FDA identifies limited human safety information for injectable GHK-Cu and potential immunogenicity concerns related to aggregation and impurities.[2]
- A potential product-quality or immune risk is not a demonstrated frequency of clinical harm.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.
· Reopened the live FDA page (curl User-Agent workaround); confirmed the GHK-Cu row is in the withdrawn-nomination table with wording unchanged from the recorded claim. No qualified clinical review.