What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

From the U.S. Food and Drug Administration

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, pet food, and other animal health products.

The U.S. Food and Drug Administration (FDA) recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD.

The Agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearingand information and data gathering through a public docket that is open for comment until July 16, 2019.

The recent increase in the number of CBD products may be because of both recent changes in state law, and because the 2018 Farm Bill removed 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. However, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.

Other than one prescription drug product to treat rare, severe forms of epilepsy, the 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 working to learn more about the safety of CBD and CBD products. More specifically:

• The effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time. During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of certain seizure disorders — the FDA identified certain safety risks, including the potential for liver injury. These are serious risks that can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how these risks might be managed when CBD is used far more widely, without medical supervision and not in accordance with FDA-approved labeling.
• The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? What if you use these products daily for a week or a month?
• The effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class).
• The safety of CBD use in animals (e.g., species, breed, or class) including pets.

Some CBD Products are Being Marketed with Unproven Medical Claims

Unlike drug products approved by the FDA, unapproved CBD drug products have not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation regarding whether they are safe and effective to treat a particular disease, 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.

Misleading and 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 existing, approved treatment options.

The FDA’s top priority is to protect the public health, and that includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, or cure serious diseases. For example, the agency has warned companies selling CBD products they claim are intended to prevent, diagnose, treat, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes.

The FDA has also 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 to contain. We have also heard reports of CBD potentially containing contaminants (e.g., pesticides, heavy metals); we are looking into this.

Some cannabis products are also being marketed as pet food and health products for animals. The FDA has not approved cannabis for any use in animals and recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.

The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds

The FDA continues to believe the drug approval process represents the best way to help 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.

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 currently illegal to market CBD this way.

The FDA is currently evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.

The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.

Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

More information is available at: FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.