Unpublished And Under Review? US FDA’s CBD Policy Draft Guidance Still Has Industry Talking
Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.
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Synthetics are necessary for drugs containing cannabinoids because the active ingredient must be consistent from dose to dose. Cannabinoids extracted from hemp vary from plant to plant and more widely from crop to crop, but consistency should matter for cannabinoids used as dietary ingredients, says BioMedican president Dennis O’Neill.
An ultraviolet lamp marketer was dinged by industry self-regulation for COVID-19 claims; the largest US natural food grocery chain had one too many undeclared allergens for the FDA's liking; and warnings note cannabidiol-containing eye drops, nasal sprays and inhalers promoted with drug claims.
As FDA continues deeming hemp-derived cannabinoids unlawful for use as dietary ingredients while allowing sales under a de facto enforcement discretion, the House passes legislation including language to legalize interstate transportation of the ingredients and products containing them.