FDA WARNING_LETTER - root bioscience brands, llc - August 30, 2024

The FDA issued a Warning Letter to Garrett Perdue regarding products sold on www.naternal.com. An August 2024 review found that Naternal's CBD, CBG, and CBN products (CBD Oils, Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad Spectrum Gummies, Ease Full Spectrum Gummies) are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. These products are marketed with claims indicating intended use for disease diagnosis, cure, mitigation, treatment, or prevention, or to affect body structure/function, making them drugs under section 201(g)(1). They are not generally recognized as safe and effective (GRASE) and lack FDA approval. The letter specifically highlights marketing for opioid addiction treatment, which is a public health concern.

Additionally, Naternal Hemp Extract Oil for Pets (300mg, 600mg, 1200mg) are deemed unapproved new animal drugs, unsafe under section 512(a) and adulterated under section 501(a)(5), violating section 301(a). Claims on the website establish their intended use for treating animal diseases or affecting animal body functions. These products are not FDA-approved, conditionally approved, or index listed.

The company must respond in writing within fifteen working days, detailing corrective actions,