On Tuesday, July 21, the FDA released draft guidance for clinical research related to the development and manufacturing of cannabis-based drugs, which gained particular interest following the legalization of hemp in December 2018.
Although the guidance does not cover other FDA-regulated products, such as hemp-derived CBD (hemp CBD)-infused foods and dietary supplements, the last section of the document — Section III C — addresses delta-9 THC and dosage calculations that may be indicative of the manner in which the FDA may propose to regulate hemp-derived finished products.
The guidance provides that those using hemp raw material in their drug development activities should follow the U.S. Department of Agriculture interim rule, or any superseding rule, for sampling and testing methods in evaluating the level of delta-9 THC. Accordingly, the agency recommends that drug approval applicants submit information, such as a certificate of analysis, indicating the percent delta-9 THC by dry weight, along with detailed descriptions of testing methods used to evaluate the level of delta-9 THC to help ensure the THC concentration doesn’t exceed 0.3 percent.
While this recommendation isn’t earth-shattering, the FDA guidance goes on to address an unexpected and highly debated issue: the legality of intermediate, unfinished hemp-derived products — in this case, drug — whose THC levels may rise above the 0.3 percent limit.
Specifically, the agency warns of the eventuality that starting materials that