What's NOT Inside VigRX Matters Too

GLP Bacterial Reverse Mutation Study (2007)

The Ames bacterial reverse mutation test is one of the gold-standard assays used globally to determine whether a substance has the potential to cause genetic mutations — a key indicator of cancer risk and long-term safety. This study was conducted by Pharmaceutical Control and Development Laboratory Co. Ltd. (Budapest, Hungary) in full compliance with Good Laboratory Practice (GLP) standards, including FDA 21 CFR Part 58, OECD GLP Principles, and EU GLP Regulations.

Study Design

Using the plate incorporation method, VigRX tablet blend was tested at five dose levels (up to 5,000 µg/plate) in triplicate across five bacterial tester strains: four Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537) and one E. coli strain (WP2 uvrA). All conditions were tested both with and without S9 metabolic activation — which simulates how the body's liver enzymes might convert a compound into an active metabolite. A cytotoxicity pre-screen was conducted, followed by a definitive assay and a full confirmatory repeat assay. Plates were incubated for 3 days before counting.

Results

VigRX tablet blend produced no mutagenic response in any strain tested, under any condition. Revertant colony counts did not exceed three times the background average in any well, with or without metabolic activation, and there was no dose-related increase in revertants across the concentration range tested. Both the definitive assay and the confirmatory repeat assay returned negative results — meeting the most stringent standards for mutagenicity assessment.

What This Means

A negative Ames test result means VigRX does not cause DNA damage or gene mutations in these validated bacterial models. This is an essential safety credential for any dietary supplement and provides regulatory-grade evidence that VigRX presents no genotoxic risk. The study's GLP compliance further ensures that results are fully auditable, reproducible, and accepted by international regulatory authorities.

Conclusion

VigRX tablet blend is confirmed non-mutagenic across all five tester strains and both metabolic conditions tested. This GLP-certified Ames test result is a critical pillar of VigRX's safety dossier, providing consumers, healthcare professionals, and regulatory reviewers with authoritative evidence that VigRX does not pose a genotoxic risk.

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