Yes, buying CBD is federally legal as long as it doesn't contain more than 0 or 3 percent THC, but some state laws have imposed restrictions on buyers. The .gov means it's official, federal government websites usually end up in .government or .mil. Before sharing sensitive information, make sure you're on a federal government site. 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 that contain cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD%26C) 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 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 FDA has not approved an application 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. 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 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. That means that the FDA has concluded that this particular drug is safe and effective for its intended use. The agency 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 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, as set out in Act FD%26C, is to review the data submitted to the FDA 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, 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. We welcome the opportunity to talk to states that are considering supporting medical research on cannabis and its derivatives so that we can provide information on federal and scientific regulations. 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 possible adverse effects of using cannabis or 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 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 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 research on new drugs was authorized as appropriate. However based on available evidence FDA has concluded this is not case with THC or CBD.
The FDA is not aware any evidence could challenge its current findings that THC and CBD products are excluded from definition dietary supplement under section 201 (ff) (B) Act FD%26C. Interested parties can submit agency any evidence they consider related.
