On November 25, 2019 the FDA sent 15 more warning letters to CBD product manufacturers and sellers regarding the content and labeling of their products. For the most part, the warnings relate to claims made about the products which the FDA concludes make the products new drugs because they claim to cure or prevent a disease. Some of the claims include:
- “CBD relieves pain and inflammation.”
- “Studies show that CBD prevents human experimental sycosis and is effective in open case reports and clinical trials and patients with schizophrenia, with a remarkable safety profile.”
- “Not only does the research show that CBD benefits including being affective in fighting breast cancer cells, data also suggests that it can be used to inhibit the invasion of lung and colon cancer, plus it possesses and anti-tumor properties and gliomas and has been used to treat leukemia.”
In addition claims related to PTSD, fibromyalgia, schizophrenia, diabetes, MS, crones disease, and opioid addiction are all claims that the FDA counts as inappropriate given the existing data. Such labeling makes the CBD products misbranded under the Food Drug and Cosmetic Act (“FDCA”).
In addition, the warnings include the addition of CBD into human food. Under current regulations CBD cannot be added to food and makes that food adulterated because CBD is already approved for use in a drug (Epiodiolex) and is not generally recognized as safe (GRAS). Food additives require premarket approval based on demonstrated safety. CBD has not been approved for its intended use and CBD is not the subject of any prior sanction allowing for its use in food.
Finally, the addition of CBD to animal food still renders the product adulterated under the act. The same food additive requirements that apply to human food also apply to animal food.
The companies have 15 days to respond to the FDA and explain how they are going to address FDA concerns.
This is more evidence that the FDA will continue to regulate CBD as a food additive and dietary supplement, and strictly construe claims that CBD cures or prevents diseases.