FDA Holds Public Meeting on Closer to Zero Action Plan for Baby Foods | Hogan Lovells

This update provides a summary of the recent public meeting held on November 18, 2021.The Closer to Zero Action Plan is discussed in more detail in our memorandum issued April 9, 2021.2

The November 18, 2021 public meeting was the first of several expected meetings intended to engage stakeholders and receive input as the action plan is implemented. This first meeting, entitlted “Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages,” focused on the scope of the agency’s action plan as related to the impact of toxic element exposure, generally, and set the foundation for future meetings focused on specific elements or issues.  The meeting featured opening remarks from FDA, two expert panels, and an open public comment forum.  The meeting was recorded and is avaiable to view on FDA’s website.3

Opening Remarks

Opening speakers included FDA Acting Commissioner Janet Woodcock, MD; CFSAN Director Susan Mayne, PhD; Director of CFSAN Office of Analytics and Outreach, Conrad Choiniere, PhD; and USDA Deputy Administrator for Nutiriton, Food Safety and Quality Utilization of Agricultural Products at the Agricultural Research Serivce, Pamela Starke-Reed, PhD.  The speakers highlighted FDA’s  historical and ongoing commitment to the issue of toxic element exposure in baby foods. They also noted the complexity of the issue, emphasizing that toxic element levels will never realistically be reduced to zero given their proliferation in the air, water, and soil. They explained that conducting studies and setting action levels is further complicated because no single food contributes significantly to exposure levels; instead, exposure depends more on the makeup of the child’s diet and underlying nutrient levels. Finally, the opening speakers discussed the need to evaluate risks and benefits of the action plan moving forward to avoid unintended negative consequences, such as pushing nutritious baby foods out of the market or pricing certain families out of these products.

Panel 1: The Impact of Toxic Element Exposures at Different Crucial Developmental Stages for Babies and Young Children

Panelists from industry, academia, and the Environmental Protection Agency (EPA) offered detailed discussions on the first 1,000 days of a child’s life, noting that this is a critical period for proper physiological and neurological development, early diet issues, and a survey of levels of toxic elements found in various foods.  The panelists emphasized that childrens’ size and physiological makeup are unqiue in calculating the risks associated with toxic element exposure and the first 1,000 days feature many so-called ”windows of sensitivity”—periods of time in which biological processes are highly sensitive to environmental influences. Further, identifying the timing and severity of exposure to each element can be difficult, since arsenic, cadmium, lead, and mercury are all found in the fruits, vegetables, and rice products which together make up a large portion of what infants and children eat.

Panel 2: The Role of Nutrition in the Closer to Zero initiative

Panelists from the Centers for Disease Control and Prevention (CDC) and academia explained the complicated relationship between a child’s nutrient intake and exposure to toxic metals from food.  They explained that when a child consumes a fruit, vegetable, or rice product, their body is exposed both to toxic elements and to healthy nutrients that can mitigate the adverse health outcomes caused by toxic element exposure.  For example, children with iron deficiencies were observed as having higher blood lead concentrations, suggesting that adequate iron intake could mitigate lead exposure.  Additionally, children’s diets often vary across different cultural and socioeconomic populations in the U.S., adding further complexity to cohort studies. The speakers emphasized that future studies need to treat dietary exposures as mixtures—a child’s diet will be comprised of various foods each with unique metal contents and nutrient profiles. This complexity needs to be examined more thoroughly.

Comments

The meeting included an opportunity for public comment, which included input from advocates for the agency’s plan and also from commenters who encouraged the agency to move more quickly and with less input from industry in setting standards.  As noted above, written comments can be submitted to the docket through December 20, 2021.

Next steps

At the meeting’s conclusion, FDA emphasized its desire to work as expeditiously as possible to lower exposure setting action levels and giving consumers advice about how improve diets. The agency intends to have more public meetings regarding the Closer to Zero initiative and encourages interested parties to submit comments and questions to the docket.

References

1 Docket ID FDA-2021-N-0966.