Cannabidiol (CBD) is a compound derived from cannabis that has gained significant interest in recent years due to its potential therapeutic benefits. The US Food and Drug Administration (FDA) has taken steps to ensure that consumers and other stakeholders have access to accurate information about CBD and its regulation. In this article, we will discuss the FDA's stance on CBD, the approved products that contain it, and the legal requirements for marketing CBD products. The FDA has concluded that products containing THC and CBD are excluded from the definition of dietary supplement in the Federal Food, Drug and Cosmetic Act (FD&C Act). This means that the FDA has not approved any cannabis-derived products as dietary supplements.
However, the FDA has approved one cannabis-derived drug and three cannabis-related drugs for therapeutic use in the United States. The FDA-approved drug Epidiolex contains a purified form of CBD and is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year or older. It is also approved for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. The FDA has also approved Marinol and Syndros, which contain the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC), for therapeutic uses in the United States. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to that of THC and is synthetically derived. The FDA is aware that some companies are marketing products containing cannabis and compounds derived from cannabis in a way that violates the FD&C Act and may put consumers' health and safety at risk.
The agency is committed to protecting public health while taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. In order to legally market a product containing CBD, companies must submit an Investigational New Drug (IND) application to the FDA. This application must include data from clinical trials demonstrating that the product is safe and effective for its intended use. Companies must also comply with all other applicable laws and regulations, including those related to current good manufacturing practice (CGMP) and labeling. The FDA is not aware of any evidence that could challenge its current findings that products containing THC and CBD are excluded from the definition of dietary supplement under section 201 (ff) (B) of the FD&C Act. Interested parties may submit evidence to the agency related to this issue.
If a substance is excluded from the definition of dietary supplement under section 201 (ff) (B) of the FD&C Act, it remains excluded unless the FDA issues a regulation determining that it would be legal under this act. The FDA encourages companies interested in bringing safe, effective, and quality products containing CBD to market to conduct scientific research on its medicinal uses. The National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA), can provide additional information on research on medical use of cannabis. The FDA also encourages consumers to report any adverse effects they experience from using cannabis or cannabis-derived products. This information can help inform future research on safety and efficacy of these products. In conclusion, while there is significant interest in developing therapies and other consumer products derived from cannabis or its components, including CBD, it is important to understand how these products are regulated by the FDA. Companies must comply with all applicable laws and regulations when marketing these products, including submitting an IND application if necessary.
Consumers should also be aware of potential risks associated with using these products.
Leave Reply