The CBD industry is buzzing with today’s news that the U.S. Food and Drug Administration (FDA) is working with Congress to develop a new regulatory framework for cannabidiol (CBD) products. This is great news for businesses developing CBD products, as it means that there will be a clear path forward for the lawful marketing of these products.
The FDA has convened a high-level internal working group to explore potential regulatory pathways for CBD products. This working group, led by FDA Principal Deputy Commissioner Janet Woodcock, M.D., has closely examined the existing scientific data related to CBD, including studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, and studies both conducted and commissioned by the agency.
Based on this examination, the FDA has determined that the existing dietary supplement and conventional food pathways are not appropriate for CBD. All substances, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement, food additive, or drug. The FDA has concluded that the use of CBD raises safety concerns, especially with long-term use. As a result, the agency is denying three citizen petitions asking the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
However, the FDA is not turning its back on the CBD industry. Instead, the agency is determined to develop a new pathway that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. This new pathway will provide consumers with safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools that could be included in this pathway are clear labels, including warning labels; prevention of contaminants; content limits; and measures to mitigate the risk of purchase or ingestion by children.
In addition, the FDA is also aware of the interest in using CBD for various medical conditions, and the agency is committed to supporting the development of safe and effective products through the appropriate scientific and regulatory channels. This includes working with companies to understand the complex regulatory landscape, and providing guidance on the development and submission of investigational new drug applications for products that contain CBD.
For businesses developing CBD products, it is important to remember that the FDA is committed to protecting the public health and ensuring that consumers have access to safe and effective products. As the agency works with Congress to develop a new pathway for CBD products, businesses can take steps to ensure that their products meet the highest standards of safety and quality. This includes ensuring that products are free from contaminants, accurately labeled, and manufactured in compliance with good manufacturing practices.
In summary, the FDA’s recent statement on CBD products is a call to action for businesses developing CBD products. It is an opportunity for them to take steps to ensure that their products meet the highest standards of safety and quality. The agency is committed to working with Congress to develop a new regulatory framework that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. In the meantime, businesses can take steps to ensure that their products meet the highest standards of safety and quality and are in compliance with the current regulations, and work closely with the FDA to understand the complex regulatory landscape.