The US Food and Drug Administration (FDA) is currently undergoing work to restructure its food program following public outcry from investigative reporting (FPF reported) and subsequent analysis by both a congressional watchdog (FPF reported) and an independent panel (FPF reported). On January 31, 2023, the agency published its initial response to the analysis, outlining which recommendations it plans to undertake and how it will restructure programs.
The changes proposed by the FDA focus on food and nutrition. These include creating a Center for Excellence in Nutrition to prioritize and organize efforts in that field, founding an Office of Integrated Food Safety System Partnerships to coordinate with state and local counterparts, and establishing a Human Foods Advisory Committee. The latter “will consist of external experts to advise on challenging and emerging issues in food safety, nutrition and innovative food technologies.”
On February 28, 2023, FDA provided additional information on the restructuring plans. The update provided more details on how offices and departments will be combined and leadership reorganized. This includes “moving cosmetics regulation and color certification functions” out of the Center for Food Safety and Applied Nutrition which is otherwise responsible for managing food and supplements including food contact chemicals and food additives (FPF reported).
The current restructuring and refocusing of the FDA food branch may align well with the goals of The Center for Science in the Public Interest (CSPI), a US-based consumer advocacy organization. In February 2023, CSPI published a report encouraging the FDA to begin incorporating risk of endocrine disruption, obesogens in particular, into evaluations of food contact chemicals and food additives.
Obesogens are endocrine disrupting chemicals that may “influence individual susceptibility to obesity by interfering with metabolic systems that regulate appetite, weight gain, and fat development and distribution.” Obesogens “are also sometimes referred to as metabolic disruptors (more precisely, a type of metabolic disruptor).” Some obesogens have demonstrated multigenerational effects in animal studies meaning that even offspring unexposed to the chemicals can have increased weight gain. These transgenerational effects may be induced by changes in gene expression (epigenetic change). Chemicals present in food contact plastic have been found to promote obesity (FPF reported and here).
The report authors explain, the “FDA currently lacks a framework for identifying and evaluating metabolic disruptors, as well as endocrine disruptors more generally, when reviewing food and color additive petitions, Generally Recognized as Safe (GRAS) notifications, food contact substance notifications, or otherwise assessing the safety of substances in or intended for the food supply.”
The CSPI report encourages the FDA to work with other scientific organizations to assess hazards of food contact chemicals. The National Academies of Sciences, Engineering, and Medicine (NASEM) “has provided advice to the EPA [Environmental Protection Agency] for many years on improving its assessments of hazard, exposure, and risk, and the FDA could benefit from such advice.”
An analysis by the Environmental Working Group (EWG) in 2022 found that between the years 2000 and 2022 nearly 99% of new chemicals in food packaging and additives were introduced to the food supply under the GRAS rule, thus without FDA review. Civil society organizations in the US have regularly called out the FDA in recent years for failing to tighten reviews of food contact chemicals currently approved under GRAS (FPF reported, also here and here). Particular focus has been on phthalates with a coalition of NGOs suing the agency in 2021 for failing to respond to citizen petitions on the issue (FPF reported). The petitions were later denied but the agency subsequently called for more information on the use of phthalates in food contact (FPF reported).
References
Robert M. Califf (January 31, 2023). “FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.” US FDA
FDA (February 28, 2023). “FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring.”
Lisa Lefferts (February 2023). “Obesogens: Assessing the evidence linking chemicals in food to obesity.” CSPI.
Read more
CSPI (February 9, 2022). “Metabolic disruptor research and action agenda.”
Peter G. Lurie (January 31, 2023). “CSPI lauds FDA’s proposed reorganization of its food function.” CSPI
Julia John (February 22, 2023). “US NGO calls for FDA to include metabolic disruption in food contact substance reviews.” Chemical Watch
