EDF Health

Selected tag(s): Food chemicals

Broken GRAS: FDA’s half-step to limit bias and conflicts of interest in GRAS determinations may backfire

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

What Happened? FDA finalized a long awaited guidance for industry in December to help reduce conflicts of interest and bias when a chemical manufacturer chooses to convene an expert panel to assess whether a new chemical additive is generally recognized as safe (GRAS).

Why It Matters: As written, FDA’s Best Practices for Convening a GRAS Panel guidance is excellent. If food companies convene GRAS panels consistent with the guidance, the panels’ evaluations will be more credible because they should have less of the pervasive bias and conflicts of interest that plague the current system and all too often result in unsafe chemicals being added to food. But that’s a big if.

Our Take: Unfortunately, we think the guidance is likely to backfire because of the limited scope — FDA explicitly makes GRAS panels optional – a choice the agency made when it finalized the GRAS rule in 2016. Chemical manufacturers will simply avoid convening GRAS panels, relying solely on their employees or a consulting firm they hire to conduct these safety evaluations. These employees and consultants typically have significant bias and conflicts of interest because positive opinions help their employer or client. We raised this issue in comments to FDA, calling for the best practices to apply to everyone involved in the safety evaluation process. FDA did not address our comments in their recommended best practices in the revised final guidance.

While making GRAS panels optional is a serious problem, a more fundamental concern is that FDA may not have an opportunity to review the GRAS safety evaluations made by employees or hire consultants because the company chooses not to notify the agency. FDA’s Office of Food Additive Safety fails to consider just how often companies choose not to tell the agency that a new chemical is being added to food. In our Broken GRAS series, we provided six examples of the serious risk posed by the GRAS system, the most public being hundreds of people sickened due to consumption of tara flour, an ingredient in a Daily Harvest frozen meal. Last November, using marketing materials we showed FDA that the number of new chemicals bypassing its review likely outnumber those voluntarily submitted to the agency.

We see no evidence that the agency systematically investigates or even audits the GRAS determinations that bypass their review despite promises made by the agency over the years and a scathing 2010 report by the U.S. Government Accountability Office calling for action.

Next Steps: In his effort to reform FDA’s dysfunctional food safety program, FDA Commissioner Califf told a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1] If he follows through, fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. If he fails, the agency will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety.

Go deeper: Broken GRAS series, Neltner et al (2013) Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance; Toxic Free Act; Food Chemical Reassessment Act.

[1] FoodFix, January 31, 2023 edition.

Updated April 9, 2023 to add link for Broken GRAS series.

Posted in Broken GRAS, Conflict of interest, FDA / Also tagged , , , | Authors: / Read 1 Response

Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects

Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director

Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.

During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.

Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.

Biology is not math and the concept of something from nothing 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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Chemicals in food continue to be a top food safety concern among consumers

Chemicals in food continue to be a top food safety concern among consumers

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The latest annual food industry survey demonstrates that U.S. consumers continue to have significant concerns about chemicals in food. Specifically, the survey from the International Food Information Council (IFIC) found:

  • 29% of consumers rated chemicals in food as their top food safety concern, more than any other issue, including foodborne illness from bacteria. Everyone rated chemicals in food among the top three concerns. Chemicals in food has been the top concern every year since 2017, tying risk from COVID-19 from food last year. It has been a significant concern back to the first IFIC Food and Health Survey in 2009.
  • 69% of consumers did not realize that the U.S. government is responsible for reviewing the safety of low-calorie sweeteners, which are among the most well-known food additives.
  • 54% of consumers reported it is important that ingredients do not have “chemical-sounding names” including 26% that rate it “very important.” Their opinion is primarily based on food safety and healthfulness concerns.

Our takeaway is that consumers continue to be concerned about chemicals in food, partly because they are not confident that the federal government is actually ensuring additives are safe. Therefore, they do their best to try and protect their health and safety by avoiding ingredients that sound like chemicals – the only way they see to control the perceived risk. In reaction to consumer concerns, food companies have undertaken “clean label” programs that either remove these ingredients (which can be helpful) or use names that do not sound like chemicals (which obscure the fact and can be misleading).

A better approach is to actually ensure the chemicals in food are safe and healthy rather than leaving consumers to judge products based on the sound of the ingredient names. Actual safety is the outcome that Congress intended when it adopted the Food Additives Amendment of 1958. Instead, the Food and Drug Administration (FDA), the agency with both the responsibility and the authority for food safety, allows companies to decide in secret that additives are safe, fails to consider the cumulative health effect of chemicals in the diet, and lacks any systematic reassessment of past decisions even when new evidence shows potential harm.

FDA needs to step up and address these shortcomings to make our food safe and restore consumer confidence. This involves not only improving its approach to addressing ingredient safety but also their approach towards contaminants that enter our food from the environment, from the packaging, or from food processing.

Read More »

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Important insight from the organic certification approach to chemical additives in food

Tom Neltner, J.D.is Chemicals Policy Director

Since 2014, chemicals in food[1] have been consumers’ most important food safety issue, reaching a high of 35% in 2018, according to annual industry surveys by the International Food Information Council. For comparison, “foodborne illness from bacteria” was half that percent.

Food companies have responded to this growing consumer alarm by adopting policies banning artificial flavors, colors and other ingredients that sound like chemicals. This approach is unlikely to do more than serve as window dressing for the underlying problems since it’s not science-based – many of these additives may be safe. The Center for Science in the Public Interest called out this practice in its 2017 “Clean Label: Public Relations or Public Health?” report and pointed readers to its Chemical Cuisine system that rates common additives for health and safety.

There are some companies, like Panera Bread, that are taking a more systematic approach to the ingredients used in the food they sell, starting with the question of whether the additives used are essential and whether the ingredients pose health or safety concerns. As a result, the company worked closely with their suppliers and reformulated many of their products.

And now, thanks to a fascinating new report from the Environmental Working Group (EWG), we are learning about another structured approach that addresses health concerns with chemical additives – the Federal organic certification program for processed foods. To be honest, before reading the report, I viewed the organic program as narrowly focused on pesticides and was only vaguely aware of how it dealt with chemical additives. I was missing the bigger picture.

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