KKB assists client in approval of meat and poultry ingredient by USDA
A client that manufactures meat products wished to include in its products an ingredient that had not yet been approved by USDA for use in meat products. The approval of an ingredient in a meat product is generally a two-step process: (1) FDA reviews a GRAS (generally recognized as safe) notification submitted by the manufacturer and then if FDA has no issues regarding the safety of the product, (2) FSIS reviews the submitted suitability data and issues a letter concluding that the ingredient may (or may not) be used for the particular use in the particular product(s). We assisted a client in navigating this approval process and USDA concluded that the ingredient was safe and suitable for the proposed use. Throughout this process, we addressed all the key legal issues raised by FDA and USDA and helped the company prepare prompt responses to questions from the agencies to keep the review process on track.