EDF Health

Over 7 million children exceed FDA’s new daily maximum intake level of lead

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 24, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the fourth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

In June, after issuing its proposed action levels for lead in juice, FDA tightened its Interim Reference Levels (IRLs) for lead to 2.2 µg/day for children and 8.8 µg/day for females of childbearing age—a drop of 27% from the original IRLs it established in 2018. We estimate this change increased the number of children over the IRL for lead from 1.2 million to more than 7 million.

The agency describes IRLs as daily maximum intake levels for lead in food and beverages. FDA scientists said the change was made to match the Centers for Disease Control and Prevention’s (CDC) October 2021 revised blood lead reference value.  This value is commonly known as the elevated blood lead level (EBLL).[1] FDA uses the “interim” label in recognition that there is no known safe level of exposure to lead and the neurotoxic harm it can cause. FDA anticipates matching the IRLs to future reductions in CDC’s reference value as the U.S. makes progress in reducing children’s exposure to lead.

We applaud FDA’s decision to tighten the IRLs. It is a good example of the type of continuous improvement to which FDA committed in its Closer to Zero Action Plan, which aims to lower levels of lead, cadmium, mercury, and inorganic arsenic in food that babies and young children eat and drink.

The challenge now is to translate the tighter daily maximum intake level into action levels for specific foods. Next steps for FDA should include:

  • Further tightening its recently proposed action level for lead in juice.
  • Using the revised lead IRLs as:
    • The basis for its proposal for foods commonly consumed by babies and young children – currently stuck in the review process at the White House’s Office of Management and Budget (OMB).
    • A model for FDA’s anticipated IRLs for inorganic arsenic and cadmium under its Closer to Zero program.

Read More »

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Tara Flour: A Reminder of the Real-Life Consequences of Broken GRAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 10, 2022

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, EDF consultant

This blog is the fifth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) system for novel chemicals added to food.

In the spring, folks who ordered from a company that sells pre-assembled smoothies and other frozen foods for home delivery, started getting sick—really sick—after consuming an item called “French Lentil and Leek Crumbles” (Crumbles). Daily Harvest, the manufacturer, recalled the product on June 17. A month later, Daily Harvest said it had ruled out various food-borne pathogens, mycotoxins, heavy metals, and major allergens and had “identified tara flour as the cause of the issue.”

By the end of July, FDA reported the product had been linked to 329 illnesses and 113 hospitalizations in 36 states—a surprising number for a product that sold only 28,000 items. Consumer Reports described the health effects as fever, fatigue, vomiting, diarrhea, and liver problems. At least 25 people who consumed the Crumbles required surgery to remove their gallbladders. Read More »

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Unleaded Juice: Getting Credible Lab Results is Essential

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 2, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the third in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.

FDA’s move to establish action levels on lead in juice – and eventually other foods that young children eat or drink – is an important step forward. While we believe that the action levels need to be tougher, any action level has a limited value if labs that analyze samples for contamination provide results that buyers, regulators, or consumers cannot trust.

We recommend that labs meet four criteria to provide credible results:

  • Be accredited under international standards for testing and calibration of labs (ISO/IEC 17025);
  • Use the analytical method based on FDA’s Method 4.7 [PDF, 1.16MB];
  • Demonstrate proficiency in a third-party, blinded test to quantify lead, arsenic, and cadmium to around 6 parts per billion (ppb); and
  • Provide a written report of results at that level.

Here is the list of labs that met these criteria as of August 2021. See below for our in-depth analysis.

Read More »

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FDA decisions leave ortho-phthalates in food and our safety in limbo

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 22, 2022

Tom Neltner, Senior Director, Safer Chemicals; Maricel Maffini, Ph.D., Consultant

On May 19, the Food and Drug Administration (FDA) announced four incongruous actions in response to petitions submitted by EDF and others asking the agency to ban the use of more than two dozen ortho-phthalates (phthalates) in food packaging and processing equipment. We filed the petitions because we were concerned that these hormone-disrupting chemicals were harming people, especially children, who consume food contaminated by this class of chemicals. Since filing the petitions six years ago, the evidence of harm – and our concern for children’s health – have only grown more compelling.

Despite a statutory duty to decide whether the authorized uses were safe, the agency delayed making a decision and then essentially dodged the safety issue, opting instead to allow nine phthalates it had approved decades ago to be used in plastics, paper, and adhesives that contact food or drinks. FDA only acted in response to a lawsuit filed by Earthjustice for EDF and other health and environmental advocates.

FDA’s decisions allow phthalates to continue to seep into our food and do little to protect the public. As a result, EDF and the other advocates, supported by Earthjustice, filed formal objections to the agency’s decisions on two food additive petitions and petitioned the agency to reconsider its denial of a separate citizen petition. We also demanded an evidentiary public hearing to consider the significant new evidence FDA glossed over. Read More »

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Unleaded Juice: Tougher limits on lead in juice would bring more than a billion dollars in socioeconomic benefits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 7, 2022

Tom Neltner, Senior Director, Safer Chemicals

This is the second in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program.

When developing its draft action levels for lead in juice, FDA started with the current 50 parts per billion limit and considered progressively tighter levels, settling on 10 ppb for apple juice and 20 ppb for other juices. FDA did not consider more protective limits despite acknowledging that there is no known safe level of children’s exposure to lead – which can harm a child’s developing brain – and that many in the food industry already meet the lower draft levels.

FDA also failed to quantify the socioeconomic benefits of its action. While this task is difficult in many settings, it is entirely reasonable for lead because the Environmental Protection Agency (EPA) has developed a quantitative model when considering rules to protect children from exposure to lead.[1] Read More »

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 3, 2022

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.  Read More »

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