FDA WARNING_LETTER - Osmosis, LLC - January 13, 2023

The FDA issued a Warning Letter to Dr. Benjamin T. Johnson following a January 2023 inspection of their Evergreen, CO facility and a review of product labels and osmosisbeauty.com. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act. Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate products are deemed unapproved new drugs (21 U.S.C. 321(g)(1)(B), 321(p)) due to disease treatment claims (e.g., inflammation, diabetes, cholesterol management). These products are also misbranded (21 U.S.C. § 352(f)(1)) for lacking adequate directions for use, as they address conditions requiring professional supervision. Significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements were found, rendering products adulterated (21 U.S.C. § 342(g)(1)). Deficiencies include failing to establish written procedures for quality control (21 CFR 111.103), equipment maintenance (21 CFR 111.25(c)), product complaints (21 CFR 111.553), returned supplements (21 CFR 111.503), and holding/distribution (21 CFR 111.453). The firm's initial response was inadequate. Furthermore, Osmosis Skin Clarifier, Recovery, Regenerate, Immune Defense Elixir, and Elevate dietary supplements are misbranded (21 U.S.C. § 343) due to various labeling non-compliances. These include failing to provide a domestic address/phone for adverse event reporting (21 U.S.C. § 343(y)), incorrect serving sizes (21 U.S.C § 343(q)(1)(A)), non-compliant nutrition information presentation (21 CFR 101.36), improper statement of identity, missing structure/function claim symbols, and incorrect plant part declarations. The FDA requires a written response within 15 working days detailing corrective actions, warning of potential legal action.