Is CBD Oil Legal in the USA?

Yes, buying CBD is federally legal as long as it doesn't contain more than 0.3 percent THC, but some state laws have imposed restrictions on buyers. The U. S. government has made it official that federal websites often end in .gov or .mil.

Before sharing sensitive information, make sure you're on a federal government site. There is a great deal of interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). The FDA acknowledges the potential opportunities that cannabis or cannabis-derived compounds may offer and recognizes the strong interest in these possibilities. However, the FDA is aware that some companies market products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.

The agency is committed to protecting public health and, at the same time, to taking steps to improve the efficiency of regulatory channels for the legal marketing of appropriate cannabis and cannabis-derived products. The FDA has several 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 place. Below are a series of frequently asked questions and answers on this topic. 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 substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Epidiolex has also been approved for the treatment of seizures associated with tuberous sclerosis complex in patients aged 1 year and older. This means that the FDA has concluded that this particular drug is safe and effective for its intended use.

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 to be 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 synthetically derived. The FDA remains concerned about the proliferation of products that claim to contain CBD and are marketed for therapeutic or medical purposes, even though they have not been approved by the FDA. These products are often sold online and are therefore available everywhere.

Selling unapproved products with baseless therapeutic claims is not only a violation of law but can also put patients at risk since these products have not been proven to be safe or effective. This misleading marketing of unproven treatments also poses significant public health problems since patients and other users can be influenced not to use approved therapies to treat serious and even fatal illnesses. Unlike FDA-approved drugs, 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 their appropriate dose may be, how they might interact with other drugs or if they have hazardous side effects or other safety concerns. The FDA knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions such as wasting associated with AIDS, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer-induced nausea and chemotherapy. The FDA relies on applicants and scientific researchers to conduct research on safety and efficacy of cannabis products through adequate and well-controlled clinical trials. The agency's role as set out in FD&C Act is to review data submitted to the FDA in an approval request to ensure that the drug meets legal approval standards.

The FDA will continue to facilitate work by companies interested in properly marketing safe, effective, and quality products including science-based research on medicinal uses of cannabis. The National Institutes of Health (NIH), particularly National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA), provide additional information on research on medical use of cannabis. The FDA knows that several states have passed laws removing 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 adequate and well-controlled clinical trials. The agency welcomes opportunity to speak with states considering supporting medical research on cannabis and its derivatives in order to provide information on federal regulations as well as scientific regulations. Information on reports of adverse events related to cannabis use is extremely limited; mainly reports from approved products are received by FDA.

General information on possible adverse effects from use of cannabis or its components may come from clinical trials published as well as from spontaneously reported adverse events sent to FDA. Additional information is needed on safety and efficacy of cannabis or its components. Cannabis clinical trials conducted under IND request could gather 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. FDA is not aware any evidence could question current findings that products containing THC & CBD are excluded from definition dietary supplement under section 201(ff)(B) FD&C Act; interested parties can submit agency any evidence consider related this issue.

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Claudette Bulkin
Claudette Bulkin

Hardcore burrito aficionado. Typical food fan. Amateur coffee evangelist. Total internet guru. Proud web fanatic.