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FDA Submits New CBD Policies to White House for Review

By Leo Bear-McGuinness

Published: Jul 25, 2020   

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FDA Submits New CBD Policies to White House for Review

The Food and Drug Administration (FDA) has drafted enforcement guidance for CBD and submitted it the White House Office of Management and Budget (OMB) for review.

If given approval from the OMB, the new regulations could come into effect in a matter of weeks.


CBD under review

Submitted on July 22, the contents of the document – titled “Cannabidiol Enforcement Policy; Draft Guidance for Industry” – have not yet been disclosed, but its registration details don’t deem it “economically significant.”

Following the passing of an appropriation act last December, the FDA was mandated to produce a report on CBD. When this initial review was released in March, the agency announced it was still reviewing the scientific data to inform “possible pathways for various types of CBD products to be lawfully marketed.”

“FDA continues to be concerned about the potential safety risks of using CBD and about problems related to a number of currently marketed CBD consumer products under FDA jurisdiction, like mislabeling or the potential for contamination with delta-9- tetrahydrocannabinol (THC), pesticides, and heavy metals,” the review read.

Indeed, the agency has recently issued several warnings and recall notices to CBD companies across the US, many of which were found to be selling products with high levels of lead.

Now, with the submission of its Cannabidiol Enforcement Policy, the FDA may soon set out its own CBD regulations regarding heavy metals and other contaminants.

The submission follows the FDA’s other recent announcement on July 21, when it revealed its draft guidance for clinical cannabis research.

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis,” Dr Amy Abernethy, the FDA’s principal deputy commissioner, said in a statement at the time.

“Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.”

 

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