A North Carolina “wellness” company has been hit with a warning from the U.S. Food & Drug Adminstration (FDA), which says it promoted a wide range of hemp cannabinoids under unproven health claims.
Root Bioscience Brands, LLC, which does business under the Naternal brand, was ordered to remove from its website extensive unsubstantiated health claims regarding five products aimed at humans and one for pets. The company complied and took down the questionable information.
The health claims suggested that Naternal brand products containing CBD, CBG and CBN help with a wide range of conditions, including Alzheimer’s Disease, concussions, cancer, high blood pressure, addiction to cocaine and opioids, PTSD, autism, ADHD, stress, anxiety, insomnia, chronic pain, inflammation, glaucoma, inflammatory bowel disease, skin infections, weak appetite, and Huntington’s Disease.
FD&C Act violations
FDA said the products “are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of . . . the Federal Food, Drug, and Cosmetic Act.”
Addressing the company’s claims regarding opioid treatment with cannabinoids, the FDA said: “The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving the opioid crisis. You market your CBD products for the treatment or cure of opioid addiction. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses.
“Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction,” according to the warning letter.
Unproven for pets
The company’s website was also warned over a wide range of health claims for its CBD products for pets, which suggested they can be treatment for seizures, arthritis, diabetes, chronic pain, anxiety, insomnia, skin ailments, Lyme Disease, nausea, osteoarthritis and epilepsy.
CBD has not been proven effective for any of those conditions, and is not approved to administer to pets, according to the letter.
The warning letter was addressed to Garrett Perdue, CEO at Morrisville, North Carolina-based Root Bioscience Brands. It was issued jointly by FDA’s Center for Drug Evaluation and Research and Center for Veterinary Medicine.