FDA Tobacco Director Provides Update on PMTA Reviews and Enforcement

Dr. Bret Koplow, Acting Director of the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP), participated in a panel discussion this week at the American Tobacco and Nicotine Forum.

Koplow stated that the FDA has decreased the its backlog of pre-market tobacco applications (PMTAs) by approximately 70% over the past year while also eliminating the “acceptance” queue to streamline the review process. He noted that while the FDA has reviewed approximately 27 million PMTAs, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits. On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes. Read more here.