Osmosis, LLC
FDA issued a warning letter to Osmosis, LLC (CEO Dr. Benjamin T. Johnson, MD) in Evergreen, CO following a January 2023 facility inspection and June 2023 website review. The agency determined that three products — Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate — were being marketed as unapproved new drugs due to disease-treatment claims (e.g., treating eczema, psoriasis, rosacea, diabetes, and high cholesterol) on product labels and the company website. FDA also cited multiple dietary supplement CGMP violations and misbranding violations across several products, warning that failure to correct these issues may result in seizure or injunction.
Flagged claims (12)
This new and improved version of Elevate … continues to offer clinically proven benefits in reducing cholesterol and triglycerides…
RECOMMENDED FOR: … High blood pressure/cholesterol
Balances digestive causes of rosacea and neutralizes skin toxins
Harmonizes the pancreas and sugar regulation
RECOMMENDED FOR: Diabetes and related neuropathy, Sugar cravings
Skin Perfection contains edible 24-karat gold, and our exclusive, clinically proven technology that targets the source of redness, inflammation, and blemishes.
TOP BENEFITS: Harmonizes the pancreas and sugar regulation
TOP BENEFITS: Balances digestive causes of Rosacea, Eczema, and Psoriasis, Neutralizes skin toxins
…detoxifies eczema, psoriasis, and inflamed skin
Improve sugar regulation, detox sweeteners, and harmonize your pancreas with our Sugar Detox Elixir. This supplement is especially vital for those who have diabetes…
RECOMMENDED FOR: … Eczema/Psoriasis, Rosacea, Other Candida related skin conditions
Renowned for its ability to . . . reduce inflammation…
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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