Regulations

FDA Warning Letter Cites Skincare Claims for CBD/CBG Products

Root Bioscience Brands makes oils and supplements for humans as well as pets.

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By: Christine Esposito

Editor-in-Chief

The US Food and Drug Administration (FDA) has sent a warning letter to Root Bioscience Brands, LLC (Naternal) following its review of its website in August 2024. The Agency says the Morrisville, NC company’s website offers various products, formulated with cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN), which have claims that establish them as unapproved new drugs. The products include: CBD Oils, Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad Spectrum Gummies and Ease Full Spectrum Gummies.

In addition to several claims around health issues spanning from concussions to cancer to autism, FDA says the company made claims regarding CBD and CBG for skin care.

For example, FDA cited the following claim from a company webpage:

“As an antibacterial agent, CBG goes where other drugs can’t, helping to fight Staphylococcus aureus (MRSA) strains. Cannabis topical formulations have also been used for decades to help fight skin infections, though an understanding of why it works is only recently coming into focus with the use of CBG for skincare.”

The page cited in the FDA’s letter has been taken down by the company.

FDA’s letter also cited Root Bioscience Brands sale of unapproved new animal drugs, including hemp extract oil for pets.

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