EDF Health

FDA sued for delay in deciding perchlorate food additive petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 31, 2016

Tom Neltner, J.D., is Chemicals Policy Director.

[pullquote]At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.[/pullquote]

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals. Read More »

Posted in Drinking water, FDA, Food, General interest, Health policy, Perchlorate, Regulation / 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.

Posted in Deep Dives, FDA / Authors: / Comments are closed

Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 26, 2022

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

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

 

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”
—Helena Bottemiller Evich, Politico article

 

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article. Read More »

Posted in FDA, Food, GRAS, Health science / Tagged , | Authors: / Comments are closed

The new FDA Commissioner has a full plate; here are 3 steps he can take to keep focused on food safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 15, 2022

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

Posted in BPA, FDA, Food, Lead, Public health / Tagged , , , , , , | Authors: / Comments are closed

FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

Posted in FDA, Food, Health policy / Tagged , , , , | Comments are closed

10 ways the incoming FDA Commissioner should protect people from toxic chemicals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 22, 2021

Tom Neltner, Chemicals Policy Director.

The FDA’s critical role in the COVID-19 pandemic has brought intense interest in whom President Biden will nominate to lead the agency as its new commissioner.

While COVID-19 is the priority, the FDA obviously has many vital other responsibilities. Though it doesn’t get that much attention, one of the important roles of the agency is to protect the public from unsafe chemicals in food. Frankly, their record has been disappointing, but the new administration has an opportunity to fix some key problems that scientists and doctors have been warning us about for years.

Here are ten things the new FDA Commissioner should do to keep unsafe chemicals out of our food. The list ranges from actions on specific chemicals to broader reforms.

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” loophole.
  2. Systematically reassess dangerous food chemicals it has allowed to be used in food based on new information. The FDA approved the use of many chemicals in food decades ago, and we now have evidence that some of these are unsafe. A chemical shouldn’t be given a forever approval. There needs to be a systematic process to review the scientific evidence, especially when new risks come to light.
  3. Ban the use of perchlorate, an ingredient in rocket fuel, from use in plastic packaging and equipment that comes into contact with food. Perchlorate gets into food, and exposure is particularly dangerous for pregnant women, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning abilities. We’ve sued the FDA to get this chemical out of food, and the case is pending.
  4. Comply with its 60-year-old Congressional mandate to look at the cumulative effect of chemical exposures people have when deciding whether to approve the use of related chemicals in food. EDF’s investigation of 900 approval decisions found that just one followed this common-sense mandate. The reality is that no one is exposed to just one chemical – so the agency shouldn’t be analyzing chemicals’ safety as if that were the case. FDA must respond to a petition filed by EDF and other organizations demanding that the agency follow the law and assess chemicals as classes.
  5. Drive down levels of heavy metals in food. Over the last decades, evidence has emerged of concerning levels of lead, arsenic, and cadmium in food consumed by children, such as rice, juice, and root crops like sweet potatoes and carrots. The FDA should move quickly and aggressively on its new commitment to set limits on heavy metals in food children eat and should also set limits for other food.
  6. Use modern science when evaluating if a chemical poses a health risk. The FDA is stuck in the past by relying on outdated, less accurate scientific methods and ignoring the evolving information we now know about chemical exposure. You wouldn’t insist on driving a car the Flintstones drove just because that was the first car ever.
  7. Prohibit lead from being added to materials that contact food, such as the tin that lines metal cans, and tighten limits for lead in bottled water. EDF’s analysis of FDA data found lead in 98% of certain canned fruits compared to 3% in fresh or frozen types. We’ve sent a formal petition to FDA requesting it immediately take action to ban these harmful and unnecessary uses of lead. Though it’s not a food safety issue, the FDA should also reject a challenge to its decision to ban lead acetate in hair dye. That challenge has put the FDA decision on hold, meaning that people are literally still putting lead on their head!
  8. Prohibit ortho-phthalates from being added to food packaging and processing equipment. These chemicals are known to disrupt hormones and harm brain development. The FDA is significantly overdue in meeting its legally required deadline to make a decision based on a petition from 2016 by EDF and nine other consumer, public health, and environmental groups to ban these chemicals.
  9. Be more transparent about the decisions it is making on chemicals in food. Information about FDA decisions should be publicly available without a Freedom of Information Act request and a months-long wait to learn more about agency actions on the chemicals in our food supply.
  10. Take aggressive action on harmful PFAS in food packaging and processing equipment. PFAS (Per- and poly-fluorinated alkyl substances) can provide water and grease resistance to paper and paperboard and can also leach into food. Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer. And now we know that many types of PFAS bioaccumulate in the body.
Posted in FDA, Food, Health policy, Public health, Regulation / Tagged , , , , | Comments are closed