FDA Deeming Authority Clarification Act of 2015

FDA Deeming Authority Clarification Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to revise premarket review and reporting requirements for products deemed by the Food and Drug Administration (FDA) to be tobacco products.

A product is not subject to premarket review by the FDA if it is introduced to market before that type of product is deemed a tobacco product.

A person introducing a tobacco product that is substantially similar to a marketed product less than 21 months after that type of product is deemed a tobacco product must submit a report to the FDA on the similar product not later than 21 months after that type of product is deemed a tobacco product. (A report is required at least 90 days prior to introduction of a tobacco product that is substantially similar to a marketed product if that type of product has been deemed a tobacco product for 21 months or more.)