Mihon Corp. d/b/a VitalityVita and Boulla, LLC

Warning LetterOpen

Michael Lee Mihon Corp. d/b/a VitalityVita and Boulla, LLC 1332 4th St. Suite B Berkeley , CA 94710 United States llcboulla@gmail.com boullallc@proton.me vitalityvita@gmail.comIssued Jan 16, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJan 16, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Mihon Corp. d/b/a VitalityVita and Boulla, LLC
Location: Michael Lee Mihon Corp. d/b/a VitalityVita and Boulla, LLC 1332 4th St. Suite B Berkeley , CA 94710 United States llcboulla@gmail.com boullallc@proton.me vitalityvita@gmail.com
FEI Number: N/A
Country: United States
Issue Date: January 16, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Mihon Corp. d/b/a VitalityVita and Boulla, LLC was warned for distributing four unapproved new drugs (VitalityXtra, PeakMax, ZapMax, and ZoomMax) through their website and Amazon storefronts in violation of the Federal Food, Drug, and Cosmetic Act. FDA laboratory testing confirmed the products contained undeclared active pharmaceutical ingredients: sildenafil (a PDE-5 inhibitor used in prescription Viagra) in all four products, and diclofenac in three of them (PeakMax, ZapMax, and ZoomMax). The products were further found to be misbranded drugs with no FDA approval for marketing or distribution. The undeclared sildenafil poses serious safety risks due to potential interactions with nitrate-based prescription medications like nitroglycerin.

Mihon Corp. d/b/a VitalityVita and Boulla, LLC FDA Warning Letter, January 16, 2025