Why Different Countries Make Different Choices About Food Safety
When "Banned in Europe" Doesn't Tell the Whole Story
Why Food Safety Dominates Today's Headlines
The Make American Health Great Again (MAHA) movement has transformed food safety from a scientific discussion into a political flashpoint. Their message appears simple: if other countries ban certain food ingredients allowed in the US, America's regulatory system must be failing us. California's recent ban on red dye 3 seems to support this narrative. But the reality of food safety regulation involves sophisticated science and nuanced regulatory tools that deserve deeper understanding. Let’s discuss.
Two Paths to Safety: Understanding Risk vs. Hazard
America's approach to food safety differs fundamentally from the European system, for example— though not in the way MAHA suggests. The EU employs a hazard-based "precautionary principle," restricting substances based on any potential for harm regardless of real-world exposure. The U.S. takes a risk-based approach, evaluating the actual likelihood of harm under typical conditions of use and exposure levels. This distinction shapes every aspect of how we regulate food ingredients.
The Hidden Costs of "Better Safe Than Sorry"
The common wisdom "better safe than sorry" seems unassailable, especially when it comes to food safety. But as former FDA Chief Social Scientist Richard Williams points out, this approach – formalized as the precautionary principle in European regulation – can sometimes create more harm than it prevents.
Consider how we determine safe levels for food ingredients. Scientists start with the lowest dose showing no effects in animal studies, then apply multiple safety factors.
As Williams illustrates with a clever analogy: If we applied the same logic to setting school zone speed limits, we'd end up with cars moving at half the speed of a garden snail – about 8 feet per hour.
The problem isn't being careful; it's failing to ask "compared to what?" When we ban or restrict an ingredient, something else usually takes its place. Sometimes that replacement carries its own, possibly greater, risks. The historical example of DDT illustrates this starkly. After its ban, malaria cases in South Africa jumped from 8,500 to 42,000, resulting in 300 additional deaths. By the 1970s, cases reached 6 million.
This doesn't mean we should abandon caution. Rather, it suggests that true safety comes from carefully weighing real-world risks against real-world benefits. America's risk-based approach to food safety, while sometimes criticized as too permissive, actually reflects this more nuanced understanding. Being "safe" requires considering not just what we're protecting against, but what we might be giving up in the process.
But isn’t it better to err on the side of caution?
Different regulatory frameworks worldwide often reach varying conclusions about ingredient safety - not because one system is inherently more protective, but because each weighs evidence and risk differently. This helps explain why some ingredients face restrictions in one region but not another.
Consider Cyclamate, an artificial sweetener banned in the U.S. since 1969 due to cancer concerns identified through our scientific review process. While the EU also employs precautionary principles, their re-evaluation of newer studies led them to permit Cyclamate under controlled conditions. Similarly, while Green S (E142) and Quinoline Yellow (E104) are approved in EU food products, the FDA has never permitted their use in the U.S. based on our assessment of safety data.
Cultural factors and historical use can also influence these differences. Borax, while permitted in some traditional European and Asian recipes, is completely prohibited as a food additive in the U.S. where cultural use doesn't typically influence safety decisions. Oil of bergamot, common in European Earl Grey tea, faces stricter controls in the U.S. due to our assessment of phototoxicity risks.
This is not an exhaustive list. Note, also, that some ingredients are simply labeled differently in other countries which leads to confusion about what is or isn’t permitted. (For example, Red 40 (Allura Red AC): Known as E129 in the EU, Red 40 is permitted in many countries but labeled with an E-number that differs from the U.S. nomenclature. This leads to confusion, with some assuming Red 40 is banned abroad when, in fact, it’s commonly used.)
These variations reflect different interpretations of safety data and varying approaches to uncertainty. While the EU's precautionary principle focuses on managing potential risks before they're conclusively proven, it doesn't mandate banning every substance with a theoretical hazard. Similarly, the U.S. risk-based approach, while focused on the likelihood of actual harm, can lead to complete bans when significant safety concerns are identified.
The key difference lies not in being more or less stringent, but in how each system evaluates scientific evidence and weighs various factors - from safety margins and exposure assessments to cultural considerations and practical implementation. Either approach can lead to stronger safety measures when warranted by scientific evidence.
The Science Behind Safety Limits
Before diving deeper into how ingredients are regulated, it's important to understand where these rules live. The Code of Federal Regulations (CFR) serves as America's rulebook for food safety. Title 21 of the CFR contains all FDA regulations, with different parts addressing specific aspects of food safety. When scientists or regulators reference "21 CFR," they're pointing to the exact legal requirements that govern food ingredients and additives.
At the heart of America's system lies the Acceptable Daily Intake (ADI) calculation - a process far more conservative than most realize. Scientists start with the No Observed Adverse Effect Level (NOAEL) - the highest dose that shows no harmful effects in long-term animal studies. But that's just the beginning of an intentionally conservative process.
From that NOAEL, scientists apply multiple safety factors:
First, they divide by 10 to account for potential differences between animals and humans
Then divide by another factor of 10 for variations within the human population
Additional safety factors may be applied for sensitive groups (children, pregnant women, elderly)
If studies suggest special concerns, even more conservative factors are added
As former FDA Chief Social Scientist Richard Williams illustrates, this approach is like taking a 15 mph school zone speed limit and repeatedly dividing by 10 – first for different driver abilities, then for varying car conditions, then for inexperienced teenage drivers – until you end up with a speed of 8 feet per hour, slower than a garden snail.
The result? The final ADI might be hundreds or even thousands of times lower than levels showing no effects in studies. This ultra-conservative approach means that even if someone consumed far more than typical amounts, they would still be well within safety margins.
Following the Food: Real-World Exposure Assessment
Establishing safe levels represents only part of the FDA's work. The Total Diet Study (TDS), one of the world's most comprehensive food safety monitoring programs, tracks how ingredients reach consumers. Scientists analyze consumption patterns across different populations, seasonal variations, regional differences, and cumulative exposure from multiple sources.
This sophisticated modeling draws on multiple data sources. The What We Eat in America study provides detailed dietary information across diverse populations. The National Health and Nutrition Examination Survey adds critical health data. Market basket studies capture regional and seasonal variations. Together, these tools help scientists understand not just what people eat, but how different foods combine in real diets.
(So, when people ask: “You’re telling me the levels of X ingredient are safe in this food, but what if eat multiple foods with X?” This is something the FDA anticipates and assesses.)
Science in Action: The Testing Process
Before any new ingredient enters the food supply, it undergoes extensive testing including:
Acute and chronic toxicity studies examining both immediate and long-term effects
Reproductive health impact assessments
Carcinogenicity evaluation
Metabolism studies showing how substances break down in the body
Allergenicity testing
Cumulative effects analysis
Scientists evaluate results against established safety factors, considering both direct effects and potential interactions with other substances. This multi-layered approach helps ensure safety while acknowledging scientific uncertainty.
Beyond Bans: America's Regulatory Toolkit
The FDA has something called, “The Substances Added to Food Inventory” [which replaces what was previously known as Everything Added to Foods in the United States (EAFUS)]. It is public and searchable.
When safety concerns arise, the FDA has several precisely defined options codified in the Code of Federal Regulations. Prohibition, specifically listed in Title 21, Part 189 of the CFR (21 CFR 189), represents the strongest action. This isn't just policy - it's federal law.
Prohibition, codified in 21 CFR Part 189, represents the strongest action. When an ingredient becomes prohibited, it cannot be used in any food product. (This is what most people are referring to when they talk about something being “banned”.) This designation comes with specific legal requirements and enforcement mechanisms. While MAHA supporters often call for more outright bans, prohibition occurs rarely because unsafe ingredients typically never reach the market thanks to pre-market safety requirements.
Prohibited with Exceptions allows continued use in specific, limited applications where benefits outweigh carefully managed risks. This nuanced approach helps maintain both safety and practical food production needs. For instance, some substances might be prohibited in general food use but allowed in tiny amounts for specific technical functions.
Delisting, particularly relevant for color additives, involves removing substances from approved lists while managing transition periods. This process, demonstrated in the 1990 removal of red dye 3 from cosmetics, allows for orderly transitions that prevent supply chain disruption while maintaining safety.
The "No Longer GRAS" designation revokes an ingredient's Generally Recognized as Safe status, requiring immediate market removal unless manufacturers can obtain explicit FDA approval through other pathways. This tool allows quick action when new evidence raises safety concerns. What do we mean by GRAS?
GRAS: Misunderstood but Rigorous
The Generally Recognized as Safe designation frequently faces criticism from MAHA supporters who characterize it as a regulatory loophole. In reality, GRAS status demands extensive scientific evidence - either published research demonstrating safety or a documented history of safe use before 1958. Achieving GRAS status requires the same level of safety evidence as formal FDA approval.
Companies seeking GRAS status must demonstrate safety through scientific consensus among qualified experts. The FDA maintains oversight through a voluntary notification program, conducting its own evaluations of the supporting science. When new evidence raises concerns, GRAS status can be revoked quickly through the "No Longer GRAS" determination.
The Red Dye 3 Case: Theory Meets Practice
Current debates over red dye 3 illustrate these systems in action. When animal studies raised concerns in 1990, the FDA used its Delisting authority to remove the substance from cosmetics. Its continued presence in food reflects careful analysis of actual exposure levels, which typically fall far below amounts showing effects in laboratory studies.
The FDA continues monitoring the situation, acknowledging public concerns while evaluating scientific evidence. According to Thomas Galligan of the Center for Science in the Public Interest, "establishing a mechanism would require long-term studies." Meanwhile, California's EPA research revealed higher synthetic dye intake in certain communities, demonstrating why simplified "ban or allow" approaches may miss important nuances.
Moving Forward: Balance and Innovation
As MAHA advocates push for wholesale adoption of European-style restrictions, understanding America's sophisticated system becomes increasingly important. Different regulatory frameworks might reach different conclusions about specific ingredients, but America's approach reflects decades of scientific advancement and practical experience in protecting public health.
The challenge isn't that our system fails to protect public health - it's explaining complex scientific processes in an age of viral social media posts. Moving forward requires acknowledging both the sophistication of current safety assessments and the legitimate concerns driving calls for reform.
Only by understanding how science guides every aspect of food safety regulation can we have meaningful discussions about protecting public health while maintaining a practical and innovative food supply.
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