EDF Health

FDA decisions leave ortho-phthalates in food and our safety in limbo

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 22, 2022

Tom Neltner, Senior Director, Safer Chemicals; Maricel Maffini, Ph.D., Consultant

On May 19, the Food and Drug Administration (FDA) announced four incongruous actions in response to petitions submitted by EDF and others asking the agency to ban the use of more than two dozen ortho-phthalates (phthalates) in food packaging and processing equipment. We filed the petitions because we were concerned that these hormone-disrupting chemicals were harming people, especially children, who consume food contaminated by this class of chemicals. Since filing the petitions six years ago, the evidence of harm – and our concern for children’s health – have only grown more compelling.

Despite a statutory duty to decide whether the authorized uses were safe, the agency delayed making a decision and then essentially dodged the safety issue, opting instead to allow nine phthalates it had approved decades ago to be used in plastics, paper, and adhesives that contact food or drinks. FDA only acted in response to a lawsuit filed by Earthjustice for EDF and other health and environmental advocates.

FDA’s decisions allow phthalates to continue to seep into our food and do little to protect the public. As a result, EDF and the other advocates, supported by Earthjustice, filed formal objections to the agency’s decisions on two food additive petitions and petitioned the agency to reconsider its denial of a separate citizen petition. We also demanded an evidentiary public hearing to consider the significant new evidence FDA glossed over. Read More »

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How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 29, 2019

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

Read More »

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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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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

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed

Alternative Figures: FDA’s food chemical reports to Congress don’t add up

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 10, 2023

In its annual justification of budget estimates to Congress, FDA describes its activities and tracks its performance. One of those performance measures is the percentage of food- and color-additive petitions (FAPs/CAPs) the agency has reviewed and completed within 360 days of receipt.[1]

We analyzed FDA’s reports to Congress published from 2016 to 2023 and found that FDA told Congress it had completed 100% of its reviews within 360 days in every year but one. The exception was FY2020, when the rate dropped to 89%. During that 7-year period, the agency reported that it had filed a total of 51 petitions. (See Table 1.)

Why It Matters

FDA’s impressive claims about the percentage of FAP/CAP reviews it completed run contrary to our experience and the available evidence:

  • FDA’s own webpage describes seven petitions that have been under review for over 360 days. (See Table 2.) Five of those overdue petitions were filed in FY2021, when the agency claimed it had reviewed and completed 89% of them. The agency reports filing and reviewing only two petitions in that year.
  • Four of five petitions submitted by food safety advocates for which the agency has made a decision were in FDA’s review pipeline for over 360 days.[2] For three of those overdue petitions, FDA acted only after petitioners sued in court for unreasonable delay. (See Table 3.)
  • FDA’s guidance for industry on these petitions says, “the average time between submission until a final rule is published for a direct food additive petition is 24 months and for color additive petitions, the approval process varies significantly.”

Our Take

Accurate and transparent reporting empowers Congress to:

  • See that the agency is having difficulty meeting its deadline for reviewing FAPs/CAPs; and
  • Set priorities and evaluate FDA’s funding requests more effectively.

Our Research Findings

Table 1 summarizes those findings. We excluded years where we did not have data for both petitions filed/reviewed in the fiscal year and the percent of petitions reviewed within 360 days.[3]

Table 1: FDA’s Reporting of Office of Food Additive Safety Activity

(Year of Budget Justification Reports)
Fiscal Year FAPs/CAPs

Filed/ Reviewed*

 FAPs/CAPs Percent Reviewed within 360 days
FY2015

10 / 11
(2016 report, p. 61)

100%

(2017 report p. 57 &

2016 report p. 59)
FY2016 7 / 7

(2017 report, p. 60)

100%

(2018 report p. 54 &

2017 report p. 57)
FY2017 10 / 10

(2018 report p. 57)

100%

(2019 report p. 67 &

2018 report p. 54)
FY2018 10 / 10

(2018 report p. 57)

100%

(2021 report p. 80 &

2020 report p. 68 &

2019 report p. 67)
FY2019 5 / 5

(2021 report p. 82 &

2020 report p. 70)

100%

(2022 report p. 96 &

2021 report p. 80 &

2020 report p. 67)

FY2020

 7 / 7

(2021 report p. 82)

89%

(2023 report p. 66)
FY2021

 

 2 / 2

(2022 report p. 98)

100%

(2023 report p. 64 &

2022 report p. 96)

* Reviewed includes approved, withdrawn, or placed in abeyance due to deficiencies during the fiscal year.

 

Table 2 identifies all food and color additive petitions that FDA’s website reported as under review (and not in abeyance or decided) as of April 7, 2023. “Days Under Review” is calculated as of that date.

Table 2: Status of Food and Color Additive Petitions
Under Review as of April 7, 2023
Substance and Requested Action Petition No. Filing Date Days Under Review
Revoke BHA FAP 0A4216 6/22/90 11,977
Allow jagua (genipin-glycine) blue CAP 0C0317 7/31/20 980
Allow Vitamin D3 FAP 1A4827 2/3/21 793
Allow Gardenia Blue Powder CAP 1C0319 4/20/21 717
Allow vitamin D2 mushroom powder FAP 1A4828 6/8/21 668
Allow blue Galdieria (Galdieria sulphuraria) extract CAP 1C0320 7/27/21 619
Allow vitamin D2 heat-killed (“inactive”) baker’s yeast FAP 1A4829 9/28/21 556
Allow myoglobin CAP 2C0322 12/13/21 480
Revoke bisphenol A (BPA) FAP 2B4831 5/2/22 340
Revoke Red Dye No. 3 CAP 3C0323 11/15/22 143

 

Table 3 reviews the timing of FAPs/CAPs submitted by food safety advocates since 2014. Where available, FDA’s decision on the petition is noted, as well as whether petitioners went to court asking a judge to issue a writ of mandamus to order the agency to act. For each of those lawsuits, FDA agreed relatively quickly to a schedule to make a final decision on the petition.

Table 3: Timing of Review for Advocates’ Petitions
Seeking Revocation of Food and Color Additive Approvals (as of April 7, 2023)
Substance and Requested Action Filing Date Decision Date Days Under Review Decision Lawsuit Filing Date
Perchlorate as FCS 12/31/14 4/28/17 849 Denied 3/31/16
Long-chain PFAS (non-sulfonated) as a food contact substance (FCS) 1/7/15 12/29/15 356 Accepted None
Carcinogenic flavors as food ingredient 8/17/15* 10/2/18 963 Accepted for 6 of 7 5/17/18
Ortho-phthalates as FCS 4/12/16** 5/20/22 1516 Denied 2/7/21
Lead acetate as cosmetic color additive 2/24/17 10/25/18 618 Accepted None
Bisphenol A as FCS 5/2/22 Pending
Red Dye No. 3 11/15/22 Pending
* Revised to 2/12/16 due to substantive amendments provided by petitioner.

** Revised to 3/26/18 due to substantive amendments provided by petitioner.

 

Next Steps

The agency should explain to Congress and stakeholders how it came up with its numbers and ensure accurate and transparent reporting.

NOTES

[1] The statutory deadline for a final decision on a food or color additive petition is 90 days, with an option to extend for an additional 90 days for a total of 180 days. See 21 U.S.C. §§ 348(c)(2) and 379e(d)(1). We do not know why FDA’s performance measure gives the agency twice as much time to complete a review than is allowed by the law.

[2] Long-chain PFAS food additive petition was processed in 356 days. See Table 3.

[3] FDA reported 100% for FY2014 in the 2016 report(p. 59) but did not include the number of FAPs/CAPs reviewed. In its 2023 report, the agency reported reviewing five FAPs/CAPs (p. 61) but did not provide the percentage of reviews that had been approved, withdrawn, or placed in abeyance in 360 days.

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