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Millions of Americans carefully check food labels before putting products into their shopping carts. They look for added sugar, sodium, artificial colors, preservatives, and unfamiliar ingredients.

But a new federal proposal has raised a question that cannot always be answered by reading the label:

What happens when a chemical enters the food supply without undergoing a traditional, individual FDA food-additive approval?

The U.S. Food and Drug Administration is considering changes to an existing exemption that allows certain substances to avoid the standard food-additive approval process when expected dietary exposure is extremely low.

The exemption has historically focused on chemicals used in food packaging, processing equipment, and other materials that come into contact with food.

Now, the proposed regulatory language could extend that approach to some substances used directly in food.

Food safety advocates warn that the change could create gaps in oversight, particularly for chemicals whose potential effects are not adequately captured by conventional cancer-risk assessments.

The FDA, meanwhile, retains authority to reject exemptions when available evidence indicates a public health risk.

The proposal has not been finalized, and it does not mean that dangerous chemicals have been given unrestricted permission to enter American food.

Still, the debate raises important questions about how the government evaluates small amounts of chemicals that Americans may consume repeatedly over many years.

The Guardian

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The FDA Proposal That Sparked the Controversy

The issue centers on a regulatory mechanism known as the Threshold of Regulation, or TOR, exemption.

Under existing FDA rules, manufacturers can request an exemption from the usual food-additive approval requirements for certain substances used in materials that contact food.

The idea is based on exposure.

If a substance is expected to enter food at an extremely low concentration, and it meets specified safety criteria, the FDA may determine that a full food-additive approval is unnecessary.

The current threshold is generally 0.5 parts per billion in the diet.

That is an extraordinarily small concentration.

However, scientists emphasize that the concentration of a chemical is only one factor in determining its safety.

Its biological effects, the duration of exposure, the populations exposed, and the possibility of exposure from multiple sources also matter.

The proposed language would broaden the existing provision from substances used in food-contact materials to substances used directly in food.

That potential expansion is what has attracted scrutiny from environmental health researchers and consumer protection organizations.

The Guardian

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The Tiny Number at the Center of the Debate

What does 0.5 parts per billion mean?

0.5 ppb

The dietary concentration threshold used in the FDA’s exemption framework.

Equivalent to approximately 0.5 micrograms of a substance per kilogram of food, assuming the comparison is made by mass.

A very low concentration does not automatically establish safety for every substance or every biological effect.

The TOR exemption reflects a principle used in chemical risk assessment: very low exposure can sometimes present very low risk.

For certain chemicals, that reasoning is supported by toxicological evidence.

But critics argue that a single threshold cannot adequately account for every possible type of harm.

Some substances may affect hormone signaling or biological development at concentrations that warrant particular attention.

Researchers also study whether exposure timing matters, including during pregnancy and early childhood.

The Guardian’s October 10 report highlighted concerns about chemicals with endocrine-disrupting properties, whose potential effects may not always be captured by a framework focused heavily on carcinogenicity.

The scientific question is not whether every trace chemical is dangerous.

It is whether the proposed exemption requires enough evidence to distinguish low-risk uses from those that deserve closer scrutiny.

The Guardian

Why the Proposal Has Alarmed Some Scientists

One important condition in the exemption framework concerns cancer.

A substance generally cannot qualify if it is known or reasonably suspected to be carcinogenic under the applicable criteria.

The proposal also allows the FDA to deny an exemption when available information indicates a public health risk.

Those safeguards are meaningful.

But critics argue that cancer is not the only possible health concern.

A chemical might raise questions about reproductive health, neurological development, thyroid function, or other biological processes without being classified as a carcinogen.

For example, endocrine-disrupting chemicals can interfere with the body’s hormonal systems under certain conditions.

Researchers have studied such substances in connection with reproductive development, metabolism, and other health outcomes.

The evidence differs substantially from one chemical to another.

It would be inaccurate to suggest that every substance capable of interacting with hormones causes disease at trace exposure levels.

Nevertheless, advocates argue that a regulatory exemption should account for more than cancer risk alone.

The central disagreement is whether the existing screening criteria, combined with the FDA’s discretion to reject problematic requests, provide sufficient protection if the exemption is expanded.

The Guardian

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The Chemical That Turned a Food-Packaging Exemption Into a Warning

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One of the most striking examples cited by critics involves a substance called perchlorate.

Perchlorate is associated with uses including rocket propellants and industrial processes. It can also interfere with the thyroid gland’s ability to absorb iodine, which the body needs to produce thyroid hormones.

In 2005, the FDA granted an exemption allowing a perchlorate-containing substance to be used in certain large plastic bags for transporting dry food ingredients.

These industrial bags, sometimes called super sacks, are used to move products such as grain, flour, and oats.

The concern was that small amounts of the chemical could migrate from the packaging material into food.

Years later, FDA testing found changes in the frequency and concentration of perchlorate detected in some foods, including certain cereal samples.

Environmental advocates argued that the findings raised questions about whether the exemption adequately protected consumers.

The FDA, however, disputed the interpretation that the available evidence demonstrated a meaningful increase across the broader food supply.

The controversy became an example of how scientists and regulators can examine the same exposure data yet disagree about its implications.

It is also important not to confuse perchlorate’s industrial uses with evidence that ordinary cereal contains rocket fuel. The concern involves potential exposure to a chemical used in multiple industrial applications, not the addition of rocket propellant to breakfast foods.

The Guardian

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Why Thyroid Health Is Part of the Conversation

The thyroid is a small gland in the neck that helps regulate metabolism and other essential functions.

It relies on iodine to produce thyroid hormones.

Perchlorate can interfere with the uptake of iodine into the thyroid gland.

That mechanism is well established, although the health implications depend on the level and duration of exposure, iodine intake, and individual susceptibility.

Pregnant people and developing children are important populations in this discussion because thyroid hormones play a critical role in early brain development.

People with existing thyroid conditions may also have questions about environmental exposures.

However, the available reporting does not establish that the FDA’s proposed regulatory change has caused thyroid disease in consumers.

The distinction matters: a substance’s ability to interfere with a biological process does not, by itself, demonstrate that every real-world exposure produces a measurable health effect.

Food safety decisions require consideration of both hazard and exposure.

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The Surprising Connection to RFK Jr.’s Food Safety Campaign

The controversy has attracted additional attention because it emerged within a broader FDA proposal promoted as a food-safety reform.

Health Secretary Robert F. Kennedy Jr. has made food ingredients and ultra-processed foods central subjects of his Make America Healthy Again agenda.

In August 2026, the Department of Health and Human Services announced a proposal intended to strengthen oversight of ingredients considered Generally Recognized as Safe, commonly abbreviated as GRAS.

Under the existing GRAS framework, manufacturers can conclude that a substance is generally recognized as safe for a particular use without necessarily notifying the FDA.

The proposed reform would require notifications for many such conclusions, giving the agency more information about substances entering the food supply.

HHS described the change as an effort to improve transparency and oversight.

But critics examining the proposal identified the separate expansion of the TOR exemption within the same rulemaking package.

They argue that the government could strengthen reporting requirements in one area while simultaneously broadening an exemption in another.

That apparent tension is a major reason the proposal has drawn attention.

It does not necessarily establish that the administration intends to weaken food safety. It does show that different provisions within the same regulatory proposal can have different consequences.

HHS.gov

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What Does GRAS Actually Mean?

GRAS stands for Generally Recognized as Safe.

It is a legal category that allows certain substances to be used in food without undergoing the standard food-additive approval process.

The conclusion must be supported by an appropriate scientific basis and recognition among qualified experts under the substance’s intended conditions of use.

Common examples of substances that have historically fallen within GRAS-related frameworks include familiar ingredients such as salt and certain traditional food components.

But the system also applies to a much wider range of modern food ingredients.

For decades, manufacturers have been able to make independent GRAS determinations.

They could voluntarily notify the FDA, but notification was not always required.

The August 2026 proposal seeks to make many of those notifications mandatory.

Importantly, mandatory notification is not the same as mandatory FDA approval before a substance is marketed.

Under the proposal, companies could still reach independent GRAS conclusions and, in some circumstances, market substances while the FDA evaluates submitted information.

That limitation has prompted some consumer advocates to argue that the reform does not go far enough.

The FDA says the additional information would improve its ability to identify questionable safety determinations and take appropriate action.

FDA

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Could Chemicals Be Added Without Appearing Clearly on Food Labels?

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For consumers, one of the most frustrating aspects of food safety regulation is the difficulty of understanding which substances are present in a finished product.

Food labels generally identify intentionally added ingredients, subject to specific regulatory requirements and exceptions.

But substances introduced through packaging or processing may not always appear individually on an ingredient list.

Some processing aids and incidental additives are exempt from certain labeling requirements when they meet the applicable conditions.

The Guardian reported that advocates are concerned consumers would have limited ability to identify substances covered by the proposed TOR expansion.

That does not mean every chemical covered by an exemption would necessarily be absent from every label.

Labeling depends on the substance’s function, how it enters the food, and the applicable regulations.

Nevertheless, the controversy highlights an important limitation of relying on ingredient lists alone to evaluate chemical exposure.

Consumers cannot independently verify every aspect of a food product’s manufacturing process simply by reading the packaging.

The Guardian

Why This Matters for Americans Over 50

Older Americans often pay particular attention to food ingredients because they may be managing conditions such as high blood pressure, diabetes, or cardiovascular disease.

Many also purchase packaged foods for convenience, affordability, and ease of preparation.

For this population, the immediate concern is not that a newly approved chemical has been identified as causing illness.

No such conclusion follows from the proposal.

Instead, the debate concerns how effectively federal oversight identifies potential risks before widespread exposure occurs.

Age can influence how the body processes some substances, while existing medical conditions and medications can affect individual vulnerability.

But the health significance of any particular food chemical depends on its toxicological properties and the amount consumed.

A general claim that all older adults are uniquely endangered by the proposed exemption would go beyond the available evidence.

The practical issue is whether the FDA’s framework adequately evaluates substances used in foods consumed regularly by people of different ages and health backgrounds.

What Consumers Can Do Right Now

There is no reason to assume that every packaged food is unsafe or that Americans need to eliminate all processed foods.

Food processing includes many useful methods, such as freezing, pasteurization, and canning.

For people who want to make informed choices while the regulatory debate continues, several established approaches remain useful:

• Choose a varied diet that includes fruits, vegetables, whole grains, and other nutrient-rich foods.
• Compare labels for sodium, added sugars, and saturated fat, especially when managing cardiovascular or metabolic health.
• Follow food recalls and official safety alerts rather than relying on unverified viral claims.
• Avoid treating unfamiliar chemical names as automatic evidence of danger; safety depends on the substance and its use.
• Consult qualified health professionals about individual dietary restrictions or medical concerns.

The FDA also maintains public information about food ingredients, food-contact substances, and safety exemptions.

Those resources can help consumers distinguish between regulatory proposals, approved uses, and actual product recalls.

The Public Has Until December 9 to Respond

The FDA’s proposal remains open for public comment.

The deadline is December 9, 2026.

The agency is accepting comments on the broader GRAS proposal, including the proposed changes to the TOR exemption.

The official docket is FDA-2025-N-3262.

Members of the public, researchers, manufacturers, and consumer organizations can submit feedback through Regulations.gov.

The FDA has also scheduled an informational webinar for October 15 to explain its proposed GRAS reforms.

After reviewing comments, the agency may revise the proposal, finalize it, or take another regulatory approach.

Until a final rule is adopted, the proposed expansion is not an enacted change to the law.

FDA

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The Bigger Question About America’s Food Supply

The debate over the FDA’s proposed exemption reveals a complicated reality about modern food safety.

Federal regulators must evaluate enormous numbers of substances used in manufacturing, packaging, and food preparation.

Not every trace exposure presents a meaningful health risk.

But scientists and consumer advocates argue that exemptions must be carefully designed so that substances with unusual toxicological properties are not overlooked.

The administration’s proposed GRAS reform aims to provide the FDA with more information about food ingredients.

At the same time, the proposed expansion of the Threshold of Regulation exemption has raised questions about whether some chemical uses could bypass the traditional approval process.

For consumers, the distinction between those two changes may be difficult to see.

Yet it could shape how food ingredients are evaluated for years to come.

The most important unanswered question is not whether all chemicals in food are dangerous. It is whether the FDA’s proposed rules will give regulators enough information and authority to identify the ones that may be.

That question will remain central as the agency reviews public comments and decides whether to move forward.

Questions about food safety are part of a wider debate over health policy – read about the measles case and death toll dispute in Pennsylvania and senators’ questions about free cancer screenings. For another look at the policy battles unfolding in Washington, see the lawsuit over Medicare drug price cuts.