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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.

CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.

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).

Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices

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.

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.

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.

“This overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” Abernethy said. The agency encouraged consumers to speak with health care professionals about how to treat diseases and conditions with existing drugs, and to be wary of “unsubstantiated claims” associated with CBD products.

CBD, short for cannabidiol, is a chemical found in cannabis that does not induce a mind-bending high. Although drug developers have long sought to uncover the potential health benefits of CBD, to date, only one CBD product has survived the FDA approval process — a prescription drug to treat rare forms of childhood epilepsy. Nonetheless, consumers can now purchase any number of unapproved CBD products, from oils to chocolate bars to pet foods, from companies that claim their goods deliver therapeutic benefits or help treat disease.

CBD products may be trendy, but health officials are worried that these products — which are often marketed illegally — may not be safe.

For instance, when scientists first tested the safety of the approved CBD epilepsy drug, they noted that CBD could inflict damage to the liver. If taken without medical supervision, the damage could prove more extensive, the FDA said in a consumer update on cannabis-derived compounds. Several studies indicate that CBD may alter how the body breaks down other drugs, either increasing or decreasing their potency. In addition, studies in animals suggest the compound may impede the function of testes and sperm, deplete testosterone levels and impair male sexual behavior.

The FDA defines a “drug” as any non-food product intended to treat a disease, have a therapeutic use, or affect the structure or function of the body. By this definition, many CBD products count as drugs and should be subject to the same scrutiny as other pharmaceuticals, Abernethy said. In addition, the FDA will continue to evaluate the safety and regulation of CBD products intended for “non-drug uses,” according to the consumer update.

Yesterday (Nov. 26), the U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies that sell CBD products because the products violate federal law. The agency also issued an update to consumers about the popular products, and stressed that there is limited evidence for their safety.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,'” Dr. Amy Abernethy, the FDA’s principal deputy commissioner, said in a statement. In reality, the FDA does not have enough data to say whether CBD can be “generally recognized as safe,” and several reports raise questions about the unintended health consequences of consuming the compound.

Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). As part of these actions, FDA 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 to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.