Authorities have been very tight lipped about the details of the proposed regulations and little is known beyond the title of the document. The FDA has warned that the draft regulation review by the OMB could take any length of time and that there was no certainty that any of the draft regulation would ever be published.
However it did say the same about recent guidance on cannabis research, which was subsequently published a short time later. As a result, it is widely expected that some form of the draft guidance will eventually see the light of day – though how much and in what form remains a mystery.
It is common for agencies to submit what they think are brilliant plans to the OMB only for the Executive Branch oversight to often pick apart a lot of this guidance and send it back to the relevant agency for a redo.
However, even a glimpse of the FDA’s proposal would give the industry some idea of what it was thinking. One area that has been attracting a lot of discussion is measuring THC in hemp products, which was included in the FDA cannabis research guidance.
That draft guidance recommends that developers base the calculation of THC percentage “on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients”. This may give some insight into how the FDA will propose the formula for testing the THC content of consumer CBD products in the future.
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