In summary, the regulatory status of an adhesive for use in food packaging is determined by the regulatory status of each individual substance that constitutes the adhesive. Any individual substance that is reasonably expected to migrate to food because of its intended use in the adhesive must be GRAS, prior sanctioned or the subject of a food additive regulation, a TOR exemption or an effective FCN. However, if it can be established that the adhesive is separated from food by a functional barrier and used in accordance with applicable GMPs, premarket clearance from FDA is not legally required. Of course, a customer may still demand the added assurance of an FDA sanction prior to using the adhesive.