EDF Health

Broken GRAS: How a food award competition revealed a secret GRAS ingredient


What happened

The Good Food Foundation recently announced its annual awards recognizing foods with both superior taste and responsible business practices, sparking controversy when a plant-based blue ‘cheese’ product was initially a finalist in the cheese category, then was disqualified and removed from the list of finalists. According to the foundation, the product was disqualified because one of the ingredients, kokum butter, had not been designated as GRAS (generally recognized as safe) by the Food and Drug Administration.


Why it matters

Kokum butter is derived from the seeds of a kokum tree’s fruit, primarily cultivated in India. The substance is not found in any of FDA’s lists of ingredients either approved or reviewed for safety. Someone somewhere determined that the use of kokum butter in food is GRAS. However, who made that determination, when, and the basis for the decision are unknown.  For example, how much of it is safe to eat? Is it safe for anyone—children, pregnant women, people with preexisting conditions? Could it cause allergic reactions or interfere with medication? Does it leave the body quickly? Does it mimic or interfere with hormones? We just don’t know and neither does FDA.

Here’s  a quick overview of the GRAS system, which we have written about extensively in our Broken GRAS blogs.

  • “General recognition” means that a safety assessment was performed and published, and the scientific community agrees that use in food is safe;
  • GRAS substances are exempted from pre-market approval by FDA;
  • FDA has interpreted the law as allowing manufacturers to independently determine the use of a substance is GRAS without informing the agency;
  • FDA created a voluntary program for manufacturers to submit their chemical’s safety determination in the form of a GRAS notice to the agency for review;
  • Manufacturers can withdraw the request for review at any time and still claim their product is GRAS. See the decision tree below.


Our Take

Back in 2022, tara flour, another ingredient of unknown safety, caused more than 400 people to get sick. Like kokum butter, tara flour was not approved or reviewed for safety by FDA.

We applaud the Good Food Foundation for requiring that the ingredients used in foods competing for its awards be reviewed by FDA. It is a matter of protecting public health. We fully support, at minimum, company submissions of GRAS notifications and FDA reviews. Although we have been critical of FDA’s outdated science in safety assessment of chemicals, these notifications provide at least some degree of visibility into the food supply that otherwise is not available to the agency in charge of protecting the public.


Next steps

We will continue to engage with FDA to ensure the agency has the tools and resources to strengthen the oversight of companies making GRAS claims without disclosing their safety assessments. The ongoing reorganization of FDA and creation of the Human Food Program is a unique opportunity to fix the broken GRAS program so that all Americans can have confidence in the safety of the food they eat.


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FDA Says We Are All Made of Chemicals So How Can Any Be Bad For You?

By Maria Doa, PhD, Senior Director, Chemicals Policy, Maricel Maffini, PhD, Consultant, and Liora Fiksel, Project Manager, Healthy Communities


Woman reading product label in grocery store

What happened

You may have seen news or online content from FDA about chemicals in our foods, including that our food – and everything else in the world – is made up of chemicals.

FDA’s online content also characterizes toxic chemicals such as lead and mercury simply as naturally occurring or naturally present in our environment. It further fails to distinguish the most harmful chemicals by asserting that for all chemicals, it is the amount of the chemical that matters when determining their harm.

Why it matters

It is true that everything, including our food, is made up of chemicals. However, that does not mean that we should treat all chemicals equally.

Highly toxic chemicals such as lead, mercury, PFAS, TCE, methylene chloride, and BPA are examples of substances that should not be in our food. These toxic metals and synthetic chemicals do not have nutritional benefits and are not equivalent to the chemicals that make up the proteins, fats and carbohydrates that are necessary for a healthy diet. We should not be exposed to toxic chemicals at any level.

The suggestion that toxic metals and synthetic chemicals such as PFAS in our food are just chemicals like essential elements such as potassium in bananas is misleading and harmful.

Unfortunately, FDA accomplished just that. In a webpage released earlier last week, the agency tried to address worries about chemicals in food, an issue that consumers have been concerned about for several years. In its attempt to bring confidence about the safety of the food supply, FDA tried to normalize the presence of toxic chemicals, including neurotoxicants, carcinogens and endocrine disruptors, in our food.

Our take

If a toxic chemical such as lead or mercury is naturally occurring, is it OK?

No. While there are very low levels of these metals that are naturally present in our environment the majority of what is now in our environment is not natural background but the result of pollution and other contamination due to human activities. These levels are not “naturally occurring.”

It is also essential to recognize that naturally occurring does not equate with safety. There is no safe level of exposure to lead and mercury which are potent neurotoxicants. They are particularly harmful to infants and small children and exposure to even small amounts can cause harm.

Is there always a safe level of exposure to a chemical?

Treating all chemicals in our food the same way ignores the science. Some chemicals, in addition to lead and mercury, are so toxic that essentially any amount of exposure is of concern:

  • Chemicals like TCE associated with multiple types of cancers and harm pregnant women and infants.
  • Chemicals like PFAS also known as forever chemicals because they are so difficult to destroy that can harm pregnant women, cause cancer and harm the immune system in vanishing small quantities. For two of the PFAS, EPA just declared that there is no safe level of exposure.
  • Chemicals like BPA that harm the immune and reproductive systems, disrupts the normal function of hormones and affects learning and memory at levels 20,000 times lower than previously estimated, and
  • Chemicals like methylene chloride are associated with cancer and liver toxicity.
  • Chemicals like phthalates that also disrupt the normal function of hormones specially during development of the male reproductive tract. These chemicals are strictly limited in children’s toys due to their toxicity.

And being exposed to more than one of these chemicals that cause the same harm, such as cancer, can increase the harmful effects.

Further, Congress also recognized that some chemicals should not be allowed to be added to our food. Period. Congress included a provision known as the Delaney Clause in our food safety laws that states a food additive cannot be deemed “safe if it is found to induce cancer when ingested by man or animal.” Yet unfortunately, some carcinogens continue to be allowed.

How can we be assured of a safe food supply if the agency that is supposed to ensure safety takes the same “it’s the amount that matters” approach to these toxic chemicals as it does to salt?

And how can we have confidence that FDA will fully consider consumers in determining food safety when the agency not only falsely equates toxic chemicals with the chemicals that make up the proteins, fats and carbohydrates in our diet but also takes a patronizing approach to the public by stating that “chemical names may sound complicated but that does not mean they are not safe.”

Next steps

In the last several years, public interest organizations have petitioned FDA to review the safety of chemicals known to pose risk to health.  Many petitions are still unresolved.

FDA should recognize toxic chemicals for what they are – chemicals that can harm our health and well-being – rather than camouflage them just as any other chemical. The science and the law demand that in making decisions about food safety, FDA recognize and act on the most toxic chemicals and fully consider consumers in its decision making.


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Podcast: You Make Me Sick! Diversity in the environmental movement

This month on our podcast, we talked with Whitney Tome, Executive Director of Green 2.0, to talk about the importance of diversity in the environmental movement. In talking about our need to have more chairs at the table, we discussed Green 2.0’s new report, Beyond Diversity, which looked at how hiring practices might be reshaped to cast a bigger net, as well as their scorecards on the state of racial and gender representation at major environmental organizations.

Want more? Subscribe to us on iTunes or Google Play, or check out our SoundCloud to listen via desktop!

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Lead in food – An overlooked, but meaningful, source of children’s exposure to lead

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

By now, it is well known that lead exposure is a significant human health concern, especially for young children. While most of the discussion about lead exposure has involved paint, drinking water, and contaminated soil or dust where young children live, play, and learn, EDF’s new report shows reason to pay more attention to another source: our food.

Until recently, we have known very little about the contribution of food to children’s lead exposure. In January 2017, an Environmental Protection Agency (EPA) draft report indicated that food is a meaningful source of children’s exposure to lead. Using EPA’s data, we estimated that over 1 million young children consume more lead than what the Food and Drug Administration (FDA) considers acceptable for children to eat every day. From EPA’s analysis, we calculated that  that if lead in food were eliminated, millions of children would live healthier lives, and the total societal economic benefit would exceed $27 billion a year in increased lifetime earnings resulting from the impact of lead on children’s IQ.

To better understand the issue of lead in food, EDF evaluated over a decade’s worth of data collected and analyzed by the FDA as part of the agency’s Total Diet Study (TDS). Since the 1970s, the TDS has tracked metals, pesticides, and nutrients in up to 280 types of food yearly.

What did we find?

Overall, 20% of 2,164 baby food samples and 14% of the other 10,064 food samples had detectable levels of lead. At least one sample in 52 of the 57 types of baby food analyzed by FDA had detectable levels of lead in it. Lead was most commonly found in the following baby foods:

  • Fruit juices: 89% of 44 grape juice samples contained detectable levels of lead, mixed fruit (67% of 111 samples), apple (55% of 44 samples), and pear (45% of 44 samples)
  • Root vegetables: Sweet potatoes (86% of 44 samples) and carrots (43% of 44 samples)
  • Cookies: Arrowroot cookies (64% of 44 samples) and teething biscuits (47% of 43 samples)

Read More »

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Toxic secrets in our food? EDF joins in lawsuit aimed at protecting food safety

Today, Environmental Defense Fund joined other groups in challenging a Food and Drug Administration (FDA) rule that allows chemical and food manufacturers to decide for themselves – in secret – what chemicals and food additives can be added to foods. The practice puts our health at risk and does not fulfill Congress’ requirement that FDA determine that chemical additives are safe before they can be used in food.

Americans would be shocked to learn that food companies routinely add novel chemicals to our food without first getting FDA approval. In doing so, the companies are exploiting a loophole exempting ingredients “Generally Recognized as Safe” (GRAS) from formal FDA review and approval.

Originally intended for ingredients like vinegar and olive oil, industry now abuses the GRAS loophole by bypassing FDA review and making safety determinations in secret. The alarming result: even FDA does not know what is in our food. In fact, FDA has no way to know what chemicals are actually being used in which food or in what quantities—even in baby food.

Last year, the FDA issued a final rule formalizing this outrageous practice. We described this decision as a lost opportunity for safer food additives when the decision was made. Today, EDF and our colleagues at the Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental Working Group, represented by CFS and the environmental law firm Earthjustice, joined in filing suit against the FDA for unconstitutionally and illegally delegating that authority to self-interested food and chemical manufacturers.

It is disappointing that the groups were forced to take legal action. In addition to being a bad policy that doesn’t comply with law, or protect public health, the FDA is oddly out of touch with public sentiment. Just last week an industry funded survey showed overwhelming consumer concern about chemicals in food, including cancer causing chemicals, while showing diminished confidence in the food supply. This continues a trend that has been building for years. Food companies would be wise to take notice: adding secret chemicals without FDA scientific review to our food is no way to improve confidence in their products.

But with thousands of secret chemicals in our food, we can’t wait for industry or FDA to wise up. Today’s lawsuit seeks to force FDA to do what should be common sense—determine that food additives are safe before they can be added to our food.

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