FDA Issues Flurry of Warning Letters to Companies Making Unapproved Claims about CBD and Delta-8 Products The FDA has become increasingly concerned about products containing cannabidiol (CBD) 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 Issues Flurry of Warning Letters to Companies Making Unapproved Claims about CBD and Delta-8 Products
The FDA has become increasingly concerned about products containing cannabidiol (CBD) and/or delta-8 tetrahydrocannabinol (delta-8), stating that such products are potentially unsafe, make claims in violation of the Federal Food, Drug and Cosmetic Act (FFDCA) and “are packaged and labeled in ways that may appeal to children.” These concerns along with recent reports related to delta-8 and CBD products led to the issuance of five additional warning letters.
In these warning letters, the FDA stated that certain products containing CBD and/or delta-8 were unapproved new drugs sold in violation of FFDCA § 505(a), § 301(d) [21 U.S.C. 355(a), 331(d)] and were misbranded under FDCA § 502(f)(1) [ 21 U.S.C. 352(f)(1)] as they are marketed by companies as unapproved treatments for various medical conditions or for other therapeutic uses. In referencing the addition of CBD and delta-8 in foods, such as gummies, chocolate and caramels, the FDA determined certain food products were adulterated under FFDCA § 402(a)(2)(C)(i) [ 21 U.S.C. 342(a)(2)(C)(i)], because delta-8 is deemed an unsafe food additive. Additionally, for those companies that also sold animal products containing delta-8, the FDA stated such products were unapproved and unsafe new animal drugs under FFDCA § 512(a) [21 U.S.C. § 360b(a)], and are adulterated under FFDCA § 501(a)(5) [21 U.S.C. 351(a)(5)].
In other words, these warning letters honed in on marketed products containing CBD or delta-8 claiming to treat medical conditions in humans and animals, promoting such products as dietary supplements, and/or adding CBD or delta-8 to human and animal foods as an unapproved food additive. Specific claims made by the manufacturers that received said warning letters include:
: “Delta-8 THC can be used to suppress the immune response in your body. If a patient is suffering from autoimmune diseases, Delta-8 THC will offer some relief and support. Some of these diseases include lupus, HIV/AIDS, and multiple sclerosis.” : “Fighting Cancer. Δ8 may also have cancer-fighting properties… [t]he researchers treated mice with cancer for 20 consecutive days with a combination of the isomer and cannabinol. The result? Tumors reduced in size.” : “CBD Oil Benefits. Pain Relief and Inflammation. Helps Fight Cancer. Relieves Nausea…Treats Seizures…Lowers Risk of Diabetes…Anxiety…Depression…Panic Disorders…OCD…PTSD…Neurological Disorders. ” : “500mg: CBD & Menthol Pain Cream…bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain. Derived from our signature potent hemp oil infused with peppermint oil, eucalyptus oil, menthol and our signature terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to aid in POWERFUL relief. You can use our new topical pain cream to FIGHT back against sore muscles and achy joints!” : “Israeli researchers have launched three clinical trials that utilize CBD’s anti-inflammatory properties as potential COVID-19 treatment…Last week, InnoCan Pharma announced a collaboration with Tel Aviv University to instill CBD medicine through exosomes…The unconventional method will utilize the exosomes as “homing missiles,” as they can uniquely target cell organs damaged by COVID-19. Researchers then believe CBD’s anti-inflammatory properties will repair the damaged cells through a synergistic effect.”
Considering the FDA’s recent focus on cannabis products, and the alleged increase in adverse event report relating to CBD and delta-8 products, the FDA will likely continue reviewing product pages and social media sites related to cannabis products and issue warning letters accordingly. As such, it will be important for your company to review all marketing and promotional materials, including that which is on social media, to ensure you are not unintentionally making unsubstantiated claims regarding your product. It will also be important for your company to understand and be prepared for any safety initiatives or regulations the FDA may put in place regarding such products.
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.