Generally Recognized as Safe — By Whom? How Washington Quietly Redefined “Food.”
The American food supply was not industrialized by a single decision. It was built, as independent commentator Robert W. Malone put it in a widely shared June 30 essay, by “thousands of decisions over seventy years” — by Congress, by regulators, and by industry, each one small enough to pass without a headline. The load-bearing beam under all of them is a three-word phrase of federal law: Generally Recognized As Safe, or GRAS.
GRAS was written in 1958 to spare traditional foods — salt, vinegar, flour, pepper — from red tape. Over the decades it stretched into something its authors never intended: a channel through which manufacturers can hire their own expert panel, declare a novel industrial additive safe, and put it on the shelf without ever telling the FDA. Roughly a thousand additives entered the food supply exactly that way, with no federal review at all.
This is not a partisan story about who to blame; it is a civic-literacy story about how the rules get set. The loophole was built slowly across administrations of both parties. The current attempt to close it — the MAHA (“Make America Healthy Again”) agenda under HHS Secretary Robert F. Kennedy Jr. — is being run by a lifelong Democrat inside a Republican administration. Here is the paperwork that redefined what “food,” “healthy,” and “safe” legally mean — and the fight now underway to rewrite it.
- 55.0%of caloriesof Americans' daily calories now come from ultra-processed foods, 2021–2023 — CDC/NCHS Data Brief No. 536
- ~1,000additivesentered the food supply via industry “self-GRAS” determinations with no notice to FDA at all — Pew Charitable Trusts, 2013
- 1980slast reviewthe last time FDA systematically reconsidered the safety of existing GRAS substances — GAO-10-246 (2010)
- 0definitionsbinding federal definitions of the term “ultra-processed food” — FDA/USDA Request for Information, July 2025
Start with the mechanism, because the mechanism is the story. In 1958, Congress passed the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. It required that new additives be proven safe before going to market — but it carved out an exception for substances that qualified experts already “generally recognized as safe.” The point was common sense: nobody needed a federal safety study to keep using table salt or baking soda. GRAS was a shortcut for the familiar.
The problem is the word “recognized,” and by whom. Nothing in the law limited GRAS to old, simple foods. As the chemistry of processing advanced, companies realized the same exemption could cover novel emulsifiers, stabilizers, flavor compounds, and preservatives — provided the maker could assemble a panel of experts willing to conclude the substance was safe. The manufacturer, in other words, could grade its own homework. Malone’s six-word summary of the loophole is the sharpest question in the whole debate.
“Generally recognized as safe — by whom?”
Robert W. Malone · independent commentator, malone.news · June 30, 2026
By the Pew Charitable Trusts’ count, roughly 10,000 additives are allowed in U.S. food. FDA has never reviewed the safety of about 3,000 of them, and of those, an estimated 1,000 reached the market through “self-GRAS” determinations the agency was never even told about. That is the quiet redefinition at the center of this story: not a dramatic vote, but the steady accumulation of substances the government simply took industry’s word on.
For years the self-GRAS practice lived in a gray zone. Then, on August 17, 2016, the FDA published its GRAS Final Rule (81 FR 54960, effective that October). The rule replaced FDA’s old system — where a company would petition the agency to formally “affirm” a substance as GRAS — with a voluntary notification procedure. And “voluntary” is the operative word: a company may notify FDA of its GRAS conclusion, or it may not. The rule codified the right to self-certify and stay silent.
The bipartisan-origin framing matters here. The 2016 rule was finalized under FDA Commissioner Robert Califf, in the Obama (D) administration — the same loophole that traces back to a 1958 Congress under President Eisenhower. No single party invented this; it was assembled slowly, over decades, by regulators trying to modernize a 1950s statute. That is precisely why the government’s own auditors had already flagged it.
Six years before the 2016 rule, the Government Accountability Office warned that FDA’s oversight of GRAS was inadequate. In GAO-10-246 (2010), auditors found that the agency had not systematically reconsidered existing GRAS substances since the 1980s, and — the loophole stated in the government’s own words — that companies simply are not required to inform FDA of the GRAS determinations they make.
“FDA generally does not have information about GRAS determinations companies have made, because companies are not required to inform FDA of them.”
Government Accountability Office · GAO-10-246 · 2010
“GRAS” governs what may enter food. A second lever governs what the package may claim — and here the government literally rewrote the definition of a regulated word. On December 27, 2024, FDA finalized a new rule (89 FR 106064) defining when a product may be labeled “healthy.” The compliance runway stretches three years, but the shift is fundamental.
The old definition was a per-nutrient math test: a food qualified as “healthy” if it stayed under set thresholds for fat, sodium, and a few other nutrients. The new definition flips to a food-group model paired with limits on nutrients to avoid. The practical result is a near-inversion of the label: salmon, nuts, avocados, olive oil, and plain water now qualify as “healthy,” while sugary cereals that gamed the old thresholds no longer do. Same word on the box — opposite meaning. It is the clearest illustration of the whole theme: the definition, not the food, is what changed.
“Safe” (GRAS): since 1958, can mean “a panel the manufacturer chose said so” — with no requirement to tell FDA. The 2016 rule made that notification voluntary.
“Healthy” (label claim): redefined Dec. 2024 from a per-nutrient threshold to a food-group model — salmon and avocados in, sugary cereals out.
“Ultra-processed”: as of mid-2025, has no binding federal definition at all — the FDA is only now asking the public how to write one.
Here is the sharpest “how it works” point of all. “Ultra-processed food,” the phrase now driving federal nutrition policy, has no legally binding U.S. definition. On July 25, 2025, FDA, USDA, and HHS jointly published a Request for Information (Docket FDA-2025-N-1793) — the first federal effort to write one. A request for information is not a rule; it is the government asking the public and industry how a term should be defined before it regulates on that term. Comments ran through late October 2025. The definition is still, at this writing, unwritten.
The scale is why the definition matters. Per the CDC’s National Center for Health Statistics, ultra-processed foods supplied 55.0% of all calories Americans consumed between 2021 and 2023 — and 61.9% of calories for youth ages 1 to 18. FDA has estimated that roughly 70% of packaged products in the U.S. supply would count as ultra-processed. Acting FDA Commissioner Kyle Diamantas — a lawyer who ran the agency’s human-foods work as deputy commissioner before Dr. Marty Makary resigned in May 2026 — has said any federal definition would weigh synthetic dyes, emulsifiers, and preservatives.
HHS Secretary Kennedy has made the category central to his message. His “70% is poison” framing tracks the FDA’s packaged-food estimate — though the underlying dietary science is drawn partly from the administration’s own MAHA Commission report, which asserted that nearly 70% of children’s calories come from ultra-processed foods and tied that to childhood obesity and diabetes. That report later drew scrutiny for citation errors, so we present its causal claims as the Commission’s assertions and lean on the independent CDC figure for the solid number.
70% of the food that we eat is ultra-processed. It's not really food — it's poison. We're going to change that. We are laser focused on making REAL whole food available for every American family at prices they can afford.
The most visible MAHA-era moves are on color additives, and they teach a subtle lesson about how legal definitions bind regulators. Two separate things are often blurred together, so precision matters. First, on January 15, 2025, FDA revoked its authorization for FD&C Red No. 3 — a completed order, with compliance required in food by January 2027. Notably, FDA said it found no human health risk from the dye at the levels people consume. It revoked it anyway, because it had to.
The reason is the Delaney Clause, a 1960 amendment barring any additive shown to induce cancer in man or animal. Red No. 3 caused cancer in laboratory rats. Under Delaney, that finding renders the additive “unsafe” as a matter of law — regardless of the human-risk assessment. It is a clean demonstration of the story’s spine: a definition, not a new scientific alarm, forced the government’s hand.
The second move is different, and it is frequently mis-described. On April 22, 2025, HHS Secretary Kennedy and then-Commissioner Makary announced a plan to phase out six petroleum-based synthetic dyes — Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 — “by the end of 2026.” This is largely voluntary: an agreement the government “requested” and industry “agreed” to, not a ban with the force of the Red No. 3 revocation. Two of the eight, Citrus Red 2 and Orange B, are slated for actual authorization revocation. The distinction — revocation versus voluntary phase-out — is exactly the kind of detail the “government banned food dyes” headlines flatten.
Harmful petroleum-based food dyes are about to become a thing of the past. Thanks to the bold leadership of @SecKennedy and @DrMakaryFDA, the FDA is moving to eliminate these synthetic dyes from our food supply — for good.
The reform agenda runs on the same lever that built the problem: definitions and the paperwork behind them. On March 10, 2025, Secretary Kennedy directed FDA to explore rulemaking that would eliminate the self-affirmation pathway — the very self-GRAS route the 2016 rule left open. The word to hold onto is “explore”: this is directed rulemaking, not a finished rule. The loophole is still open while the process runs.
Two more definitional projects are moving alongside it. On July 16, 2025, FDA announced it would revoke 52 obsolete Standards of Identity — the federal rules that dictate what a product must contain to be called, say, “milk chocolate” — out of more than 250 on the books. And on January 7, 2026, Secretary Kennedy and Agriculture Secretary Brooke Rollins (R) released the 2025–2030 Dietary Guidelines for Americans, built around the tagline “Eat real food,” an inverted food pyramid, and an explicit call to avoid highly processed foods.
The Dietary Guidelines are not a suggestion pamphlet; they set the standards for school lunches, SNAP, and military food. That is the fiscal muscle behind the redefinition — the channel through which a changed word on paper reshapes what actually lands on a cafeteria tray. Whether one calls the effort overdue reform or messaging, the mechanism is identical to the one that created the mess: whoever gets to write the definition gets to shape the diet.
Ultra-processed foods are out. Whole, nutrient-dense foods are in. This will transform the American dietary culture and Make America Healthy Again.
The industrialization of American food ran on a single loophole — a 1958 exemption for “generally recognized as safe” ingredients that quietly grew into a right for companies to self-certify novel additives and never tell the FDA. The 2016 rule made that silence official.
The 2025–2026 reforms are real but unfinished: the “healthy” label has been redefined, Red No. 3 is genuinely revoked, and the self-GRAS pathway is under review — but the dye phase-out is largely voluntary, and “ultra-processed” still has no legal meaning. The fight, start to finish, is over who gets to write the definitions.
