FDA Budget Request Includes $5M For CBD Regulation With Pathway Unclear
FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.
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In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.
FDA has little in the way of good information it can list on its CBD policy agenda so far, says Principal Deputy Commissioner Amy Abernethy. At recent regulatory conference, she said, "Like it or not, there is a massive human experiment going on right now. There’s CBD in most different product categories and people of many different backgrounds with potential vulnerabilities taking CBD."
Minnesota Democrat Collin Peterson’s bill, the first targeting FDA’s CBD question, could provide an entire answer or it could set table for discussion in Congress about legislation on establishing an FDA regulation on using CBD, and potentially other hemp-derived substances, in products other than drugs subject to its oversight.