The FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the FD&C Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Today, the U.S. Food and Drug Administration issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. FDA has issued warning letters to 4 companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest. These firms also market products for people.
FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
Violations Include Marketing Unapproved New Drugs, Misbranding, Adding Delta-8 THC to Food Products
Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.
There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, 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.
Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.
In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods. CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements. One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.
The FDA issued warning letters to:
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief
Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations
The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.
“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. 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 a risk to public health.”
The FDA issued warning letters to:
The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, 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.
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.
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, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.
The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.
The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these 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, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.
Under the Federal Food, Drug, and Cosmetic (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 human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. Therefore, all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell. Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs.
Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.
The FDA is concerned about these CBD products for food-producing animals not only because CBD could pose a safety risk for the animals themselves, but also because of lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products.
After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system. Part of the animal drug approval process includes setting a withdrawal period to establish the minimum amount of time between the last dose of a drug and the slaughter or harvesting of food products from the treated animals. Since CBD is an unapproved drug, the FDA has not had the opportunity to evaluate CBD residues in food or to establish an appropriate withdrawal period.
To date, there is a lack of data on the residues that may result when food-producing animals consume CBD products. There is also a lack of data on what levels of potential residues are safe for a person consuming the foods that come from CBD-treated animals. In addition, the manufacturing processes of unapproved CBD drug products have not been reviewed by the FDA as part of the human or animal drug approval processes. The FDA has received reports of some CBD products containing contaminants such as pesticides and heavy metals, thus introducing additional concerns for the use of CBD products.
The FDA is also concerned that consumers may postpone seeking professional medical care for their animals, such as getting a proper diagnosis, treatment and supportive care, because they are relying on unproven claims associated with unapproved CBD products. Many of the products marketed by the four companies that received warning letters made claims about alleviating anxiety. Anxiety in animals can be a signal of a range of medical conditions requiring veterinary care from a licensed professional. This is why it is critical that consumers talk to a health care professional about the best way to treat medical conditions using approved treatment options that have been proven to be safe and effective.
In addition to the CBD products marketed for food-producing animals, Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest also sell CBD-containing unapproved new drugs for humans and adulterated human foods. Some of the products were also marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement. These products include oils, creams, extracts, salves, and gummies.
The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency. To report a problem with an animal product, visit fda.gov/vetproductreporting. To report a problem with a human product, use FDA’s MedWatch program.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.