FDA endorsement of CBD-based drug signals bright future for legal cannabis market | Articles | Chief Innovation Officer – Innovation Enterprise

Cannabis, in general, has gained major approval, as evidenced by the latest studies by Pew Research Center showing that 62% of Americans approve legalization. The doubling of the 31% that supported legalization back in 2000 has been fueled by increasing studies that reveal the intricacies of cannabis and how it provides its therapeutic effects.

Cannabidiol (CBD), in particular, has made major headway as a potent source of relief from everyday symptoms suffered by people worldwide such as anxiety, PTSD, depression, as well as helping people wean off substance addictions and dangerous prescription medication such as opioids. It incorporates several major benefits such as anti-inflammatory properties to treat pain and antimicrobial effects to fights off viruses by stimulating the body’s endocannabinoid system.

This system is critical for maintaining homeostasis and works to ensure that essential functions like sleep, emotional regulation, and memory, making the endocannabinoid system critical for optimum health. There are several receptors such as CB1 and CB2, which work to maintain cellular health through the endocannabinoid system, which is triggered by the presence of endocannabinoids such as THC, CBD, and endocannabinoids that are produced by the body.

Endorsing CBD

An increased understanding of how cannabinoids like CBD work their magic has prompted a shift in the way many view cannabis as opposed to just another banned schedule 1 substance. However, it is still viewed in a negative light by some and this had led to opposing views and often confusing regulations in regards to CBD.

CBD’s merits have been approved by the WHO, which stated that the cannabinoid had various medicinal benefits while being completely safe for use and being devoid of any major side effects resulting from use.

This stance was also echoed by WADA, which found CBD to be non-addictive and have medicinal properties that could benefit athletes. They officially allowed for the use of the cannabinoid on the grounds that it doesn’t include any THC, the psychoactive cannabinoid found in the plant.

The FDA approved Epidiolex, the very first CBD-derived pharmaceutical that was found to be effective in people suffering from seizures related to rare cases of epilepsy called Lennox-Gastaut Syndrome and Dravet syndrome. As CBD still remains federally illegal due to its association with cannabis, this was great news that had some thinking the DEA might legalize CBD as a result.

The DEA did indeed reclassify CBD as a schedule 5 substance, the lowest criteria available, but only for FDA approved CBD drugs that contained 0.1% THC or less. With the FDA continuing to support CBD, they recently wrote a letter to the DEA recommending that CBD be rescheduled entirely.

The proposal

The letter was sent by Health and Human Services Assistant Secretary Brett Giroir, who stated, “After reviewing the available information, the FDA and NIDA “conclude that CBD and its salts [should] be controlled in Schedule V of the Controlled Substances Act.””

With mounting evidence of CBD’s medicinal benefits as well as being safe, non-toxic, and non-addictive, many are questioning why it remains on the strictest level of classification, schedule 1, which is reserved for substances without medicinal use and high risk of abuse. Schedule 1 includes heroin, LSD, and ecstasy, and CBD would seem to be the odd number in the sequence, to say the least.

In fact, the letter also revealed that the DEA responded to this appeal by stating that decriminalizing CBD would violate the United Nations Single Convention on Narcotics, which requires countries like the US to regulate cannabis as well as its related cannabinoids and other derivatives.

The DEA has remained firm on their stance of only rescheduling CBD that is used for FDA approved and research-backed medicinal therapy. This ardent stance on CBD also serves to hamper the very research efforts that could justify legitimate CBD products in their eyes, and it is this often perplexing resistance to cannabis that has many wondering if it will ever be successfully rescheduled.

Hope for the future

Many cite the 2014 Farm Bill which allowed for legal CBD derived from industrial hemp as hope for the future of CBD in medical treatment. This ruling signifies a major breakthrough, as this will allow for the legalization of other CBD applications to help utilize its therapeutic capabilities to address other health concerns. Increased acceptance and usage of CBD-driven medication could very well prompt more tolerance of its application which would be further corroborated by research that is used to develop other pharmaceuticals containing CBD.

“Continuing to study the benefits of CBD would increase the number of practical uses for the compound,” said Centuria Natural Foods CEO Michael Brubeck.

In fact, a letter was actually sent by 15 members of Congress and directed to the DEA and Attorney General Jeff Sessions, a staunch cannabis opponent, to address the discrepancy between approval of foreign cannabis cultivators while being unresponsive to local requests for research-driven cultivation projects.

The University of Mississippi is the sole beneficiary or being a licensed marijuana cultivator for research purposes since 1968, and despite DEA policy to enable additional cultivators to fuel additional studies on the plant, there has yet to be a single approved case so far.

In another letter addressed to Sessions in April, Senator Kamala Harris and Orrin Hatch emphasized the importance of promoting increased research to better understand cannabis and its potential, stating that “research on marijuana is necessary to resolve critical questions of public health and safety, such as learning the impacts of marijuana on developing brains and formulating methods to test marijuana impairment in drivers”.


Visit Innovation Enterprise’s AI & Big Data for Pharma Summit 2018, part of DATAx New York on December 12–13, 2018


Many believe that CBD can be legally acquired through specific sources such as industrial hemp. Whether grown outside the US or locally as part of pilot programs specifically for research, hemp-driven CBD still continues to dominate the market with names like PotNetwork Holdings, Inc.(OTCMKTS:POTN) accommodating cannabis consumers with such products like gummy edibles, vaping additives, and even athletic recovery creams designed to help provide pain relief and help promote wellbeing.

While the DEA still remains firm on their stance regarding cannabis and all derivatives, organizations such as the FDA, WHO, and WADA have all endorsed CBD as a safe and non-addictive substance that clearly has medicinal efficacy. As the FDA continues to press the issue for complete decriminalization of all CBD products, this represents a major green light by an administration responsible for public health and a huge stamp of approval for CBD.

Source: https://channels.theinnovationenterprise.com/articles/fda-endorsement-of-cbd-based-drug-signals-a-bright-future-for-legal-cannabis-market

« »