CBD Drug Approval Not A Sign FDA Will Allow Its Use In Supplements
This article was originally published in The Rose Sheet
As a Schedule I controlled substance, CBD is not allowed by FDA for use in dietary supplements. Although CBD will be rescheduled by DEA to a less prohibitive Controlled Substances Act classification before GW Pharmaceuticals can launch its drug FDA approved June 25, its status for use in supplements won't change.
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Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
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."
In comments on VMS industry oversight, PhRMA recommends FDA adhere to clear regulations that determine whether substances are eligible for use as dietary ingredients. DSHEA makes clear that some dietary ingredients are not eligible for use VMS products.