# FDA WARNING_LETTER - Skin Authority, L.L.C. - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/skin-authority-llc/28d6d31b-b98b-4d0d-8394-a4bedc141856

> FDA WARNING_LETTER for Skin Authority, L.L.C. on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Skin Authority, L.L.C.
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Mr. Hilling concerning the distribution of skinauthority® Hyperpigmentation Treatment, a drug product intended to bleach and/or lighten skin. The product is cited as an unapproved new drug and a misbranded drug, violating sections 505(a) and 502(ee) of the FD&C Act, respectively. Its introduction into interstate commerce is prohibited under sections 301(d) and (a).

The product is classified as a drug due to its intended use for diagnosis, cure, mitigation, treatment, prevention of disease, and/or affecting body structure/function, specifically as a skin bleaching product. Claims like "Skin Lightener," "Hydroquinone (2%)," "Whitening Agent," and "fade spots, freckles, and hyperpigmentation" support this intended use.

As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, deeming it not generally recognized as safe and effective (GRASE) per a 2006 proposed rule. Consequently, it is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act since September 23, 2020. No such application is in effect for skinauthority® Hyperpigmentation Treatment.

The letter requires prompt corrective action within 15 working days, including specifying steps

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/skin-authority-llc/a702a30f-a82a-4b64-bfe8-4936f51c5a71

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c