FDA Action Items For CBD Policy? The List Is Short Due To 'Critical' Data Gaps
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."
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Denver firm recently announced self-affirmed GRAS for proprietary hemp-derived CBD extract. “I have access now to food, beverage and I can add to a dietary supplement my extract as a food additive ingredient,” says CEO Jason Mitchell. While GRAS is a US regulatory pathway for food, currently none is available for lawful use of hemp-derived ingredients in supplements.
FDA is testing cannabidiol and other cannabinoids for whether labeled amounts match what’s in a product, says CFSAN Deputy Director Doug Stearn. The work is supported with $5m provided in the agency’s FY21 appropriation.
FDA is conducting lab testing on CBD products with funding in its FY2021 appropriations, says senior agency advisor Sharon Mayl. Some work planned work in the area has been delayed by the agency's response to COVID-19.