Polyurethane manufacturers are often asked if their products have been approved for use in food contact applications by the United States Food and Drug Administration (FDA). Manufacturers supplying the polyurethane materials (hereinafter referred to as supplier) and manufacturers of the end-use article (hereinafter referred to as converter) have the independent responsibility to comply with applicable FDA regulations. This document is designed to address common questions related to the FDA’s role in this area and to provide guidance as to where additional information may be obtained.
The FDA regulates the use of all resins whose intended use results, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, unless the resin is generally recognized to be safe under the intended conditions of use.