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The FDA just released a report titled "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research." This is a non-binding, draft guidance but does inform the FDA's thinking on things Hemp CBD. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry
This guidance provides insight for clinical research into cannabis drugs. It does not provide guidance for non-drug products like the CBD gummies, tinctures, and vape pens that are widely available.
To clarify, any product can be a "drug" based on its intended use. If you are marketing CBD w/ medical claims, then the FDA can take the position that you're are marketing an unapproved drug. This guidance is directed to folks knowingly developing drugs from the jump
The FDA guidance 1st covers the source of cannabis for clinical research. Cannabis, as used here, is a general term that encompasses both marijuana and hemp. Hemp is not subject to the Controlled Substances Act. Marijuana is. That's important.
The CSA has made it basically impossible to study marijuana to develop drugs. @vince_sliwoski recently wrote about how difficult it is to research a Schedule I controlled substance. https://harrisbricken.com/cannalawblog/how-to-study-schedule-i-controlled-substances/
Hemp, on the other hand, is legal to grow, with the appropriate authorization from the USDA, an Indian Tribe, or a state department of agriculture. That opens up a lot of possibilities for studying cannabinoids such as THC and CBD if derived from hemp.
The FDA also provides insight into quality considerations for manufacturing a cannabis drugs.
Finally, and importantly, the FDA states that derivatives from cannabis with more than 0.3% delta-9 THC must comply with DEA requirements. The FDA also indicates that if the finished product will have more than .3% THC, investigators should figure that out early:
Overall this is pretty helpful for stakeholders interested in developing drugs from cannabis. However, the FDA has not addressed the more pressing issue of cannabis derivatives that are widely used in food, dietary supplements, cosmetics, and smokable products.
