EDF Health

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 / Tagged , , , , , , , | 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

FDA Acknowledged Ortho-Phthalates Could Be Grouped Into Classes For Safety, Then Punted

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2022

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.

FDA’s obligation to evaluate related chemicals as a class

FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]

But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]

In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.

A phthalate scorecard: Where we stand on which phthalates can be used and their health effects

The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.

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

Towards Safer Food Additives

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 11, 2015

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

EDF strives to make safer food available by partnering with companies to reduce and eliminate potentially unsafe chemical food additives and supporting efforts to fix a broken regulatory system.

For many years this blog has focused on the safety of chemicals and nanomaterials used in industrial and consumer products.  Most of these substances are regulated federally by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA).  But we also encounter chemicals in other ways, including those present in or added to food.  Such chemicals are regulated under a different law, the Federal Food, Drug and Cosmetics Act (FFDCA), administered by the Food and Drug Administration (FDA).  This blog introduces EDF’s “Behind the Label” initiative to get unsafe and questionable chemicals out of our food by using dual levers of change—corporate leadershIFIC Charts - 5-16-16ip and public policy.   Making our food trustworthy demands leadership in both the private sector and the FDA.

The food market is changing rapidly as manufacturers work to keep up with consumer concerns about what’s in our food. And it’s not just about added sugar, salt and trans fats, or whether the food was grown locally or with or without pesticides. Public campaigns increasingly put the spotlight on many chemicals commonly used in food and food packaging—food additives—with growing scientific evidence questioning the safety of their use.

A respected industry survey released in May 2015 showed that 36% of consumers rated chemicals in food as their most important food safety concern – greater than pathogens, pesticides, animal antibiotics and allergens, and up from 23% in 2014 and 9% in 2011. These concerns translated into action; 23% of consumers reported changing their buying habits (corrected from 45% on May 16, 2016). Read More »

Posted in FDA, Food, Health policy, Markets and Retail / Tagged , , , | Authors: / Comments are closed