The U.S. FDA sent another series of warning letters to CBD vendors and reiterated its concerns about the safety of cannabidiol.
15 companies have recently received warning letters regarding the alleged illegal sale of CBD products. Which the FDA believes violates the Federal Food, Drugs and Cosmetics Act (FD&C Act).
It also issued a revised consumer update describing the FDA’s concerns about cannabidiol products in general. The FDA states that, based on lack of scientific information regarding the safety of CBD in food. It cannot conclude that CBD is generally recognized as safe (GRAS).
“We want to make it clear that a number of questions remain regarding the safety of the CBD . Including reports on products containing contaminants, such as pesticides and heavy metals . And that there are real risks that must be considered. ” said Amy Abernethy, MD, PhD, Senior Deputy Commissioner at the FDA.
In the Consumer Update, the FDA reaffirmed its view that it is currently illegal to market CBD in the United States by adding it to food or labeling it as a dietary supplement.
In terms of drugs, the FDA has so far approved only one CBD-based product – Epidiolex. During her review of Epidiolex, she identified certain safety risks, including the risk of liver damage. Other concerns raised by the Administration include the possibility that the CBD may affect the metabolism of other drugs and its interaction with CNS depressants such as alcohol.
In short, what the FDA is saying is that it still a lot it doesn’t about CBD and applies the precautionary principle; and that it probably scares some consumers – the desired effect. It remains to be seen to what extent this approach is justified – but no one can claim that there are no products currently available that should not be on the shelves due to quality and labeling issues.
“We recognize the important public interest in the CBD and we must work with stakeholders and industry to address the gaps in scientific knowledge, safety, and quality of many of these products,” said Dr. Abernethy.