Originally published by A Voice For Choice Advocacy on April 23, 2026.

EDITOR’S SUMMARY: The GRAS (“Generally Recognized as Safe”) designation was designed to streamline food safety, but over time it has evolved into a complex and often opaque process through which many ingredients enter the food supply without formal FDA review. While some substances are later restricted or removed as new evidence emerges, others are reviewed, withdrawn, or reconsidered outside public view. As the system continues to shift under increasing scrutiny, understanding how these determinations are made offers a clearer lens into what safety in modern food truly means—and where its limits lie.

For most of human history, food was not a question of chemistry—it was a matter of survival. Where would the next meal come from? Would the harvest hold? Would the hunt succeed? What was meant to be eaten was recognizable—perishable and imperfect. It came from the soil, from animals, and with the rhythms of seasons that could not be controlled. The risks were immediate and visible—scarcity, spoilage, famine. But rarely was it considered whether the food itself, once obtained, was inherently unsafe to eat. Today, that question of survival has changed dramatically.

The modern consumer no longer asks just where their food comes from—but whether what is being presented is, in fact, safe. Not spoiled. Not contaminated in the traditional sense. But something more abstract: chemically altered, industrially processed, and engineered in ways that are no longer visible to the naked eye. This becomes clear the moment you visit a grocery store, where nearly 70% of food on store shelves is considered ultra-processed.

These products are made with ingredients that are difficult to recognize and far removed from anything found in a kitchen or growing naturally. Food is no longer just food—it’s a formulation. It’s a chemistry experiment designed to manipulate your taste buds and encourage overconsumption. In a profit-driven food system, your health is not the first priority—the bottom line is.

Yet, most people move through the grocery store with their list in hand and an unspoken agreement in place. There is an assumption that someone, somewhere—a chemist in a lab coat, a panel of toxicologists, a federal oversight committee—has already asked the hard questions on your behalf. That the emulsifier keeping the almond milk smooth, the preservative extending the shelf life of the gluten-free crackers, or the flavor enhancer rounding out the plant-based protein bar has been reviewed for safety long before you ever take a bite.

This assumption becomes the scaffolding of modern life. After all, in a world where a parent is juggling work, school drop-offs, personal commitments, and weeknight dinners—or a caregiver is preparing meals for a dependent family member—few people have the time (or training) to individually evaluate the toxicological profile of every additive in every jar, bag, carton, or box. You rely on a system that is designed (at least in theory) to keep you safe. A regulatory framework intended to ensure that what enters the food supply has been reviewed, assessed, and deemed safe for consumption under its intended conditions of use. But that determination is not a guarantee—it is an assertion.

Enter GRAS: Generally Recognized as Safe

In 1958, the GRAS designation was established under the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The intention was practical: to exempt substances with a long history of common use in food—like salt, vinegar, or baking soda—from the lengthy (often 2–5 year) pre-market approval process required for new chemical additives. In other words, if something had already been widely consumed and understood to be safe, it did not need to be re-proven.

A substance could be classified as GRAS (pronounced grass), as the U.S. Food and Drug Administration (FDA) puts it, “…either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food…” George P. Larrick, then FDA Commissioner, explained:

“We believe only those chemicals should be automatically exempted from the new law which are recognized among competent experts as safe for their intended use. This would make it unnecessary, for example, to do studies on table salt, but would not approve the continued use, without proof of safety, of the synthetic emulsifiers now widely used in some fabricated foods.”

Substances that were already long consumed and familiar before 1958 were “grandfathered in” and automatically qualified as GRAS. No new testing or formal FDA review was required. For all other substances—new, engineered, or not yet well understood—a different set of regulatory processes applied. Companies must establish that these ingredients can be used safely, and the system allows several distinct approaches:

1. Self-affirmed GRAS (with FDA notification): A company assembles a body of evidence (published studies, toxicology data, and sometimes research on structurally or functionally similar compounds) and concludes that the substance is safe. The company may then voluntarily notify the FDA. In response, the agency typically issues a “no questions” letter, indicating it does not object to the conclusion and the product can be brought to market without formal approval.

2. Self-affirmed GRAS (without FDA notification): A company can also bring a substance to market based solely on expert consensus, without ever informing the FDA.

3. Formal food additive approval: Ingredients without historical use or clear expert consensus must undergo a full Food Additive Petition process. This requires extensive safety data, toxicology studies, metabolic analyses, intended use levels, and projected dietary exposure. The FDA conducts a mandatory, exhaustive review and only grants legal authorization once it concludes there is reasonable certainty the product causes no harm. This process is government-driven, legally binding, and far more rigorous than any GRAS pathway.

In reality, many substances enter the food supply not through mandatory government review, but via a system in which safety is largely determined outside the agency—by qualified experts, often hired and compensated by the company, provided their conclusions are supported by publicly available scientific evidence. Over time, the GRAS framework has evolved. What began as a narrow exemption for familiar, time-tested ingredients gradually expanded, and the line between historically recognized substances and newly engineered compounds grew increasingly difficult to distinguish. In a world built on trust in unseen systems, GRAS is one that operates in the shadows—shaping what ends up on your shelves, in your kitchen, and ultimately, in your body.

The Ingredients That Were “Safe”…Until They Weren’t

For decades, partially hydrogenated oils (PHOs)—the primary dietary source of artificial trans fats—were considered GRAS. They appeared in everything from margarine to peanut butter to bread products, in part because early GRAS lists created in 1958 relied on the scientific knowledge available at the time. It wasn’t until years later—after mounting research linked trans fats to artery-clogging plaque (atherosclerosis) and increased risk of cardiovascular disease—that the FDA made a pivotal decision in 2015: PHOs were no longer GRAS. In their final determination notice, the agency summarized their findings:

“…the Food and Drug Administration (FDA or we) has made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food. This action responds, in part, to citizen petitions we received, and we base our determination on available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat.”

By 2018, manufacturers were prohibited from adding them to foods, with final compliance deadlines extending through 2021 to allow products already in distribution to clear the market. A substance that once moved through the food supply without notice under a safety designation had now been formally removed from it—with the FDA estimating that its elimination could prevent thousands of heart attacks and deaths each year.

Then there’s the story of brominated vegetable oil (BVO). Used since the 1930s to stabilize citrus-flavored soft drinks and prevent separation, BVO was initially designated as GRAS in 1958—only to have that status withdrawn in 1970 after safety concerns began to surface. Even so, it remained permitted at limited concentrations in beverages for decades under an “interim” regulatory status. In 2012, 15-year-old Sarah Kavanagh turned to the internet after noticing BVO on the label of a Gatorade. What she found was startling: it was patented for use as a flame retardant. She then launched a petition asking Gatorade’s parent company, PepsiCo, to remove the ingredient. After more than 200,000 signatures, they agreed.

It wasn’t until July 2024—following collaborative studies with the National Institutes of Health suggesting potential adverse effects, including neurological symptoms—that the FDA formally revoked authorization for its use in food. Manufacturers had until August 2025 to reformulate affected products. These two examples share a common thread: meaningful change came from outside the system, not from within it. While the removal of PHOs and BVO eventually made headlines, not every ingredient follows the same visible path. Some are gradually reformulated, withdrawn, or reconsidered behind the scenes—within the GRAS process itself—long before they ever attract public attention.

The Ones You Never See

What reaches the shelf is only part of the story. Beyond the ingredients that are approved, there is another category that rarely enters the conversation—those that come close but never reach the market. In recent years:

• DHA-rich algal oil (GRN 1128) was withdrawn due to concerns over chemical impurities linked to manufacturing processes.

• A rice bran wax ingredient (GRN 962) was pulled after estimated dietary exposure in children exceeded safety thresholds.

• The synthetic folate compound, Monosodium L-5-methyltetrahydrofolate (GRN 1023), was abandoned when safety data for infants proved insufficient.

In these cases, the issue wasn’t necessarily that harm had already occurred—but that the evidence needed to confidently assert safety simply wasn’t there. While these ingredients never reached the market, their withdrawal is revealing. Before an ingredient enters the food supply, companies compile detailed safety dossiers—bringing together toxicology data, projected intake levels, metabolic studies, and manufacturing details, including potential impurities or byproducts. These materials are reviewed by qualified experts to determine whether there is a reasonable certainty of no harm under the intended conditions of use. It is at this stage that problems often emerge.

Sometimes the concern lies in the manufacturing process itself—where trace impurities, solvent residues, or unintended chemical byproducts alter the safety profile of the final ingredient. In other cases, projected exposure levels—particularly in vulnerable populations like children—exceed established safety thresholds. And at times, the limitation is more fundamental: the available data is incomplete, leaving too much uncertainty to support a conclusion of safety.

When these issues arise, a submission may be revised or halted entirely, sometimes before formal FDA review is completed. The result is a category of substances that were developed, evaluated, and nearly introduced—but ultimately halted before reaching consumers. From one perspective, this reflects a system functioning as intended—identifying potential risks before exposure occurs. From another, it reveals something less visible: that safety determinations are contingent on available data, expert interpretation, and voluntary disclosure. Importantly, a withdrawal is not always an endpoint. In many cases, it marks a pause.

Manufacturers can return with additional studies, refined data, or new expert analysis to address the gaps that prevented a GRAS conclusion the first time. The same ingredient—reformulated, recharacterized, or supported by new evidence—can re-enter the process and be reconsidered. The GRAS system, in other words, relies on judgment as much as interpretation. The absence of exposure is not always evidence that a risk never existed. Sometimes, it is a sign that the question of safety is still being answered—out of view and over time.

The System Is Still Changing

The scale of this landscape is difficult to fully grasp. It is estimated that more than 10,000 chemicals and additives are permitted in the U.S. food supply, often used in small amounts, yet many have not been re-evaluated by the FDA in decades. The actual number is unknown. While the majority are considered safe, some substances still allowed in the United States have been restricted or banned in other countries—such as the UK and Canada—after research linked them to cancer, developmental concerns, or behavioral effects.

Another concern is that the system treats each ingredient as a separate entity, ignoring the reality that the Standard American Diet exposes you to a constant overlap of multiple additives at once. When ingredients are researched and approved in a vacuum, there is no clear understanding of how they interact with other substances, and new additives continue to be introduced.

At the same time, GRAS is not a fixed list but an evolving pipeline. Since 1998, more than 1,200 substances have been submitted through GRAS notices, resulting in “no questions” responses, ongoing reviews, or voluntary withdrawals. Even though the total number of ingredients in the food supply remains uncertain, recent leadership changes and increased public scrutiny have contributed to growing regulatory momentum.

In April 2025, the U.S. Department of Health and Human Services (HHS) and the FDA announced plans to phase out petroleum-based synthetic dyes from the national food supply—revoking authorization for Citrus Red No. 2 and Orange B. The agencies are also working with industry to eliminate several remaining FD&C dyes by the following year. Under HHS Secretary Robert F. Kennedy Jr., the FDA is exploring the elimination of the self-affirmed GRAS avenue as part of a broader push for “radical transparency” so Americans know exactly what is in their food. In a statement, Kennedy said:

“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

This is the same “loophole” that has allowed companies to self-affirm the safety of new ingredients—without FDA review, public disclosure, or independent verification—before introducing them into the food supply, often with unknown safety implications. Closing this provision would require companies to publicly notify the FDA and submit supporting safety data before ingredients enter the market. HHS has already submitted plans to tighten oversight of the GRAS program to the White House, where they are now pending review.

In July 2025, Senator Edward J. Markey and Senator Cory Booker proposed the “Ensuring Safe and Toxic-Free Foods Act,” which would require manufacturers to submit safety data to HHS, make that data publicly available for a 90-day FDA review, bar carcinogenic or reproductively toxic substances, exclude experts with conflicts of interest from the GRAS process, and establish a system to reassess previously approved GRAS substances.

Real Food, Real Safety

Rather than getting lost in the complexity of GRAS notifications, self-affirmed determinations, and ingredient withdrawals, there is a simpler way to navigate the modern food environment. Instead of scrutinizing labels on the 70% of ultra-processed foods in the grocery store, turn your attention to the 30% that likely doesn’t need an ingredient list at all—whole, minimally processed foods like meat, dairy, fruits, and vegetables. These foods come with a history and a track record of safety that do not rely on GRAS designation for validation. As functional medicine doctor Robert Reier says:

“What’s the answer to achieve health, wellness and vibrancy? Well, drum roll please. Eat real one ingredient foods. That’s it end of story, and you’ll be well on your way to a healthier existence. Eat foods that come in nature’s wrapping without any ingredients.”

Prioritizing whole foods means bypassing much of the regulatory uncertainty, chemical additives, and marketing spin—returning to the kind of food your ancestors recognized and trusted. And the evidence supports it: dietary patterns lower in ultra-processed foods and higher in whole, minimally processed foods are associated with lower rates of chronic disease, improved metabolic health, and reduced risk of premature death.

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IPAK-EDU is grateful to A Voice for Choice Advocacy as this piece was originally published there and is included in this news feed with mutual agreement. Read More