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Tuesday, September 10, 2024

 Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing business as Naternal, for illegally selling cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) products for people and pets. Naternal makes unproven claims their products can treat multiple diseases in people including Alzheimer’s disease, substance use disorder, autism and high blood pressure. Naternal also makes unproven claims their hemp extract oil products for pets can treat conditions such as separation anxiety, pain, arthritis and skin ailments. The Naternal products that are the subject of the warning letter are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The FDA requested a response from the company within 15 working days stating how they will correct the violations. 

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