The U.S. Food and Drug Administration (FDA) has announced that its current regulatory framework is insufficient to control products containing cannabidiol (CBD), and as a result, the agency will modify its regulatory oversight.
The late January announcement describes how the agency intends to balance the consumer’s desire for CBD products with its mandate to manage risk by implementing regulations on CBD that would fall outside the normal purview of dietary supplement regulations.
Cannabidiol is an organic chemical found in the cannabis plant. CBD lacks the psychoactive chemical tetrahydrocannabinol (THC) found in marijuana that produces a sensation of being “high.” CBD products come in the form of oils, extracts, vaporized liquids, oil-based capsules and edibles. Because these products do not contain psychoactive THC, CBD exists in a legal gray area, being neither explicitly illegal nor completely allowed.
The FDA statement notes that “the use of CBD raises various safety concerns, especially with long-term use.” The agency cites studies that show potential harm to the liver, dangerous interaction with medications and potential damage to male reproductive organs. Additionally, CBD is not vetted for use in vulnerable populations such as children or those who are pregnant.
The FDA’s new regulatory pathway would provide safeguards and oversights to benefit consumers and minimize risks. Currently, the agency’s existing food and dietary supplement regulations provide only “limited tools” and must currently meet safety standards for dietary supplements or food additives. However, the FDA has denied three citizen petitions requesting that CBD be marketed as a dietary supplement.
Some risk management tools of the new pathway include:
- Clear labels describing the product’s composition
- Best practices for the prevention of contaminants
- CBD content limits
- Regulatory measures, such as creating a minimum purchase age, to mitigate the risk of ingestion by children
Creating a new pathway for CBD products would also allow the FDA to regulate CBD products intended for animal consumption. This pathway would allow for the study of CBD exposure through the meat, milk, or eggs of animals who were fed CBD.
In order for the FDA to acquire a new regulatory pathway, it will need an act of Congress to expand the Food Drug & Cosmetics Act.