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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FDA “didn’t really take any steps towards a resolution” in 2021 and is “mostly content” with enforcement discretion allowing sales of non-drug products which contain cannabinoids and other hemp-derive ingredients, says Stuart Pape, of Polsinelli PC, during a recent Food and Drug Law Institute conference.
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.