True Earth Health Products, LLC Warning Letter Details

Summary

True Earth Health Products, LLC distributed Plexaderm® Skincare DARK SPOT FADE GEL, a skin lightening product containing 2% hydroquinone, without FDA approval and in violation of the Federal Food, Drug, and Cosmetic Act. The product was classified as an unapproved new drug under section 505(a) of the FD&C Act and was misbranded under section 502(ee) because it made drug claims for treating hyperpigmentation, dark spots, freckles, and age spots without the required new drug application. The company marketed and sold the product through its website SheerScience.com with labeling that clearly identified it as a skin lightener with active pharmaceutical ingredients, making it subject to FDA approval requirements.