EDF Health

Selected tag(s): Food additives

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

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 / Also tagged , | Authors: , / Comments are closed

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

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 »

Posted in FDA, Food / Also tagged , , , | Authors: / Comments are closed

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

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, GRAS, Health policy, PFAS / Also tagged , | Comments are closed

FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

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

Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

Read More »

Posted in FDA, Food, GRAS, Public health / Also tagged , | Comments are closed

FDA takes an important step by phasing out paper greaseproofing agents containing a specific PFAS

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

Last week, the Food and Drug Administration (FDA) announced the phase-out of per- and polyfluorinated alkyl substances (PFAS) used to greaseproof paper and paperboard food packaging made from a specific type of short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH).  The action, narrow as it is, is welcome news for efforts to protect public health and the environment from the risks posed by short chain PFAS, known as “forever chemicals” because they do not degrade.

FDA secured voluntary agreements with three companies, Archroma, Asahi Glass, and Daikin, to phase-out products based on 6:2 FTOH. A fourth company, Chemours, asked FDA to suspend the agency’s approvals on its products containing the PFAS one year ago. The action affects 15 food contact substance notifications (FCN) approved by the agency between 2006 and 2016. It does not address 13 FCNs for similar greaseproofing uses made from PFAS other than 6:2 FTOH. And, under the agreement, consumers may still find 6:2 FTOH-laden, carry-out containers until June 2025.

The process FDA took, and the time it took to get there, reveals the significant difficulties the agency has in reversing past actions in the face of mounting evidence of a chemical’s risk:

  • FDA must seek out information because companies have no obligation to affirmatively notify the agency of new studies showing potential problems;
  • When FDA finds the information and identifies potential safety concerns, it appears to act as if it has the burden of proving the use is no longer safe; and
  • FDA continued approving uses of 6:2 FTOH even after it identified problematic data gaps.

These difficulties reinforce the need for actions being taken by states such as Washington, Maine, New York, and California, by Congress, and by retailers to reduce uses of PFAS in their products. When it comes to food packaging, PFAS are dinosaurs and their time is running out.

Read More »

Posted in FDA, Food, Health policy, PFAS / Also tagged , , , | Comments are closed

Without a food safety overhaul for additives, the innovative food craze could spiral out of control

Tom Neltner, J.D.Chemicals Policy Director

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At an FDA-sponsored conference, EDF proposed a new path forward to ensure innovative food ingredients are safe by overhauling how food additives are regulated today.

[/pullquote]Every day brings reports of new ingredients that food innovators around the world have developed to meet consumer demands for a healthier and more sustainable food supply. The innovations range from new ways to extract useful additives from existing sources such as algae to bioengineering to make novel ingredients like sweeteners or proteins that can be grown in a tank instead of on a farm.

At EDF, we encourage innovation that helps communities and the environment thrive, especially in the face of the threats posed by climate change. However, an innovator’s bold claims, especially those involving food safety, must be closely scrutinized before the additive hits the marketplace. Given the potential for harm to consumers, we cannot simply take a company’s assertion of safety at face value – there must be transparency and the Food and Drug Administration (FDA) must provide an independent review.

Read More »

Posted in FDA, Food, GRAS, Public health / Also tagged | Comments are closed