The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
17. Does the FDA object to the clinical investigation of cannabis for medical use?
Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.
The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
Hemp-derived oil and CBD products are sourced from industrial hemp plants, which are grown primarily for their fiber andseeds. These plants tend to differ from marijuana plants in appearance; they are often skinny and have sparse foliage. Hemp is also differentiated from marijuana by its levels of tetrahydrocannabinol (THC), the cannabinoid that causes consumers to feel “high.”. As outlined in the 2018 Farm Bill, a hemp plant must contain no more than 0.3% THC.
For instance, in China there are few regulations enforced on the agricultural industry, leading to the production of hemp-based CBD products that tend to contain high levels of contaminants. Studies have shown that, due to the country’s mining activities, the water and soil in some regions of China are contaminated with heavy metals.
Despite the identical molecular constitution of CBD sourced from hemp and CBD sourced from marijuana, there are certain factors that differentiate CBD sourced from the two plants.
For those who have the freedom to choose the plant source of their CBD, the experts tend to highlight the benefits of choosing whole-plant products when possible, whether that whole plant is hemp or marijuana.
Research indicates that full-spectrum CBD, whether extracted from hemp or marijuana, may offer enhanced therapeutic benefits.
-Can be found in many varieties and strains with varying flavors, percentages, and more
Transcribed from an email written by Franjo Grotenhermen of the International Association for Cannabinoid Medicines ( cannabis-med.org ).
The buzz around CBD has launched it to the forefront of many treatment regimens as a promising product that can effectively treat or manage many symptoms, but what is the difference between hemp-derived and marijuana-derived CBD oils?
“CBD is CBD. The human body does not care where the molecule comes from.”
I posed the same question to Mary’s Medicinals of Colorado who specializes in high CBD medical marijuana and this was their response:
-Has many options of flavor and consumption method via flavored oils, e-juices, and tinctures
At this point, multiple states are already selling medical marijuana or are looking to jump on board; however, there are still other states that may never be open to the idea of medical marijuana. Either way, hemp-derived CBD is legal and obtainable in all 50 states making it much more accessible than THC.