What happened
Original notice title
New Horizon Nutraceuticals LLC 7/22/16
From the archived source record
Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Additionally, based on our review of your products’ labeling collected during this inspection, we found serious violations of section 403 and 505(a) of the Act [21 U.S.C. §§ 343 and 355(a)] and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR part 101. The significant violations documented during the inspection include, but are not limited to, the following: Unapproved New Drug This is to advise you that the Food and Drug Administration (FDA) reviewed your product label for One World Whey Protein Power Food following an inspection of your facility at 578 Rosedale Road, Kennett Square, Pennsylvania between January 26, 2016 through February 8, 2016. Examples of some of the claims on your product label that provide evidence that your product is intended for use as a drug include: From the One World Whey Protein Power Food product label: “Glutathione works to eliminate mercury, heavy metals, and virtually all toxins. Dietary Supplement CGMP Violations The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)], in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 3cdb50ea13bb
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.
Sources, dates, and coverage →