Osmosis
has received a warning letter from the FDA following the inspection of the company’s manufacturing facility between January 5-13, 2023.
has received a warning letter from the FDA following the inspection of the company’s manufacturing facility between January 5-13, 2023. The FDA also reviewed product labels and the company’s website for products such as Osmosis Skin Perfection Elixir.
Both the review and inspection revealed violations of the Federal Food, Drug, and Cosmetic Act and FDA regulations. (letter details)
According to the FDA, the Osmosis Skin Perfection Elixir, Sugar Detox Elixir and Osmosis Elevate products are intended for use in diagnosis, cure, treatment, mitigation or prevention of disease and are drugs under section 201(g)(1)(B) of the act [21U.S.C.321(g)(1)(B)].
The FDA investigator found significant violations of the FDA’s regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 11 (21 CRF Part 111).
According to the FDA, the Osmosis Skin Perfection Elixir, Sugar Detox Elixir and Osmosis Elevate products are intended for use in diagnosis, cure, treatment, mitigation or prevention of disease and are drugs under section 201(g)(1)(B) of the act [21U.S.C.321(g)(1)(B)].
At-Issue Claims Made:
- “Renowned for its ability to… reduce inflammation…”
- “… detoxifies eczema, psoriasis, and inflamed skin.”
- “Balances digestive causes of rosaces and neutralizes skin toxins.”
- “Skin Perfection contains edible 24-karat gold, and our exclusive, clinically proven technology that targets the source of redness, inflammation, and blemishes.”
- “TOP BENEFITS: Balances digestive causes of Rosacea, Eczema, and Psoriasis, Neutralizes skin toxins.”
- “RECOMMENDED FOR: … Eczema/Psoriasis, Rosacea, Other Candida related skin conditions.”
The FDA investigator found significant violations of the FDA’s regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 11 (21 CRF Part 111).
