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

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA confirmed through laboratory analyses that samples of your “VitalityXtra,”***1*** “PeakMax,”***2*** “ZapMax,”***3*** and “ZoomMax,”***4*** purchased from your before-noted websites, contain undeclared active pharmaceutical ingredient (API) sildenafil. Additionally, laboratory analyses identified the presence of undeclared API diclofenac in your “PeakMax,” “ZapMax, and “ZoomMax” products.

Passage 2

The labeling for “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products do not declare that the products contain a PDE-5 inhibitor or diclofenac. The failure to disclose these ingredients in the product labeling renders your “VitalityXtra,” “PeakMax,” “ZapMax” and “ZoomMax” products misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

Passage 3

Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products, which contain undeclared sildenafil, are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), and as such, can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products such that a layperson can use the drugs safely for their intended uses.

Passage 4

The undeclared active pharmaceutical ingredients in your products also causes these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings for the protection of users.