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Cannabis-Related Clinical Research Draft Guidance by the FDA Has Been Released

The American FDA (Food & Drugs Administration) has released its initial guidance on the development of cannabis-based drugs this week but still has to get around to covering the usage of CBD in food and related supplements.


GW Pharmaceuticals' Epidiolex, which is used to deal with epileptic seizures, is presently the most effective FDA-approved drug containing cannabis. Since the 2018 Farm Bill was enacted in the U.S., corporations that manufacture various fitness and well-being CBD-based products have been anxiously waiting for the organisation to release policies and vouch for the safety of CBD as part of a nutritional diet.


Since then, the FDA has been cautioning companies not to be making unsubstantiated health claims concerning CBD and it's medicinal applications.


Officials at the FDA are saying that part of why the organisation has been so slow in forming regulations is the fact that there aren’t sufficient studies obtainable to support the numerous claims made regarding CBD consumption. In any case, it was only a year and a half ago that CBD was removed from their Schedule of Controlled Substances.


A spokesperson for The FDA said earlier this week: “We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress. There are many questions to explore regarding the science, safety, effectiveness, and quality of products containing CBD, and we need to do our due diligence.”


The new guidelines are open for a 60-day period for public comment and among the guidelines, the FDA has advised researchers to consult with the DEA (Drug Enforcement Administration) about THC levels in the cannabis used in the clinical trials since more than 0.3% is still illegal in the eyes of the feds.


In the guidelines, it is stated: “Sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product.”


Companies producing CBD products are still waiting for regulations from the FDA and in the meantime, the US Congress recently received a report from the FDA about the many cases of labelling violations in the American CBD e-commerce market concerning a wide range of different products not containing the same level of CBD as stated on the label.






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