FDA Food Safety Overhaul Could Allow More Chemicals Without Full Approval Despite Pledge to Close Ad

A proposed federal rule would require food manufacturers to disclose ingredients they consider safe, but consumer advocates warn that a separate provision could expand exemptions for chemicals added directly to food, including substances containing trace amounts of carcinogenic impurities.

By yourNEWS Media Newsroom

A Food and Drug Administration proposal intended to strengthen oversight of chemicals in the American food supply is drawing criticism after analysts identified a provision that would broaden exemptions from formal food-additive approval. The change could allow manufacturers to seek exemptions for extremely small quantities of chemicals intentionally added to food, rather than limiting the procedure primarily to substances that migrate from packaging and processing equipment.

The provision appears within a sweeping regulatory proposal announced by the Trump administration in August as part of Health and Human Services Secretary Robert F. Kennedy Jr.’s effort to close longstanding gaps in food ingredient oversight. Although the administration has emphasized new disclosure requirements for manufacturers, consumer advocates contend that the accompanying exemption could weaken protections by allowing additional chemical uses without the comprehensive safety review ordinarily associated with food-additive approval.

The proposed regulation, published in the Federal Register on Aug. 11, would require manufacturers to notify the FDA when they independently determine that an ingredient is generally recognized as safe, commonly known as GRAS. Under existing regulations, companies can make those determinations without submitting a notice to the agency, leaving federal regulators with incomplete information about some substances entering the food supply.

The proposed disclosure requirement represents a change in federal oversight. However, the rule would also modify the threshold-of-regulation exemption, a separate legal mechanism allowing certain uses of substances to avoid ordinary food-additive approval when estimated dietary exposure falls below specified limits.

Under the current framework, that exemption primarily applies to substances that migrate into food from packaging, containers, processing machinery and other materials that contact food. The FDA’s proposed revision would make the pathway available for substances deliberately added to food, provided their intended uses meet specified exposure and safety criteria.

The distinction has prompted objections from scientists and consumer organizations, who question whether the amount of a chemical consumed is sufficient to establish its safety without more extensive toxicological information.

In an investigation published Saturday by The Guardian, independent food safety consultant Maricel Maffini disputed the assumption that extremely low exposure automatically eliminates potential health concerns.

Maffini said the proposition that a small amount of a chemical necessarily presents no problem “isn’t supported by science of any kind.”

Her criticism concerns the possibility that some substances may cause biological effects at concentrations lower than those traditionally considered significant, particularly when exposure occurs repeatedly over many years.

The proposed exemption would not automatically permit every chemical to be used without oversight. Companies would still have to submit information concerning the substance, its intended use, expected dietary exposure and available toxicological evidence. The FDA would retain authority to deny an exemption when information indicated a potential public health risk.

However, the process would remain considerably different from a full food-additive approval, which generally requires a more extensive assessment of safety under the proposed conditions of use.

The regulatory language detailing the exemption establishes a proposed exposure limit of 0.025 micrograms per kilogram of body weight per day. The agency describes this approach as an update intended to account for differences in body size and food consumption among population groups.

The existing regulation generally uses a dietary concentration threshold of 0.5 parts per billion, corresponding to approximately 1.5 micrograms of exposure per person per day under the FDA’s historical dietary assumptions. That concentration is equivalent to roughly half a gram of a substance distributed through 1,000 metric tons of food.

Under the proposed revision, estimated exposure would be calculated relative to body weight rather than relying on a single concentration threshold across the population.

The agency maintains that this change better accounts for differences among adults, children and other groups whose food intake and body weight may vary substantially.

The proposed language also allows an alternative exemption pathway involving substances already authorized for direct addition to food, provided exposure from the proposed use remains at or below 1% of an established acceptable daily intake.

Critics acknowledge that exposure levels matter in chemical risk assessment but argue that broadening eligibility could allow manufacturers to rely on limited evidence when introducing substances intentionally into the food supply.

Particular concern has focused on provisions addressing carcinogenic impurities.

Under the proposed regulation, a substance containing a carcinogenic impurity could qualify for an exemption if the estimated lifetime cancer risk associated with that impurity does not exceed one in a million, based on accepted toxicological methods.

The FDA characterizes the threshold as consistent with existing risk-assessment practices and argues that exposures meeting the criteria would not present meaningful safety concerns.

The proposal does not establish unrestricted permission to add known carcinogens to food. It requires information about carcinogenicity and potential toxic effects, and the agency retains discretion to deny exemptions. Nevertheless, consumer advocates question whether the framework adequately accounts for exposures from multiple sources, emerging toxicological research and chemicals whose effects may not be fully captured by traditional testing methods.

The nonprofit advocacy organization Consumer Reports raised those concerns in an Aug. 25 analysis titled A Regulatory Mirage: Why the Proposed GRAS Rule Fails to Protect Public Health.

The organization described the threshold revision as a “dangerous expansion,” arguing that existing scientific findings demonstrate that certain chemicals can cause adverse effects at concentrations substantially below conventional regulatory thresholds.

Its analysis cited perfluorooctanoic acid and perfluorooctane sulfonic acid, commonly known as PFOA and PFOS, as examples of substances for which evidence of health risks has prompted increasingly stringent environmental standards.

Both chemicals belong to the broader family of per- and polyfluoroalkyl substances, or PFAS, sometimes referred to as forever chemicals because many persist in the environment and human body for extended periods.

The Environmental Protection Agency regulates PFOA and PFOS in drinking water at concentrations measured in parts per trillion, considerably below the parts-per-billion measurements historically used in the FDA’s threshold-of-regulation framework.

Consumer Reports argues that the existence of health concerns at such low concentrations demonstrates why a general assumption about negligible exposure may not adequately address every chemical.

Drinking water limits and food-additive exemptions are different regulatory systems, however, and their numerical thresholds cannot be treated as directly interchangeable without considering the particular chemical, exposure route and health effects involved.

The comparison nevertheless illustrates the broader disagreement over whether fixed exposure thresholds remain appropriate as research identifies substances capable of producing harmful effects at very low concentrations.

Maria Doa, a scientist with the Environmental Defense Fund, criticized the apparent contradiction between the administration’s stated objective of strengthening food safety and its proposal to expand a regulatory exemption.

“They’re widening another loophole, but trying to say they made our food safer,” Doa told The Guardian.

The Environmental Defense Fund has also warned that companies may be able to seek exemptions using existing toxicological information rather than conducting new testing sufficient to identify effects that have not previously been investigated.

Under the proposed rule, applicants would have to identify the substance and intended conditions of use, provide estimates of dietary exposure and analyze available information concerning potential toxicity and impurities.

That information could include evidence from animal studies, published scientific literature and other sources available to the FDA.

Unlike traditional food-additive petitions, however, qualifying exemption requests would not necessarily require the same extensive collection of safety studies.

The distinction is particularly important for substances entering food intentionally because their presence is a deliberate component of the manufacturing process rather than an incidental result of contact with packaging or equipment.

One example cited by critics involves perchlorate, a chemical used in rocket propellants, explosives and certain industrial processes.

Perchlorate can interfere with the thyroid gland’s ability to absorb iodine, which is necessary for producing thyroid hormones. Those hormones play an important role in fetal and childhood brain development, making exposure a concern for pregnant women, infants and young children.

In 2005, the FDA granted a threshold-of-regulation exemption allowing the use of potassium perchlorate as an antistatic agent in certain food-contact materials used for dry food packaging and handling.

The exemption permitted BASF to use the substance in plastic materials associated with bulk food storage and transportation.

Subsequent research raised concerns about perchlorate contamination in foods, including products consumed by children. FDA testing examined the chemical’s presence in foods over time, with some samples showing measurable concentrations.

According to the Guardian investigation, government data indicated that perchlorate was detected more frequently in children’s cereal samples after the exemption was granted.

The findings do not independently establish that BASF’s authorized use caused the reported increase. Perchlorate can enter the food supply through additional pathways, including contaminated water and environmental sources.

Nevertheless, the example has become part of the argument that chemicals permitted at low exposure levels can present questions that were not fully understood when exemptions were initially issued.

The controversy surrounding the exemption is unfolding within a broader effort to reform the federal system governing food ingredients.

The GRAS designation originated under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The law generally requires approval before new food additives can be marketed, but it excludes substances whose safety is generally recognized by qualified experts under their intended conditions of use.

The exclusion was designed to accommodate ingredients with established histories of safe consumption or substantial scientific evidence supporting their safety.

Over time, however, the process evolved into a system under which manufacturers could independently determine that an ingredient qualified as GRAS without necessarily informing the FDA.

Companies could commission safety assessments and conclude that an ingredient met the statutory standard, then introduce it into food without obtaining formal agency approval.

Although manufacturers remain legally responsible for ensuring the safety of their ingredients, the absence of mandatory notification has limited the FDA’s ability to maintain a complete inventory of substances used in food.

Federal regulators have acknowledged that an unknown number of ingredients may have entered the market through independent GRAS determinations.

The agency has also cited concerns that a manufacturer could conclude a substance is safe while relying on evidence that federal regulators have never evaluated.

Those information gaps contributed to the administration’s decision to propose mandatory notifications.

The rule originated from a March 2025 directive by Kennedy calling for action to address what he characterized as weaknesses in the GRAS framework.

When the FDA announced the proposal Aug. 10, Kennedy accused food manufacturers of exploiting the existing exemption from premarket review.

In coverage of the administration’s announcement carried by NBC Palm Springs, Kennedy said industry “drove a convoy of chemical trucks through it.”

The administration presented the rule as a means of increasing transparency and giving regulators better information about substances being added to food.

Under the proposed framework, companies making GRAS determinations would generally be required to submit notices identifying the ingredient, describing its intended uses and providing the scientific basis for concluding that the substance is safe.

Those notices would allow the FDA to review the information and identify potential concerns that might otherwise remain undisclosed until after an ingredient had been widely used.

The proposal also includes transitional provisions for certain substances already present in the food supply, allowing companies to submit specified information through a temporary streamlined process.

However, mandatory notification would not necessarily mean that every ingredient receives full premarket approval.

Companies would continue making GRAS determinations under the statutory framework, and the agency’s review and enforcement responsibilities would remain distinct from the formal approval process required for conventional food additives.

That distinction has become another focus of criticism.

Consumer organizations argue that a system allowing manufacturers to determine safety while notifying regulators afterward may not provide the same protections as requiring the FDA to approve substances before they enter the market.

The agency, however, maintains that mandatory reporting would improve its ability to identify potentially unsafe ingredients and prioritize additional reviews.

It also contends that the proposed threshold-of-regulation revisions are scientifically justified and would preserve public health protections while reducing unnecessary regulatory burdens for extremely low-exposure substances.

The FDA has explicitly retained authority to reject exemption requests when available evidence indicates a public health concern, even when estimated exposure falls below the proposed numerical threshold.

The central disagreement therefore concerns how much evidence should be required before regulators conclude that exposure is sufficiently small to justify an exemption.

Supporters of threshold-based regulation argue that chemical risk depends on both toxicity and exposure, and that extremely small amounts of a substance do not necessarily produce adverse effects.

Critics respond that some substances may have effects that are difficult to detect through conventional toxicological studies, particularly when exposure occurs repeatedly or during sensitive stages of development.

They also question whether evaluating one chemical at a time adequately reflects the combined exposure consumers experience through food, drinking water, household products and environmental contamination.

The resulting debate involves both scientific and regulatory judgments. Agencies must determine how to interpret incomplete evidence, how much uncertainty is acceptable and when additional testing should be required.

For consumers, the proposed changes are not yet in effect. The FDA published the measure as a proposed rule, meaning it must review public comments and consider whether to revise its provisions before issuing a final regulation.

As of Saturday, the proposal had received 705 public comments, reflecting interest from consumer advocates, scientific organizations, manufacturers and other stakeholders.

The public comment period remains open through Dec. 9, 2026. Individuals and organizations may submit comments through the federal rulemaking process, including recommendations concerning the GRAS notification requirements and the proposed expansion of threshold-of-regulation exemptions.

The FDA will then evaluate the submissions and determine whether to finalize, modify or withdraw portions of the proposal.

The outcome could affect how thousands of food manufacturers document ingredient safety and how federal regulators evaluate substances present at extremely low concentrations.

The central policy question is whether the benefits of greater transparency under mandatory GRAS reporting would be accompanied by an exemption broad enough to permit additional chemical uses without more extensive premarket scrutiny.

For the FDA, the proposal represents an effort to modernize oversight and focus regulatory resources on substances presenting meaningful risks. For critics, the expansion of an existing exemption raises concerns that some ingredients could enter food without sufficient evidence to establish their long-term safety.

With the public comment deadline approaching, the administration faces pressure to reconcile those competing objectives before adopting final requirements governing chemicals in the American food supply.