The Platinum Healthcare LLC
FDA issued a warning letter to The Platinum Healthcare LLC (CEO Jamey Hagan) in Pulaski, TN, citing the sale of two unapproved new drugs — 'Sycosis' and 'Syphillinum' — marketed as homeopathic oral antigens for conditions caused by the Gonorrhea and Syphilis miasms, respectively. These products were found to violate sections 301(d) and 505(a) of the FD&C Act as unapproved new drugs lacking FDA-approved applications, and their marketing for STI-related conditions poses a serious public health risk. FDA warned that failure to correct violations may result in seizure and injunction. The company was required to respond within 15 business days with corrective steps.
Flagged claims (2)
Oral antigen for desensitizing and stimulating the body's immune defense mechanism against problems caused by the Gonorrhea miasm.
Oral antigen for desensitizing and stimulating the body's immune defense mechanism against problems caused by the Syphilis miasm.
Required actions (2)
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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