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

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.