What happened
Original notice title
TruVision Health LLC 11/30/17
From the archived source record
The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Further, a review of the product labels collected during the inspection, and a review of your website at [see original source] / , identified serious violations of the Act and applicable regulations. Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at the internet address [see original source] in November 2017 and has determined that you take orders there for the products truWeight & Energy™ Gen 2, Ubiquinol, Omega 3, Pycnogenol®, reNU, and truElevate™. 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, truWeight & Energy™ Gen 2, Pycnogenol®, and truElevate™ 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulation, Title 21, Code of Federal Regulations, 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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 63ddddb23cae
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 →