The Food and Drug Administration (FDA) prohibits the sale of foods or dietary supplements containing an “approved drug ingredient” without explicit approval from the FDA. When the FDA approved Epidiolex, a seizure medication containing CBD, it became an approved pharmacological ingredient. This measure makes the use of CBD in most products illegal without FDA approval, as the FDA has not yet issued a regulation that establishes clear lines between approved and unapproved uses of CBD in other products. The potential for profits in this area has created strong financial pressures to legalize the use of CBD.
To make a decision on whether an ingredient in a drug should be approved for use in food products, research must be conducted to provide the FDA with sufficient evidence. However, current research into the benefits of CBD is contradictory. Despite this, CBD products are widely available in stores, gas stations, beauty salons, and online. The FDA has sent warning letters to companies that illegally sold unapproved CBD products on the grounds of preventing, diagnosing, mitigating, treating or curing various diseases, in violation of Act FD&C.
The FDA has also explained that its delay in issuing regulations on CBD is necessary to investigate the side effects of CBD. Over-the-counter drugs must be approved by the FDA or meet marketing requirements without an application for a new drug approved under federal law, including drugs containing CBD. We still don't have clear answers to important questions about CBD products, such as what adverse reactions may be associated with them and what risks are associated with long-term use. The FDA is studying issues related to CBD products, some state governments are striving to replace these products with their own standards, and Congress is considering measures to reduce or eliminate FDA restrictions. Sampling and testing of marketed CBD products is another way in which the FDA has collected more information about the safety profile of these products. In the end, time will tell if the FDA believes in the high hopes of CBD and, if so, how its regulatory approach will change.
It's essential that research is conducted to address the most important practical and scientific challenges in this area so that data collection and analysis efforts can have maximum scientific impact.