The Food and Drug Administration (FDA) is the federal agency responsible for regulating cannabis and cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act (FD&C) (21 U, S, C). The FDA recognizes the potential opportunities that cannabis or compounds derived from cannabis may offer and 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. To date, the FDA has not approved a request to commercialize cannabis for the treatment of any disease or condition. However, the agency 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 the tuberous sclerosis complex in patients 1 year of age or older. Marinol and Syndros have also been approved by the FDA for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS.
These drugs contain active ingredients such as dronabinol (a synthetic delta-9-tetrahydrocannabinol (THC)) and nabilone (a chemical structure similar to THC).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. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as the emaciation of AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy.
The agency relies on applicants and scientific researchers to conduct research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. 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 Act FD&C. Interested parties may submit to the agency any evidence they consider related to this issue. Our continuous review of the information that has been presented so far has not led us to change our conclusions. The FDA wants to ensure that consumers and other stakeholders have access to resources related to cannabis and cannabis-derived products in a centralized location. The agency will continue to facilitate the work of companies interested in adequately bringing safe, effective and quality products to the market, including scientifically based research on the medicinal uses of cannabis.
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