This is the second post in a two-part series. The first is available here.
Last week, the Food and Drug Administration (FDA) submitted a CBD enforcement policy to the White House. We do not yet have the text of that document but we anticipate that it will have a significant impact on hemp-derived CBD (Hemp CBD) products. In my last post, I summarized the FDA’s current enforcement policy and briefly discussed the FDA’s recently released guidance for drug manufacturers interested in cannabinoid research. An issue that came up in the FDA’s guidance for drug manufacturers was testing finished and intermediary products for cannabinoids.
Here’s how the FDA frames the issue of testing hemp products in the drug guidance document:
In general, the composition of a botanical raw material is calculated as the amount of the compound(s) of interest naturally present relative to the dry weight of botanical raw material prior to extraction or other manufacturing steps. However, this type of dry weight calculation has limited utility for intermediates such as solutions, extracts in solution (whether aqueous or nonaqueous), and for finished products. Therefore, FDA recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis