EDF Health

Senator Markey asks: What if people could buy food they know is free of secret ingredients?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 30, 2016

[pullquote]Senator Markey (D-MA) asked FDA if it can require a label to tell consumers when the food they are eating contains chemicals it has not reviewed for safety. In his April 26 letter, he asked the agency to respond by May 17.

[/pullquote]Tom Neltner, J.D., is Chemicals Policy Director.

In May 2015, 36% of consumers said that chemicals in food was their most important food safety issue and 23% of consumer said they changed their purchase habits out of concern with chemicals in their food. Leading food manufacturers responded by reformulating their products to remove artificial flavors and colors.

What if these same consumers knew that chemicals added to their food had not been reviewed for safety by the Food and Drug Administration (FDA)? As the Natural Resources Defense Council made clear two years ago, 56 food additive makers chose to avoid FDA’s scrutiny by taking advantage of a loophole in the law for “Generally Recognized as Safe” (GRAS) substances. They purposely chose not to be transparent by keeping secret the safety evaluation conducted by their employees or consultants. These companies appear to make only a few of the estimated 1000 chemicals that FDA has not checked for safety or is aware they exist.

In February, we learned that 51% of consumers think that safety means not only that a product is free of harmful ingredients but that its labeling is clear and accurate. Forty-seven percent want clear information on ingredients and sourcing. With this in mind, it’s fair to assume that consumers also expect that all food chemicals are safe and known to the FDA. Many consumers would likely not buy products where the labeling failed to disclose that the food they serve their families contained ingredients the FDA has admitted it “cannot vouch for their safety”.

On April 26, Senator Edward Markey (D-MA) put the issue front and center when he asked FDA whether it has “sufficient authority to require a special label on any foods or beverages containing ingredients that have been self-determined to be GRAS without an FDA review?” If FDA had sufficient authority, then “what would the label look like?” Read More »

Also posted in FDA, Markets and Retail, Regulation / Tagged , , , , | Authors: / Comments are closed

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 »

Also posted in FDA, Health policy, Phthalates, Regulation / Tagged , , , , , , , , , | Authors: / 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, FDA, 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, FDA, 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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Advancing the ball while minding the gaps: EDF’s comments on EPA’s risk scoping documents for flame retardant chemicals

By Lindsay McCormick / Published: December 1, 2015

Lindsay McCormick is a Research Analyst.

Until June 2014, EPA had not completed a chemical risk assessment under its Toxic Substances Control Act (TSCA) authority in 28 years.  Since then, EPA seems to have been somewhat picking up the pace: Over the past year and a half EPA has completed four additional risk assessments through the TSCA Work Plan Chemical Program, which is designed to assess the risks of priority chemicals currently on the market.

Recently, EPA initiated its assessment process for the next set of Work Plan chemicals, including three “clusters” of flame retardant chemicals.  We fully support EPA’s current efforts to assess the risks of these flame retardants – with the end goal of managing identified risks – and have provided quite extensive comments on EPA’s initial scoping documents.  In this post, I’ll highlight some of our comments and recommendations; see the links at the end to access the comments themselves.   Read More »

Also posted in Health policy, Health science / Tagged , , , | Comments are closed