EDF Health

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Also posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed

Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 14, 2022

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

Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.

During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.

Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.

Biology is not math and the concept of something from nothing Read More »

Also posted in Adverse health effects, FDA / Tagged , , , , | Authors: / Read 1 Response

FDA agrees to reconsider safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2016

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

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered “food additives.”

FDA acted in response to a food additive petition submitted by the Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, and Learning Disabilities Association of America – groups all concerned by the adverse health effects of ortho-phthalates at the levels typically seen in food.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

Read More »

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