FDA sends warning letters to companies that illegally sell CBD and Delta-8 THC products
Violations include marketing unapproved new drugs, misbranding, adding Delta-8 THC to food products
SILVER SPRING, MD., May 4, 2022 /PRNewswire/ — Today, the United States Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) of a manner that violates 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 can be dangerous for consumers. The FDA has received reports of adverse events suffered 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 disease is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses claimed by the manufacturers, what an appropriate dose might be, how they might interact with FDA-approved drugs or other products, or they have dangerous side effects or other safety issues.
Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis-sativa L. plants but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are usually made from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in a variety of forms, including but not limited to candies, cookies, breakfast cereals, chocolate, gummies, vape cartridges ( carts), dabs, shatter, smokable hemp pulverized with delta-8-THC extract, distillates, 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 mislabeling of drugs (e.g., products lack proper directions for use) and the addition of delta-8 THC to foods, such as gummies, chocolate , caramels, chewing gum and brittle peanuts.
“The FDA is very concerned about the growing popularity of delta-8 THC products sold online and in stores nationwide. These products often include claims that they treat or mitigate side effects related to a wide variety of illnesses or medical conditions, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” said the FDA’s senior deputy commissioner. Janet WoodcockMD “It is extremely disturbing that certain food products are packaged and labeled in ways that may appeal to children. We will continue to protect the health and safety of Americans by monitoring the marketplace and taking action when companies illegally sell products that pose a problem risk to public health.”
The FDA recently released a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The FDA has received reports of adverse events involving products containing delta-8 THC from consumers, healthcare professionals, and law enforcement, some of which have resulted in the need for hospitalization or emergency 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 side effects with products containing delta-8 THC.
In addition to violations related to FDA-regulated products containing delta-8 THC, several of the warning letters describe additional violations of FD&C law, including the marketing of CBD products claiming to treat medical conditions in humans and humans. animals, the promotion of CBD products as dietary supplements, and the addition of CBD to human and animal foods. CBD and delta-8 THC are food additives not approved for use in any human or animal food product, as the FDA is not aware of any basis for concluding that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements. One of the letters expresses concerns about CBD products marketed for food-producing animals and potential safety issues with human food products (e.g. meat, milk, eggs) from animals that consume of CBD, as there is a lack of safety data. CBD residue levels.
The FDA sent 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 FD&C law. In some cases, there have been other violations because CBD has been added to food products. The FDA has not approved any CBD products other than a prescription drug for human use to treat rare and severe forms of epilepsy.
The FDA has asked the companies for written responses within 15 business days indicating how they will address these violations and prevent their recurrence. Failure to promptly remedy violations may result in legal action, including seizure of the product and/or an injunction.
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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.
SOURCE US Food and Drug Administration