The U.S. Food and Drug Administration (FDA) has issued a warning to Root Bioscience Brands LLC, doing business as Naternal, for marketing unapproved cannabidiol (CBD) products with misleading health claims. According to the FDA, Naternal’s products, which include cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) formulations, are being marketed as treatments for a range of serious health conditions such as Alzheimer’s disease, substance use disorder, autism, high blood pressure, and anxiety (FDA.gov).
Unsubstantiated Health Claims
The FDA’s warning comes as part of its ongoing effort to regulate the booming CBD market, which has seen rapid growth in recent years. Naternal’s claims that its CBD products can treat conditions like Alzheimer’s and anxiety are problematic because they are unproven and unauthorized by the FDA. The agency has emphasized that these products have not gone through the necessary clinical trials to verify their safety and efficacy for such serious medical conditions(FDA.gov).
The FDA also pointed out that Naternal has been marketing hemp extract oils for pets, making unproven claims about their ability to treat conditions like separation anxiety, pain, arthritis, and skin ailments in animals. These claims, too, have not been validated through FDA-approved research (FDA.gov).
Regulatory Actions and Concerns
The FDA has requested that Naternal respond within 15 working days to explain how they plan to correct the violations. If the company fails to act, they could face legal consequences, including product seizures or injunctions. This is part of the FDA’s broader crackdown on the CBD industry, where many companies have been found making similar unverified medical claims (FDA.gov).
Risks of Unregulated CBD Products
The FDA has long warned consumers about the potential risks of using unapproved CBD products, particularly when they are marketed as miracle cures for serious health conditions. Without regulatory oversight, there is no guarantee of these products’ safety, potency, or effectiveness. Misleading claims could lead consumers to forgo proven medical treatments in favor of unverified alternatives.
Ongoing FDA Scrutiny
In addition to addressing specific violations, the FDA is conducting broader reviews of CBD products. This includes a comprehensive study on the potential health risks associated with metals in tampons, as well as monitoring the safety of CBD-infused products that are becoming increasingly popular in the wellness market (FDA.gov).
This latest warning serves as a reminder of the importance of regulation and oversight in the CBD industry, particularly as consumer demand for these products continues to rise.
