Amazon Receives FDA Warning for Selling Unapproved Herpes Remedies
The FDA issued a warning letter to Amazon after buying several herpes products from its website in July and determining they were unapproved drugs. The agency said such products could lead people to delay proper medical care or unknowingly pass infections to partners. FDA noted it has not approved any over-the-counter treatments for sexually transmitted infections, and the cited items included FemiClear, Hclear for him, and HerpCare products.
The agency said it ordered multiple herpes-related items from Amazon in July and concluded they were unapproved new drugs. The cited lineup included FemiClear, Hclear for him, HerpCare Ointment and Spray, Herstat GST, Genital Herpes Ointment, RoyceDerm Herpes Relief Cream, Terragen HG Formula, and Genital Herpes Intimate Wash.
Although some are marketed as homeopathic, the FDA said that label does not remove drug-approval obligations. Many contained lemongrass, which is not recognized as an active ingredient in the Homeopathic Pharmacopeia of the United States. The warning letter, dated Oct. 1, went to CEO Andy Jassy and sought a response within 15 business days.
Count words: first para: The(1) agency2 said3 it4 ordered5 multiple6 herpes-related7 items8 from9 Amazon10 in11 July12 and13 concluded14 they15 were16 unapproved17 new18 drugs19. The20 cited21 lineup22 included23 FemiClear24, Hclear25 for26 him27, HerpCare28 Ointment29 and30 Spray31, Herstat32 GST33, Genital34 Herpes35 Ointment36, RoyceDerm37 Herpes38 Relief39 Cream40, Terragen41 HG42 Formula43, and44 Genital45 Herpes46 Intimate47 Wash48. Good.
Second: Although1 some2 are3 marketed4 as5 homeopathic6, the7 FDA8 said9 that10 label11 does12 not13 remove14 drug-approval15 obligations16. Many17 contained18 lemongrass19, which20 is21 not22 recognized23 as24 an25 active26 ingredient27 in28 the29 Homeopathic30 Pharmacopeia31 of32 the33 United34 States35. The36 warning37 letter38, dated39 Oct.40 1,41 went42 to43 CEO44 Andy
... No extra. Plain text. Good. Potential issue: "additional factual detail and background drawn ONLY from material above" We included all from material. Good. "entirely original wording, never copying source phrasing." We used "unapproved new drugs" maybe source phrase. Could rephrase "new drugs lacking approval" to avoid. "Homeopathic Pharmacopeia of the United States" proper noun unavoidable. "15 business days" factual. "CEO Andy Jassy" proper. "FemiClear" etc product names. Fine. Maybe "unapproved new drugs" is source phrase. Let's change to "drugs that had not received agency approval." But "unapproved new drugs" is legal term. To be safe: "concluded they were drugs lacking FDA approval." Good. "drug-approval obligations" okay. "active ingredient" source phrase? common. "Homeopathic Pharmacopeia of the United States" proper. "warning letter" common. "dated Oct. 1" source. "sought a response within 15 business days." Source says requests written response within 15 business days. W