Nearly three years following the passage of federal legislation legalizing hemp production, the US Food and Drug Administration (FDA) has yet to promulgate rules regulating the marketing and sale of commercial products containing hemp-derived CBD.

Speaking last month at the National Industrial Hemp Business Summit in Washington, DC, FDA representative Gail Sipes said that the agency cannot move forward with regulations without more data on the safety of CBD products. She reiterated the agency’s position that companies which market CBD-infused products as either food products or as dietary supplements are violating the Food, Drugs, and Cosmetics Act.

NORML and other groups have urged the FDA to provide regulatory guidelines overseeing the production, testing, labeling, and marketing of hemp-derived CBD products. Analyses conducted by the FDA and others have consistently reported that many over-the-counter (OTC) CBD products are of variable quality and potency, and that they may contain contaminants or elevated levels of heavy metals.

Survey data compiled last year by the National Consumers League reported that more than eight in ten US voters desire greater federal regulatory oversight over the labeling and marketing of commercially available CBD products.

In a report provided by the FDA to Congress in 2020, the agency said that regulating OTC CBD products presents unique challenges because the substance is already available as a FDA-approved medicine (Epidiolex).

Additional information is available from the NORML fact sheet, “FAQs About Cannabidiol (CBD).”

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