TruVision Health LLC FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on November 29, 2017
Executive Summary
The FDA issued a warning letter to TruVision Health LLC on November 29, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Denver District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Huperzine (A) [an ingredient in the product]: Currently being researched for its potential benefits to individuals with Alzheimer’s disease…”
“PYCNOGENOL is one of nature’s most powerful anti-oxidants. Anti-oxidants neutralize free-radicals in the body. Free radical damage has been linked to almost every debilitating and degenerative disease and condition known to man. These include: Alzheimer’s, cancer, M.S., dementia, coronary failure, stroke, and pulmonary disease to name a very view. Free radical damage has also been linked to prostrate (sic) dysfunction, menstrual complications, arthritic conditions, immune system dysfunction and more.”
Potential Health Risks
Consumers should be aware of potential risks associated with products from TruVision Health LLC.
Regulatory Context
“[U]biquinol actually keeps your LDL (often referred to as the ‘bad’ cholesterol) reduced”
The labels for your products reNU™ and truSlumber™ products lack a heavy bar beneath the subheading “Serving Per Container,” as required by 21 CFR 101.36(e)(6)(i).
The label for truWeight & Energy™ Gen 2 product fails to include a heavy bar beneath the last (b)(2)-dietary ingredient and beneath the last (b)(3)-dietary ingredient (other dietary ingredient), as required by 21 CFR 101.36(e)(6)(ii) and (iii). Furthermore, the “other ingredients list” must be located immediately below the Supplement Facts label, as required by 21 CFR 101.4(g).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with TruVision Health LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are TruVision Health LLC products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used TruVision Health LLC products?
- If you have used products from TruVision Health LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter