Mihon Corp. d/b/a VitalityVita and Boulla, LLC
FDA issued a warning letter to Mihon Corp. d/b/a VitalityVita and Boulla, LLC for marketing four products — VitalityXtra, PeakMax, ZapMax, and ZoomMax — as dietary supplements while laboratory analysis confirmed they contained undeclared active pharmaceutical ingredients sildenafil (a PDE-5 inhibitor, the active ingredient in Viagra) and, in three products, diclofenac (an NSAID). The products are classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and as misbranded drugs under section 502 for failing to disclose prescription drug ingredients, lacking adequate directions for use, and omitting required safety warnings. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.
Flagged claims (12)
[F]or Energy and Endurance
Greater endurance and stamina
Endurance
Male Supplement for Endurance, Vitality, Energy
Stamina
Are you looking to boost your vitality, endurance, drive, and stamina when you need it the most? Well, look no further! Our amazing blue pill supplement is here to help.
Our natural herbal blend helps maximize demands for sports and other physical activity. Our natural ingredients helps [sic] your body improve its endurance and stamina to perform longer at your peak performance. It also improves your energy by raising your body's vigor and energy. Lastly, feel the improved physical strength.
The labeling for "VitalityXtra," "PeakMax," "ZapMax," and "ZoomMax" products do not declare that the products contain a PDE-5 inhibitor or diclofenac.
Boost your energy for higher vitality.
Strength
[I]ncrease your endurance, and enhance your over health.
VitalityXtra, Male Supplement for Endurance, Vitality, Energy, Stamina, and Strength
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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