What happened
Original notice title
Time Challenger Labs International, Inc. MARCS-CMS 706900, September 18, 2025
From the archived source record
Based on inspectional findings, our review of the product labeling collected during the inspection, and our review of your website, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drug[s] FDA reviewed your website at the Internet address www.timechallengerlabs.com in May 2025 and has determined that you take orders there for the products “Adrenal Boost,” “Chaga,” “Brain & Vein,” “Thyroid Support,” and “UTI” for sale in the United States. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C 355(a) and 331(d)]. Adulterated Dietary Supplements The inspection of your facility on December 18-19, 2024 identified serious violations of the FDA’s regulations 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). These violations cause the dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. You failed to establish product specifications for identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(e). The response states you plan to implement GMP records and correct the violations for each product before resuming commercial activities and that you would respond no later than March 3, 2025.
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
- e20a5ea49d63
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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