Elements Brands Inc. – FDA Warning Letter, Apr 19, 2022

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