EDF Health

Selected tag(s): food additives

EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food

Tom Neltner, J.D.is Chemicals Policy Director

At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.

In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.

  1. FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.

When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.

Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.

As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.

By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.

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Important insight from the organic certification approach to chemical additives in food

Tom Neltner, J.D.is Chemicals Policy Director

Since 2014, chemicals in food[1] have been consumers’ most important food safety issue, reaching a high of 35% in 2018, according to annual industry surveys by the International Food Information Council. For comparison, “foodborne illness from bacteria” was half that percent.

Food companies have responded to this growing consumer alarm by adopting policies banning artificial flavors, colors and other ingredients that sound like chemicals. This approach is unlikely to do more than serve as window dressing for the underlying problems since it’s not science-based – many of these additives may be safe. The Center for Science in the Public Interest called out this practice in its 2017 “Clean Label: Public Relations or Public Health?” report and pointed readers to its Chemical Cuisine system that rates common additives for health and safety.

There are some companies, like Panera Bread, that are taking a more systematic approach to the ingredients used in the food they sell, starting with the question of whether the additives used are essential and whether the ingredients pose health or safety concerns. As a result, the company worked closely with their suppliers and reformulated many of their products.

And now, thanks to a fascinating new report from the Environmental Working Group (EWG), we are learning about another structured approach that addresses health concerns with chemical additives – the Federal organic certification program for processed foods. To be honest, before reading the report, I viewed the organic program as narrowly focused on pesticides and was only vaguely aware of how it dealt with chemical additives. I was missing the bigger picture.

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

FDA is dragging its feet while children continue to be exposed to perchlorate in food

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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Posted in FDA, Food, Health Policy, Health Science, perchlorate, Public Health / Also tagged , | Comments are closed

FDA-approved PFAS: A serious breakdown in assessing food additive safety

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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Posted in Drinking Water, EPA, FDA, Food, Health Policy, PFAS, Public Health, Regulation / Also tagged , , , | Read 1 Response

Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

Tom Neltner, J.D.is Chemicals Policy Director

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

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American Academy of Pediatrics calls for “urgently needed reforms” to fix broken food additive regulatory system

Tom Neltner, J.D. is Chemicals Policy Director

Today, the American Academy of Pediatrics (AAP) released a “Food Additives and Child Health” policy statement calling for “urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives.” The policy applies to chemicals deliberately added to food or to food packaging or food processing equipment that get into food. These substances are used to flavor, color, preserve, package, process and store our food, but many never appear among the list of ingredients. AAP’s statement calls specifically for the following:

  • “Greatly strengthening or replacing the GRAS [Generally Recognized as Safe] determination process;
  • Updating the scientific foundation of the FDA’s safety assessment program;
  • Retesting all previously approved chemicals; and
  • Labeling direct additives with limited or no toxicity data.”

EDF applauds AAP’s policy statement and its decision to add its influential voice to the rising call for reform of the process by which FDA and food manufacturers decide additives are safe. AAP, a professional society representing 67,000 pediatricians, develops policy statements regarding federal, state, and community policies that affect children through an extensive, deliberative process that draws on tremendous scientific expertise. As with past policies, such as those concerning lead toxicity and fruit juice consumption, this statement on chemicals in food presents a well-reasoned assessment of the problem and clear recommendations for reform.

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Posted in FDA, Food, GRAS, Health Policy, Health Science, perchlorate, PFAS, Public Health / Also tagged , , , , , , , , | Comments are closed