EDF Health

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

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

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

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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Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

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

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”

– Helena Bottemiller Evich

from Politico article

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article. Read More »

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FDA has new funding to start modernizing how it assesses food chemical risks

Joanna Slaney, Sr. Director, Federal Affairs; and Tom Neltner, Senior Director, Safer Chemicals Initiative

For the first time in recent memory Congress approved funds for FDA specifically to address food safety from potentially dangerous chemicals that may present health hazards. Now it’s time for the agency to get to work.

Congress appropriated $7 million for “Emerging Chemical and Toxicology Issues” and $11 million for “Maternal and Infant Health and Nutrition” for the current fiscal year. While these numbers are below the agency requests of $19.7 million and $18 million respectively, the funds can help FDA meet its stated goals to bring on new staff and to:

  • “Enhance and update its approach to chemicals—both those directly added as food ingredients and those that come into the food supply through food contact and environmental contamination” and
  • Address issues of concern that include lead, cadmium, and arsenic in children’s food.

Read More »

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Broken GRAS: A scary maze of questions a corn oil producer couldn’t answer

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

This blog is the fourth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food, how the process works in practice, and why it is broken. Companies voluntarily submit these notices seeking a “no questions” letter from FDA that makes it easier to market the chemical to food companies.

In our latest blog we address a chemical called “COZ corn oil” developed by the Iowa-based company, Corn Oil ONE. We obtained documents from FDA revealing that the agency twice raised significant concerns about the safety of COZ corn oil with the company, which withdrew its notification without addressing the agency’s questions. As with the other examples in the series, FDA did not make its concerns public or take steps to block the chemical’s use in food.  Read More »

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