What is FDA Approved CBD?

The FDA has given its stamp of approval to a drug called Epidiolex, which contains a highly purified form of CBD. This drug is used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or the tuberous sclerosis complex (TSC) in people aged one year and older. Epidiolex, produced by GW Pharmaceuticals, is the only plant-based drug approved by the FDA that contains CBD. It is used to treat two rare forms of epilepsy in children over two years of age, Lennox-Gastaut syndrome and Dravet syndrome.

The FDCA prohibits the sale of foods or dietary supplements containing an “approved drug ingredient” without explicit FDA approval. This means that the use of CBD in most products is illegal without FDA approval. However, the FDA has not yet issued a regulation that establishes a clear line between approved and unapproved uses of CBD in other products. Looking ahead, it is likely that Congress will pass a law requiring the FDA to regulate CBD as a supplement.

This would help to ensure that consumers are receiving safe and effective products. The FDA is also concerned that consumers may postpone seeking professional medical care for their animals due to unproven claims associated with unapproved CBD products. The FDA has not had the opportunity to evaluate CBD residues in foods or to establish an adequate withdrawal period. Additionally, the limits on the FDA's research budget have posed problems during the time the FDA had CBD-related issues on its agenda due to the demands associated with the COVID-19 pandemic.

The FDA remains concerned about the proliferation of products that claim to contain CBD and are marketed for therapeutic or medical purposes, even though they have not been approved by the FDA. The FDA has received reports of some CBD products that contain contaminants, such as pesticides and heavy metals, raising additional concerns about the use of CBD products. Conducting research that can provide the FDA with sufficient evidence to decide if a drug ingredient should be approved for use in food products is essential. Currently, research on the benefits of CBD is mixed.

This change could speed up the process for researchers to study cannabis and its derivatives, including CBD, which fall under the definition of hemp, which could accelerate the development of new drugs. Therefore, the FDA has concluded that it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any food or animal feed) to which THC or CBD has been added. To date, there is no data on the waste that can be produced when food-producing animals consume CBD products.