ISIS.GOLD – FDA Warning Letter, Mar 31, 2024
On July 25, 2024, the FDA issued a Warning Letter to Michelle Golde regarding products offered on the website https://www.isis.gold/. A review of the website in February and March 2024 revealed the sale of "TCA 100% Trichloroacetic Acid" and "Whitening SA Peels" products.
The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 301(d)). The products are considered drugs under section 201(g)(1) (21 U.S.C. 321(g)(1)) due to claims establishing their intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect body structure/function. Examples of drug claims include "REMOVES: Thick Dead Skin, Fine Lines & Wrinkles, Deep Pock Marks, Tattoos, Warts, Genital Warts, Skin Tags, Acne Scars, Melasma & Hyperpigmentation" for TCA 100% and "BENEFITS: Peels Skin Like Saliclear, Whitens/Bleaches Skin, Anti-aging: Removes Wrinkles & Smooths Skin" for Whitening SA Peels
ID · d4e8497a-253f-46b0-a687-c4e6a81b49c0
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