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FDA Warning Letter Explorer
Drugs · Oct 1, 2026

Amazon.com, Inc.

4 extracted findings

FDA source excerpt, selected passage

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
02
“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” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
03
The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application.
04
These products do not meet the definition of a “homeopathic drug product” because they include lemongrass, which is not listed in the HPUS as an active ingredient. Therefore, these products fall outside the scope of products addressed in this guidance.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 201.128

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