The Food and Drug Administration says there are too many unknowns about CBD products to regulate them as foods or supplements.
The FDA said Congress needs to create new rules for the massive and growing market.
FDA officials said Thursday that the marijuana-derived compound poses risks to people and animals that can't be adequately addressed through the current system and a new regulations are needed to protect consumers.
The agency also denied petitions from three advocacy groups to allow CBD products to be marketed as dietary supplements.
Fans of the products claim benefits including relief for pain and anxiety.