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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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.
Developing rules for using CBD in supplements will prevent pharma industry from creating “sweeping monopoly” over the ingredient, CRN says. CHPA says FDA's existing NDA process is appropriate not only for Rx drugs containing CBD, but also for OTC products. NPA supports allowing an exemption for CBD in supplements by establishing a daily exposure level for a healthy population through a Health Hazard Evaluation.