# FDA WARNING_LETTER - Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/neoteric-cosmetics-incorporatedscotts-liquid-gold-inc/f9a5024b-02ab-469b-8cb7-ab3b8b2bb439

> FDA WARNING_LETTER for Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc.
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Ms. Pedrazzini concerning her subsidiary, Neoteric Cosmetics, Inc., for distributing ALPHA® SKIN CARE Dual Action Fade Cream. This product is an unapproved new drug and misbranded under the Federal Food, Drug & Cosmetic Act (FD&C Act).

The product is deemed a drug due to its intended use for skin bleaching, with claims like "Dual Action Skin Lightener," "Helps to fade the dark spots," and containing "2% Hydroquinone, a proven skin lightener." These claims, found on the product label and website, indicate its intent to affect body structure/function and treat/mitigate disease.

As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, which deems it not generally recognized as safe and effective (GRASE) per a 2006 proposed rule. Consequently, it is considered a new drug requiring an approved application under section 505 of the FD&C Act since September 23, 2020. No such approval exists for ALPHA® SKIN CARE Dual Action Fade Cream, violating section 505(a) and 301(d).

Furthermore, the product is misbranded under section 502(ee) and 301(a) because it is a nonprescription drug subject to section 505G but lacks an approved application

## Related Officers

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

Company: https://www.keypedia.com/companies/neoteric-cosmetics-incorporatedscotts-liquid-gold-inc/a726130e-1964-47b9-88a0-d538aee5d286

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