# FDA WARNING_LETTER - Clinical Formula LLC - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/clinical-formula-llc/f3cbc070-327f-46ff-8e26-5ccde5f19ef2

> FDA WARNING_LETTER for Clinical Formula LLC on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Clinical Formula LLC
- 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. Kutanakit on April 13, 2022, concerning the manufacturing of Clinical Formula™ Bleaching Lotion. This product, intended to bleach and/or lighten skin, is cited as an unapproved new drug and a misbranded drug.

The product is deemed a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act due to claims like "BLEACHING LOTION," "Skin Lightener," and "For Bleaching of Hyperpigmented Skin" with Hydroquinone 2% as an active ingredient. It falls under section 505G(a)(4) of the FD&C Act, as it is subject to a proposed rule (71 FR 51146) determining that OTC skin bleaching products, including those with hydroquinone, are not generally recognized as safe and effective (GRASE).

Consequently, Clinical Formula™ Bleaching Lotion is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act, effective September 23, 2020. No such application is in effect, violating section 505(a) and prohibiting its interstate commerce under section 301(d). Furthermore, it is misbranded under section 502(ee) and 505G(

## Related Documents

- [483 - 2021-12-03](https://www.keypedia.com/records/483/clinical-formula-llc/b6b816c7-5541-407a-9fd0-54110f75ce81)

## Related Officers

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

Company: https://www.keypedia.com/companies/clinical-formula-llc/8a18d62e-efa3-4bb2-847e-b4fe3a8bdea5

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