The United States Food and Drug Administration is cracking down on cannabidiol (CBD) and Delta-8 tetrahydrocannabinol (THC) producers who violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA has sent letters to five companies for selling products containing Delta-8 in ways that violate the FD&C Act.
The FDA says this is the first time it has issued warning letters for products that contain Delta-8 THC.
Delta-8 is a CBD derivative that possesses psychoactive effects, much like the more common Delta-9 THC.
Unaltered, CBD is non-psychoactive.
FDA Concerns
The FDA says that it has received reports from healthcare practitioners, consumers, and law enforcement regarding adverse effects from Delta-8 THC consumption.
There are currently no FDA-approved products that contain Delta-8 THC.
According to the FDA, any Delta-8 product that claims to diagnose, cure, mitigate, treat, or prevent disease is an unapproved new drug which it has not evaluated to confirm manufacturer claims.
The FDA also says it has not determined appropriate Delta-8 THC dosages, how it interacts with other approved drugs, or whether it has adverse side effects or other properties that might cause concern.
FDA Principal Deputy Commissioner Janet Woodcock says the Administration is very concerned about Delta-8 THC’s growing popularity.
Woodcock says the manufacturers make claims about health benefits or ability to treat medical conditions.
“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,” says Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We 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.”
FDA Warnings
FDA says the warning letters address companies that illegally market Delta-8 THC products for therapeutic or medical use.
The FDA’s letters cite drug misbranding-related violations and Delta-8 THC-infused foods like gummies, chocolate, chewing gum, caramels, and peanut brittle.
FDA recently expressed concerns about potential Delta-8 THC health effects in a consumer update.
According to the FDA, some Delta-8 THC consumers have required hospitalization or emergency room treatment.
The FDA also says there are increasing numbers of reports of Delta-8 THC exposure cases from state poison control centers.
FDA on CBD
But Delta-8 was not the only cannabinoid that the FDA cited in its letters.
The agency also detailed FD&A Act violations in CBD production.
The violations included promoting CBD as dietary supplements, adding CBD to food, and marketing CBD products with unproven medical treatment claims to humans and animals.
According to the FDA, CBD and Delta-8 THC are unapproved as food additives in human or animal food products.
FDA says it is not aware of any basis to conclude that CBD or Delta-8 THC are generally recognized as safe (GRAS) or exempt from food requirements.
In its letter to Kingdom Harvest LLC, the FDA expressed concerns about CBD products for food-producing animals and the lack of data on safe residue levels in animals that consume CBD.
In addition to Kingdom Harvest LLC, the FDA also sent letters to ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, and M Six Labs Inc.
The companies have fifteen working days to respond in writing how they intend to address the violations and prevent them from happening again.
According to the FDA, failing to address the violations may result in legal action, including product seizure and injunction.
The FDA has previously sent letters to other CBD companies for making unproven claims about their products, in violation of the FD&C Act.
The FDA says, in some cases, there were additional violations due for companies adding CBD to food products.
GW Pharmaceutical’s epilepsy treatment Epidiolex is currently the only FDA-approved prescribable CBD product.
