobacco to market its Newport Non-Menthol Gold Box and Newport Non-Menthol Gold Box 100s, FDA Center for Tobacco Products Director Mitch Zeller writes. The agency also issued the first not substantially equivalent orders that would restrict the marketing of four new tobacco products, because the applicant failed to show enough proof that the new products didn't raise different public health questions and that the new products possess qualities that are different from their predicate products, he writes.

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