The FDA allows food companies to self-certify new additives as “Generally Recognized as Safe” (GRAS) without any requirement to notify the agency or submit evidence for independent review. This loophole, originally intended for well-known substances like salt and vinegar, has become the primary way food chemicals enter the U.S. supply. 

As Professor Marion Nestle, a leading scholar on food politics and former chair of NYU’s Department of Nutrition, explains:

“The FDA set the current plan because additives are low priority compared to everything else it has to regulate. Assessing the science requires huge amounts of skill and staff time, and the agency had neither the budget nor staff to handle the workload. So they shifted the burden to industry.”

The loophole wasn’t just exploited by corporations. It was practically built for them. In 2024, The Economist reported that while the FDA’s official registry lists around 4,000 approved additives, experts estimate there are over 1,000 more substances in use that the agency doesn’t even know about. The article put it plainly: “The FDA does not know, and makes no serious effort to find out, what chemicals are being added to foods.” —The Economist, December 5, 2024

The Government Accountability Office came to a similar conclusion more than a decade earlier. In a 2010 report, it warned that the FDA “does not know the full universe of substances being used in food” and “is not systematically ensuring the continued safety” of those already approved 

“The FDA does not know, and makes no serious effort to find out, what chemicals are being added to foods.” —The Economist, December 5, 2024

In contrast, European regulators require pre-market review of additives. The European Food Safety Authority (EFSA) demands toxicology data, estimates of consumer exposure, and long-term risk assessments before approval. Some additives are limited by strict numerical caps; others fall under quantum satis, which is Latin for “as much as is sufficient.” In practice: use only the minimum amount needed to get the job done.

The difference is stark. But loopholes alone aren’t the full story. If no one’s guarding the gate, it’s because the guards were taken care of by the intruders.

McFDA: The Capture of Food Regulation by Corporate Interests 

Why does the FDA lag so far behind?

Because it’s been captured by the food industry. 

From 2000 to 2024, every single FDA commissioner left government to work for the pharmaceutical or food industries after stepping down. And more broadly, over 60% of food industry lobbyists are former government employees—many of them ex-FDA officials who now use their connections to influence the very agency they once served.

This isn’t a door anymore. It’s a fast food conveyor belt, shuffling government regulators to the very industries they used to regulate. Take Michael Taylor, one of the most visible faces of regulatory capture in food policy. Michael sat at his FDA desk stacking memos. The next day, he’d sit at another desk—Monsanto’s—signing checks instead. This wasn’t a career change; it was the fast food conveyor belt doing what it does. Regulator, lobbyist, regulator again.

He started at the FDA as a staff attorney. Then he joined Monsanto as a lawyer and lobbyist. He returned to the FDA in the 1990s as Deputy Commissioner for Policy, where he helped shape policies that accelerated the approval of genetically modified organisms and relaxed labeling requirements. He then left again; back to Monsanto, this time as Vice President for Public Policy. And later, under the Obama administration, he came back to the FDA as the agency’s senior food safety official.

That kind of zig-zagging, regulator, lobbyist, regulator again, would be disqualifying in most democratic systems. In the U.S., it’s commonplace. These former regulators use their knowledge and connections to help their new employers. 

In 2024, Freedom of Information Act (FOIA) requests revealed a pattern of informal coaching among FDA staff: outgoing officials advising one another on how to “influence the agency from the outside” without triggering federal lobbying disclosure requirements. 

Internal communications included guidance such as avoiding job titles like “lobbyist” in favor of “consultant” or “advisor,” using third-party industry trade groups to relay messages to FDA personnel, and opting for phone calls or in-person meetings to avoid creating a paper trail. 

It is corruption, plain and simple. So when it comes to fixing the system—like closing the GRAS loophole that lets companies declare new chemicals safe without notifying the FDA—why would they?

The very people who could fix GRAS are the ones benefiting from it. They’ve worked for the companies that use it. They plan to work for them again. And in many cases, they wrote the loophole into existence in the first place.

So when it comes to fixing the system—like closing the GRAS loophole that lets companies declare new chemicals safe without notifying the FDA—why would they?

In 2020, a Pew Charitable Trusts report found that almost all new food additives entering the U.S. market go through the GRAS process, not formal FDA review. And when companies do notify the FDA of new additives, the agency has no authority to demand more data or block their use—only to accept or quietly file away the submission.

And what decisions does this shadow lobbying protect?

• • The FDA’s 40-year delay in banning Red No. 3, a synthetic dye linked to thyroid tumors in animal studies. Though the agency banned it from cosmetics back in 1990, it continued to allow the dye in foods like candy, fruit snacks, and children’s medications. It was only in late 2023, after a petition from the Center for Science in the Public Interest, growing consumer activism, and mounting pressure from Europe’s full ban, that the FDA finally moved to revoke its use in food and ingestible drugs. 
  • The delay in banning titanium dioxide, despite evidence of genotoxicity and a full ban in the European Union.
  • The failure to reassess thousands of legacy additives—chemicals that were “grandfathered in” before modern safety standards even existed.

The result is a culture of passivity and not protection. A system that prioritizes industry convenience over consumer safety. And an agency that too often plays the role of enabler, not enforcer. More than regulatory dysfunction, this represents a regulatory surrender to corporations. 

How We Got Here: The Road to Deregulation

The FDA didn’t always have such a hands-off approach. In fact, it was born out of populist fury. The foundation of America’s modern food safety system was laid in 1906 with the passage of the Pure Food and Drug Act, passed in response to muckraking exposés like Upton Sinclair’s The Jungle. The book’s description of the filthy and unregulated meatpacking industry was so repulsive to Americans that it sparked national outrage, leading directly to federal action to prevent unsafe, filthy, and misbranded food and drugs. 

By the 1950s, outrage gave way to blind trust. America, distracted by prosperity, let corporations quietly slip through the GRAS loophole.

Then came the loopholes.

The 1958 Food Additives Amendment created the aforementioned “Generally Recognized as Safe” (GRAS) exemption. But its open-ended language—lacking clear criteria for safety or independent review—allowed manufacturers to self-certify new chemicals as GRAS without notifying the FDA. What began as a narrow carveout became a broad loophole in the regulatory state. 

While the populist fury that followed Upton Sinclair’s The Jungle led to basic rules for hygiene and sanitation, Congress never granted similar powers when it came to additives. And corporations took full advantage. 

As Professor Richard Daynard—a leading public health lawyer and longtime president of the Public Health Advocacy Institute—explains, the FDA’s limited role is structural. 

“On the food side, Congress simply didn’t give the FDA much authority. Their hands are tied unless it’s a clear case of contamination. Making food hyper-palatable or obesity-inducing? That’s much harder for them to regulate.”

While the populist fury that followed Upton Sinclair’s The Jungle led to basic rules for hygiene and sanitation, Congress never granted similar powers when it came to additives. And corporations took full advantage. 

By the 1990s, corporations were using GRAS to fast-track thousands of additives, including novel synthetic chemicals.

This deregulatory shift didn’t happen in a vacuum. In the 1980s and 1990s, Presidents Reagan and Clinton both embraced deregulation as a political virtue. Reagan slashed federal oversight, famously declaring, “Government is not the solution to our problem; government is the problem.” Clinton’s “reinventing government” campaign encouraged public-private partnerships and made industry-friendly streamlining a central goal. During this period, FDA enforcement budgets shrank, and industry lobbying surged. 

Under Reagan and Clinton, the watchdog’s teeth slowly dulled; oversight budgets shrank, lobbyists thrived, and corporations took control.

The FDA began life as a fierce watchdog; today, it’s more like a sleepy lapdog curled comfortably under the glow of the golden arches.

President Reagan liked to say “the nine most terrifying words in the English language are: I’m from the Government, and I’m here to help.” But the real nightmare is one word longer: ‘I want big corporations to have control over your food.’ That’s not limited government. That’s a green light to chemical companies, lobbyists, and fast food giants to serve you whatever they want, no questions asked.

One defining moment came in 1999, when the Center for Science in the Public Interest petitioned the FDA to ban potassium bromate, a flour additive linked to kidney and thyroid tumors in animals. Countries like the U.K., Canada, and the EU had already banned it. The FDA reviewed the data—and did nothing. The additive remains legal in U.S. foods to this day, though it has been “under review” for a quarter of a century. 

“There are literally thousands of chemicals in food that have never been reviewed by the FDA” 

Meanwhile, industry’s influence only grew. From 2000 to 2022, the food and beverage industry spent over $760 million lobbying Congress and federal agencies. Giants like Coca-Cola, PepsiCo, and the Grocery Manufacturers Association worked aggressively to shape food labeling laws, block sodium limits, and delay restrictions on harmful additives.

The result? A system of “honor code science,” where companies can self-certify ingredients as safe, hire their own experts, and introduce chemicals into the food supply without public disclosure or FDA vetting. As former FDA Deputy Commissioner Michael Taylor put it:

“There are literally thousands of chemicals in food that have never been reviewed by the FDA” 

This wasn’t regulatory neglect. It was a deliberate dismantling, fueled by decades of lobbying, legal loopholes, and bipartisan political decisions to prioritize industry “efficiency” over consumer safety. We built, or allowed corporate interests to build, a food safety system that allows companies to police themselves, then act shocked when the results are unequal, unsafe, and unfair.

Clean Doesn’t Mean Costly  

Industry defenders argue that American food is full of these additives because it’s cheaper. But that doesn’t hold up.

McDonald’s manages to serve additive-free fries, sodas, and nuggets in Europe, where the price of a meal is often on par with or cheaper than in U.S. cities. A Big Mac in Great Britain doesn’t cost dramatically more than one in Boston. According to global pricing data, a Big Mac in Great Britain runs about $5.71 USD, while in the U.S., it averages just $5.69, depending on the region. 

More importantly, ingredient cost differences for cleaner formulations are surprisingly modest. Replacing synthetic dyes with natural ones like beet juice or paprika extract may increase unit costs by pennies—not dollars. 

Removing preservatives may affect shelf life slightly, but in a fast-moving system like McDonald’s, most products don’t sit long enough to justify chemical preservation.

Then there’s scale. With McDonald’s serving millions of customers daily, ingredient shifts become cost-efficient at mass scale. When McDonald’s reformulated its buns to remove high-fructose corn syrup in 2016, it didn’t raise prices. It leaned on supplier negotiations and internal adjustments. When they phased out pink slime, there was no price hike. When they eliminated artificial preservatives from McNuggets in 2016 (before reintroducing some later), the menu didn’t suddenly get more expensive. In fact, consumers reacted positively to the move and McNugget sales soared.

And consider this: McDonald’s already runs entirely separate supply chains in Europe to comply with tougher regulations. The infrastructure exists. The logistics are solved. They’re not reinventing the wheel, they’re just choosing not to roll it across the Atlantic.

Even industry analysts acknowledge that clean label reformulations are scalable. A 2023 Deloitte report on sustainability in food and agriculture found that 77% of food service providers and 80% of retailers achieved at least a 2% cost reduction through sustainable sourcing and supply chain adjustments—demonstrating that cleaner, more transparent ingredient strategies can align with economic goals. When adopted at scale, the shift away from artificial additives doesn’t have to come with a premium.

What does all this mean? The cost argument isn’t economic but rather ideological. 

It’s about resisting regulation and accountability. Clean food isn’t unattainable. It’s just inconvenient for companies that benefit from a lax American regulatory framework. If the price of a marginally cheaper soda is a side of harmful additives, we should be asking: cheaper for whom? At what long-term cost?

McDonald’s already built a cleaner menu blueprint in Europe. Why won’t they offer it to the country that made them great? 

What Real Reform Looks Like

Remember “pink slime”? In 2012, ABC News revealed that fast food chains were using lean beef trimmings treated with ammonia to kill pathogens—a practice technically legal under USDA rules but widely viewed as grotesque once it hit the headlines. The FDA never stepped in. McDonald’s dropped it anyway, bowing to overwhelming consumer backlash—not a government ban.

As Professor Daynard put it:

“Litigation was the main lever that finally forced change with tobacco, and I think you’ll start to see similar efforts with food—especially if companies are found to have misled the public about safety.”

Lawsuits—and public outrage—can succeed where regulators stall.

The same playbook applied in 2023 when California passed AB 418, banning several additives already outlawed in the EU: Red Dye No. 3, brominated vegetable oil (BVO), potassium bromate, and propylparaben. Major manufacturers initially protested—but they quietly reformulated nationwide. California’s market was too big to ignore. Now, New York, Illinois, and other states are following suit, creating a new kind of food safety coalition from the ground up — forcing these corporations to raise their standards through combined power. 

Imagine McDonald’s executives realizing it’s cheaper to remove problematic additives nationwide than create separate supply chains. It’s pragmatic—and proof reform is possible.

And they don’t have to go it alone. A 2023 Deloitte report found that 77% of food service providers and 80% of retailers achieved at least a 2% cost reduction by adopting more sustainable sourcing and internal reforms—proof that cleaner, additive-free supply chains can scale without significantly increasing costs.

When a large state takes action—or when smaller states coordinate with each other—companies reformulate. Not out of the goodness of their hearts, but because it’s cheaper to change a national product than to produce two supply chains. That’s how real change happens.

Don’t expect help from the feds. U.S Health and Human Services Secretary Robert F. Kennedy Jr., for example, has promised to ban artificial dyes like Red 40 and Yellow 5, but he’s also committed to gutting the FDA’s food inspection power. If you’re waiting for RFK or his “Make America Healthy Again” movement  to save you: don’t.

“At minimum, companies should be required to disclose when their foods are designed to be hyper-palatable—to make it hard to put down. Consumers deserve to know when they’re being manipulated.”

So what does real reform look like?

First, we need to end the GRAS loophole—the absurd legal fiction that lets companies decide for themselves whether a new food chemical is “generally recognized as safe.” If an additive is going into the food supply, it should go through a real FDA approval process. No more self-certifications. No more rubber stamps.

Second, we should ban known carcinogens and endocrine disruptors—starting with the ones already banned in Europe. There’s no excuse for allowing chemicals into our food that other developed nations have rejected.

Third, we need clear front-of-package labeling for controversial additives. If a substance is banned abroad or linked to serious health risks, consumers deserve to know that—without having to decode a 12-syllable name buried in the extra-small-font fine print.

Fourth, we have to close the revolving door between regulators and industry. FDA officials shouldn’t be allowed to greenlight an additive one year and consult for the manufacturer the next. Cooling-off periods should be the rule, not the exception.

Professor Daynard offers a final idea. 

“At minimum, companies should be required to disclose when their foods are designed to be hyper-palatable—to make it hard to put down. Consumers deserve to know when they’re being manipulated.”

Transparency, not secrecy should be the baseline. 

Conclusion: Would You Eat What They Don’t?

A week later, Tessy returns to McDonald’s. The golden arches glow unchanged, but she has changed. As her son orders McNuggets, Tessy hesitates. The menu hasn’t changed—but she has.

​​The fries still smell the same. The nuggets still glisten in their box. But to Tessy, the meal feels heavier now. A reminder that trust can be misplaced, even in something as familiar as dinner.

McDonald’s doesn’t feed Europeans the same chemicals it serves Americans. That’s not an accident. It’s a policy choice—enabled by weak laws and a broken regulatory system. 

But things are changing. Parents are starting to ask why their kids are eating foods laced with chemical experiments. States are stepping up where the FDA won’t. And corporations, when pressed, prove they can clean up their act without making things more expensive for you and me. 

A world where food companies don’t get to police themselves—or profit at our expense—is possible. But it won’t happen unless we demand it. 

Next time, standing under the glow of the Golden Arches, ask yourself: why is an American company selling worse products in their own country than overseas?