EDF Health

Selected tag(s): Food additives

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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Posted in FDA, Food, GRAS, Health policy, Public health / Also tagged , , | Authors: / Comments are closed

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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Posted in FDA, Food, GRAS, Health policy, Health science, Perchlorate, PFAS, Public health / Also tagged , , , , , , | Comments are closed

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, GRAS / Tagged | Comments are closed

The hidden – and potentially dangerous – chemicals in your diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2017

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

While picking up groceries for the week, a shopper may compare brands, prices, and nutritional information to ensure they make economical and healthy choices for their family. Unfortunately, there’s much more to our food than meets the eye – or makes the label.

Approximately 10,000 food additives are allowed in our food. Food additives are substances used to flavor, color, preserve, package, process, and store our food. While some of the chemicals added to food or used in packaging are harmless, others are downright dangerous and linked to health concerns. Certain additives are linked to reproductive problems, developmental issues, and even cancer.

Perchlorate was approved in 2005 as a component of plastic packaging for dry food despite the fact that it is a known endocrine disruptor that impairs infant brain development. Benzophenone – an artificial flavor added to baked goods, dessert, beverages, and candy – is classified as a possible human carcinogen. The list goes on. No matter where you shop, your family’s health may be at risk.

Check out the cupboard below to see what else could be lurking in your food.

Illustration of a kitchen cabinet with labels showing the toxic chemicals in the bottles, boxes, and cans stored inside.

 

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Posted in BPA, FDA, Food, GRAS, Health policy, Markets and Retail, Regulation / Also tagged , , , , , , , , | Authors: / Comments are closed

EPA to consider perchlorate risks from degradation of hypochlorite bleach

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 3, 2017

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

Virtually all types of food contain measurable amounts of perchlorate. Young children are the most highly exposed, and they consume levels that may be unsafe. Reducing exposure to perchlorate is of public health importance because it presents a risk to children’s brain development

One potentially significant source of the toxic chemical in food is hypochlorite bleach that, when not well managed, degrades to perchlorate. Bleach is used to sanitize food manufacturing equipment or to wash or peel fruits and vegetables. Thanks to a recent decision by Environmental Protection Agency’s (EPA) Office of Pesticide Programs, we will better understand the risk posed by perchlorate-contaminated bleach and whether standards are needed to improve the management of bleach.

Reduce perchlorate exposure by improving bleach management

In 2011, an excellent report by the American Water Works Association (AWWA) and the Water Research Foundation documented that hypochlorite bleach degrades into perchlorate. The report also included guidelines on better management of hypochlorite to preserve its effectiveness for drinking water utilities using it to disinfect water.

Most of AWWA’s recommendations are equally relevant to food manufacturers and anyone using bleach to disinfect food contact surfaces. The key recommendations are:

  • Dilute hypochlorite solutions on delivery. Cutting the concentration in half decreases the degradation rate by a factor of 7.
  • Store hypochlorite solutions at lower temperatures. Reducing temperature by 5oC decreases degradation rate by a factor of 2.
  • Keep pH between 11 and 13 even after dilution.
  • Avoid extended storage times, and use fresh hypochlorite solutions when possible.

The objective is not to reduce the use of bleach. Rather it is to preserve its effectiveness by preventing degradation to perchlorate through careful management.

Bleach: a food additive and a pesticide

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Posted in Drinking water, Emerging science, FDA, Food, Perchlorate, Regulation / Also tagged , , , , , | Authors: / Comments are closed

FDA accepting public comments on the safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 19, 2016

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

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves. Read More »

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