Based on available evidence, the FDA has concluded that THC and CBD products are excluded from the definition of dietary supplement. This means that these products are not legally available as dietary supplements. The FDA has approved one cannabis-derived drug and three cannabis-related drugs, which are only available with a prescription from a licensed healthcare provider. The agency is committed to protecting public health and, at the same time, taking steps to improve the efficiency of regulatory pathways for the legal marketing of appropriate cannabis and cannabis-derived products.
The FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other interested parties have access to these resources in a centralized location. To date, the agency has not approved an application for the marketing of cannabis for the treatment of any disease or condition. However, the FDA has approved Epidiolex, which contains a purified form of the drug CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. It has also approved Epidiolex for the treatment of seizures associated with the tuberous sclerosis complex in patients aged 1 year or older.
Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is obtained synthetically. The FDA remains concerned about the proliferation of products that claim to contain CBD and that are marketed for therapeutic or medical uses, although they have not been approved by the FDA. Often, these products are sold online and are therefore available across the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but it can also put patients at risk, as these products have not been proven to be safe or effective.
This misleading advertising of unproven treatments also raises significant public health problems, since patients and other consumers can be influenced not to use approved therapies to treat serious and even fatal diseases. Unlike drugs approved by the FDA, products that have not been reviewed by the FDA as part of the drug approval process have not been evaluated to determine if they work, what is the right dosage, if they work, how they might interact with other drugs, or if they have dangerous side effects or other safety issues. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as wasting caused by AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. The FDA depends on applicants and scientific researchers to conduct its research. The agency's role is to review the data submitted to it in an application for approval to ensure that the drug meets legal approval standards. The FDA will continue to facilitate the work of companies interested in properly marketing safe, effective and quality products, including science-based research on the medicinal uses of cannabis.
The National Institutes of Health provide additional information on research on the medical use of cannabis. It is important to conduct medical research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. The FDA knows that several states have passed laws that remove state restrictions on the medical use of cannabis and its derivatives, or are considering doing so. Information in reports of adverse events related to cannabis use is extremely limited; however general information on possible adverse effects may come from published clinical trials. Additional information is needed on the safety and efficacy of cannabis and its components. Clinical trials on cannabis conducted under an IND request could collect this important information as part of the drug development process.
There is an exception to section 201 (ff) (B) if the substance was marketed as a dietary supplement or as a conventional food before the drug was approved or before research on new drugs was authorized; however based on available evidence this is not applicable for THC or CBD.
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