Hank Schultz wrote up a piece via Nutra Ingredients USA that the FDA sent out warning letters to eight companies marketing dietary supplements containing CBD. The letters also mention illegal drug claims based on CBD being the active ingredient in two drugs currently in development.
What is CBD?
Cannabidiol (CBD) is a fraction of the Cannabis sativa. Producers are quick to note that CBD is dissimilar to medical marijuana, as the CBD is derived from industrial hemp. The low THC content of hemp is widely popular feature of the plant and allows for a wide breadth of use.
However, CBD’s classification is still currently being debated between government agencies. Is it a drug? Is it a dietary supplement? Do we have to treat it the same way as medical marijuana is treated? The current answer remains unclear.
CBD is mainly popular for treatment of seizures, chronic pain, arthritis, PTSD, and a multitude of other symptoms or diseases. Companies cannot necessarily make these claims unless they are substantiated by credible data from scientific studies.
In six of the letters, the FDA told them that they were prohibited from marketing their drugs as dietary supplements, as CBD is excluded from that definition. The other two products were presented as food products, which would also not be the case for CBD.
GW Pharmaceuticals filed an Investigational New Drug (IND) application to continue the development of their two drugs: Sativex and Epidiolex featuring the molecule as the active ingredient. The drugs are aiming to lessen spasticity symptoms of MS and address certain childhood forms of epilepsy.
Josh Long echoes the same issues as Schultz in his Natural Products Insider article. The problem is that way the progression with the CBD to an active ingredient occurred. Generally speaking, active pharmaceutical ingredients (APIs) from botanicals (or from other sources) can be promoted as a dietary supplement as long as it fits the definition. It can then be picked up by a developer that wishes to file an IND using the substance but not the other way around.
The FDA as noted that they are willing to revisit the classification if evidence to the contrary is presented to them. Schultz asserts that the crux of the issue is whether or not the dietary supplements containing CBD were legally being marketed before INDs being filed.
Developers are undeterred, clinging to hemp’s current status as being classified as a food product.
At InstantGMP, we believe that these substances that are more than just food in that they provide health benefits. In our opinion, CBD should be manufactured to the same standards as dietary supplements. We’re experts in quality in the dietary supplements industry and are fluent in 21 CFR Part 111. Our software has been used by a multitude of companies who have a desire to improve or to introduce a quality system to their manufacturing process. We invite you to learn more about our InstantGMP™ MES solution for dietary supplements! Click here to watch our online demo and click here to get in touch.