RWD Curtain Lifted On US Cannabinoids Information Gap, But Lawful Use Remains TBD
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.
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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.
Four major trade organizations applauded the introduction of HR 8179, which would remove statutory impediments to CBD’s lawful use in dietary supplements, subjecting CBD to the same requirements in place for any new dietary ingredient. The Natural Products Association, on the other hand, is calling the bill a misstep.
Both Senate and House reports on FDA FY 2020 appropriation include requests for agency’s research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities related to regulated products that contain hemp-derived CBD. House report, though, expresses stronger concern about exploding sales of potentially unsafe CBD supplements.