October 3, 2024
US FDA recently held a public meeting to introduce a two-pronged, fit-for-purpose process for post-market assessment of chemicals in food to be implemented by the agency’s newly established Human Foods Program (HFP).
On September 25, 2024, the US Food and Drug Administration (US FDA) held a public meeting on its proposal to develop an enhanced systematic process for post-market assessment of chemicals in food under the newly established Human Foods Program (HFP). In this meeting, US FDA provided additional details regarding the process outlined in its recent discussion paper and an opportunity for external stakeholder comments.
To date, US FDA has conducted its post-market assessment of chemicals in food on an ad hoc basis, centering its activity around regulatory petitions or resubmissions, issues of great public interest or inquiry, and potential topics identified by US FDA experts. In addition, most of the agency’s work in this capacity has not been publicized unless there was a regulatory action. In the public meeting, US FDA acknowledged that the increasing number of state-level restrictions and questions surrounding the adequacy of current pre-market systems have prompted the agency, in part, to develop this enhanced approach for post-market assessment.
In its proposal, US FDA outlines an approach that aims to leverage artificial intelligence (AI) to monitor and identify “signals,” which are then triaged and addressed in a fit-for-purpose manner. This two-pronged process includes assessments that are both focused (relatively limited in scope) and comprehensive (complex and resource intensive), and the agency intends to publish scientific assessments and/or conclusions from both assessment types. In addition, US FDA notes that the process should allow for flexibility to address chemicals with varying levels of pre-market activity, including generally recognized as safe (GRAS) substances, food and color additives, food contact substances, and environmental contaminants.
Gradient scientists are at the forefront of the toxicological assessment of food ingredients and contaminants, including conducting weight-of-evidence reviews, providing regulatory comments, and overseeing ingredient vulnerability assessments. To discuss this issue further, please contact:
Charlotte Marsh, M.S., CPPS
Senior Toxicologist
Charlotte.Marsh@gradientcorp.com
Ari Lewis, M.S.
Principal
Ari.Lewis@gradientcorp.com
Julie Goodman, Ph.D., DABT, FACE, ATS
Principal
Julie.Goodman@gradientcorp.com