FDA Proposal Could Allow Toxic Chemicals in Food Without Safety Reviews

A proposed expansion of the FDA’s food chemical exemption raises concerns about children’s brain development, hormone disruption, reproductive injuries, and the legal rights of consumers exposed to potentially dangerous substances.

What Parker Waichman LLP Found

Based on the reported FDA proposal and the concerns raised by public health advocates, several issues deserve attention:

• Expanded exemptions: The proposal could allow qualifying chemicals to be added directly to food without the standard food additive approval process.
• Children’s health: Certain chemical exposures may interfere with thyroid hormones essential to neurological development.
• Repeated exposure: Consuming multiple products containing low levels of harmful substances may raise cumulative exposure concerns.
• Manufacturer accountability: Companies may face product liability claims when evidence establishes that a defective or improperly marketed food product caused an injury.
• Lawsuit eligibility: Medical records, exposure evidence, scientific findings, and applicable state laws are central to determining whether a claim is viable.

Millions of Americans purchase groceries believing that the ingredients in their food have been evaluated for safety. Parents buying breakfast cereal, families preparing meals, and consumers choosing packaged foods generally expect federal regulations to protect them from dangerous chemical exposure. However, a proposed change to the U.S. Food and Drug Administration’s (FDA) food safety regulations has raised concerns about whether potentially harmful chemicals could enter the nation’s food supply without undergoing an individualized FDA safety review. The controversy centers on a regulatory exemption that could be expanded to cover substances intentionally added to food.

The FDA’s proposed expansion of the Threshold of Regulation (TOR) exemption would potentially allow certain substances to be used directly in food without following the ordinary food additive approval process. These substances could include ingredients used as flavorings, preservatives, emulsifiers, stabilizers, binders, enzymes, and processing aids.

Public health advocates argue that the proposal could expose consumers to chemicals capable of interfering with thyroid function, disrupting hormones, affecting neurological development, or damaging reproductive health. Of particular concern are children, pregnant women, and people who may experience repeated exposure through commonly consumed foods.

Although the proposed rule does not establish that specific food products are dangerous or that consumers have already suffered injuries, it raises significant questions about chemical safety, manufacturer accountability, and the circumstances under which injured consumers may pursue legal action.

What Is the FDA’s Threshold of Regulation Exemption?

The Threshold of Regulation exemption is a regulatory mechanism that allows certain low-exposure substances to avoid the standard food additive approval process when specified safety criteria are satisfied.

Historically, the exemption has primarily applied to substances used in food-contact materials, including packaging, storage containers, and food-processing equipment. Under the existing framework, exposure generally must fall below 0.5 parts per billion in the diet, and additional restrictions apply, including limitations involving carcinogenic substances.

The FDA’s proposed expansion would extend the exemption to qualifying substances intentionally added to food. This distinction matters because chemicals used directly in food may become part of a consumer’s regular diet rather than entering food incidentally through packaging or equipment.

Regulators would still have to apply the exemption’s legal criteria, including the requirement that qualifying uses present no appreciable risk to human health. However, critics question whether the underlying exposure assumptions adequately account for endocrine disruption, developmental vulnerability, and repeated exposure to multiple chemicals.

Importantly, an exemption from the standard approval process is not the same as a determination that every qualifying substance is harmless under all circumstances.

How Toxic Food Chemicals Could Affect Brain Development and Thyroid Function

One of the most serious concerns involves chemicals capable of interfering with the endocrine system, which regulates hormones responsible for growth, metabolism, reproduction, and neurological development.

Perchlorate provides an important example. This chemical is associated with rocket propellants and certain industrial applications, but it can also enter food through environmental contamination or food-contact materials.

Perchlorate can interfere with the thyroid gland’s ability to absorb iodine. The thyroid requires iodine to produce hormones, including thyroxine, commonly called T4. These hormones play an essential role in fetal and childhood brain development.

Research has raised concerns about associations between perchlorate exposure, altered thyroid hormone levels, and developmental outcomes. However, the degree of risk depends on exposure, iodine status, age, pregnancy, and other factors. The presence of perchlorate in food does not automatically establish that an individual has suffered brain damage.

For pregnant women, inadequate thyroid hormone availability can be especially concerning because fetal neurological development depends partly on maternal thyroid function. Children may also be more vulnerable to certain chemical exposures because their bodies and nervous systems are still developing.

These concerns underscore why chemical safety assessments must consider sensitive populations rather than relying exclusively on assumptions about average adult exposure.

Perchlorate in Children’s Cereal Demonstrates the Importance of Food Packaging Safety

The controversy surrounding perchlorate illustrates how substances used in food-contact materials can become part of the food supply.

In 2005, a regulatory exemption permitted a perchlorate-related use involving large polypropylene storage bags commonly used to transport grains and other agricultural products. These bags, sometimes called super sacks, can hold substantial quantities of oats, flour, rice, and similar ingredients.

Food safety advocates subsequently questioned whether perchlorate could migrate from these materials into food during storage and handling.

FDA monitoring data published in 2017 identified changes in perchlorate findings in certain food categories, including children’s cereal. Environmental organizations argued that the results warranted stronger regulatory action, particularly because cereal is frequently consumed by children.

The FDA maintained that its broader assessment did not establish a meaningful overall increase across the foods examined. Advocates challenged that conclusion, arguing that averaging results across numerous food categories could obscure elevated exposure in particular products.

The dispute demonstrates an important scientific and legal distinction: identifying a chemical in food, establishing a harmful exposure level, and proving that exposure caused an individual’s injury are separate questions requiring different forms of evidence.

Other Chemicals That Could Raise Health Concerns

Perchlorate is not the only substance attracting attention. Researchers and public health organizations have also raised concerns about certain phthalates, bisphenols, per- and polyfluoroalkyl substances (PFAS), and flame retardants.

These chemical families contain many different compounds with varying toxicological properties. Some have been associated with endocrine disruption, immune effects, developmental problems, or reproductive harm, depending on the particular substance and exposure circumstances.

The proposed TOR expansion does not automatically authorize all these chemicals for direct food use. Nevertheless, critics argue that a regulatory framework focused heavily on very low estimated exposure may fail to identify certain biological effects.

Another concern involves cumulative exposure. Consumers may encounter similar substances through multiple foods, drinking water, household products, and environmental sources.

A safety evaluation that examines one substance and one exposure pathway may not fully describe the potential consequences of combined exposures. Determining whether those exposures produce injury requires substance-specific scientific evidence.

When Can Toxic Chemical Exposure Lead to a Food Contamination Lawsuit?

Consumers who suffer injuries allegedly caused by dangerous substances in food may have legal options under state product liability, negligence, or related laws.

A viable lawsuit generally requires more than evidence that a chemical was present in a product. The injured person must establish an applicable legal basis for liability and a sufficiently supported connection between the exposure and the claimed harm.

Depending on the facts and governing state law, potential claims may involve defective product design or formulation, manufacturing contamination, inadequate warnings, negligent safety testing, or misrepresentations about product safety.

Manufacturers, ingredient suppliers, processors, and other entities in the distribution chain may face liability when their conduct or products satisfy the relevant legal requirements.

A regulatory exemption does not necessarily eliminate civil liability. However, compliance with federal requirements, federal preemption, and the specific nature of the alleged defect may affect whether a claim can proceed.

What Evidence Is Needed to File a Toxic Food Exposure Lawsuit?

Evidence is particularly important in toxic exposure litigation because some illnesses develop gradually and may have several possible causes.

Attorneys investigating these cases may examine product purchase records, ingredient information, manufacturing documents, laboratory testing, medical histories, exposure timelines, and scientific research.

Medical evidence may help establish whether a person experienced thyroid dysfunction, developmental injury, reproductive harm, or another identifiable condition. Additional investigation may be needed to determine whether a particular chemical could have caused that condition at the documented exposure level.

Families should preserve available packaging, receipts, product photographs, and medical records when they suspect a food-related chemical injury. They should also obtain appropriate medical care rather than waiting for a legal investigation.

A proposed FDA rule alone does not establish grounds for compensation. A lawsuit must be supported by evidence of an actionable violation or defect, injury, causation, and legally recoverable damages.

Frequently Asked Questions About Toxic Food Chemical Lawsuits

Can I Sue a Food Manufacturer if Toxic Chemicals Made Me Sick?

Potentially. A consumer may pursue compensation when evidence supports a legally recognized claim involving a contaminated, defective, or improperly marketed food product. The case must generally establish that the defendant was legally responsible and that the chemical exposure caused or contributed to an identifiable injury. Simply discovering that a food contains a potentially hazardous substance does not automatically establish liability. Attorneys evaluate the chemical involved, exposure circumstances, medical diagnosis, and applicable state product liability laws before determining whether litigation is appropriate.

Can Parents File a Lawsuit if Their Child Was Harmed by Chemicals in Food?

Parents or legal guardians may be able to pursue claims on behalf of children who suffered injuries caused by defective or contaminated food products. Potential allegations could involve developmental injuries, thyroid disorders, or other medically supported conditions. These cases often require pediatric medical records, developmental evaluations, exposure histories, and scientific evidence connecting the substance to the claimed injury. Because children may experience different exposure risks than adults, their age, development, and individual medical circumstances can be particularly important.

What Compensation May Be Available in a Toxic Food Exposure Lawsuit?

Depending on the applicable law and supporting evidence, compensation may include past and future medical expenses, lost earnings, diminished earning capacity, and physical pain and suffering. Cases involving serious childhood injuries may also involve future treatment costs, rehabilitation, and other long-term needs. Some jurisdictions permit additional categories of damages under particular circumstances. The amount recoverable depends on the severity of the injury, the evidence of causation, the defendants’ legal responsibility, and state-specific limitations.

Can I File a Lawsuit if the FDA Allowed the Chemical to Be Used?

Possibly. FDA authorization or a regulatory exemption does not automatically prevent every product liability claim. However, federal law may preempt certain state-law claims, and regulatory compliance can be relevant to the defense. Attorneys must examine the particular substance, its authorized use, the alleged defect, and the legal theory being asserted. A successful claim still requires proof of injury and causation. Whether a manufacturer complied with applicable FDA requirements is only one part of the legal analysis.

How Long Do I Have to File a Toxic Chemical Exposure Lawsuit?

Filing deadlines vary by state and the type of claim. Many personal injury lawsuits are subject to statutes of limitations that may begin when an injury occurs or, in certain circumstances, when an injury and its potential cause are discovered. Special rules may apply to minors, delayed diagnoses, wrongful death claims, and claims involving particular defendants. Missing an applicable deadline can prevent recovery even when substantial evidence supports the allegations. Prompt legal review is important when a food-related chemical injury is suspected.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

Consumers who believe they suffered serious injuries because of toxic chemicals in food may have questions about their legal rights, medical expenses, and the responsibility of food manufacturers.

Parker Waichman LLP is a national personal injury law firm that represents individuals and families pursuing claims involving dangerous products and harmful exposures. The firm can evaluate the circumstances of a suspected food chemical injury, assess available evidence, and discuss whether a legal claim may be appropriate.

Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. Learn whether your circumstances may support a claim for compensation and what steps may be necessary to protect your legal rights. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.