EDF Health

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

By Maricel Maffini, PhD, Consultant / Published: June 10, 2024

 

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.

 

Also posted in Broken GRAS, FDA, Food / Authors: / Read 1 Response

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

By EDF Blogs / Published: April 11, 2024

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.

 

Posted in General interest / Authors: / Read 1 Response

Unleading Baby Food: FDA needs to tighten its proposed action levels

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 28, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative

Note: This is the first of three blogs in this series. Click here for Blog 2 or Blog 3.

On January 24, 2023, FDA released draft action levels1 for lead in foods intended for babies and young toddlers.2 This proposal is a key step in implementing the agency’s Closer to Zero Action Plan.

For most of these foods, the lead limit would be 10 parts per billion (ppb). FDA proposed a 20-ppb limit for dry infant cereals and single-ingredient root vegetable products (i.e., carrots and sweet potatoes), because these products may have greater lead contamination levels.

The action levels do not apply to five types of foods that young children frequently eat:

  • Grain-based snacks such as teething biscuits, sandwich cookies, and puffs—despite FDA’s finding that the biscuits and cookies were two of the three foods with the highest mean lead concentrations that the agency tested for its Total Diet Study from 2018-2020.
  • Fruits, cereals, and vegetables that parents use to make homemade foods for their babies and young toddlers—despite those products being likely to be more contaminated, whether or not it was labelled as organic.
  • Food marketed for a general audience (e.g., raisins, applesauce, canned food) that parents commonly feed to children —especially families on tight budgets.
  • Food marketed to young children over age 2, including kids’ meals and some snack bars.
  • Juices, since FDA proposed limits on those in April 2022 and should finalize them this year.

FDA has not set—or even proposed—action levels for lead for any of these foods (except juice). Based on the current Closer to Zero Action Plan schedule, the agency has no plans to establish action levels for the foods listed in items 2 and 3, above.

Do Food Companies Have to Comply with Action Levels?
The short answer is technically and legally “No”—but in practice, “Yes”…with important caveats. As with all guidance, FDA makes clear that:

[G]uidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

As a practical matter, action levels serve as limits that companies meet to decrease the risk of having FDA deem their products adulterated and subject to a recall. In addition, FDA expects food facilities to use their Hazard Analysis and Preventive Control Program to achieve action levels by managing their facilities and suppliers to ensure compliance and taking action if problems are revealed through testing or other efforts.

FDA’s Criteria for Setting Action Levels
There is no safe level of lead in the diet. Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

In its proposed guidance, FDA said:

[W]hen evaluating possible action levels under 21 CFR 109.6 for lead in foods intended for babies and young children less than two years old, we took into account several considerations, including:

  • the action level should minimize the likelihood that a consumer will be exposed to lead levels exceeding the IRL (interim reference level);
  • as appropriate, there should be a limited number of unique action levels for simplicity;
  • the action levels should result in a reduction in exposure to lead; and
  • for those baby foods where lead levels are already relatively low, the action levels should be established where achievability is in the 90th-95th percentile range.

EDF’s Recommendations for Making FDA’s Proposed Action Levels More Protective
We did a deeper dive into FDA’s proposal and the three datasets3 it published to support its decision. We applied FDA’s achievability target of 90th percentile to develop four recommendations to improve the action-level proposal and reduce dietary exposure to lead for babies and young toddlers, even though we think FDA should use a stricter target for infants and babies—as it did for inorganic arsenic in infant rice cereal.4 For the sake of simplicity, we also sought to minimize the number of unique action levels:

  1. The 20-ppb action level for dry infant cereals should be limited to rice cereals; other grains should have a 10-ppb action level. For the 299 rice cereal samples, the 90th percentile was 21 ppb of lead, and 28% had levels of 10 ppb or more. By contrast, only 1 of 85 samples (1.2%) for non-rice or multigrain cereals had 10 ppb or more of lead, and the 90th percentile was 8 ppb—so a 10-ppb level can be met and is justified. Note that rice cereal is also high in inorganic arsenic.
  2. Beyond dry infant cereals, foods that contain no root vegetables as ingredients should have an action level of 5 ppb instead of 10 ppb. For 478 samples without root vegetables5, the 90th percentile was 3.3 ppb of lead, while 6% had 5 ppb or more. Note that half of those over 5 ppb had quinoa as an ingredient. Based on these results, foods other than dry cereals that do not have root vegetables should have an action level of 5 ppb. For 110 samples of food with root vegetables as one of multiple ingredients, the 90th percentile was 11 ppb of lead and 22% had 5 ppb or more. For foods whose only ingredient is a root vegetable, a 20-ppb action level is justified.
  3. Grain snacks, such as teething biscuits, puffs, snack bars, and cookies should have an action level of 20 ppb; they are some of the most contaminated baby foods. For 123 samples of these foods collected in 2013-14, the 90th percentile was 18 ppb of lead and 26% had 5 ppb or more. While the samples are old, there are sufficient samples of these popular products with high enough levels that the agency should set a level of 20 ppb.
  4. Quinoa, an increasingly popular ingredient for baby food, requires greater scrutiny, starting with increased sampling, since almost half of the samples with quinoa as the sole or main ingredient have lead levels of 20 ppb or more. The levels of lead in quinoa were worse than rice cereal, grain snacks, or root vegetables. While the data set is older (from 2014) and much smaller (29 samples), the 90th percentile was an astounding 90 ppb of lead. In addition, 41% had 20 ppb or more of lead and 58% were over 10 ppb.6 Without more data, FDA should maintain a limit of 20 ppb for dry cereal and 10 ppb if that cereal is combined with other ingredients.

We made these recommendations in our formal comments (PDF) on the proposal that we submitted on March 27, 2023 . In subsequent blogs, we identify significant problems with the process FDA uses to establish action levels for lead and to describe specific research needs. (Updated on 3/28/23 to reflect submission of our comments to FDA and link to the document.)

Up Next: Unleading Baby Food: FDA needs to improve how it sets action levels to be more transparent and credible

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NOTES

1 FDA’s guidance refers to babies and young children. However, the action levels only apply to foods intended for children younger than 24 months, a very narrow definition of young children, especially since children up to six years of age are particularly vulnerable to the harm to their brain from lead. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “toddlers” to avoid confusion.

2 Action levels represent levels at which FDA may regard food as adulterated and seek a recall.

3 In its 2018 sample results, 29% of the 149 samples exceeded 100 ppb of inorganic arsenic in infant rice cereal.

4 1) Toxic Element Program consisting of 356 samples of dry infant cereals, fruits, mixtures and vegetables collected from 2008-2021; 2) FDA Survey 1 consisting of 147 samples of dry infant cereals and mixtures collected from 2013 to 2014; and FDA Survey 2 consisting of 360 samples of fruits, mixtures, vegetables, yogurts, custards/puddings, and single-ingredient meats collected in 2021.

5 Excluding dry infant cereals.

6 We included all 29 samples that FDA identified as quinoa, even if the agency did not also identify them as  dry cereal.

Also posted in Deep Dives, FDA, Food, Health policy, Health science, Lead / Authors: / Comments are closed

A message to our RSS subscribers only:

By EDF Blogs / Published: July 18, 2017

A message to our RSS subscribers:


We are making a change to how our blog subscriptions are managed. Please update your RSS feed URL to: https://blogs.edf.org/health/feed/ by Thursday, July 27th to ensure you don’t miss a blog.

 

Posted in General interest / Comments are closed

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

By / Published: June 30, 2017

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!

Posted in General interest / Tagged | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 15, 2017

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 »

Also posted in FDA, Food, Lead / Tagged , | Comments are closed