FDA Appropriation Targets $100,000 To Find Safe CBD Level In Supplements
Rep. McNerneny's amendment calls for process that would follow steps FDA used in exercising enforcement discretion on natural products that contain levels of an approved drug ingredient, with red yeast rice most notable. But critics of FDA's VMS industry oversight don't see McNerney's amendment as effective not only for strengthening FDA's overall regulation but also for solving its CBD problem.
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As it recently told Congress it would, FDA reopens docket on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived,. "Reopening the comment period will do nothing to protect public health when the FDA is already sitting on a ticking time bomb," says NPA head Daniel Fabricant.
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.
Instruction in Appropriations Committee report on FY 2020 spending bill garners support from some stakeholders while others say setting a safe level of CBD's use in non-drug products should come first. Senate appropriators endorses FDA policy that regulations allowing sales of CBD non-drug products "not discourage the development of new drugs."