Skin Authority, L.L.C.

Warning LetterOpen

Ted Hilling Skin Authority, L.L.C. 3186 Lionshead Ave Ste 150 Carlsbad , CA 92010 United States Ted@skinauthority.comIssued Apr 13, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 13, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Skin Authority, L.L.C.
Location: Ted Hilling Skin Authority, L.L.C. 3186 Lionshead Ave Ste 150 Carlsbad , CA 92010 United States Ted@skinauthority.com
FEI Number: N/A
Country: United States
Issue Date: April 13, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Skin Authority, L.L.C. distributed skinauthority® Hyperpigmentation Treatment, a skin bleaching drug containing 2% hydroquinone, without FDA approval in violation of section 505(a) of the FD&C Act. The product was also misbranded under section 502(ee) of the FD&C Act, with labeling claims such as "Skin Lightener" and "Whitening Agent" that established its intended use for fading spots and hyperpigmentation without regulatory authorization. The product fell under section 505G of the FD&C Act, which specifically governs nonprescription skin bleaching drugs and requires approved applications for marketing.

Skin Authority, L.L.C. FDA Warning Letter, April 13, 2022