# FDA WARNING_LETTER - True Earth Health Products, LLC - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/true-earth-health-products-llc/c7d37484-49f6-4c36-8cb2-5e81edcbc2d2

> FDA WARNING_LETTER for True Earth Health Products, LLC on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: True Earth Health Products, LLC
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 13, 2022, the FDA issued a Warning Letter to Mr. Greenhut concerning the distribution of Plexaderm® Skincare DARK SPOT FADE GEL, a drug product intended to bleach and/or lighten skin. The FDA determined this product is an unapproved new drug and is misbranded, violating sections 505(a) and 502(ee) of the FD&C Act, respectively.

The product is considered a drug due to claims on its label and website (Sheerscience.com) indicating its use for "skin brightening treatment for hyperpigmentation, skin discoloration and age spots," and containing Hydroquinone 2% as an active ingredient for "Skin Lightener." Under section 505G(a)(4) of the FD&C Act, skin bleaching products are not generally recognized as safe and effective (GRASE) and require an approved new drug application for marketing since September 23, 2020. No such application exists for Plexaderm® Skincare DARK SPOT FADE GEL.

The letter mandates prompt corrective action within 15 working days, including investigating and preventing recurrence of violations. Failure to comply may result in legal action, including seizure and injunction, and could affect approval of export certificates or pending drug applications.

## Related Officers

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

Company: https://www.keypedia.com/companies/true-earth-health-products-llc/54da84f8-ae38-49d2-b210-75eb65b64b14

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