We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.
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.
Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
Evaluation of the regulatory frameworks
The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
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 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.
In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).
There are several reasons why someone might want to use CBD. The substance can be found in a multitude of products ranging from pain-relieving creams to edible tinctures to skincare. Research is still underway, but over the last few decades scientists have become more aware of how CBD might prove beneficial when applied either topically or ingested.
Because CBD supplements come in so many different forms—such as oils, gummies, tinctures, and vapors—the amount that’s actually absorbed can vary drastically. This, combined with each person, will ultimately affect which (if any) CBD side effects you might experience.
She adds, “[Another difference is that] CBD is derived from hemp and has been classified as a legal substance. Hemp has <0.3% THC. Conversely, cannabis plants such as marijuana are grown to have much higher levels of THC and are still illegal according to the FDA, although individual states vary as to their use.”
What Is Cannabidiol (CBD)?
CBD is technically an unregulated substance in the United States and therefore it ought to be used with caution. This is especially important for those taking additional medications and/or those with ongoing medical issues. That said, preliminary research on CBD and its benefits are promising in relation to helping with mild to moderate health concerns and it is generally considered a safe substance. Health professionals do not consider CBD a cure-all for serious medical issues, including cancer.
Some people may get diarrhea or liver problems [when using CBD]. This is dependent on the individual and their medical history, so monitoring is important,” says Dr. Matharu-Daley.
Steven Gans, MD is board-certified in psychiatry and is an active supervisor, teacher, and mentor at Massachusetts General Hospital.
Also known as “cotton mouth,” CBD can potentially cause your mouth and eyes to feel very dry, notes Dr. Brent A. Bauer via Mayo Clinic. Though this side effect is more likely to occur with THC, it can happen with CBD, as well.
CBD oil is an extract of Cannabis indica or Cannabis sativa—the same plants that, when dried, make marijuana. CBD oil is believed by some to treat pain, reduce anxiety, and stimulate appetite in the same way that marijuana does, but without its psychoactive effects. CBD has also shown promise in treating certain types of seizures.
Here is just some of what the current evidence says.
This cannabis extract may help treat nerve pain, anxiety, and epilepsy
There are no guidelines for the appropriate use of CBD oil. CBD oil is usually delivered sublingually (under the tongue). Most oils are sold in 30-milliliter (mL) bottles with a dropper cap.
Medical marijuana is frequently prescribed to people with intractable (treatment-resistant) pain, including those with terminal cancer. There is some evidence that CBD contributes to this benefit.
Outside of these two disorders, CBD’s effectiveness in treating seizures is uncertain. Even with Epidiolex, it is uncertain whether the anti-seizure effects can be attributed to CBD or some other factor.