FDA today issued MDOs to JUUL Labs for all products currently marketed in the Untied States. In citing the rational for the Orders, FDA stated that the “applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health (APPH).” What exactly constitutes APPH has not been determined.
All new tobacco products on the market without a premarket authorization are considered to be marketed unlawfully and subject to enforcement action. FDA previously stated that products for which no application is pending, for instance those that received a MDO, are among the Agency’s highest enforcement priorities.