Certain violations include unapproved marketing drugs, misbranding food products, and adding Delta-8 THC (a synthetic form of tetrahydrocannabinol) to food items.
Five firms were issued warning letters by the U.S. Food and Drug Administration for selling items described as having delta-8 tetrahydrocannabinol (delta-8 THC) in methods that violated the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has issued warning letters for items containing delta-8 THC for the first time. Delta-8 THC is psychotropic and intoxicating, and it is deemed to be hazardous to users by some. The FDA has received complaints of people experiencing adverse effects after consuming these items.
There are no FDA-approved medications that include delta-8 THC. Any delta-8 THC product that claims to diagnose, cure, mitigate, treat, or prevent illness is still unapproved as a medication. The FDA has not determined if these unapproved drug items are helpful for the purposes claimed by the producers, what an acceptable dose might be, how they might interact with FDA-approved pharmaceuticals or other products, or whether they have harmful side effects or other safety issues.
Delta-8 THC, also known as delta-8 tetrahydrocannabinol, is one of more than 100 cannabinoids generated by the Cannabis sativa L. plant. However, it is not found in substantial quantities naturally. Delta-8 THC concentrates are generally made from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Delta-8-THC products include, but are not limited to, candies, cookies, morning cereal, chocolate, gummies, smokable hemp sprayed, vape cartridges (carts), dabs, shatter, with delta-8-THC extract, distillate, tinctures, and infused drinks.
The warning letters address firms “unlawfully “promoting unapproved delta-8 THC products as unapproved treatments for various medical illnesses or other therapeutic purposes. The letters also mention drug misbranding offenses (e.g., the products lack adequate warnings for use) and the inclusion of delta-8 THC in foods such as candies, chocolate, chewing gum, caramels, and peanut brittle.
The FDA has issued an update in which they expressed severe concerns about the possible health impacts of delta-8 THC products. Consumers, healthcare practitioners, and law enforcement have reported adverse event reports regarding products containing delta-8 THC to the FDA, with some requiring hospitalization or emergency room treatment. The FDA is also aware of increased exposure cases involving delta-8 THC products received by national poison control centers and warnings issued by state poison control centers indicating safety issues and adverse events with delta-8 THC products.
“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 alleviate the side effects of various diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” Janet Woodcock, M.D., FDA Principal Commissioner, added.
He also added, “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.”
Delta-8 THC and CBD are unapproved food additives for use in any human or animal food product since the FDA is unaware of any evidence that the compounds are safe or otherwise exempt from food additive regulations.
One of the letters raises worry about CBD products marketed for food-producing animals and possible safety issues about human food items (e.g., meat, milk, eggs) derived from CBD-consuming animals due to a lack of data on safe CBD residual levels.
The FDA issued warning letters to:
- ATLRx Inc.
- Delta 8 Hemp
- Kingdom Harvest LLC
- BioMD Plus LLC
- M Six Labs Inc.
In addition to the violations involving FDA-regulated products containing delta-8 THC, several warning letters detail additional FD&C Act violations, such as marketing CBD products claiming to treat medical conditions in animals and humans, promoting CBD products as dietary supplements, and incorporating CBD into human and animal foods.
The FDA has previously sent warning letters to firms unlawfully marketing unapproved CBD products that claimed to diagnose, cure, mitigate, treat, or prevent different conditions, violating the FD&C Act. Except for one prescription human drug product used to treat uncommon, severe types of epilepsy, the FDA has not authorized any CBD products.
The FDA has asked the corporations to respond in writing within 15 working days, detailing how they will rectify these breaches and prevent them. Failure to immediately infractions may result in legal action, including product seizure and an injunction.
The FDA, an agency within the United States Department of Health and Human Services, safeguards public health by ensuring the safety, efficiency, and security of human and veterinary pharmaceuticals, vaccines, and other biological products for medical devices and human use. The agency is also in charge of the safety and security of our country’s food supply, cosmetics, nutritional supplements, devices that emit electronic radiation, and tobacco product regulation.