FDA WARNING_LETTER - PotNetwork Holdings, Inc. - April 02, 2019

The FDA issued a Warning Letter to PotNetwork Holdings, Inc. on March 28, 2019, following a September 2018 review of their website, www.diamondcbd.com. The FDA determined that products like "Liquid Gold Gummies (Sweet Mix)," "Liquid Gold Gummies (Sour Mix)," and "blue CBD Crystals Isolate 1500mg," which claim to contain CBD, are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are considered drugs because website claims suggest they are intended for disease treatment, cure, mitigation, or prevention (e.g., "CBD in the Treatment of Cancer," "CBD Shows Potential in Treating Alzheimer’s Disease"). As they are not generally recognized as safe and effective for these uses, they are "new drugs" requiring FDA approval. Furthermore, they are misbranded because they lack adequate directions for use by a layperson, as their intended uses require professional supervision.

The FDA also stated that CBD products are excluded from the dietary supplement definition and are prohibited from being added to food, citing CBD as an active ingredient in the approved drug Epidiolex and subject to substantial clinical investigations.

The Federal Trade Commission (FTC) also reviewed the website for potential violations of the FTC Act, specifically concerning unsubstantiated advertising claims. The FTC requires competent and reliable scientific evidence for disease-related claims.

PotNetwork Holdings, Inc.