The FDA had already sent warning letters to other companies that illegally sold unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of Act FD&C. In some cases, there were more violations because CBD was added to food products. The FDA has not approved any CBD product other than a prescription drug for humans to treat severe and rare forms of epilepsy. Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD.
As part of these actions, the FDA analyzed the chemical content of cannabinoid compounds in some of the products, and it was found that many did not contain the levels of CBD they claimed to contain. New FDA tests revealed that nearly half of the randomly selected cannabidiol (CBD) products also tested positive for THC, the main active compound in marijuana, calling into question the accuracy of the labeling of CBD products. CBD and delta-8 THC are food additives not approved for use in any human or animal food product, since the FDA knows no basis for concluding that the substances are generally recognized as safe (GRAS) or are exempt from food additive requirements. As for CBD's mischiest cousin, THC, the study found that 49 percent of the products tested (72 in total) contained THC in quantities above the limit of quantification (LOQ).
Of that group, only two products that claimed to contain CBD did not contain CBD, a relatively high level of accuracy. Over the past few years, the FDA has issued several warning letters to companies that market new, unapproved drugs that supposedly contain cannabidiol (CBD). Of the 102 products that included a specific amount of CBD, less than half of 45 percent contained CBD within 20 percent of the indicated amount. We remain focused on exploring possible avenues for CBD products to be legally marketed and, at the same time, we are informing the public about these outstanding issues regarding the safety of CBD.
Of these, FDA researchers found that only 45% of the products “contained CBD within 20% of the indicated amount.” It is important to note that the FDA has not approved any other cannabis product, derived from cannabis or cannabidiol (CBD) currently available on the market. In addition to violations related to FDA-regulated products containing THC delta-8, several of the warning letters describe additional violations of Act FD&C, including the marketing of CBD products that claim to treat medical conditions in humans and animals, the promotion of CBD products such as dietary supplements and adding CBD to food for humans and animals. This change in the law could result in a more streamlined process for researchers to study cannabis and its derivatives, including CBD, which fall under the definition of hemp, a result that could accelerate the development of new drugs containing hemp. And in the 21 that did, only seven had a CBD concentration within 20% of the amount indicated on their labels.
While CBD is unlikely to cause a “high”, THC is a psychoactive substance that can cause this response.
