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US Wellness Market In 2019: Farm Bill Made Cultivating Cannabidiol Policy FDA's Main Course In Supplements

Executive Summary

As HBW Insight looks back on notable US wellness market developments and events for the previous 12 months, we find that news in the CBD space from the FDA and the industry dominated the sector throughout 2019.

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Lawful CBD Sales In US Might Swing On Closing Door To Private Safety Data

"I think dietary supplement is a pathway where the agency can get data to protect public health and folks in the industry that have spent time and treasure on CBD will get a chance to try and market it," says Bob Durkin, former FDA ODSP deputy director. NDI notifications for CBD ingredients should focus on safety in the formulation of a particular product, not about the substance generally, he says.

$2m For CBD Policy In FDA Budget, But No Directive On Setting Safe Level

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.

Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

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