EDF Health

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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Making “safer” accessible to all

By Lindsay McCormick / Published: April 4, 2016

Lindsay McCormick is a Research Analyst.

I find purchasing shampoo and other common personal care products to be a surprisingly stressful experience – I pace the aisles at the drugstore for a good 10-15 minutes, read every product ingredient list, contemplate the legitimacy of claims like “paraben-free” or “no artificial colors or fragrances,” and weigh the impact on my wallet. In the end, I usually choose a moderately priced product with some sort of ingredient safety claim brightly printed on the front label, and hope the extra $2 I spent will actually reduce my exposure to hazardous chemicals.

Many consumers are hungry for information and solutions that help reduce their exposure to toxic chemicals.  As more research links exposures to common ingredients in personal care products and health impacts – like certain parabens to reduced fertility; certain phthalates to asthma, reproductive disorders, and neurological effects; and triclosan to obesity – many consumers want to feel empowered to take action. That’s why the results of a recent intervention study are so intriguing: researchers found that exposures to certain chemicals fell in a population of low-income Latina girls after using personal care products labeled as being free of such chemicals for three days.

The implications of this study raise several interesting questions that I’ll explore in this post. Specifically, are personal shopping choices an effective way to avoid chemical exposures?  And, is this strategy equally available to everyone in our society?   Read More »

Also posted in Emerging science, Health policy, Health science, Markets and Retail / Tagged , , | Comments are closed

FDA sued for delay in deciding perchlorate food additive petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 31, 2016

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

[pullquote]At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.[/pullquote]

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals. Read More »

Also posted in Drinking water, Food, General interest, Health policy, Perchlorate, Regulation / Comments are closed

FDA decides 3 PFCs are unsafe: Detailed look at the decision

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2016

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

FDA’s decision to remove its approval of three long-chain perfluorinated compounds sets important precedents on the assessment of food ingredients, food contact substances, and chemicals used to make food.

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FDA concluded:

  • Class: All long-chain chemicals with at least one linear, perfluorinated chain of eight or more carbon atoms should be considered a class.
  • Data gaps: Where reproductive and developmental toxicity data are lacking for any chemical in this class, the data available for perfluorinated octanoic acid (PFOA) should be used to fill the gaps.
  • Study methods: If a chemical is biopersistent in the body, standard toxicology methods used to evaluate food additives need to be upgraded.

[/pullquote]On Jan. 4, 2016, the Food and Drug Administration (FDA) announced that it changed its regulations to remove the agency’s approval of three specific long-chain perfluorinated compounds (PFCs) as food additives. The agency approved use of these chemicals between 1967 and 1997, allowing them to be added to paper and paperboard that comes in contact with aqueous and fatty foods. Until the late 2000s, they were commonly used in pizza boxes, sandwich wrappers, and paper in frozen food packaging – virtually anywhere a food manufacturer wanted to use paper packaging that would repel oil and water.

Domestic PFC manufacturers report that these food contact substance (FCS) uses have been abandoned, although others report trace levels still appearing in paper products used for food, most likely as a result of contamination. There are reports, however, that foreign companies have begun producing PFCs. As long as these additives are officially allowed by FDA, there is a possibility that food manufacturers who are not diligent could resume their use without knowing it. The agency’s decision makes it less likely that will happen.

FDA’s decision marks the first time it has used a food additive petition to remove an approval based on safety concerns; a few years ago, it removed approvals for use of bisphenol A in infant formula packaging and baby bottles and sippy cups – but those removals were based on market abandonment, not safety. This safety-driven decision sets a precedent and serves as a roadmap for how safety decisions should be made for all additives including those considered by industry to be ‘generally recognized as safe’ (GRAS).

No longer safe – unpacking the agency’s reasoning for a class of chemicals and safety concerns Read More »

Also posted in Emerging science, Emerging testing methods, Food, Health policy, Health science, Regulation / Tagged | Comments are closed

Seeing Red on Food Dyes

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 20, 2016

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.

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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.

Read More »

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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 »

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