On November 27, 2019, the Office of Advocacy submitted comments to the Food and Drug Administration (FDA) asserting that the agency improperly certified the Tobacco Product Applications and Recordkeeping Requirements Proposed Rule. The proposed rule lays out the form and content for a premarket product tobacco application (PMTA) and describes the FDA’s PMTA review process and recordkeeping requirements for those who submit a PMTA for review. The FDA certified that the proposed rule would not have a significant economic impact on a substantial amount of small entities. For purposes of the Regulatory Flexibility Act, Advocacy cautioned the FDA that its certification was improper because there was no factual basis supporting their claim that PMTA costs were negligible and the Deeming Rule’s Final Regulatory Flexibility Analysis was inadequate and not a proper basis for certification. Advocacy recommends that the FDA prepare and make available for public comment an Initial Regulatory Flexibility Analysis and consider significant alternatives for small entities in the industry. The comment letter and fact sheet are available at the links below:
For more information, contact Charles Jeane at (202) 205-7168 or charles.jeane@sba.gov