The Food and Drug Administration (FDA) has updated its adverse drug event reporting forms to begin tracking incidents related to hemp-derived cannabinoid products such as CBD.
The change to the federal documents—which are used by healthcare professionals, consumers and companies to report adverse experiences with drugs, cosmetics and other products—received sign-off from the White House Office of Management and Budget (OMB) earlier this month.
This comes about three months after FDA posted a notice in the Federal Register advising that it would be requesting the approval for the cannabis-related change to the forms, which was first unveiled in January.
The FDA change revises the “Product Type” field of safety reporting documents that are part of the agency’s MedWatch program to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).” It was finalized following an initial public comment period that ended in May and a second round that closed in July.
Two comments FDA received expressed support for the addition of a “cannabinoid hemp product” category “but encouraged FDA to include additional categories as well that would allow for specific data as it pertained to a wider variety of individual products,” the agency said at the time. A
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