The U.S. Food and Drug Administration (FDA) has recently issued a warning to North Carolina-based Root Bioscience Brands, LLC, which operates under the Naternal brand. The company was instructed to remove various health claims related to their hemp cannabinoid products.
These claims, according to the FDA, were unsubstantiated and promoted products containing CBD, CBG, and CBN as solutions for numerous medical conditions.
Unsubstantiated Health Claims
The products in question were marketed with claims that they could alleviate conditions such as Alzheimer’s disease, cancer, PTSD, addiction, stress, anxiety, and more. These claims were deemed by the FDA as unsupported by scientific evidence, and the products were labeled as “unapproved new drugs.”
This classification puts the company in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the introduction of such products into interstate commerce without FDA approval.
Potential Risks for Consumers
Of particular concern to the FDA was the company’s suggestion that their products could help treat opioid addiction. In the context of the national opioid crisis, the FDA emphasized that promoting unproven treatments for addiction could prevent individuals from seeking legitimate, FDA-approved therapies, putting their health at significant risk.
This, the agency noted, represents a serious public health threat.
Unapproved Claims for Pets
In addition to health claims for human products, Naternal also made unproven assertions about the benefits of their CBD products for pets. These products were advertised as treatments for a variety of conditions in animals, including arthritis, diabetes, seizures, and skin ailments.
The FDA has not approved CBD for these uses in pets, raising concerns over the potential impact of such claims.
FDA’s Response
The FDA has made it clear that companies like Naternal must adhere to federal guidelines when marketing health-related products. Failure to comply with these standards could lead to further enforcement actions, including product seizures or court injunctions.
The letter was directed to Garrett Perdue, CEO of Root Bioscience Brands, and the company promptly removed the questionable claims from their website following the FDA's notice.
Personal Perspective
In my opinion, the situation with Naternal underscores the importance of regulatory oversight in the hemp and CBD industry. As a person who has followed the development of this industry closely, I believe that while hemp products hold promise, the public deserves access to products that are both safe and scientifically validated.
When companies make unsubstantiated health claims, it not only jeopardizes consumer trust but also risks public health, particularly in sensitive areas like opioid addiction treatment. Companies must be held accountable for ensuring their products are marketed responsibly.
