Cannabidiol
FDA has explicitly stated that CBD cannot be lawfully added to a food or marketed as a dietary supplement under the FD&C Act because it is the active ingredient of the approved drug Epidiolex. EFSA has classified CBD as a novel food and currently considers safety data insufficient.
What it is
Cannabidiol (CBD), a non-psychoactive cannabinoid (CAS 13956-29-1) extracted from Cannabis sativa.
Bioactive supplement / functional ingredient. Not approved as a conventional food or dietary supplement ingredient by FDA.
Why it's flagged
- FDA prohibits in food and dietary supplements
- novel food in EU pending safety review
- drug interactions and hepatotoxicity
What regulators actually say
"It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement... CBD products are excluded from the dietary supplement definition."
"EFSA's experts cannot currently establish the safety of CBD as a novel food due to data gaps and uncertainties about potential hazards."
Regulatory status
United States — FDA
FDA has concluded that CBD is excluded from the dietary supplement definition under 21 U.S.C. 321(ff)(3)(B) and may not be added to conventional food.
European Union — EFSA
Novel food status under Regulation 2015/2283; EFSA 2022 statement found data insufficient to set a safe intake level.
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