# FDA WARNING_LETTER - Elements Brands Inc. - April 19, 2022

Source: https://www.keypedia.com/records/warning_letter/elements-brands-inc/301fef11-405a-4911-8a0f-45e5dc2334c4

> FDA WARNING_LETTER for Elements Brands Inc. on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Elements Brands Inc.
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Summary: On April 13, 2022, the FDA issued a Warning Letter to a firm regarding the distribution of eb5® Skin Lightening Cream. The FDA determined this product is an unapproved new drug and is misbranded.

The product is considered a drug under section 201(g)(1)(B) and (C) of the FD&C Act due to its intended use as a skin bleaching product, with claims such as "AGE SPOT TREATMENT," "Skin Lightening Cream," and "Lightens dark spots in the skin such as freckles, age spots and liver spots," containing Hydroquinone 2%.

Under section 505G(a)(4) of the FD&C Act, skin bleaching products are deemed not generally recognized as safe and effective (GRASE) based on a 2006 proposed rule. Consequently, eb5® Skin Lightening Cream is considered a new drug requiring an approved application under section 505 of the FD&C Act since September 23, 2020. No such application is in effect, violating section 505(a) and 301(d) of the FD&C Act.

Furthermore, the product is misbranded under section 502(ee) of the FD&C Act because it is a nonprescription drug subject to section 505G but lacks an approved application and does not comply with section

## Related Officers

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

Company: https://www.keypedia.com/companies/elements-brands-inc/897704f5-8da7-4431-b130-f8da17166c29