The Agricultural Improvement Act of 2018 removed hemp from the federal Controlled Substances Act, effectively legalizing CBD if it comes from hemp. The U. S. Food and Drug Administration (FDA) has developed and implemented inter-agency strategies and policies for the regulation of cannabis products.
To date, the FDA has not approved any applications for the marketing of cannabis for the treatment of any disease or condition. However, the FDA has approved one cannabis-derived drug and three cannabis-related drugs, all of which require a prescription from a licensed healthcare provider. 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 (NIH), in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), provide additional information on research on the medical use of cannabis. 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.
It is important to conduct medical research on the safety and efficacy of cannabis products through appropriate and well-controlled clinical trials. The agency welcomes opportunities to talk to states that are considering supporting medical research on cannabis and its derivatives. Information in reports of adverse events related to cannabis use is extremely limited; the FDA mainly receives reports of adverse events from approved products. General information on the possible adverse effects of using cannabis and its components may come from published clinical trials as well as from spontaneously reported adverse events sent to the FDA. Additional information is needed on the safety and efficacy of cannabis and its components. Clinical trials on cannabis conducted under an Investigational New Drug (IND) request could collect this important information as part of the drug development process. There is an exception to section 201(ff)(B) if a substance was marketed as a dietary supplement or as a conventional food before a drug was approved or before research on new drugs was authorized.
However, based on available evidence, the FDA has concluded that this is not applicable to THC or CBD. When a substance is excluded from being defined as a dietary supplement under section 201(ff)(B) of Act FD&C, this exclusion applies unless the FDA has issued a regulation determining that it would be legal under Act FD&C. To date, no such regulation has been issued for any substance. Many other legal requirements apply to dietary supplement products including requirements related to current good manufacturing practices (cGMP) and labeling.
THC (dronabinol) is an active ingredient in approved drugs such as Marinol....
