EDF Health

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.

Read More »

Posted in FDA, Food / Tagged , | Comments are closed

Broken GRAS: FDA must declare abandoned uses of ortho-phthalates are not GRAS.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 25, 2022

Maricel Maffini, EDF consultant and Tom Neltner, Chemicals Policy Director

This blog is the sixth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food.

In May, FDA removed its approval for all uses of 19 ortho-phthalates (aka phthalates) and some uses for two more because it agreed with the industry petition claiming the uses had been abandoned. During the comment period when the petition was filed and again when the decision was published, Earthjustice, EDF, and others warned FDA that despite the removal of approvals, a company could still use any of the abandoned phthalates without the agency’s knowledge by determining on its own that the use was Generally Recognized as Safe (GRAS).

In its decision, FDA implicitly acknowledged that this could indeed happen. After explaining what a GRAS safety determination[1] entails and how its voluntary GRAS notification program[2] works, the agency said:

In the future, if a manufacturer wishes to establish safe conditions of use for one or more of these substances in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification prior to market entry because these intended uses were previously authorized under section 409 of the FD&C Act.[3]

Since the agency has no way of knowing that a company determined a substance’s use was GRAS or that it was actually in use, FDA’s expectation is little more than a hope. The agency’s own studies show that the abandoned phthalates show up in food and in food contact materials. Many other studies have shown the same thing, including one that found an unapproved phthalate in fast food.

Read More »

Posted in FDA, Food / 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, Health science / Tagged , | Authors: / Comments are closed

FDA has new funding to start modernizing how it assesses food chemical risks

By Joanna Slaney / Published: April 22, 2022

Joanna Slaney, Sr. Director, Federal Affairs; and Tom Neltner, Senior Director, Safer Chemicals Initiative

For the first time in recent memory Congress approved funds for FDA specifically to address food safety from potentially dangerous chemicals that may present health hazards. Now it’s time for the agency to get to work.

Congress appropriated $7 million for “Emerging Chemical and Toxicology Issues” and $11 million for “Maternal and Infant Health and Nutrition” for the current fiscal year. While these numbers are below the agency requests of $19.7 million and $18 million respectively, the funds can help FDA meet its stated goals to bring on new staff and to:

  • “Enhance and update its approach to chemicals—both those directly added as food ingredients and those that come into the food supply through food contact and environmental contamination” and
  • Address issues of concern that include lead, cadmium, and arsenic in children’s food.

Read More »

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

The new FDA Commissioner has a full plate; here are 3 steps he can take to keep focused on food safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 15, 2022

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

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

10 ways the incoming FDA Commissioner should protect people from toxic chemicals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 22, 2021

Tom Neltner, Chemicals Policy Director.

The FDA’s critical role in the COVID-19 pandemic has brought intense interest in whom President Biden will nominate to lead the agency as its new commissioner.

While COVID-19 is the priority, the FDA obviously has many vital other responsibilities. Though it doesn’t get that much attention, one of the important roles of the agency is to protect the public from unsafe chemicals in food. Frankly, their record has been disappointing, but the new administration has an opportunity to fix some key problems that scientists and doctors have been warning us about for years.

Here are ten things the new FDA Commissioner should do to keep unsafe chemicals out of our food. The list ranges from actions on specific chemicals to broader reforms.

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” loophole.
  2. Systematically reassess dangerous food chemicals it has allowed to be used in food based on new information. The FDA approved the use of many chemicals in food decades ago, and we now have evidence that some of these are unsafe. A chemical shouldn’t be given a forever approval. There needs to be a systematic process to review the scientific evidence, especially when new risks come to light.
  3. Ban the use of perchlorate, an ingredient in rocket fuel, from use in plastic packaging and equipment that comes into contact with food. Perchlorate gets into food, and exposure is particularly dangerous for pregnant women, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning abilities. We’ve sued the FDA to get this chemical out of food, and the case is pending.
  4. Comply with its 60-year-old Congressional mandate to look at the cumulative effect of chemical exposures people have when deciding whether to approve the use of related chemicals in food. EDF’s investigation of 900 approval decisions found that just one followed this common-sense mandate. The reality is that no one is exposed to just one chemical – so the agency shouldn’t be analyzing chemicals’ safety as if that were the case. FDA must respond to a petition filed by EDF and other organizations demanding that the agency follow the law and assess chemicals as classes.
  5. Drive down levels of heavy metals in food. Over the last decades, evidence has emerged of concerning levels of lead, arsenic, and cadmium in food consumed by children, such as rice, juice, and root crops like sweet potatoes and carrots. The FDA should move quickly and aggressively on its new commitment to set limits on heavy metals in food children eat and should also set limits for other food.
  6. Use modern science when evaluating if a chemical poses a health risk. The FDA is stuck in the past by relying on outdated, less accurate scientific methods and ignoring the evolving information we now know about chemical exposure. You wouldn’t insist on driving a car the Flintstones drove just because that was the first car ever.
  7. Prohibit lead from being added to materials that contact food, such as the tin that lines metal cans, and tighten limits for lead in bottled water. EDF’s analysis of FDA data found lead in 98% of certain canned fruits compared to 3% in fresh or frozen types. We’ve sent a formal petition to FDA requesting it immediately take action to ban these harmful and unnecessary uses of lead. Though it’s not a food safety issue, the FDA should also reject a challenge to its decision to ban lead acetate in hair dye. That challenge has put the FDA decision on hold, meaning that people are literally still putting lead on their head!
  8. Prohibit ortho-phthalates from being added to food packaging and processing equipment. These chemicals are known to disrupt hormones and harm brain development. The FDA is significantly overdue in meeting its legally required deadline to make a decision based on a petition from 2016 by EDF and nine other consumer, public health, and environmental groups to ban these chemicals.
  9. Be more transparent about the decisions it is making on chemicals in food. Information about FDA decisions should be publicly available without a Freedom of Information Act request and a months-long wait to learn more about agency actions on the chemicals in our food supply.
  10. Take aggressive action on harmful PFAS in food packaging and processing equipment. PFAS (Per- and poly-fluorinated alkyl substances) can provide water and grease resistance to paper and paperboard and can also leach into food. Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer. And now we know that many types of PFAS bioaccumulate in the body.
Posted in FDA, Food, Health policy, Public health, Regulation / Tagged , , , , | Comments are closed