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. Studies have been conducted on CBD products not approved by the FDA that have shown that the labeling is highly inaccurate. This is because they are not regulated in the same way as EPIDIOLEX. In recent years, CBD, one of the compounds found in marijuana that is psychoactive but does not produce a “high”, has been used in products as varied as chocolate, mascara and lotions.
The agency's silence on over-the-counter CBD means that companies have to guess what are the best ways to manufacture products. Those who produce and sell CBD products and those seeking access to them are likely to strive for favorable changes in the law. With respect to products labeled to contain hemp that may also contain THC or CBD, as mentioned above, it is prohibited under section 301 (ll) of Act FD&C to introduce or deliver for introduction into interstate commerce any food of animal origin to which THC or CBD has been added. The Food and Drug Administration's Scientific Council will finally present a way to treat CBD like other dietary supplements: it's regulated but sold without a prescription.
While the FDA appreciates the information and commitment of numerous stakeholders on CBD-related issues, there are still many gaps in the evidence. The FDA has not evaluated unapproved drugs, such as these CBD products, to determine if they are effective for their intended use, what the appropriate dosage might be, how the products might interact with FDA-approved drugs, or if they have dangerous side effects or other safety issues. These products are still available for purchase, but the Cannafyl website now contains a legal notice stating that its CBD products “are not intended to diagnose, treat, cure or prevent any disease. Over the next year and a half, the FDA published some non-binding guidance documents related to CBD products, but, citing the need for further research, there were no regulations.
While this measure prohibits the use of CBD in most products without FDA approval, the FDA has not issued a regulation that establishes clear lines between approved and unapproved uses of CBD in other products. In the past, the FDA sent warning letters to companies that illegally sold CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. This change could speed up the process for researchers to study cannabis and its derivatives, including CBD, which are included in the definition of hemp, which could accelerate the development of new drugs. We see an important public health opportunity in the use of novel data sources and rigorous analytical methods to build a stronger base of scientific evidence on the safety profile and use of CBD products.
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.