FDA’s Partial Approval of CBD
The United States’ federal law illegalizes the use of cannabis. Nonetheless, the usage of cannabidiol products (CBD) is legal. CBD usage is standard as medication and not as a food or dietary supplement. The US Food and Drug Administration (FDA) approved CBD oral solution for epilepsy.
It is the first cannabis-based drug to be approved under the FDA. However, the FDA is hesitant to legalize the use of CBD products. Some companies market CBD products inconsistently with the laws put in place. Marketing that violates the FDA’s laws puts the health and safety of consumers at risk.
Challenges Encountered By the FDA
The FDA is vitally interested in the development of treatments and consumer products that are cannabis-based. It recognizes the potential opportunities cannabis-based products stand to offer. FDA lacks detailed guidelines and policies to govern the approval of CBD products, however. Food and cannabis companies are, therefore, unable to sell and market in the US freely.
For the FDA, its primary concern is on the marketing of the CBD products by some companies. Some include inaccurate claims of its efficiency. Others have wrong ratios in their products. This violates the Federal Food, Drug, and Cosmetic Act as well as the FDA’s laws. Ultimately, this violation puts the health and safety of consumers at risk.
FDA Works on CBD Guidelines for Dietary Supplements
Currently, the use of cannabis is illegal under US federal law. The legalization of cannabidiol products is a recent ordinance. Information on the safety of CBD as dietary supplements is minimal. The agency is, therefore, working with individual manufacturers to learn how cannabis-products are derived. It is also investigating and coming up with rules that would allow the use of CBD in food derivatives.
The FDA is hesitant in allowing CBD as a food derivative as it thinks this may raise concerns. Thus, the agency is seeking and evaluating information from trade groups and manufacturers. The information obtained assists in understanding the therapeutic use of hemp derivatives. The cannabis industry enthusiastically awaits the clear guidelines from the agency.
Safety of CBD Products
The agency is devoted to securing the health of the public. The FDA, therefore, requires intensive research and controlled clinical trials to be carried out before approval. It also seeks to improve and establish guidelines for the development of CBD products. In light of this, the FDA has opened a public docket to allow insights from the public. In gathering this information, the agency will better understand the risks and benefits involved.
CBD for Epilepsy Is Approved by the FDA
The CBD oral solution, Epidiolex, is the first approved hemp derivative to be used in treatment. Epidiolex is ratified for treatment in the two most severe forms of epilepsy. Lennox-Gastaut syndrome (LSG) and Dravet syndrome are severe epileptic disorders and resistant to many forms of treatment.
LSG is a childhood epilepsy syndrome depicted by multiple seizure types and mental degradation. Dravet syndrome is epilepsy characterized by seizures and accelerated by high temperatures and fever. Both ailments often do not respond to treatment and have a high mortality rate.
Epidiolex is the first drug to be accepted by the FDA for the treatment of Dravet syndrome. GW Pharmaceuticals developed the CBD oral solution. Approval of the drug had been preceded by rigorous research and controlled clinical trials.