Charlotte’s Web Sponsors Clinical Trial on CBD Products’ Health Benefits

Lori Ann Reese

Posted by Lori Ann Reese on 06/23/2020 in CBD Resources

cbd products health benefits

Do CBD products provide health benefits? The research to date has been conflicting. Most studies have been conducted with bias or sponsored by a CBD brand or producer. There has also been a rapid increase in bogus CBD oil products on the market. You may see these types of products on online marketplaces like Amazon. Unfortunately, they have little to no cannabinoid content and therefore have minimal wellness potential.

That is just the tip of the iceberg when it comes to validating the medicinal value of CBD for health therapeutics. There are many questions about CBD oil and patient wellness, health applications, suitable treatment recommendations (and dose amounts), and other definitive factors that could help patients achieve beneficial results.

The Food and Drug Administration Needs Research to Classify and Regulate CBD Products

There are thousands of CBD products currently available on the market, while the FDA recognizes and regulates only one as a prescription drug.

In America, there is only one drug that contains CBD that is regulated by the Food and Drug Administration (FDA), and that is Epidiolex. It is prescribed for severe childhood epilepsy. All other hemp-derived CBD products are not currently regulated because they lack sufficient clinical research and human trials.

Right now, the FDA does not know if CBD works. Even if it did provide health benefits, they are unsure which conditions it may help moderate or relieve. There may also be a concern for an unwanted drug interaction between CBD and specific prescription medications. Therefore, thorough research is needed to fill in the knowledge gap about CBD.

Because of the unknown factors about CBD oil, the FDA considers CBD to be a restricted drug and controlled substance. Adding full strength CBD oil to food products, for instance, is illegal. Cannabinoid oils that are below 0.3% in potency can be sold in the United States. However, some states—like Virginia—have criminalized the use of CBD oil unless the individual has a prescription from a board-certified physician.

ValidCare Launches a Collaborative Scientific Study to Provide Evidence-Based CBD Data to FDA

Manufacturers of CBD products for medicinal use are motivated to provide the evidence-based data required by the Food and Drug Administration (FDA). The data will be used to categorize, legitimize, and legalize CBD products in the United States.

ValidCare announced a new collaborative research effort involving CBD companies located in the United States. ValidCare is a clinical trial outsourcing company that serves the pharmaceutical sector with pilots and research of compounds and medications. They invited over 100 CBD processors and manufacturers to participate in the study. Only seven (7) companies responded and agreed to contribute data to the study. The seven businesses are both participants and sponsors in the medical research effort. 

The participant companies for the ValidCare CBD oil clinical study are:

  • Charlotte’s Web
  • Kannaway
  • HempFusion
  • Columbia Care
  • CBD American Shaman
  • CBDistillery
  • Boulder Botanical & Bioscience Labs

Each participating business has expressed its eagerness to expand research into the medicinal and therapeutic aspects of CBD products. The study aims to satisfy the FDA’s need for evidence-based data and to further learn about aspects of CBD that will promote consumer safety.

The Impact of the ValidCare Clinical Trial and Medical Research of CBD Products’ Health Benefits

The study is expected to start in the third quarter of 2020 and involve a minimum of 700 patients. A standard clinical review of health history and medical data, lifestyle factors, and other demographic patient data will help gather relevant insights into the therapeutic potential of CBD products. 

Currently, 0.3% CBD oil and additives are legalized in most states. Some dispensaries carry hybrid products of CBD and THC active medical marijuana products. They are available for certified patients with qualifying health conditions.

There are thousands of CBD products currently available on the market, while the FDA recognizes and regulates only one as a prescription drug. There are increasing concerns about inauthentic imported CBD products that may pose a health threat to American consumers. After the data is collected and reviewed, the information will help the FDA answer many questions about CBD oil and develop a new series of standards and regulations for CBD products.

If the results from the CBD trials are positive and prove both wellness benefits and safety of use, it could launch a new era for the American CBD industry. We could see new products introduced to the market, making the identification of illegal domestic or imported products easier.

This story was originally published by New Cannabis Ventures.

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