EDF Health

Why are four notorious carcinogens approved by FDA for food?

By Liora Fiksel, Project Manager, Healthy Communities, and Lisa Lefferts, Environmental Health Consultant

Pregnant woman rests a cup of coffee on her belly.

While exposure data are scant, people who are choosing decaf coffee during pregnancy or for other health reasons may not realize that some popular brands contain methylene chloride.

What’s Happening?

On December 21, 2023, FDA filed a food-additive petition and a color-additive petition submitted by EDF and partners that asks FDA to revoke its approval for four carcinogenic chemicals approved for use in food.

There is broad agreement that benzene, trichloroethylene (TCE), methylene chloride, and ethylene dichloride are carcinogenic,1 and federal law2 is clear: additives that cause cancer in humans or animals are not considered “safe.” All the chemicals have been identified as causing cancer in humans or animals since the 1970s and 1980s.3 Read More »

Also posted in Adverse health effects, Carcinogenic, Chemical exposure, Chemical regulation, Food, Health hazards, Public health, Vulnerable populations / Tagged , , , , , , | Authors: / Comments are closed

FDA’s latest study reaffirms short-chain PFAS biopersist. Now it must act.

By Maricel Maffini, PhD, Consultant, and Tom Neltner, JD

Female rat nursing multiple pups

FDA study found biopersistent PFAS in female rats and their pups,

What Happened

In December 2023, FDA’s scientists published a new study showing that when pregnant rats ingest a form of per- and polyfluorinated alkyl substance (PFAS) called 6:2 fluorotelomer alcohol (6:2 FTOH) their bodies break it down into other PFAS that reach the fetuses and biopersist in the mother and the pups.

The study also showed that the body of a non-pregnant animal produces different breakdown products that also biopersist. This study is the latest evidence that the assumptions made about the safety of short-chain PFAS (chemicals with fewer than 8 carbons) have been wrong. Read More »

Also posted in Adverse health effects, Chemical regulation, Emerging science, Health science, Industry influence, PFAS, Public health, Rules/Regulations, Vulnerable populations / Tagged , , , , , , , | Authors: / Comments are closed

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 »

Also posted in Broken GRAS, Chemical regulation, Food, Health policy, Industry influence, Public health, Regulation / 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

Read More »

Also posted in Chemical exposure, Food, Health hazards, Public health / 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.”

Read More »

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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.

Read More »

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