FDA WARNING_LETTER - Green Water, LLC - July 26, 2018

The FDA issued a Warning Letter to Green Water, LLC following an inspection of their Conifer, Colorado facility from June 25 to July 26, 2018. The inspection, product labels, and website revealed serious violations of the Federal Food, Drug, and Cosmetic Act, with no response received to the initial FDA-483. The firm's products, including various tinctures, creams, and remedies, are deemed unapproved new drugs under Section 201(p) of the Act due to therapeutic claims (e.g., treating headaches, insomnia, eczema, inflammation) without FDA approval. Sleep Ease Tincture is also misbranded under Section 502(f)(1) for lacking adequate directions for use. Products containing colloidal silver, when promoted for disease treatment, are considered unapproved new drugs and misbranded under Section 502. The firm also committed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), including failures to establish specifications for components and finished products, implement written quality control procedures, prepare Master Manufacturing Records (MMRs) and Batch Production Records (BPRs), establish product complaint procedures, and provide adequate handwashing facilities. Additionally, several dietary supplement products are misbranded under Section 403 for false labeling (e.g.,