EDF Health

California mandates toxics testing/disclosure for baby food

Tom Neltner, Senior Director, Safer Chemicals and Katelyn Roedner Sutter, State Director, California

Three jars of baby food surrounded by cut-up vegetables and fruit

What Happened?

On October 10, 2023, California Assembly Bill 899, authored by Assembly Member Al Muratsuchi, became law. It requires manufacturers of baby food (other than infant formula) who wish to sell their products in California to:

  • Test a representative sample of each baby food product for four toxic elements (arsenic, cadmium, lead, and mercury) at least monthly starting in 2024.
  • Provide the test results to the California Department of Health upon request.
  • Make the results of the testing publicly available on the manufacturer’s website for the shelf life of the product plus one month. That provision goes into effect in 2025.

In addition, as FDA establishes action levels for the four toxic elements, manufacturers must also include a quick response (QR) code on the label that links to the manufacturer’s website, where consumers can find the test results for that toxic element.

Why It Matters

By requiring testing and reporting on these foods, California will provide parents and guardians with important information they need to compare products and make purchasing decisions. The law also:

  • Sets a precedent for greater testing and disclosure of food contaminants; and,
  • Is noteworthy, in that baby food companies did not oppose the bill.

The law will strengthen FDA’s efforts to reduce children’s dietary exposure to those toxic elements to the lowest possible levels, while maintaining access to nutritious foods by filling two critical gaps in FDA’s Closer to Zero program. FDA current approach sets action levels on final products that food companies must meet and requires they use preventive controls to manage toxic elements in their ingredients. It does not require final product testing or disclosure of any testing results.

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

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

By Tom Neltner, Senior Director, Safer Chemicals, Klara Matouskova, PhD, Consultant, and Maricel Maffini, PhD, Consultant

What Happened?

In our new study, we evaluated Generally Recognized As Safe (GRAS) notices—a total of 403 between 2015-2020that food manufacturers voluntarily submitted to FDA for review. Our goal was to determine whether industry was adhering to FDA’s Guidance on Best Practices for Convening a GRAS Panel.

The guidance was designed to help companies comply with the law and avoid biases and conflicts of interest when determining whether substances added to food are safe and recognized as such by the scientific community. FDA published a draft of the guidance in 2017 and finalized it essentially unchanged in December 2022.Infographic showing how a small group of individuals populate almost half of GRAS review panels. Seven individuals accounted for 46 percent of available panel positions.

Our study found that no GRAS notices followed the draft guidance. Specifically, we also found there were high risks of bias and conflicts of interest because the companies:

  • Had a role—either directly or through a hired third party—in
    selecting panelists that likely resulted in bias and conflicts of interest.
  • Depended on a small pool of experts in which seven individuals occupied 46% of panel positions. The seven often served together, further enhancing risk of bias.
  • Relied on panels that did not realistically reflect the diverse scientific community that evaluates chemical risks to public health—which is needed to comply with the law’s requirement that there be a “general recognition” within that community that a substance is GRAS.

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Also posted in Broken GRAS, Conflict of interest, Food, Industry influence / Tagged , , , | Authors: / Comments are closed

FDA says “Cookware that exhibits any level of leachable lead upon testing is prohibited.”

What’s New?

For the first time, FDA has provided guidance on how to evaluate whether metal cookware is prohibited due to lead leaching into food.

As part of an investigation to find the source of elevated blood lead levels in some refugee children, the Hazardous Waste Management Program in King County, Washington [1] encountered high lead levels in certain imported [2] aluminum cookware, including pressure cookers and pots & pans. The program attempted to bring this to FDA’s attention in late 2019, and submitted a formal product report to FDA in October 2021, after several attempts to contact an FDA representative directly.

In May 2022, the Program published a journal article about its findings; a year later, staff emailed FDA again seeking guidance. On June 1, 2023, FDA responded with a letter [PDF, 166KB] providing a method (see below) to evaluate lead in metal cookware. The agency also said:

  • “The marketing in interstate commerce, including importation, of cookware that exhibits any level of leachable lead upon testing is prohibited.”
  • “Neither lead nor lead-containing materials (e.g., metals, solder) are permitted under FDA regulations for use in contact with food.”
  • The Program should “feel free to share this letter or any of its contents with Amazon.com, Inc.,[3] and any other firms involved in the marketing or sale of cookware.”[4]

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Also posted in Health hazards, Lead, Risk evaluation, Vulnerable populations / Tagged , , | Authors: / Comments are closed

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

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Also posted in Adverse health effects, Broken GRAS, Food, Health hazards, Industry influence, Risk assessment, Risk evaluation / Tagged , , , , , , , | Authors: , / Read 1 Response

Is it time to rethink “lead-safe” and “lead-free”?

By Tom Neltner, Senior Director, Safer Chemicals Initiative, Environmental Defense Fund and Charlotte Brody, National Director, Healthy Babies Bright Futures

Key Message

The scientific consensus is that there is no known safe level of lead exposure, and that no environment or home is truly free of lead.

With a few exceptions, we think it is time to retire the terms “lead-safe” and “lead-free” from our vocabulary. It sends conflicting messages to the public, consumers, and decision-makers. And it may undermine our efforts to reduce children’s exposure to lead from any source.

Rationale

Collectively, we have dedicated over a half-century to protecting children from lead. During that time, we and other advocates have used different terms to communicate our goals. Often, we drew our terms from the federal government. For example:

  • “Lead-free” has been used by Congress since 1986 to define drinking water pipes with no more than 80,000 parts per million (ppm) of lead. It kept the term in 2014 when it changed the level from 80,000 to 2,500 ppm. Similarly, FDA issued guidance in 2010 allowing a “lead-free” label on pottery if it meets the agency’s limits on lead.
  • “Lead-safe” is in the title for HUD’s 1999 rule to reduce lead-based paint exposure in federally assisted EPA also refers to “lead-safe work practices” in its 2008 renovation, repair and painting (RRP) rule for residential property. In addition, EPA created a “lead-safe” logo in 2010 for certified RRP firms. And HUD, EPA, and CPSC use the term in their pamphlet given to millions of families renting or buying homes built before 1978.

As a result, terms like “lead-safe” and “lead-free” have been commonly used to describe community-wide initiatives, label houses on maps, describe the state of a house after remediation, and much more.

What does lead-free mean? It depends on who you’re asking and what you’re asking about. A contractor may understand the term to mean that a house meets the EPA definition of not having a lead hazard, but does the average resident understand the term the same way? Is it accurate to describe a house as lead-free if there is still lead in the drinking water? Or in the spices in the cabinets?

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Also posted in Contamination, Lead, Public health, Unleaded Juice / Tagged , , , , | Authors: / Read 2 Responses

FDA’s squishy definition of adverse health effects of substances in food

Maricel Maffini, consultant, and Tom Neltner, Senior Director, Safer Chemicals

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Also posted in Adverse health effects, Health hazards, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed