FDA takes action to limit lead in juice, proposes significant – but insufficient – limits

Tom Neltner, Senior Director, Safery Chemicals

The Food and Drug Administration (FDA) recently released draft action levels for lead in juice, proposing to reduce lead limits from 50 parts per billion (ppb) to 10 ppb for apple juice and 20 ppb for all other juices. However, the draft limits don’t go far enough to protect children. They also risk undermining the agency’s broader Closer to Zero effort to drive down children’s exposure to lead, arsenic, and cadmium in food. 

If finalized, these levels would be the most stringent in the world, including current European standards[1] and anticipated international standards.[2] For that FDA deserves credit. Public comments to FDA are due June 28. 

This blog is the first in our Unleaded Juice blog series where we explore these issues. Heavy metals like lead are potent neurotoxicants that can impair children’s brain development. Lead can also result in lower IQs in children. 

Strategically, juices are a smart place for FDA to begin driving down lead exposure in young children[3] for two reasons:  

  1. Fruits represent 25% of children’s exposure to lead, a close second to grains.[4] While whole fruits have significant nutritional value, juices do not because much of the fiber and protein are removed. In addition, juices are high in calories and often very sweet, one of the reasons children like them. For these reasons, the American Academy of Pediatrics discourages serving fruit juices to young children.
  2. FDA and consumer advocacy groups like Consumer Reports have conducted significant testing of juices. As a liquid, it is easier to get a representative sample of juices, and they can be analyzed at a lower cost because sample preparation is simpler than for solids and mixtures.

For these reasons, juices represent an important opportunity for FDA to set aggressive limits that prioritize children’s health over marketplace impacts while still balancing access to nutritious foods. Juices also represent the outer limit of what FDA will demand from industry since it will take a more cautious approach when setting lead limits for more nutritious foods.  

With its draft action levels for lead in juices, FDA has taken a needed – but insufficient – step forward, but much more is required. In this blog series, we will focus on: 

  • Evaluating socioeconomic benefits of more protective lead limits; 
  • Strengthening FDA’s approach to setting limits;
  • Considering the overall risk using FDA’s Interim Reference Levels (IRLs), the agency’s maximum daily intake of lead from food; 
  • Screening out laboratories that cannot reliably measure lead in juice; 
  • Using preventive controls to ensure compliance with lead limits; and 
  • Planning for continuous improvement to drive levels down closer to zero.

We see reason for optimism. FDA submitted the draft action levels for lead in juice to the Office of Management and Budget for review in March 2021 – a month before it launched its Closer to Zero plan. Over the past year, FDA has made a concerted effort to reconsider the science and how it approaches setting standards for substances like lead for which there is no known safe level of exposure. We hope that investment will translate into more protective limits for children as they finalize the juice limits and propose additional limits for other foods that children commonly eat. 

[1] Europe uses 50 ppb for juice and has supported 20 ppb for juice marketed for infants and toddlers.

[2] Codex Alimentarius is near final stages of 50 ppb for juices from small fruits and 40 ppb for other juices. With US support, in May 2022, the key Codex committee rejected European Union proposal for 20 ppb in juice for infants and toddler. EDF opposed FDA’s position. Outcome based on EDF monitoring of committee meeting.

[3] FDA looks at children one to six years of age in its analysis.

[4] Judith H Spungen (2019) Children’s exposures to lead and cadmium: FDA total diet study 2014-16, Food Additives & Contaminants: Part A, 36:6, 893-903, DOI: 10.1080/19440049.2019.1595170.

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