KKB assists client in obtaining an FDA "no questions" letter for a GRAS food ingredient
A client that makes functional ingredients for the food and dietary supplement industry sought the strongest possible statement by FDA in support of the use of its ingredient in conventional foods. KKB recommended that the company evaluate the general recognition of safety of the ingredient and, if supported by the scientific evidence, reach a determination that the ingredient is "generally recognized as safe" (GRAS) for its intended use in food. Then, a notification of this GRAS determination could be submitted to FDA. The goal would be to obtain a letter from FDA saying that it has "no questions" about the GRAS determination. This could then be used to assure customers that the ingredient is acceptable for use in food under US law.
KKB worked together with the company's scientists and regulatory staff to organize a step-by-step approach to undertaking a sound and thorough GRAS evaluation. We convened a panel of independent experts to review the publicly available data and conduct a rigorous analysis of the ingredient's safety. When the panel provided its report supporting GRAS status, we assisted the company's scientists in preparing an accurate and well-documented GRAS notification that expressed the panel's conclusions consistent with legal requirements and FDA's established practice. We then organized a meeting with FDA at which, together with the company's scientists, we outlined the evidence supporting the ingredient's GRAS status.
Throughout this process, we addressed all the key legal issues that a GRAS ingredient routinely faces and helped the company organize prompt responses to FDA's questions to keep the review process on track. Ultimately, the notification was successful, and FDA issued a letter to the company stating that it had "no questions" about the company's GRAS determination.