CBD Market Provides ‘Enormous Incentive’ For FDA's Regulatory Answer But Decision Remains TBD
FDA commissioner’s office representative Joseph Franklin explained, as other agency officials have previously, at FDLI confereice that determining whether to make lawful cannabinoids’ use in products other than drugs is both a priority and a challenge.
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Appropriation Committee’s report with FDA’s FY2022 funding bill appears to signal that other than getting something done, members have little to say about establishing lawful use of hemp-derived cannabinoids in non-drug products.
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.
FDA gives directions on research needed for sufficiently robust “real world data” about non-drug products containing cannabinoids. While optimistic that real world data will help bridge information gap about the ingredients' safety, it’s also candid about the size of the gap.