What Are the Regulations Surrounding Hemp Products?

The cultivation, processing, and sale of industrial hemp or cannabis products are regulated in at least 47 states. The laws usually define industrial hemp as having a concentration of 0.3 percent or less of THC, except for West Virginia which has a concentration limit of 1 percent or less. There is a great deal of interest in the development of therapies and other consumer products derived from cannabis and its components, such as cannabidiol (CBD).The FDA is aware that some companies market products containing cannabis and compounds derived from cannabis in a way that violates the Federal Food, Drug and Cosmetic Act (FD&C Act) and may put consumers' health and safety at risk. The agency is committed to protecting public health while also 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 wants to ensure that consumers and other stakeholders have access to these resources in one place. To date, the FDA has not approved any requests 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 tuberous sclerosis complex in patients 1 year of age or older.

Marinol and Syndros have been approved for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS. Marinol and Syndros contain the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that is considered the psychoactive component of cannabis. Cesamet contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. The FDA is concerned about products claiming to contain CBD that are marketed for therapeutic or medical uses without being reviewed by the FDA as part of the drug approval process. These products have not been proven to be safe or effective, may interact with other drugs, or have dangerous side effects.

The agency knows that unapproved cannabis or cannabis-derived products are used to treat a number of medical conditions, such as AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and nausea induced by cancer and chemotherapy. The FDA relies on applicants and scientific researchers to conduct research. The agency's role is to review data submitted in an approval request to ensure that the drug meets legal approval standards. The FDA will continue to facilitate companies interested in bringing safe, effective, and quality products to market, including research on the medicinal uses of cannabis. The FDA knows that several states have passed laws eliminating 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 clinical trials.

The agency welcomes the opportunity to speak with states considering supporting medical research on cannabis and its derivatives. The FDA receives adverse event reports for approved products but information on reports of adverse effects from cannabis use is limited. General information on possible adverse effects from using cannabis and its components may come from published clinical trials or spontaneously reported adverse events sent to the FDA. The FDA is not aware of any evidence challenging its current findings that products containing THC and CBD are excluded from the definition of dietary supplement under section 201 (ff) (B) of FD&C Act.

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