FDA WARNING_LETTER - Mihon Corp. d/b/a VitalityVita and Boulla, LLC - November 08, 2024
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The FDA issued a Warning Letter to Michael Lee regarding products sold on vitalityvita.com and Amazon storefronts, specifically "VitalityXtra," "PeakMax," "ZapMax," and "ZoomMax." An FDA review from August to December 2024 and laboratory analyses confirmed these products contain undeclared active pharmaceutical ingredients (APIs): sildenafil (in all four products) and diclofenac (in "PeakMax," "ZapMax," and "ZoomMax").
These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) because sildenafil and diclofenac were approved as drugs (Viagra in 1998, Voltaren in 1988) before being marketed as dietary supplements, thus excluding them from the dietary supplement definition. Product claims like "Strength," "Stamina," and "Endurance" further classify them as drugs intended to affect body function or treat disease.
Furthermore, the products are misbranded drugs under section 502 of the FD&C Act (21 U.S.C. 352) and violate section 301(a) (21 U.S.C. 331(a)). Misbranding occurs because the labeling is false
- Inspection Date
- November 8, 2024
- Product Type
- Drugs
ID · b35a0e67-b406-4028-8703-65e1e90112d4
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