The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices
The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:
You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.
Unproven medical claims, unsafe manufacturing practices
Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
After Charlotte’s story got out, hundreds of families relocated to Colorado where they could procure CBD for their children, though not all experienced such life-changing results. Instead of moving, other families obtained CBD oil through the illegal distribution networks.
CBD first came to public attention in a 2013 CNN documentary called Weed. The piece, reported by Dr Sanjay Gupta, featured a little girl in Colorado named Charlotte, who had a rare life-threatening form of epilepsy called Dravet syndrome.
While studies have shown CBD to have anti-inflammatory, anti-pain and anti-psychotic properties, it has seen only minimal testing in human clinical trials, where scientists determine what a drug does, how much patients should take, its side effects and so on.
The first thing to know about CBD is that it is not psychoactive; it doesn’t get people high. The primary psychoactive ingredient in marijuana is tetrahydrocannabinol (THC). But THC is only one of the scores of chemicals – known as cannabinoids – produced by the cannabis plant.
The ruling was contrary to existing evidence, which suggests the chemical is safe and could have multiple important uses as medicine. Many cannabis advocates consider it a miracle medicine, capable of relieving conditions as disparate as depression, arthritis and diabetes.
While parents treating their children with CBD had to proceed based on trial and error, like a folk medicine, they also had to wonder whether dispensary purchased CBD was professionally manufactured and contained what the package said it did. GW brought a scientific understanding and pharmaceutical grade manufacturing to this promising compound.
Despite the government ruling, CBD is widely available over the counter in dispensaries in states where marijuana is legal.
In early May, a federal court declined to protect cannabidiol (CBD), a chemical produced by the cannabis plant, from federal law enforcement, despite widespread belief in its medical value.
Editorial Director, Analytical Cannabis
THC and CBD are just two compounds from a family of around 113 bi- and tri-cyclic compounds found naturally in cannabis. Both CBD and THC share the exact same molecular formula, C21H30O2, containing twenty-one atoms of carbon, thirty of hydrogen and two of oxygen. Their molecular mass is practically identical with THC and CBD having masses of 314.469 g/mol 314.464 g/mol, respectively.
The use of cannabis as a medicinal plant dates back thousands of years across cultures around the world. However, due to relatively modern restrictions and regulations, the research into the use of cannabis as a medicine in the modern world has been severely limited. As the legalization and decimalization of cannabis increase around the world, the ability to research its potential uses is opening up.