EDF Health

Selected tag(s): Safety

FDA agrees to reconsider safety of ortho-phthalates

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.

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Seeing Red on Food Dyes

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

The Center for Science in the Public Interest’s (CSPI) “Seeing Red: Time for Action on Food Dyes” report, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and consumers should take action to protect children from the behavior problems associated with these chemicals.


What are color additives?

  • The FD&C number on a color means it is a “certified” color pursuant to 21 CFR Part 74. These colors are synthetically made from oil or coal. Decades ago, FDA determined they were safe and only certifies that each batch meets quality standards and does do not contain particularly dangerous contaminants.
  • A color additive is not safe unless there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use.”
  • FDA labeling rules maintain that all added colors to food are artificial. Technically, there are no natural colors – not even beet juice – since they mask the natural color of the food.
  • FDA does not limit the amount of a certified color that can be added to food except in one case. The food manufacturer decides how much is needed.

[/pullquote]Last Friday, FDA released a stream of five consecutive tweets telling people why certified artificial color additives, commonly known by their FD&C number, are used and how to avoid them if people are sensitive to them. The tweets, while true, said nothing about who may be sensitive to the chemicals. They should have said that any child may be sensitive and that the 6.4 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) appear to be particularly sensitive.

So what prompted FDA’s tweets? Most likely the agency anticipated CSPI’s report “Seeing Red: Time for Action on Food Dyes” issued January 19. It follows on the organization’s 2010 “Food Dyes: Rainbow of Risks” report and its 2008 citizens petition calling on the agency to: 1) revoke its approvals of eight synthetic food dyes; 2) require warning labels on the package in the interim; and 3) correct statements about the dyes on its website and other materials.

While FDA has yet to take action on the citizens petition, the marketplace has already passed judgment. In 2015, leading food manufacturer and restaurants committed to reformulating their iconic brands to remove certified artificial colors. They follow the lead of major retailers who reformulated their private brands to remove the chemicals.

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