Food Supplements, the FDA and COVID-19 Infection
In this era of COVID-19, there is a heightened awareness that the FDA is charged with ensuring the safety and effectiveness of synthetic drugs. We have all heard about the role of clinical trials for FDA approval of vaccines and drugs that might mitigate COVID infection. What has received less attention is FDA’s regulatory pathway for natural or botanical products that might prevent COVID.
According to the FDA, botanical products are “products that include plant
materials, algae, macroscopic fungi, and combinations thereof” and can be designated as a botanical drug product or dietary supplement. What makes a botanical drug product different than a dietary supplement is its intended use. If it is intended to be used and marketed as a drug that can diagnose, cure, mitigate, treatment, or prevent disease, then it is a botanical drug product. If it is not intended to be used and marketed as a drug, but rather marketed as an agent that promotes health, it is designated as a food supplement. Just because a botanical product is purified or modified does not make it a botanical drug product.
Often, makers of dietary supplements want to make health claims. Dietary supplement health claims must be limited to claims about risk reduction and cannot be about the diagnosis, cure, mitigation, or treatment of disease. For example, a dietary supplement cannot claim to lower blood sugar in diabetics. Manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing. FDA is responsible approving health claims based on the scientific agreement standard. The scientific agreement standard involves a review of publicly available scientific evidence and significant scientific agreement among qualified experts that the claim is supported by the evidence.
An example of a botanical product that might be on the pathway to a health claim is CBDA. CBDA is a precursor to CBD and extracted from hemp by a method developed and marketed by MontKush. CBD and CBDA are legal under federal and state laws. New scientific research suggests that CBDA may help prevent COVID-19. This study showed that in laboratory test tubes, CBDA can block COVID entry into cells and thus could possibly prevent COVID infection. There have been no human or animal studies or trials of CBDA and COVID to date. Nonetheless, this study provides the type of information that begins the process of gaining significant scientific agreement necessary for FDA approval of a health claim.
In summary, the FDA has a standard for what is a botanical drug product and what is a food supplement. As consumers look for food supplements that may prevent COVID, they should be helped by knowing the there is a structured process for making any health claims.