FDA Labeling Warning Letter for Anastasia Marie Laboratories, Inc.

On July 15, 2013, the FDA issued a warning letter to us regarding the way we labeled our product, Diapedic® Foot & Leg Treatment. The warning letter, which is quite common for over-the-counter product companies to receive, had nothing to do with the product, the intended use, ingredients, or safety. The letter simply stated that we needed to correct the way we labeled the product.

We took immediate action and made the changes requested by the FDA. An independent FDA consultant reviewed our new label and has stated that it is in compliance with FDA labeling standards.

You can read our consultant’s opinion below.