What happened
Original notice title
Osmosis, LLC MARCS-CMS 652059, August 23, 2023
From the archived source record
The inspection and our review of your product labels and website revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. Unapproved New Drugs and Misbranded Drugs FDA reviewed your product labels and website in June 2023 and has determined that your Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This supplement is especially vital for those who have diabetes…” • “TOP BENEFITS: Harmonizes the pancreas and sugar regulation” • “RECOMMENDED FOR: Diabetes and related neuropathy, Sugar cravings” Product: Osmosis Elevate On your website, [see original source] • “This new and improved version of Elevate … continues to offer clinically proven benefits in reducing cholesterol and triglycerides…” • “RECOMMENDED FOR: … High blood pressure/cholesterol” Your above products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Dietary Supplement CGMP Violations During the inspection, our investigator found significant violations of 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 111 (21 CFR Part 111).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- f7ae789abb5b
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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