Fecha:25 de abril de 2025
Secciones de contenido
- ● Escuche el artículo
- ● Understanding the Precautionary Principle
- ● How the US Got Here—and Why It Matters for the UK and Europe
- ● Unpacking the Paradox
- ● The Dose Makes the Poison
- ● Selective Science and Political Influence
- ● The UK’s Crossroads: Regulation or Liberation?
- ● A Better Way Forward
- ● Let’s Not Repeat Europe’s Mistake
Por Rob Verkerk PhD, director ejecutivo y científico de ANH-Intl y ANH-USA
In a bold move, US health authorities, led by Robert F. Kennedy Jr., are considering gutting a longstanding system that has helped ensure the availability of safe, beneficial food ingredients. His rationale is a desire to close a loophole that has allowed thousands of untested food additives to enter the US food market. It sounds like an exceptionally good idea at face value, given it is abundantly clear to any European who scans ingredients listings in American grocers or gas stations, the US food supply is riddled with questionable or dangerous food additives, including ones banned or phased out in other countries. Not only that: what’s of increasing concern is that there is a catalogue of new foods entering the market that contain ingredients of modern bioengineering that escape public notice because there’s no indication they are genetically modified.
Kennedy’s so-called loophole is category of ingredients that are considered “Generally Regarded As Safe” —or GRAS for short. The GRAS system came into play in 1958 with a view to grandfather in all sorts of ingredients that had long histories of safe use, while requiring newer additives to be affirmed as safe by the FDA after undergoing scientific assessment. The kind of ingredients that both the FDA and US Congress had in mind back in the late 1950s were spics and seasonings like salt, pepper, vinegars, common herbs and spices, common cooking fats and oils, basic food components like flour, cornmeal and traditional preservatives.
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As technological processes evolved, the FDA found itself increasingly overwhelmed by the weight of petitions it faced. So in 1997, a self-affirmation route was created meaning the FDA didn’t have to trouble itself with the scientific assessment of new ingredients; these would be self-affirmed by the companies who made or used the additives or ingredients—the onus for ensuring safety being passed from the regulator back to the private sector.
Kennedy and others are right that the self-affirmed route (often referred to as ‘self-GRAS’) has been exploited by companies putting relatively untried and definitely untested substances onto the US market, including ingredients produced through synthetic biology (‘synbio’). But he’s wrong on two assumptions:
- Erroneous Assumption 1: All the nasty additives on the US market have gone through the self-GRAS pathway. Absolutely not. Take, for example, the Environmental Working Group (EWG)’s Dirty Dozen Guide to Food Chemicals, including potassium bromate, propylparaben, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium benzoate, and brominated vegetable oil (BVO). Literally every one of these ‘dirty dozen’ that EWG rightly tell health conscious Americans to avoid didn’t undergo self-GRAS. Instead, they were approved as safe by the FDA through its scientific procedure. This would suggest there’s a flaw in the FDA’s risk assessment process, something we address directly in our white paper.
- Erroneous Assumption 2: If you close down the self-GRAS ‘loophole’, you’ll create a healthier food supply. This assumption can be challenged if it can be determined that closing self-GRAS would result in the removal from the market hundreds of ingredients that are beneficial to humans, that pose no health risks in their intended uses. As we argue in our white paper, this is the case. Presently, some of the most important and beneficial, health transforming ingredients used in functional foods and dietary supplements have made their way onto the US market courtesy of manufacturers’ self-GRAS determinations. This includes substances as varied as EGCG in green tea extracts, curcumin, resveratrol, sulforaphane, ursolic acid, limonene, boswellic acids, acetyl-L-carnitine and numerous others (see pp. 30-32 of our media pack linked to our white paper for more examples).
Now, let’s get to the mechanism that’s being proposed to justify the closing of the self-GRAS ‘loophole’? Surprise, surprise: it’s the tried-and-tested cornerstone of the environmental movement, and an especially European tenet, the so-called “precautionary principle”—a concept that, while sounding reassuring, may in practice, in certain contexts, do more harm than good.
While the new US administration considers who to get the nasties out of the US food supply, across the pond, the implications resonate in the UK and Europe, where the precautionary principle has already become entrenched in regulatory practice. As Britain redefines its post-Brexit food and supplement policy, and its relationship with the European Union, it’s vital to reflect on whether our current, global, trajectory of increasing dependence on the precautionary principle will enhance public health—or inadvertently undermine it.
Understanding the Precautionary Principle
The precautionary principle is simple in theory: if there’s a risk of harm, act to prevent it—even in the absence of conclusive scientific evidence. It has strong rhetorical appeal—who wouldn’t want to prevent harm before it occurs?
Yet the principle’s application in food and nutrition policy can be dangerously one-sided. When it’s used to remove or restrict beneficial foods, nutrients, or additives based on hypothetical risks, we start to rob people of the very tools they use to stay healthy.
The example of vitamin D highlights a paradox: very high intakes can be problematic, with the potential to cause nausea, vomiting, abdominal pain, weakness, fatigue, headache, dehydration, bone pain, bone fractures, kidney stones, high blood pressure, calcification of arteries, pancreatitis, depression, and even stupor, coma or death. Vitamin D3 (cholecalciferol) is used as a rodenticide at high doses due to its ability to kill rats and mice via hypercalcaemia. Given that vitamin D’s benefits below these harmful doses are well-recognised, including immune system function, bone health and reduced cancer risk, the risk of exposure to very high doses (say 50,000 IU or 1250 micrograms per day, which would be detrimental to most adults if maintained over weeks or months) is managed through warnings on product labels and guidance. This kind of risk management approach is widely applied by regulators around the world to ‘essential nutrients’, because it’s recognised that an excessively cautious approach would deprive many of the undisputed benefits of these nutrients.
Let’s remind ourselves that an essential nutrient is simply one that the body needs to function properly but cannot produce on its own, or cannot produce in sufficient quantities to meet its needs. So-called ‘non-essential’ nutrients, while not being essential for fundamental physiological processes, can be vital for the maintenance of long-term health, including preventing chronic and degenerative diseases.
The problem with the use of the precautionary principle lies with nutrients or other natural substances that are not deemed ‘essential’, but have still been shown to deliver a host of benefits linked to disease remediation or supporting long-term health. These are the very kinds of ingredients that could suffer mortal collateral damage in Kennedy’s efforts to lock out the real nasties from the US food supply.
How the US Got Here—and Why It Matters for the UK and Europe
On March 10, 2025, US presidential candidate Robert F. Kennedy Jr., acting as Secretary of Health, directed the Food and Drug Administration (FDA) to reconsider the self-affirmed GRAS (Generally Recognised As Safe) system—a regulatory pathway in place since 1958. It allows food manufacturers to introduce ingredients deemed safe based on expert consensus, scientific data, and long-standing use.
What is the precautionary rationale when applied to food ingredients? Until an ingredient is definitively proven safe, it should be kept out of the food supply. If that determination is to be done by the FDA itself, it would mirror the approach used by the European Food Safety Authority, which has seen fit to not recognise the benefits of thousands of plant-derived (botanical) ingredients when it rejected nearly all of the 2,078 health claims it assessed back in 2009.
While this led the European Commission establishing an ‘on-hold’ list of claims which can be used where they are approved by individual EU member states, where regulators demand near-absolute safety before approving food ingredients or supplements, the result is nearly always the restriction of choice or information. This throttles innovation, reduces consumer choice, and—ironically—exposes populations to unintended health harms.
Unpacking the Paradox
Legal scholars in the US like Cass Sunstein and Frank Cross have long pointed out the inherent contradictions of the precautionary principle. By focusing solely on preventing hypothetical harm, regulators often overlook the very real costs of inaction: lives unenhanced, diseases unchecked, and health benefits foregone.
A stark example comes from Japan. After the Fukushima nuclear disaster, authorities shut down nuclear power, turning to fossil fuels. The resulting spike in energy prices led to less heating during cold weather, which in turn increased mortality. The intent was safety; the result was increased harm—a classic case of precaution gone awry.
The same logic applies to food. Oily fish contains trace contaminants like mercury, yet its omega-3 content offers major cardiovascular benefits. Should we ban it? That’s the kind of blunt decision the precautionary principle often leads to.
The Dose Makes the Poison
A cornerstone of modern toxicology—called the Principio paracelsiano—holds that “the dose makes the poison”. In other words, every substance can be toxic at a high enough dose, even water. Regulators in the UK, EU, and US have traditionally relied on this principle to set safe thresholds, balancing risks with benefits.
As toxicology and health sciences have progressed, there is a more nuanced version of the relationship between dose and response. It’s referred to as hormesis, where low doses of particular substances, such as dietary phytochemicals, can have profound benefits, while high doses can induce harm. This relationship for naturally-occurring substances is very rarely a linear.
The problem with the precautionary principle is that it tends to ignore dose-response logic. If something is risky in theory even at very high levels of intake (even if these have never or very rarely found to occur in practice), it’s treated as if it’s dangerous at any level. That’s neither scientifically robust nor fair to consumers seeking health improvements through diet.
Selective Science and Political Influence
The precautionary principle, far from being neutral, often masks political agendas. In Europe, its application is inconsistent—heavily influenced by lobbying from powerful industry groups. Dairy, for instance, is spared from many restrictions despite containing compounds like lactose and casein that are problematic for some. Why? Because dairy is considered by some experts to be healthy for those who are not sensitive to its sugar or proteins, and the dairy lobby wields massive political clout.
This selective enforcement undermines the very ethos of managing risks and benefits. Why for example is the precautionary principle applied to botanicals for which there are hundreds or even thousands of years of evidence of safe use in traditional systems of medicine, yet it isn’t applied to products of modern bioengineering? Is this down to the relative amount of political leverage each sector can muster?
The UK’s Crossroads: Regulation or Liberation?
The UK, having left the European Union, has a unique opportunity to reassess its adherence to the precautionary model. Will it follow the EU’s increasingly restrictive food regulations, or pioneer a more balanced, evidence-led approach that empowers consumers without stifling innovation? We are deeply concerned with how it’s intending to proceed with new genome techniques, having now departed from the EU with its Genetic Technology (Precision Breeding) Act of 2023. This new law differentiates between precision bred organisms (PBOs) and genetically modified organisms (GMOs). Interestingly, the model that has been approved by the UK Parliament that received Royal Ascent in March 2023, involves companies simply notifying UK authorities of the marketing of a PBO via a public register. This is the very system we are recommending to Secretary Kennedy to use for self-GRAS ingredients, albeit not products of bioengineering.
If the US FDA moves to eliminate GRAS—a move currently being floated—it risks replicating the EU’s restrictive system, where regulators require ingredients to be proven safe before being allowed on the market. That may sound prudent, but it places an impossible burden on innovators and deprives consumers of choice, particularly because the self-GRAS system has been a portal for wide range of nutrients. It also contradicts the major questions doctrine established by the US Supreme Court, which holds that major regulatory changes must be approved by elected lawmakers—not imposed by agencies.
A Better Way Forward
Rather than swinging between extremes, we need a system that evaluates both risks and benefits holistically. Reforming GRAS or equivalent UK systems should focus on increasing transparency, rooting out bad actors, and ensuring public safety—without creating barriers to beneficial products. Precautionary approaches should be reserved for substances or ingredients on which we have little or no long-term data, such as products derived from modern bioengineering. It is ironic that the UK has placed the onus on the biotech industry to justify that its precision bred, bioengineered GMO v2.0 products and ingredients are safe. That’s down to the sheer might of this lobby, and a previous Tory government that was impervious to conflicts of interest.
What we should work to avoid—this being central to our strategy at ANH—is the use of scientific uncertainty over the potential for risk to paralyse innovation, or prevent individuals from accessing nutrients they’ve relied on for generations. Long-term, safe history of use is one of the most reliable indicators of safety that we have. Moreover, efforts by regulators to limit exposure based on a potential risk of excessive exposure, should also take into account the potential risk of inadequate exposure (i.e., benefits).
Let’s Not Repeat Europe’s Mistake
The European experience offers a cautionary tale. Overzealous application of the precautionary principle has led to reduced access to high-dose vitamins and minerals, and an increasing diversity of herbal and botanical ingredients, often without clear evidence of harm at the intended levels of intake. This paternalistic model disempowers citizens, undermines health autonomy, and places bureaucrats—not consumers—at the helm of dietary decisions.
The UK, as well as the US, have the chance to chart a different course. We can protect health without overregulating it into stagnation. The goal should be clear and simple: prevent real harm while preserving access to beneficial foods and nutrients.
As we’re reminded time and again in public policy: sometimes, playing it too safe is the biggest risk of all.
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