EDF Health

Selected tag(s): GRAS

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 31, 2019

Tom Neltner, J.D., Chemicals Policy Director

[pullquote]

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.

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 18, 2019

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2018

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 23, 2018

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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Toxic secrets in our food? EDF joins in lawsuit aimed at protecting food safety

By Jack Pratt / Published: May 22, 2017

Today, Environmental Defense Fund joined other groups in challenging a Food and Drug Administration (FDA) rule that allows chemical and food manufacturers to decide for themselves – in secret – what chemicals and food additives can be added to foods. The practice puts our health at risk and does not fulfill Congress’ requirement that FDA determine that chemical additives are safe before they can be used in food.

Americans would be shocked to learn that food companies routinely add novel chemicals to our food without first getting FDA approval. In doing so, the companies are exploiting a loophole exempting ingredients “Generally Recognized as Safe” (GRAS) from formal FDA review and approval.

Originally intended for ingredients like vinegar and olive oil, industry now abuses the GRAS loophole by bypassing FDA review and making safety determinations in secret. The alarming result: even FDA does not know what is in our food. In fact, FDA has no way to know what chemicals are actually being used in which food or in what quantities—even in baby food.

Last year, the FDA issued a final rule formalizing this outrageous practice. We described this decision as a lost opportunity for safer food additives when the decision was made. Today, EDF and our colleagues at the Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental Working Group, represented by CFS and the environmental law firm Earthjustice, joined in filing suit against the FDA for unconstitutionally and illegally delegating that authority to self-interested food and chemical manufacturers.

It is disappointing that the groups were forced to take legal action. In addition to being a bad policy that doesn’t comply with law, or protect public health, the FDA is oddly out of touch with public sentiment. Just last week an industry funded survey showed overwhelming consumer concern about chemicals in food, including cancer causing chemicals, while showing diminished confidence in the food supply. This continues a trend that has been building for years. Food companies would be wise to take notice: adding secret chemicals without FDA scientific review to our food is no way to improve confidence in their products.

But with thousands of secret chemicals in our food, we can’t wait for industry or FDA to wise up. Today’s lawsuit seeks to force FDA to do what should be common sense—determine that food additives are safe before they can be added to our food.

Posted in FDA, Food, General interest / Also tagged | Comments are closed

Lost opportunity for safer food additives

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2016

[pullquote]In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching.  It is especially common around the holidays or in August when many people, especially those in Congress are on vacation.  On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline[/pullquote]

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

On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).

The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.  The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.

Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole. Read More »

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