On December 6, 2022, the Reagan-Udall Foundation published an independent evaluation of the US Food and Drug Administration’s (FDA) Human Foods Program “with the aim of strengthening FDA’s food regulatory role.” The Human Foods Program includes the Center for Food Safety and Nutrition (CFSAN) which is responsible for regulation of food contact chemicals within the United States. The independent panel evaluated the agency’s culture, structure, resources, and authorities. Overall, the panel gave 32 recommendations across the four domains. Including stating that the FDA should:
- “identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.”
- “develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework.”
- implement structural changes (including potentially separating the food and drug branches of the FDA into two entities).
- increase staff engagement with outside conferences.
- “amend the Federal Food, Drug, and Cosmetic Act… to allow for disclosure of non-public information to state, local, and U.S. territorial government agencies.”
- “routinely review… current and recent FDA practices related to GRAS [generally recognized as safe] implementation in light of current U.S. Dietary Guidelines and the evolution of modern manufacturing practices.”
FDA Commissioner Robert Califf commissioned the independent review in June 2022 after the agency received strong criticism following reporting from Politico (FPF reported) and others. Califf said in a statement that “after reviewing the report and consulting with stakeholders both externally and internally” he will be responsible for “making final decisions regarding the future of the FDA Human Foods Program.” To that end he is forming an advisory group of agency leaders which he expects “to be bold and focused on the transformative opportunities ahead for the FDA’s food program.”
Around the same time, the US Congress tasked the Government Accountability Office (GAO) with investigating how the FDA could improve “oversight of substances used in manufacturing, packaging, and transporting food.” GAO published its findings in November 2022 (FPF reported). It recommended the FDA (i) “request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances and (ii) track the dates of the last reviews for all food contact substances to allow FDA to readily identify substances that may warrant post-market review.”
Concerning the generally recognized as safe (GRAS) rule, on December 21, 2022, the FDA published guidance for industry around best practices for those responsible for concluding that a substance may be used in food on the basis of GRAS. However, manufacturers are not always required to notify the FDA of a GRAS decision. Chemical Watch reported concerns from Maricel Maffini, an independent consultant and member of Food Packaging Forum’s Scientific Advisory Board, that the guidance “won’t do much to fix the broken GRAS system” and may in fact “exacerbate” challenges by highlighting how voluntary many of the steps of a GRAS review are.
FDA originally published the draft guidance on GRAS in November 2017 (FPF reported). In the intervening years there has been considerable scrutiny of the GRAS rule from civil society organizations (FPF reported, also here and here). In April 2022, the Environmental Working Group published a report that 756 of the 766 chemicals introduced to the US food supply since 2000 were allowed under GRAS (FPF reported).
References
Henney, J, et. al. (2022). “Operational evaluation of the FDA Human Foods Program: A report of the human foods independent expert panel.” Reagan-Udall Foundation
Robert M. Califf (December 6, 2022). “FDA provides update on external evaluation to strengthen agency’s human foods program.” FDA
Center for Veterinary Medicine and CFSAN (December 21, 2022). “Guidance for industry: Best practices for convening a GRAS panel.” FDA
Julia John (December 21, 2022) “US FDA issues best practices for Gras panels convened to examine food contact substance safety.” Chemical Watch
