U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a \u201cformal enforcement discretion policy\u201d by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements.<\/p>\n\n\n\n
Without such a policy, \u201chemp producers and their customers will continue to be left in a regulatory gray zone,\u201d Wyden, a Democrat from Oregon, wrote to the leaders of FDA and the U.S. Department of Health and Human Services (HHS).<\/p>\n\n\n\n
In a letter<\/a> to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, M.D., Wyden also urged FDA to publish an interim final rule to ensure CBD can be lawfully sold in food and dietary supplements, pending the agency\u2019s publication of a final rule.<\/p>\n\n\n\n Congress in 2018 removed hemp from the federal Controlled Substances Act (CSA), but lawmakers preserved FDA\u2019s authority to regulate cannabis-derived products.<\/p>\n\n\n\n FDA has maintained CBD cannot be lawfully added to conventional food or marketed as a dietary supplement because essentially the compound was first studied as a drug. The agency, however, has authority to create an exception, and it hosted an all-day public hearing May 31<\/a> to examine issues around its regulation of cannabis-derived products.<\/p>\n\n\n\n Wyden characterized as \u201cfully unacceptable\u201d a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.<\/p>\n\n\n\n \u201cThe regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,\u201d the senator wrote.<\/p>\n\n\n\n Wyden also urged FDA to streamline the process for reviewing safety-related notifications for hemp-derived CBD ingredients and dedicate staff to the process.<\/p>\n\n\n\n \u201cI feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD,\u201d Wyden said.<\/p>\n\n\n\n