EDF Health

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.

[pullquote]

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, PFAS, Regulation / 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.

[pullquote]

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 »

Also posted in FDA / Tagged , , , , , , , , , , , , , , | Authors: / Comments are closed

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

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 FDA, Health policy, Markets and Retail / Tagged , , , | Authors: / Comments are closed