The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued a joint warning letter to Rooted Apothecary LLC, of Naples, Florida for illegally selling and advertising unapproved cannabidiol (CBD) products online with unsubstantiated health claims.
The warning letter states that Rooted Apothecary falsely marketed their CBD products on their social media website and online store claiming that the products can be used to treat a variety of conditions and diseases including teething pain and earaches in infants, skin problems, autism, ADHD, Parkinson disease, and Alzheimer disease, among others. The FDA also noted that the Company was in violation of the Federal Food, Drug and Cosmetic Act as their â€śHemp Capsules, 750mgâ€ť and â€śHemp Oilâ€ť products are being marketed as dietary supplements. According to the Agency, CBD products cannot be marketed as dietary supplements as they are excluded from the dietary supplement definition based on available evidence.Â
Moreover, under the FTC Act, the products were unlawfully advertised to prevent, treat, or cure human disease without reliable scientific evidence. Rooted Apothecary violated the FTC Act with their unsubstantiated and exaggerated claims on their website. The Company will have 15 working days to respond to the Agencies with how they plan to correct the violations; failure to do so could result in legal action.Â
â€śWeâ€™ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,â€ť said Acting FDA Commissioner Ned Sharpless, MD. â€śAs we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.â€ť
For more information visit FDA.gov.