Amazon.com, Inc.
FDA issued a warning letter to Amazon.com, Inc. (CEO Andy Jassy) regarding nine OTC drug products sold via its Fulfillment by Amazon service — FemiClear, HClear for him, HerpCare Ointment, HerpCare Spray, Herstat GST, Genital Herpes Ointment, RoyceDerm Herpes Relief Cream, Terragen HG Formula, and Genital Herpes Intimate Wash — all marketed for the treatment of genital herpes symptoms without FDA approval. FDA determined these products are unapproved new drugs under sections 301(d) and 505(a) of the FD&C Act, noting that no OTC drug product has ever been approved for treating any STI. The agency warned that consumers relying on these products may forgo appropriate medical care, risking infertility, sepsis, or death, and that failure to address violations may result in seizure and injunction.
Flagged claims (26)
Pain Relief . . . numbs pain and soothes itching by targeting nerve endings, providing fast and lasting relief during flare-ups
FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING
Fast-acting ointment for recurring outbreak symptoms
Formulated for Herpes Relief
Genital Herpes Symptoms
Genital Sore Treatment
help manage symptoms effectively throughout the day and night.
Antiviral Action . . . reduce viral activity . . . powerful antimicrobial properties
>90% OF USERS REPORTED LESS SEVERE OUTBREAKS
FIGHTS OUTBREAKS
[R]elieves pain and itching associated with genital sores.
GENITAL HERPES SYMPTOMS
[B]est used at first sign of outbreak. Early use ensures the best results.
FAST-ACTING GENITAL HERPES SYMPTOM RELIEF
Soothes and calms genital sores
Relief on the Go: o Fast-acting formula in a convenient spray format . . . o Herpes Symptoms
[R]elief of inflammation, irritation, and tingling caused by genital herpes.
Provides temporary relief from skin inflammation, irritation, and/or tingling caused by genital herpes.
Uses . . . relief of swelling and pain associated with genital sores.
>90 of USERS REPORTED LESS SEVERE OUTBREAKS
[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.
FAST ACTING GENITAL HERPES RELIEF
Helps relieve the symptoms of rashes or blisters, itchy, redness and pain.
[S]pecifically formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.
REDUCES RECURRENCE
Healing Support . . . hydrates and promotes skin repair, aiding in faster recovery
Required actions (3)
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.
Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence.
Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWant this watched for you? Free monthly monitoring re-scans your site against the Atlas ruleset and emails you when new flagged wording appears, and your site gets the "Compliance Monitored" seal. Start free monitoring.
Worried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker