cbd fda warning letter

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. New human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs. CBD was not an ingredient considered under the OTC Drug Review.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food, and some of the products were impermissibly marketed as “dietary supplements.”

The warning letters were issued to:

Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.

“The FDA’s first priority is to protect the health and safety of Americans. Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose the greatest risk of harm to the public.”

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The FDA has not approved any CBD products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in human patients. CBD has not been approved as a food additive and does not meet the statutory definition of a dietary supplement.

The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs. It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of these unapproved CBD-containing drug products has not been subject to FDA review as part of the human or animal drug approval processes, so it is not known what the manufacturing conditions of, or contaminant levels in these products may be.

The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.

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The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

Additionally, some of the products outlined in the warning letters issued today raise other legal and public health concerns:

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

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“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “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.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”