EDF Health

FDA Says We Are All Made of Chemicals So How Can Any Be Bad For You?

By Maria Doa, PhD, Senior Director, Chemicals Policy, Maricel Maffini, PhD, Consultant, and Liora Fiksel, Project Manager, Healthy Communities

 

Woman reading product label in grocery store

What happened

You may have seen news or online content from FDA about chemicals in our foods, including that our food – and everything else in the world – is made up of chemicals.

FDA’s online content also characterizes toxic chemicals such as lead and mercury simply as naturally occurring or naturally present in our environment. It further fails to distinguish the most harmful chemicals by asserting that for all chemicals, it is the amount of the chemical that matters when determining their harm.

Why it matters

It is true that everything, including our food, is made up of chemicals. However, that does not mean that we should treat all chemicals equally.

Highly toxic chemicals such as lead, mercury, PFAS, TCE, methylene chloride, and BPA are examples of substances that should not be in our food. These toxic metals and synthetic chemicals do not have nutritional benefits and are not equivalent to the chemicals that make up the proteins, fats and carbohydrates that are necessary for a healthy diet. We should not be exposed to toxic chemicals at any level.

The suggestion that toxic metals and synthetic chemicals such as PFAS in our food are just chemicals like essential elements such as potassium in bananas is misleading and harmful.

Unfortunately, FDA accomplished just that. In a webpage released earlier last week, the agency tried to address worries about chemicals in food, an issue that consumers have been concerned about for several years. In its attempt to bring confidence about the safety of the food supply, FDA tried to normalize the presence of toxic chemicals, including neurotoxicants, carcinogens and endocrine disruptors, in our food.

Our take

If a toxic chemical such as lead or mercury is naturally occurring, is it OK?

No. While there are very low levels of these metals that are naturally present in our environment the majority of what is now in our environment is not natural background but the result of pollution and other contamination due to human activities. These levels are not “naturally occurring.”

It is also essential to recognize that naturally occurring does not equate with safety. There is no safe level of exposure to lead and mercury which are potent neurotoxicants. They are particularly harmful to infants and small children and exposure to even small amounts can cause harm.

Is there always a safe level of exposure to a chemical?

Treating all chemicals in our food the same way ignores the science. Some chemicals, in addition to lead and mercury, are so toxic that essentially any amount of exposure is of concern:

  • Chemicals like TCE associated with multiple types of cancers and harm pregnant women and infants.
  • Chemicals like PFAS also known as forever chemicals because they are so difficult to destroy that can harm pregnant women, cause cancer and harm the immune system in vanishing small quantities. For two of the PFAS, EPA just declared that there is no safe level of exposure.
  • Chemicals like BPA that harm the immune and reproductive systems, disrupts the normal function of hormones and affects learning and memory at levels 20,000 times lower than previously estimated, and
  • Chemicals like methylene chloride are associated with cancer and liver toxicity.
  • Chemicals like phthalates that also disrupt the normal function of hormones specially during development of the male reproductive tract. These chemicals are strictly limited in children’s toys due to their toxicity.

And being exposed to more than one of these chemicals that cause the same harm, such as cancer, can increase the harmful effects.

Further, Congress also recognized that some chemicals should not be allowed to be added to our food. Period. Congress included a provision known as the Delaney Clause in our food safety laws that states a food additive cannot be deemed “safe if it is found to induce cancer when ingested by man or animal.” Yet unfortunately, some carcinogens continue to be allowed.

How can we be assured of a safe food supply if the agency that is supposed to ensure safety takes the same “it’s the amount that matters” approach to these toxic chemicals as it does to salt?

And how can we have confidence that FDA will fully consider consumers in determining food safety when the agency not only falsely equates toxic chemicals with the chemicals that make up the proteins, fats and carbohydrates in our diet but also takes a patronizing approach to the public by stating that “chemical names may sound complicated but that does not mean they are not safe.”

Next steps

In the last several years, public interest organizations have petitioned FDA to review the safety of chemicals known to pose risk to health.  Many petitions are still unresolved.

FDA should recognize toxic chemicals for what they are – chemicals that can harm our health and well-being – rather than camouflage them just as any other chemical. The science and the law demand that in making decisions about food safety, FDA recognize and act on the most toxic chemicals and fully consider consumers in its decision making.

 

Posted in General interest / Authors: / Leave a comment

EU gets ready to ban most BPA uses. Once again: Where’s FDA?

By Maricel Maffini, PhD, Consultant, and Tom Neltner, Executive Director, Unleaded Kids

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What’s Happening?

On February 9, 2024, the European Commission published a proposed regulation [PDF, 502KB] that would ban most uses of bisphenol A (BPA) in materials that contact food—including plastic and coatings applied to metal cans—and restrict other uses. Interested parties can comment on the draft until March 8, 2024. (You must register to comment.)

This proposed regulation is based on the 2023 European Food Safety Authority’s (EFSA) risk assessment of BPA that concluded that dietary exposures are a health concern. The proposed regulation would impact the following bisphenol-based food contact materials:

  • Plastics: Would be banned from use if made from BPA at any stage of manufacturing.1 The only exception is polysulfone resins made from a sodium salt of BPA, which are allowed for use in filtration membranes if there is no detectable migration into food.
  • Varnishes, coatings, printing inks, adhesives, ion-exchange resins, and rubbers: Use of BPA and bisphenol S (BPS)2 would be banned at any stage of manufacture. Use of BPS or other bisphenols may be authorized on a case-by-case basis. The exception to the ban is bisphenol-A diglycidyl ether (BADGE)3 made from BPA and used to make epoxy-based varnishes and coatings, which are allowed only in making materials with capacity of more than 250 liters and there is no detectable migration4 into food.
  • Recycled materials: Unintentional BPA contamination would be allowed if there is no detectable migration into food.

Why It Matters

In its 2023 reassessment, EFSA estimated that the amount of BPA that could be safely consumed daily is 20,000 times less than its 2015 estimate. Among the health problems associated with BPA exposure are harm to the immune and reproductive systems, disruption of the normal function of hormones and reduced learning and memory.

The draft rule would manage the risk of BPA uses to significantly reduce dietary exposure after considering alternatives that are technically feasible at a commercial scale.

Our Take

The European Commission’s proposed rule is an excellent example of a risk management decision that considers safety and achievability. The Commission balanced protecting human health by eliminating as many sources of BPA as fast as possible with the implementation challenges. The Commission has included transition periods to eliminate all uses of food-contact articles manufactured with BPA ranging from 18 months for final food packaging (e.g., plastics, can coating) to 10 years for repeat-use, final food contact articles used in food production equipment.

In a previous blog, we stated that Americans’ exposure to BPA from food is similar to that of Europeans. Unfortunately, FDA doesn’t share the same sense of urgency as the European Commission. While Europe is on track to ban most uses of BPA in food contact materials, FDA is failing to take action to protect our families.

EDF and our allies submitted a food additive petition [PDF, 542KB] asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022, and has not made a final decision on it, despite a 180-day statutory deadline. It is now more than 600 days overdue.

Timeline

Once the rules are finalized, compliance would be required within 18 months for most products and within 36 months for:

  • Varnishes and coatings for processed fruit, vegetable, and processed fish products.
  • Varnishes and coatings used outside of metal packaging.
  • Manufacture of repeat-use components in professional food production equipment.

The rule would also allow repeat-use, final food contact articles used in professional food production equipment to remain in service for up to 10 years.

What’s Next?

We will submit comments to the European Commission seeking clarity on some aspects of the proposal. In addition, we will continue to press FDA to make a final decision on our petition, including potentially taking legal action for unreasonable delay in responding to it.

Go Deeper

Read our blogs on BPA.

NOTES

1 The rule is inconsistent regarding status of plastics other than polysulfone. EDF will submit comments seeking clarity.

2 The Commission may expand to more bisphenols if they are added to Annex VI, Part 3 of Regulation (EC) No 1272/2008 due to their harmonized classification as category 1A or 1B “mutagenic,” “carcinogenic,” “toxic to reproduction” or category 1 “endocrine disrupting” for human health.

3 BADGE (CAS No 1675-54-3) – is a type of epoxy resin manufactured from BPA.

4 Rule defines the limit of detection as 0.01 milligram of bisphenol per kilogram of food.

Posted in BPA, EFSA, FDA / 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 »

Posted in Adverse health effects, Chemical regulation, Emerging science, FDA, Health science, Industry influence, PFAS, Public health, Rules/Regulations, Vulnerable populations / 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.

Read More »

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

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.

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

European Commission plans to ban food uses of BPA. We ask again: Where is FDA?

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

What Happened?

On June 2, the European Commission, the executive body of the European Union (EU) responsible for proposing legislation and implementing decisions, announced it is preparing an initiative that “will impose a ban on the use of BPA [bisphenol A] in food contact materials (FCMs), including plastic and coated packaging.” It also said it would “address the use of other bisphenols in FCMs to avoid replacing BPA with other harmful substances.” The Commission’s proposal is based on the European Food Safety Authority’s (EFSA) scientific opinion that exposure to BPA is a “concern for human health.”

Why It Matters

In April, EFSA concluded that Europeans were exposed to levels of BPA from food that were 100 to 1,000 times greater than the estimated safe amount, and that this exposure could lead to an overactive immune system producing out-of-control inflammation. BPA was also associated with disrupting the endocrine system, harming reproduction, and reducing learning and memory. The immune system was most sensitive to BPA exposure. Recognizing these risks, the Commission moved quickly to protect Europeans’ public health by banning uses of BPA.

Our Take

Americans’ exposure to BPA from food is similar to that in Europe. Unfortunately, FDA doesn’t share the same sense of urgency to protect our families as the European Commission is demonstrating by its actions. While Europe is moving forward to ban the use of BPA in food contact materials, the FDA has failed to take action.

EDF and our allies submitted a food additive petition asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022 and has not made a final decision on it despite a 180-day statutory deadline. It is now more than 400 days overdue.

In January, FDA Commissioner Califf announced “a new and transformative vision for the FDA Human Food Programs” which includes a Deputy Commissioner for Human Foods with “decision-making authority over policy, strategy and regulatory program activities.” These are important steps, but a real measure is making timely decisions to protect American’s health by restricting the use of toxic chemicals such as BPA.

Pile of silver metal food cans with no labels

Next Steps

We will continue to press FDA to make a final decision on the petition, including potentially taking legal action for unreasonable delay in responding to our petition.

Posted in BPA, EFSA, Endocrine disruptors, FDA, Food contact materials, Food packaging, Health hazards, Plastic, Public health, Reproductive toxicity / Tagged , , | Authors: , / Comments are closed