EDF Health

Selected tag(s): food safety

Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

Tom Neltner, J.D.is Chemicals Policy Director

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

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Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant.

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

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A path to leadership: Food packaging product stewardship considerations released

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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We are what we eat: New paper outlines how the regulatory gaps in the US threaten our health

Sarah Vogel, Ph.D.is Vice-President for Health.

In a new paper published in PLoS Biology today, Maricel Maffini, Tom Neltner and I detail the regulatory gaps in how the US manages chemicals in food. We explore how failures in our current regulatory system put the public’s health at risk as exemplified in the case of perchlorate, a chemical allowed in food and a well-known endocrine disrupting compound. Perchlorate’s ability to disrupt normal functioning of the thyroid means that even low levels of exposure, especially in those with inadequate iodine intake, can adversely impact the developing brains of infants and children. It is not a chemical that should be in the food of pregnant women, infants and children. And yet it is, and the levels children consume have increased in recent years.

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