Lead in Food: Court of Appeals Doubts FDA’s Commitment to Standards

What Happened?

Bloomberg Law Journal’s Nyah Phensitthy reported on a decision by the Second Court of Appeals that reversed a dismissal of class action lawsuit against Beech-Nut Nutrition regarding levels of lead, cadmium, and arsenic in its baby food products.1 The court returned the case to the federal district court for further proceedings because it concluded that “any advantages of deferring to the FDA under the primary jurisdiction doctrine are outweighed by the potential costs resulting from the delay in administrative proceedings.”

In its January 2023 decision, the district court had relied on commitments made by FDA as part of the agency’s Closer to Zero Initiative to reduce childhood exposure to contaminants in food. FDA has prioritized reductions of three toxic elements—lead, cadmium, and arsenic—in baby food. 

The same month that federal district court initially dismissed the case, FDA substantially relaxed its commitments. As a result, the Second Court of Appeals stated that “FDA no longer expects to finalize lead action levels in April 2024 and has also revised its expected timeline for issuing draft guidance on proposed action levels for arsenic and cadmium. For arsenic and cadmium, the FDA now indicates only that it expects to reach the interagency review process sometime in 2024—a step that precedes issuing draft guidance. Given the delays in even proposing action levels, the agency has unsurprisingly provided no timelines for when it expects to finalize action levels.” 

Why It Matters

In February 2021, a report from the House of Representatives’ Subcommittee on Economic and Consumer Policy prompted more than 100 lawsuits against baby food contamination due to the presence of lead, cadmium, and arsenic. Most of those lawsuits claimed the levels of these toxic elements were unsafe or that marketing claims about the healthfulness of the products were misleading. 

FDA responded to the report by launching its Closer to Zero Initiative in April 2021. It focused on these three toxic elements, as well as mercury, and explained that it “prioritized foods commonly eaten by babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.”

As part of the initiative, FDA said it would propose an action level for lead in baby food by April 2022 and finalize it by April 2024. The agency took that first step in January 2023. At the same time, it dropped the deadline to finalize the lead action level and based the deadlines on submitting the documents for interagency review, an opaque process that can last more than a year. On the positive side, it committed to proposing an action level for lead by April 2024. 

These action levels are essential to driving companies to lower contamination levels to the extent they can.  While proposals are useful to proactive companies, they have their real impact when finalized.

Our Take

FDA is already under pressure to move faster on its action levels for lead, cadmium, and arsenic under the leadership of its new Deputy Commissioner for Human Foods, Jim Jones. This court decision, along with the recall of applesauce pouches, should increase that pressure.  

Next Steps 

Unleaded Kids will continue to press FDA to move faster to propose and finalize these action levels. When they are proposed, we will submit comments to FDA. 


The Environmental Defense Fund and Healthy Babies Bright Futures submitted extensive comments to FDA calling on the agency to strengthen the proposal. EDF also published a series of blogs on the issue. 

  1. Many lawsuits, including one filed by the District of Columbia Attorney General, were dismissed because the court relied on FDA’s commitments to issue action levels for lead, cadmium, and arsenic in a timely manner.  ↩︎

Leave a Reply

Your email address will not be published. Required fields are marked *