argus.hq — daily brief
3 recent FDA Warning Letters.
Live from Argus HQ’s own ingestion feed — not a demo.
critical · Center for Drug Evaluation and Research (CDER) · Unapproved drug
Terramed — Unapproved New Drugs (issued 2026-10-01)
On October 1, 2026, the FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter to Terramed (CEO Krystsina Uradzimskaya, La Mesa, CA) regarding unapproved new drugs marketed on terramed.info: "Genital Herpes Intimate Wash," "HerpCare Ointment," "HerpCare Spray," and "HerpCare Genital Wart Remover Ointment" (Reference 735070). The FDA states these products make disease-treatment claims for sexually transmitted infections without FDA approval, violating sections 301(d) and 505(a) of the FD&C Act, and notes that unapproved STI drugs present serious public health risks including potential for patients to forgo appropriate medical care. The letter directs Terramed to promptly address violations or face regulatory action including seizure and injunction.
Read the full letter on fda.gov →
critical · Center for Drug Evaluation and Research (CDER) · Unapproved drug
Aidance Scientific, Inc. — Unapproved New Drugs (issued 2026-10-01)
The FDA Center for Drug Evaluation and Research issued a warning letter to Aidance Scientific, Inc. (October 1, 2026, Reference 735346) regarding "Terragen HG Formula," marketed on the company's website and Amazon storefront as a treatment for genital herpes and associated symptoms. The FDA determined the product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act because it is not generally recognized as safe and effective for its labeled uses, and its marketing claims—including "genital sores treatment," "relief of swelling and pain," and "outbreak support"—establish drug intent regardless of homeopathic labeling. The agency noted that unapproved OTC drugs for sexually transmitted infections present serious public health risks, as patients may forgo appropriate medical care and unknowingly transmit infections to others.
Read the full letter on fda.gov →
critical · Center for Drug Evaluation and Research (CDER) · Unapproved drug
DesBio/Deseret Biologicals, Inc. — Unapproved New Drugs (issued 2026-10-01)
On October 1, 2026, the FDA Center for Drug Evaluation and Research issued Warning Letter 735464 to DesBio/Deseret Biologicals, Inc. (CEO Jake Carter) identifying "CHLA:10M," marketed on desbio.com for chlamydia symptom relief, as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA noted that unapproved OTC products marketed for sexually transmitted infections present a serious public health concern because individuals may forgo timely medical care, risking severe complications including infertility, sepsis, and death. DesBio was directed to submit a written response within 15 business days detailing corrective actions and preventative measures.
Read the full letter on fda.gov →
