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The FDA does not require pre-market approval for cosmetic ingredients the way it does for drugs, so a topical GHK-Cu product can be sold legally as a cosmetic without being an "FDA-approved" drug

contains 100% pure L-Carnitine

Taking a high dose once a week is far less effective than taking a moderate, bioavailable dose every single day

They're not at this time considered right for everyone

It is available only by prescription, and outside that approved indication it is prescribed off-label and often dispensed as a compounded preparation through 503A/503B compounding pharmacies for bodybuilding, fat-loss, or anti-aging purposes, uses the FDA has not evaluated or approved