Understanding Hemp CBD Regulations

The New York State Cannabis Management Office is responsible for regulating hemp used or marketed for its cannabinoid content, such as cannabidiol (CBD). It is important to note that the FDA recognizes the potential opportunities that cannabis or compounds derived from cannabis may offer and is committed to protecting public health. 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 a centralized location. 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 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 for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in patients with AIDS.

Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to that of THC and is synthetically derived. 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's role is to review the data submitted to the FDA in an approval request to ensure that the drug meets legal approval standards. The FDA 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. The National Institutes of Health, in particular the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA), can obtain additional information on research on the medical use of cannabis. The FDA knows that several states have passed laws that eliminate state restrictions on the medical use of cannabis and its derivatives or are considering doing so. We welcome the opportunity to speak with states that are considering supporting medical research on cannabis and its derivatives. Information on reports of adverse effects on cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products.

General information on the possible adverse effects of the use of 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 effectiveness of cannabis and its components. Clinical trials with cannabis conducted pursuant to a request from the IND could collect this important information as part of the drug development process. There is an exception to section 201 (ff) (B) if the substance was marketed as a dietary supplement or as a conventional food before the drug was approved or before new pharmacological research was authorized, as appropriate. However, based on available evidence, the FDA has concluded that this is not the case with THC or CBD. 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.

Micaela de Gallardo
Micaela de Gallardo

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