The United States Food and Drug Administration said that it is now taking a science-based approach in determining the efficacy and safety of cannabis.
It can be recalled that the FDA has recently held its first-ever public hearings as it considers how to handle the legality of cannabidiol or CBD. The FDA is starting the process of figuring out how to regulate the burgeoning industry.
What happened at the hearings?
The FDA’s campus auditorium overflowed with various interested parties when it conducted its hearing last month. There were reportedly more than 400 applicants who had petitioned for a chance to testify and the agency had to create a lottery system to narrow down the list to 120.
Each witness was given two or five minutes to make a case to the FDA’s presiding panel of top officials. This resulted in an all-day affair of claims and counterclaims being volleyed over matters of cannabis efficacy and safety.
Needless to say, the hearing was the FDA’s first step in what is going to be a very long process of defining a legal path for the cannabis and CBD market.
FDA commits to sound, science-based policy
In its website, the FDA signals a willingness to open its mind to the potential benefits of cannabis, CBD, and other cannabis-derived compounds. However, the agency is urging the public to allow them to analyze scientific evidence.
The FDA states that they recognize the substantial public interest in accessing and marketing CBD in food and in dietary supplements. They also recognize the potential benefits of CBD.
However, the FDA also points out that questions remain regarding the science, safety, and quality of CBD products. There are also challenging and important questions regarding public health and regulatory policy.
The agency says that they will approach these questions as a science-based regulatory body that is committed to their mission of promoting and protecting public health.
Next issues to tackle
The FDA is looking at cannabis or CBD on two parallel tracks: one is CBD for drugs and the other is CBD for food and dietary supplements. As of now, it is illegal to sell food containing CBD or to market it as a supplement. The FDA says that they are serious about their consideration of CBD in food and in other non-drug products.
The FDA has already approved one CBD-based drug: Epidiolex. In fact, it is the first and only FDA-approved prescription CBD. The drug, manufactured by UK-based GW Pharmaceuticals, was developed to treat seizures that are associated with Dravet syndrome and Lennox-Gastaut syndrome in patients two years old and older. It is, however, not yet known whether Epidiolex is safe and effective in children younger than two. It is also feared that Epidiolex may cause liver problems.
According to the agency, among the potential issues they want to know more about is whether cannabis-derived substances affect the liver. They are also interested in knowing whether these substances can be beneficial in the field of veterinary medicine.
While many players in the health community believe that cannabis has therapeutic value, the FDA maintains that it is critical that they continue to support the science needed to develop new medications from cannabis. They assure the public that they are committed to taking a science-based decision-making process where CBD is concerned, while also taking steps to consider appropriate regulatory pathways for the lawful marketing of this compound outside of the drug setting.
The agency is still currently reviewing written comments and testimonies that were submitted to its public docket. This docket will remain open for those who wish to submit more comments until July 16, 2019.