FDA WARNING_LETTER - TruVision Health LLC - May 31, 2017

On May 15, 22-25, 30-31, 2017, the FDA inspected TruVision Health, LLC in Draper, Utah, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. A review of product labels and the company website (https://truvisionhealth.com/) identified additional violations.

Several products, including truWeight & Energy™ Gen 2, Ubiquinol, Omega 3, Pycnogenol™, reNU, and truElevate™, were deemed unapproved new drugs and misbranded drugs due to therapeutic claims on the website, such as "lessen muscle pain," "combat mild levels of depression," "regulate blood sugar," "combat high cholesterol," and "gentle relief from irregularity and constipation." These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, truWeight & Energy™ Gen 2, Pycnogenol™, and truElevate™ were misbranded as they lacked adequate directions for layperson use for conditions requiring professional supervision.

Dietary supplement products were adulterated due to CGMP violations. Specifically, the quality control unit failed to approve or reject packaged and labeled dietary supplements (21 CFR 111.127(h)) and lacked written documentation of quality control reviews (21 CFR 111.14