FDA Releases Initial Guidelines for Cannabis-Derived Drugs

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The Food and Drug Administration released a draft of rules that companies should follow to develop cannabis-derived drugs -- a new category that has exploded with few federal laws to govern it.

The guidelines cover drugs and treatments containing cannabis oil and other compounds found in the plant, the agency said on Tuesday. They include references for calculating weights for oral dosages and online resources related to clinical trials for cannabis-derived products.

The draft draws on a 2019 public hearing where industry representatives expressed concern about inaccurate or misleading labels for products with CBD, a cannabis extract, and the potential for contamination. The FDA will accept comments on the rules for 60 days before it writes a final version.

The U.S. has seen an explosion in unregulated hemp-derived products with CBD, which unlike marijuana isn’t psychoactive. Companies are touting CBD as a cure for ailments like insomnia, pain and anxiety -- categories traditionally covered by over-the-counter or prescription drugs.

The FDA has authority to regulate both cannabis and cannabis-derived compounds following a 2018 farm bill.

So far, Epidiolex, a treatment from GW Pharmaceuticals to reduce epileptic seizures, is the only FDA-approved product using a cannabis extract.

©2020 Bloomberg L.P.

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