05.04.22
The FDA issued five warning letters to companies selling products containing cannabidiol (CBD) or delta-8 THC, the latter of which is one of many trace cannabinoids found in hemp, and is not naturally found in significant amounts. Most delta-8 THC products on the market today are synthetically produced, and the agency reports that there has been an increase in exposure reports to U.S. Poison Control centers involving products containing this cannabinoid.
This action is the first time the agency 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,” the agency said.
The five warning letters it sent out were to the following companies: ATLRx Inc.; BioMD Plus LLC; Delta 8 Hemp; Kingdom Harvest LLC; and M Six Labs Inc .
The agency noted that it has not approved any drugs containing delta-8 THC, and considers any product containing this cannabinoid with disease-related claims to be an unapproved new drug. The agency hasn’t evaluated whether delta-8 THC is effective for the uses manufacturers claim, or any data regarding safe dosage, how it may interact with other drugs or substances, or whether there are any specific dangerous side effects or safety concerns.
Products containing delta-8 THC are available in varying forms, including candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges, dabs, shatter, smokable hemp sprayed with delta-8 THC extract, distillate, tinctures, and infused beverages.
Specifically, the warning letters addressed alleged illegal marketing of delta-8 THC products by companies claiming that these products were treatments for conditions, or had therapeutic uses. The letters also cite violations related to drug misbranding, 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, MD. “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.”
FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The agency received adverse event reports involving 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 increasing 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.
FDA has not approved of the use of either CBD or delta-8 THC in any human or animal food product, and has only approved of the use of CBD in a prescription drug called Epidiolex.
One of the letters expresses concerns regarding CBD products marketing for food-producing animals, and the potential safety concerns related to human food products from animals that consume CBD, as there is a lack of data on CBD residue levels.
FDA requested in the letters that the companies provide written responses within 15 working days stating how they will address these violations and prevent their recurrence, noting that failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
FDA previously has sent warning letters to companies selling CBD-containing products that made claims to diagnose, cure, mitigate, treat, or prevent various diseases. This includes a number of products which have made “opioid-related claims.”
This action is the first time the agency 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,” the agency said.
The five warning letters it sent out were to the following companies: ATLRx Inc.; BioMD Plus LLC; Delta 8 Hemp; Kingdom Harvest LLC; and M Six Labs Inc .
The agency noted that it has not approved any drugs containing delta-8 THC, and considers any product containing this cannabinoid with disease-related claims to be an unapproved new drug. The agency hasn’t evaluated whether delta-8 THC is effective for the uses manufacturers claim, or any data regarding safe dosage, how it may interact with other drugs or substances, or whether there are any specific dangerous side effects or safety concerns.
Products containing delta-8 THC are available in varying forms, including candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges, dabs, shatter, smokable hemp sprayed with delta-8 THC extract, distillate, tinctures, and infused beverages.
Specifically, the warning letters addressed alleged illegal marketing of delta-8 THC products by companies claiming that these products were treatments for conditions, or had therapeutic uses. The letters also cite violations related to drug misbranding, 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, MD. “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.”
FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The agency received adverse event reports involving 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 increasing 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.
FDA has not approved of the use of either CBD or delta-8 THC in any human or animal food product, and has only approved of the use of CBD in a prescription drug called Epidiolex.
One of the letters expresses concerns regarding CBD products marketing for food-producing animals, and the potential safety concerns related to human food products from animals that consume CBD, as there is a lack of data on CBD residue levels.
FDA requested in the letters that the companies provide written responses within 15 working days stating how they will address these violations and prevent their recurrence, noting that failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
FDA previously has sent warning letters to companies selling CBD-containing products that made claims to diagnose, cure, mitigate, treat, or prevent various diseases. This includes a number of products which have made “opioid-related claims.”
