EDF Health

Six ways FDA can do better on food safety

By Maria Doa, PhD, Senior Director, Chemicals Policy, Liora Fiksel, Project Manager, Healthy Communities and Maricel Maffini, PhD, Consultant / Published: February 6, 2025

Refrigerated groceriesWhat Happened: 
Bipartisan support is growing for food safety reform as U.S. Food and Drug Administration (FDA) is considering comments on a new process for reassessing chemicals already on the market . On January 21, EDF submitted comments to FDA on how the agency should strengthen its proposal for a process to ensure the safety of existing ingredients in the market. While EDF supports modernizing FDA’s Human Food Program processes and methods, the current proposal falls short on transparency, efficiency, and scientific rigor.  

Why it Matters:
The public deserves a systematic, science-based approach to food chemical safety. FDA’s current process is outdated, opaque, and reactive rather than proactive. Delays in addressing chemical safety are common, with FDA often taking years to act on food additive petitions and chemical reassessments. Many food chemicals were approved decades ago using little or no data and have not been reevaluated since.    

FDA often relies only on its own studies, while ignoring or disregarding findings from other authoritative institutions such as the National Institutes of Health (NIH) and the European Food Safety Authority (EFSA), seemingly unable to acknowledge modernizing science. This failure to consider the full picture and the best available science undermines public health.  

Additionally, the agency fails to consider the cumulative effects of multiple related substances. People aren’t exposed to single chemicals in isolation, yet the FDA continues to evaluate them as if they are.  

While FDA leadership has emphasized that food chemical safety is a top priority for the Human Foods Program, historical lack of action has driven states like California to implement its own food additive regulations. This state-by-state approach creates a patchwork of rules that highlights the urgency for stronger federal leadership to protect all Americans from toxic chemicals. 

Our Take: 
FDA’s proposed process is a step forward but needs significant improvements.  

  1. FDA should set up a true prioritization process

    • FDA’s proposed process doesn’t identify which of the 10,000+ chemicals authorized to be used in food will be reassessed or why. FDA needs to outline specific criteria for prioritizing chemicals (e.g., risks to children’s health, endocrine disruption, biomonitoring data); start with high-priority chemicals identified by authoritative bodies like U.S. Environmental Protection Agency (EPA), International Agency for Research on Cancer (IARC) and the National Toxicology (NTP) Program; and make the process transparent by publishing rankings and methodology. Other agencies such as EPA have done this; FDA could build on their successful approaches.  
  2. Commit to comprehensive assessments 
    • FDA proposes using “focused assessments” based on limited data, skipping peer review and public transparency. FDA should commit to comprehensive assessments that use all available evidence and limit focused assessments to when immediate action is needed. 
  3. Enforce the Delaney Clause 
    • FDA must prioritize removing carcinogens, as mandated by law, without redundant reassessments. 
  4. Embed peer review and public input 
    • FDA should establish a scientific advisory committee, hold public comment periods, and ensure robust, external peer review for influential decisions.
  5. Separate risk assessment from risk management 
    • FDA should create an independent office to ensure unbiased chemical risk reassessments to avoid bias from teams that approve chemicals for market use. 
  6. Consider cumulative effects 
    • FDA often assesses chemicals in isolation, ignoring how we are exposed to multiple chemicals at the same time in real life. FDA should evaluate combined chemicals exposures, as required by law.

While developing this process, FDA can take immediate action on priority chemicals. EDF and others have already petitioned the agency to act on harmful phthalates, per- and poly-fluoroalkyl substances (PFAS), cancer-causing solvents (including methylene chloride), and titanium dioxide, BPA and lead. These toxic chemicals do not belong in our food. With growing bipartisan support for stronger food safety regulations, FDA has an obligation to be a leader in this space.  About two-thirds of American adults across political ideologies “strongly or somewhat favor” restricting or reformulating processed foods to remove added sugars and dyes signifying wide support for greater regulation on food additives.  

Next Steps: 
It is critical that FDA reevaluates its processes for determining the safety of chemicals in our food. EDF will continue to pressure FDA to act now on high-priority food chemicals, using the best available science and enforcing laws that effectively protect people’s health.  

Go Deeper:
Read the full version of the comments EDF submitted to FDA here. 

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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.

 

Posted in Broken GRAS, FDA, Food, General interest / Authors: / Read 1 Response

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

By Tom Neltner, Senior Director, Safer Chemicals Initiative and Maricel Maffini, PhD, Consultant / Published: November 22, 2023

Quote from FDA Commissioner Robert Califf, MD. "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."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Public health, Regulation / Tagged , , | Authors: , / Comments are closed

FDA’s approach to systematic review of chemicals got off on the wrong foot

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 16, 2023

Scientist working on a digital tablet showing data on the chemical element Cadmium

What Happened?

Last month, FDA’s scientists published the toxicological reference value (TRV) for exposure to cadmium in the diet. This value is the amount of a chemical—in this case cadmium—a person can consume in their daily diet that would not be expected to cause adverse health effects and can be used for food safety decision-making. The TRV was based on a systematic review FDA scientists published last year. We will turn to the TRV itself in an upcoming blog but are focusing on the systematic review here.

In a May 2023 publication, experts in systematic reviews from the University of California San Francisco (UCSF) raised concerns about FDA’s “lack of compliance” from established procedures.

We discussed these concerns with FDA. They said:

  • “The systematic review and the TRV” publication “have both undergone external peer review by a third-party and experts in the field.” The agency expects to publish the reviews on its website, and
  • FDA “is working on developing a protocol for a systematic review of cardiovascular effects of cadmium exposure that will be published.”

Why It Matters

Systematic review is a method designed to collect and synthesize scientific evidence on specific questions to increase transparency and objectivity and provide conclusions that are more reliable and of higher confidence than traditional literature reviews. In particular, the National Academies of Sciences, Engineering, and Medicine have recommended the use of systematic reviews to establish values such as the TRV that may be used to inform regulatory decisions.

The National Toxicology Program (NTP) and others have developed specific methodologies to conduct systematic reviews. FDA’s authors said they followed NTP’s Office of Health Assessment and Translation (OHAT) handbook.

Unfortunately, FDA’s adherence to the methodology fell short on both transparency and objectivity grounds, undermining the credibility of its conclusions. Credibility is crucial because FDA’s authors stated that “this systematic review ultimately supports regulatory decisions and FDA initiatives, such as Closer to Zero, which identifies actions the agency will take to reduce exposures to contaminants like cadmium through foods.”

Read More »

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Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

Read More »

Posted in Adverse health effects, Broken GRAS, FDA, Food, GRAS, Health hazards, Industry influence, Risk assessment, Risk evaluation / Tagged , , , , , , | Authors: , / Read 1 Response

FDA’s squishy definition of adverse health effects of substances in food

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 15, 2023

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

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Posted in Adverse health effects, FDA, Health hazards, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed