Terramed
FDA issued a warning letter to Terramed (CEO Krystsina Uradzimskaya, La Mesa, CA) for marketing four products — 'Genital Herpes Intimate Wash,' 'HerpCare Ointment,' 'HerpCare Spray,' and 'HerpCare Genital Wart Remover Ointment' — as unapproved new drugs intended to treat sexually transmitted infections and their symptoms. The products' website labeling made explicit drug-intended-use claims (e.g., herpes symptom relief, genital wart removal) without any FDA-approved application in effect, violating FD&C Act sections 301(d) and 505(a). FDA warned that consumers relying on these products may forgo appropriate medical care, risking infertility, sepsis, or death, and may unknowingly transmit infections. The company was directed to respond within 15 business days with corrective steps, and was warned that failure to comply may result in seizure or injunction.
Flagged claims (12)
This genital herpes relief spray is designed to support soothing comfort for genital sores, itching, burning, tingling, and irritation associated with herpes outbreaks. The convenient spray format allows targeted application to sensitive areas while helping calm irritated skin.
Genital Wart Treatment Support o Designed to support treatment for genital wart symptoms.
HerpCare Genital Wart Remover Ointment o Targets Genital Warts
This genital herpes intimate wash is designed to support soothing relief for itching, tingling, burning, and irritation associated with genital herpes symptoms. The gentle cleansing formula helps maintain intimate hygiene while supporting skin comfort for sensitive intimate areas. The wash is suitable for daily intimate care for both men and women experiencing discomfort associated with herpes outbreaks.
Supports Genital Herpes Comfort.
This genital wart remover ointment with salicylic acid is designed to support targeted treatment for genital warts, irritation, redness, itching, and discomfort. The formula helps soften and break down wart tissue while supporting gentle skin recovery. The ointment helps provide targeted wart treatment while supporting skin comfort for sensitive areas.
Supports Genital Wart Removal
This genital herpes relief ointment is designed to support soothing comfort for genital sores, itching, tingling, burning, and irritation associated with herpes outbreaks. The soothing formula helps calm sensitive skin while supporting comfort and relief for intimate areas. Each tube provides targeted topical support for genital herpes symptoms.
HerpCare – Proprietary Genital Herpes Care Line HerpCare is a proprietary and exclusively developed product line, fully owned and commercially distributed by Terramed Just Think Comfort, specifically created to support individuals managing genital herpes (HSV-2).
Fast-acting Genital Herpes Symptom Relief o Soothes and calms genital sores.
GENITAL HERPES INTIMATE WASH o Formulated for Herpes Relief
GENITAL HERPES SYMPTOMS o Soothes and calms genital sores
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 any address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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