EDF Health

Eight steps to strengthen FDA’s Closer to Zero plan to reduce toxic metals in children’s food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 21, 2021

Tom Neltner, Senior Director, Safer Chemicals

EDF this week submitted comments to the Food and Drug Administration (FDA), applauding the agency’s recent activities related to its Closer to Zero Action Plan for reducing toxic elements in children’s food and outlining specific steps to strengthen the FDA’s action.

The agency’s November 18 public meeting on the action plan included excellent presentations by scientists as well as an extended public comment period and an opportunity to provide written follow-up comments. We also appreciate the December 1 colloquium focusing on the latest evidence showing the significant risks posed by arsenic to the development of children’s nervous and immune systems.

Our primary takeaways from these meetings are that:

  • There is an urgent need for FDA and industry to do more to reduce lead, arsenic, and cadmium levels in food that children eat, given the evidence that there are no safe levels of exposure;
  • FDA faces a challenge in effectively communicating to the public about the risks from even relatively low-level, short-term exposure to lead and arsenic;
  • Folic acid and iron play an important role in reducing – but not eliminating – the harm from these toxic elements; and
  • The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) play a critical supporting role in the overall effort to protect children from these toxic elements.

The Closer to Zero plan is a step forward because it commits FDA to specific actions and general deadlines for the first time. In our comments, we identify eight areas for improvement with specific suggestions for each that we think the agency can and should adopt to strengthen its efforts. These are:

  • Reduce the maximum daily intake level / IRL for lead from 3 to 2 µg per day for children and from 12.5 to 9 µg per day for adults as the next step towards the Closer to Zero goal.
  • Reverse the flawed practice of evaluating lead content of each food in isolation and allowing those with high levels to remain in commerce. Instead, FDA should focus on comparing the product to other lot numbers or private brand to its competitors as recommended by 22 state attorneys general.
  • Release the Total Diet Study results for 2018-19 cycle and investigate outliers.
  • Define “as low as possible” based on best performing ingredients or products in a class.
  • Define “children’s food” to include foods commonly consumed by children younger than six years of age.
  • Be consistent on public health messaging and avoid phrases like “no immediate health hazard.”
  • Move up deadlines for arsenic and cadmium action levels.
  • Add milestone for compliance verification with action levels and preventive controls.

We look forward to continuing to work with FDA to ensure that levels of toxic metals in children’s food really do get closer to zero.

Also posted in Food / Comments are closed

FDA reinstates ban on lead added to hair dyes

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 8, 2021

Tom Neltner, Chemicals Policy Director

On October 7, FDA announced that it is reinstating its ban on lead acetate as the active ingredient in hair dyes that hide grey hair when used regularly. In 1980, the agency approved the chemical for hair dyes. In response to a color additive petition from the Environmental Defense Fund and others, in October 2018, the agency revoked its approval. Combe Inc, the maker of Grecian Formula, objected and forced the FDA to suspend its decision. With this new action, the FDA reinstates its decision effective January 6, 2022 and gives companies one year to reformulate lead acetate out of their products.

Grecian Formula reportedly stopped using lead acetate shortly before the FDA acted in 2018. From our searches, Youthair is the remaining brand that uses the chemical.

We applaud the FDA’s affirmation of its 2018 decision where it determined these products are not safe. The agency soundly rejects Combe’s arguments that low levels of lead are safe and concludes that “we have determined that there is no known level of exposure to lead that does not produce adverse effects” in adults. These adverse effects include heart and kidney damage.

People should not be spreading lead on their head! It gets through the skin where it can hurt their body in myriad of ways. While we applaud the decision, we don’t see anything in the record that explains why FDA took almost three years to reaffirm the obvious and allow consumers to unknowingly continue using the unsafe product. Therefore, it is even harder to understand why FDA chose to give Youthair another year – until January 2023 – to remove the product from the shelves.

The FDA has known for more than forty years that the lead in these hair dyes is absorbed through the scalp, especially when used every day to hide grey hair, but previously thought there was a safe level. Other federal agencies acknowledged a decade ago there is no known safe amount of exposure to lead in adults or children. The FDA’s action in 2018, reaffirmed today, brings it in line with the scientific consensus.

Beyond lead acetate hair dyes, the FDA needs to do more to drive down consumer’s exposures from all sources of lead in food and cosmetics by tightening limits on this heavy metal in common ingredients. To protect kids and adults, it needs to translate its recognition that there is no known safe level of lead exposure by updating its outdated standards for food additives, bottled water, metal cans, and brass faucets as we demanded in a petition last year. The agency’s Closer to Zero Action Plan for children’s foods is critical but not sufficient to protect adults.

Posted in FDA / Comments are closed

Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

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FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

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Chemicals in food continue to be a top food safety concern among consumers

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2021

Chemicals in food continue to be a top food safety concern among consumers

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The latest annual food industry survey demonstrates that U.S. consumers continue to have significant concerns about chemicals in food. Specifically, the survey from the International Food Information Council (IFIC) found:

  • 29% of consumers rated chemicals in food as their top food safety concern, more than any other issue, including foodborne illness from bacteria. Everyone rated chemicals in food among the top three concerns. Chemicals in food has been the top concern every year since 2017, tying risk from COVID-19 from food last year. It has been a significant concern back to the first IFIC Food and Health Survey in 2009.
  • 69% of consumers did not realize that the U.S. government is responsible for reviewing the safety of low-calorie sweeteners, which are among the most well-known food additives.
  • 54% of consumers reported it is important that ingredients do not have “chemical-sounding names” including 26% that rate it “very important.” Their opinion is primarily based on food safety and healthfulness concerns.

Our takeaway is that consumers continue to be concerned about chemicals in food, partly because they are not confident that the federal government is actually ensuring additives are safe. Therefore, they do their best to try and protect their health and safety by avoiding ingredients that sound like chemicals – the only way they see to control the perceived risk. In reaction to consumer concerns, food companies have undertaken “clean label” programs that either remove these ingredients (which can be helpful) or use names that do not sound like chemicals (which obscure the fact and can be misleading).

A better approach is to actually ensure the chemicals in food are safe and healthy rather than leaving consumers to judge products based on the sound of the ingredient names. Actual safety is the outcome that Congress intended when it adopted the Food Additives Amendment of 1958. Instead, the Food and Drug Administration (FDA), the agency with both the responsibility and the authority for food safety, allows companies to decide in secret that additives are safe, fails to consider the cumulative health effect of chemicals in the diet, and lacks any systematic reassessment of past decisions even when new evidence shows potential harm.

FDA needs to step up and address these shortcomings to make our food safe and restore consumer confidence. This involves not only improving its approach to addressing ingredient safety but also their approach towards contaminants that enter our food from the environment, from the packaging, or from food processing.

Read More »

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Beyond paper, part 2: PFAS intentionally used to make plastic food packaging

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 12, 2021

Tom Neltner, Chemicals Policy Director; Maricel Maffini, consultant; and Tom Bruton with Green Science Policy Institute

Since 2002, FDA has authorized the use of four types of per- and polyfluorinated alkyl substances (PFAS) to make plastic food packaging, one as recently as 2016. The PFAS are allowed in plastic at levels up to 2000 parts per million (ppm); although lower than those used to greaseproof paper, these levels still contaminate food. The PFAS are added to facilitate the production of articles such as bottles and wraps. They reportedly improve polymer extrusion, reduce build-up on the injection mold, and improve surface roughness among other technical effects.

EDF submitted a Freedom of Information Act (FOIA) request for seven food contact substance notices (FCNs) that FDA has authorized. From FDA’s response[1], we learned that these PFAS can contaminate food in contact with the packaging. In one case the overall amount of the PFAS in the diet would be as high as 41 ppb (see pages 31-32 of FOIA response) – much more than is tolerated for some PFAS in drinking water.

These plastic processing aids, along with fluorinated polyethylene, are the latest additions to a growing list of sources of ‘forever chemicals’ in the diet. They join environmental contamination and greaseproofed paper and cardboard as sources that food companies must consider in order to keep PFAS out of their products and respond to consumer demand for safer food. Given the evidence, FDA needs to move forward pursuant to our June 2021 citizens petition to evaluate the safety of PFAS taking into account the cumulative effect of these chemicals in the diet from many sources.

Read More »

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