FDA Warning Letter Explorer
Drugs · Oct 1, 2026

Graceful Touch, LLC

2 extracted findings

FDA source excerpt, selected passage

On the webpage https://gracefultouchproducts.org/products/herpes-b-gone: - "Herpes B Gone" and images of what appears to be cold sores on the lips. - "Say No to Sores on Your Mouth or Genitals" - "Lower the dangers of herpes virus" - "Herpes B Gone is a certified organic, plant-based cream formulated specifically to soothe herpes sores, calm irritated skin, and support your body's natural healing process — so you can get through an outbreak with less discomfort and more confidence."

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
On the webpage https://gracefultouchproducts.org/products/herpes-b-gone: - "Herpes B Gone" and images of what appears to be cold sores on the lips. - "Say No to Sores on Your Mouth or Genitals" - "Lower the dangers of herpes virus" - "Herpes B Gone is a certified organic, plant-based cream formulated specifically to soothe herpes sores, calm irritated skin, and support your body's natural healing process — so you can get through an outbreak with less discomfort and more confidence."
02
No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug.

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