The US Food and Drug Administration issued a statement yesterday warning the public about the dangers of using CBD including liver injury, drug interactions, and possible male reproductive toxicity. The FDA also stated that, due to the lack of information about CBD, it will use scientific methods to determine whether it is safe. The FDA’s review will most likely result in the federal oversight of CBD and other cannabis products as it is also considering a regulatory framework.
The FDA’s proactive approach may be in response to the recent vaping illnesses that the CDC has attributed mostly to THC and CBD products. The CDC found THC in 82% of the samples collected from patients. To date, there are 2,290 persons who experienced vaping related illnesses with 47 deaths. The FDA has been publicly criticized for not acting more quickly in establishing regulations to ensure the safety of vaping products.
The FDA seems to be moving on CBD products to avoid a similar result. The FDA noted that consumers believe that CBD is safe to use. The FDA notes that information from drug trials shows that CBD can negatively impact a person’s health. As a result, the FDA is investigating how CBD impacts the body, different types of people and animals.
The FDA bolsters its claims about the mysteries of CBD by citing results from its own internal tests. The tests showed that the levels of CBD in the products were not as marketed. The FDA also notes that it has received reports of CBD that contained contaminants including heavy metals, pesticides, and THC. The FDA noted the products are being sold as a cure for numerous health-related issues without corresponding data.
The FDA’s warning foreshadows the fate of the CBD industry- federal regulatory oversight. The FDA will use scientific data to show that CBD is not safe as sold currently to the general public and to justify regulatory oversight.
Why is this the case? On May 31, 2019, the FDA provided the industry with the opportunity to prove that CBD products are safe. The FDA held a full day of public hearings to gather scientific data and information from the industry. The FDA apparently did not obtain the scientific information that it was seeking.
Yesterday, the FDA noted that there is little information available about CBD and the effects on the body. The FDA emphasized that “there are many unanswered questions about the science, safety, and quality of products containing CBD.” Since CBD is a drug, the FDA has the upper hand to ensure that similar products are proven to be safe for use by the general public.
What can the industry do? The industry should focus on the FDA’s skepticism of the safety, marketing, and labeling of CBD products. The industry needs to proactively implement a self-regulatory framework that addresses these three prongs. This might not stop the regulatory train. It could, however, stop the FDA from banning the products altogether.