JUL 21, 2020 11:07 PM PDT

FDA Produces Draft Guidelines on Developing Cannabis Drugs

WRITTEN BY: Angela Dowden

The FDA’s Center for Drug Evaluation and Research has produced guidelines for research into cannabis-related ingredients that may make potential drugs.

The document covers the drug review and approval process, including clinical trials, that must be followed by research teams working with cannabis compounds. Botanical raw materials, extracts and highly purified substances of botanical origin are included within the scope of the new guidelines. However fully synthetic versions of substances that occur in cannabis are not included, as these are already regulated the same as other fully synthetic drugs.  

The guidelines also lay out the approved sources of cannabis that investigators are allowed to use. For cannabis containing more than 0.3 percent of the psychoactive ingredient THC, the FDA confirm that this must be sourced from the National Institute on Drug Abuse’s (NIDA) Drug Supply Program (DSP), which is still the only domestic federally legal source. However the 2018 Farm Bill legalized hemp plants containing less than 0.3 percent THC, so researchers can now access hemp that meet this specification from any manufacturer.

Though the new guidelines offer useful clarity for researchers investigating cannabis compounds as drug candidates, they are still notable for their absence of any guidance on CBD oil. Already a big sales ticket item across the US, CBD exists in some sort of semi-legal limbo land.

While the Farm Bill legalized hemp, it did not legalize CBD, moving its enforcement from the Drug Enforcement Administration to the FDA. When the FDA approved the epilepsy drug Epidiolex, which contains CBD, it subsequently told companies that they cannot not add the ingredient to food or drink or make health claims for its use in topicals.

The FDA is currently in an open-ended consultation period over CBD that should result in the agency finally issuing regulations for its legal marketing.

“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,” an FDA spokesperson told website MarketWatch in written comments.

The FDA has issued warnings in situations where companies marketing CBD as supplements made unauthorized claims about cancer, arthritis and other diseases.

 Sources: MarketWatch, FDA, Marijuana Moment

 

About the Author
  • I'm a journalist and author with many year's experience of writing for both a consumer and professional audience, mostly on nutrition, health and medical prescribing. My background is food science and I'm a registered nutritionist.
You May Also Like
MAR 23, 2021
Cell & Molecular Biology
One Metabolic Problem May Cause Multiple Diseases
MAR 23, 2021
One Metabolic Problem May Cause Multiple Diseases
Patients with a disease often see specialists, and there may not be much communication among them when individuals suffe ...
MAR 24, 2021
Cancer
What toxic chemicals are lurking in your couch?
MAR 24, 2021
What toxic chemicals are lurking in your couch?
New research published in the journal Environment International suggests a weekend trip to the nearest furniture st ...
APR 04, 2021
Cell & Molecular Biology
Human Malaria Trial Creates More Questions
APR 04, 2021
Human Malaria Trial Creates More Questions
Malaria is a major health problem in many parts of the world; nearly half a million people die from malaria, and another ...
APR 05, 2021
Cannabis Sciences
Can Smoking Cannabis Cause Lung Cancer?
APR 05, 2021
Can Smoking Cannabis Cause Lung Cancer?
So far, there is no firm consensus on whether smoking cannabis can cause lung cancer. As cannabis smoke contains many si ...
APR 06, 2021
Microbiology
A Bacterial Protein That Causes Nausea
APR 06, 2021
A Bacterial Protein That Causes Nausea
The bacterium Campylobacter is thought to cause more cases of food poisoning than any other microbial pathogen. Scientis ...
APR 14, 2021
Clinical & Molecular DX
AI-Powered Imaging System Can Tell If a Patient Is Cancer-Free
APR 14, 2021
AI-Powered Imaging System Can Tell If a Patient Is Cancer-Free
A patient undergoes chemotherapy and radiation for rectal cancer. How do doctors know whether all the malignant tissue h ...
Loading Comments...