The Food and Drug Administration (FDA) has approved Epidiolex, a drug containing purified CBD from hemp, to help treat rare seizure disorders. The FDA has concluded that this medication is safe and effective for its intended use. However, other marketed products and uses of CBD may not be approved by the FDA. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD).
The FDA recognizes the potential opportunities that cannabis or compounds derived from cannabis may offer and recognizes the strong interest in these possibilities. However, the FDA knows that some companies market products containing cannabis and compounds derived from cannabis in a way that violates the Federal Food, Drug and Cosmetic Act (Law FD&C) and that may jeopardize the health and safety of consumers. The agency is committed to protecting public health and, at the same time, taking steps to improve the efficiency of regulatory channels 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 stakeholders have access to these resources in a centralized location.
To date, the agency has not approved a request to commercialize cannabis for the treatment of any disease or condition. However, the FDA has approved one cannabis-derived drug and three cannabis-related drugs. These approved products are only available with a prescription from a licensed healthcare provider. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year or older.
It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. The agency has also approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. 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 that of THC and is synthetically derived.
The FDA remains concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses, even though 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 unfounded 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 deceptive marketing 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 the appropriate dose might be if they work, how they might interact with other drugs, or if they have dangerous side effects or other safety problems. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions such as emaciation associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. The agency's role is to review data submitted to it in an approval request to ensure that the drug meets legal approval standards. The National Institutes of Health can obtain additional information on research on medical use of cannabis.
The FDA knows that several states have passed laws that eliminate state restrictions on medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research on safety and efficacy of cannabis products through appropriate clinical trials. The agency welcomes opportunity to speak with states considering supporting medical research on cannabis and its derivatives so it can provide information on federal and scientific standards. Information on reports of adverse effects on cannabis use is extremely limited; primarily adverse event reports for approved products are received by FDA.
General information on possible adverse effects of use of cannabis and its components may come from published clinical trials as well as from spontaneously reported adverse events sent to FDA. Additional information is needed on safety and effectiveness of cannabis and its components; clinical trials with cannabis conducted pursuant to request from IND could collect this important information as part of drug development process. There is an exception to section 201 (ff) (B) if substance was marketed as dietary supplement or conventional food before drug was approved or before new pharmacological research was authorized; however based on available evidence FDA has concluded this is not case with THC or CBD.
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