The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-9 to grant broad new regulatory authority to the FDA that will empower the FDA to significantly restrict marketing of dietary and herbal supplements currently on the market (S 4348). While some of the dietary supplement trade groups supported this legislation in a transparent ploy to eliminate competition in the dietary and herbal supplement marketplace, key Senators sounded the alarm that they will not tolerate abuse of these new discretionary regulatory authorities granted to the FDA.
The House passed version of what is known as the Prescription Drug User Fee Act (PDUFA) does not include the language on dietary and herbal supplements (HR 7667), and House Energy and Commerce Chairman Frank Pallone has stated his concerns about the sections of the bill that have not been subject to congressional hearings or public testimony. The AKA will continue to lobby House members to strike or modify the Senate passed language that gives these new powers to the FDA.
This action highlights the importance of the passage of the federal Kratom Consumer Protection Act that is expected to be filed in the next month. Mac Haddow, Senior Fellow on Public Policy for the AKA, pointed out how the Senate passed bill “is the most significant change in the Dietary Supplement Health and Education Act (DSHEA) since its passage, and grants broad new regulatory authorities that the FDA has proven it cannot fairly implement when it comes to herbal supplements like kratom."