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ICYMI: Secret GRAS determinations may outnumber those FDA reviews

Quote from FDA Commissioner Robert Califf, MD. "I want to throw in chemical safety as another really, really important area for the future—for humankind, really—and where science is evolving rapidly."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Industry influence, Public health, Regulation / Also tagged , | Authors: , / Comments are closed

Unleaded Food: FDA acts quickly on contaminated applesauce

What’s Happening?

The North Carolina Departments of Health & Human Services and Agriculture & Consumer Services identified WanaBana cinnamon applesauce pouches as a source for elevated blood lead levels in multiple children. They found extraordinarily high concentrations of lead (1,900- 5,100 ppb) in the products, leading to the identification of at least 34 cases of elevated blood lead levels across 22 states to date.

On October 28, 2023, FDA issued a safety alert advising that “parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.” Three days later, the company issued a voluntary recall.

As the recall expanded, FDA transferred the investigation to its Coordinated Outbreak Response & Evaluation (CORE) Network to determine the source of lead contamination and whether additional products are linked to illnesses.

Brands under a voluntary recall. Photo credit: FDA

Brands under a voluntary recall. Photo credit: FDA

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Posted in Chemical exposure, FDA, Food, Health hazards, Public health / Also tagged , , | Authors: , / Read 1 Response

FDA’s approach to systematic review of chemicals got off on the wrong foot

Scientist working on a digital tablet showing data on the chemical element Cadmium

What Happened?

Last month, FDA’s scientists published the toxicological reference value (TRV) for exposure to cadmium in the diet. This value is the amount of a chemical—in this case cadmium—a person can consume in their daily diet that would not be expected to cause adverse health effects and can be used for food safety decision-making. The TRV was based on a systematic review FDA scientists published last year. We will turn to the TRV itself in an upcoming blog but are focusing on the systematic review here.

In a May 2023 publication, experts in systematic reviews from the University of California San Francisco (UCSF) raised concerns about FDA’s “lack of compliance” from established procedures.

We discussed these concerns with FDA. They said:

  • “The systematic review and the TRV” publication “have both undergone external peer review by a third-party and experts in the field.” The agency expects to publish the reviews on its website, and
  • FDA “is working on developing a protocol for a systematic review of cardiovascular effects of cadmium exposure that will be published.”

Why It Matters

Systematic review is a method designed to collect and synthesize scientific evidence on specific questions to increase transparency and objectivity and provide conclusions that are more reliable and of higher confidence than traditional literature reviews. In particular, the National Academies of Sciences, Engineering, and Medicine have recommended the use of systematic reviews to establish values such as the TRV that may be used to inform regulatory decisions.

The National Toxicology Program (NTP) and others have developed specific methodologies to conduct systematic reviews. FDA’s authors said they followed NTP’s Office of Health Assessment and Translation (OHAT) handbook.

Unfortunately, FDA’s adherence to the methodology fell short on both transparency and objectivity grounds, undermining the credibility of its conclusions. Credibility is crucial because FDA’s authors stated that “this systematic review ultimately supports regulatory decisions and FDA initiatives, such as Closer to Zero, which identifies actions the agency will take to reduce exposures to contaminants like cadmium through foods.”

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Posted in FDA, Health science, Public health / Also tagged , , , , | Authors: , / Comments are closed

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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Posted in FDA, Food, Health policy, Markets and Retail / Also 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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Posted in Broken GRAS, Conflict of interest, FDA, Food, GRAS, Industry influence / Also 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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Posted in FDA, Health hazards, Lead, Risk evaluation, Vulnerable populations / Also tagged , | Authors: / Comments are closed