Facts Over Fear: Debunking Many Myths Around Food Ingredient Misinformation

Fight The Fear!

Getting food safety right is critical. I’m a parent. I’m a son. I’m an uncle. I am also a regulatory toxicologist. I’m a risk assessor. I’m a biostatistician. I’m a bioethicist. I am currently the President of the Ethical, Legal, Forensic, and Societal Implications Specialty Section of the Society of Toxicology. I think about foods, and what we put on our kids’ plates all of the time.

Thus, getting food safety, especially ingredient safety, is critical for me. It’s critical for all of us.

This is why it is essential that science, not fear, informs policy.

The science about FD&C colors, titanium dioxide, and many other food ingredients is clear – these colors and ingredients are safe when used as intended for their approved purposes at their approved concentrations or amounts.

FD&C colors, titanium dioxide, and food ingredients in general are among the most carefully studied and regulated substances in the world – precisely because we ingest them as part of our diet. That is why Congress passed the Food, Drug, and Cosmetic Act, and various amendments, and charged the US FDA with ensuring the safety of our food supply. Congress, as well as federal government scientists, believed it is completely unreasonable for people to intentionally introduce substances into food unless we were certain that these substances would cause no harm.

FD&C Colors and Hyperactivity

I have carefully examined the questions surrounding FD&C colors and whether they cause hyperactivity. I am a father of two children. I get asked by other parents all the time if FD&C colors cause hyperactivity. And it is good that people are asking these questions – that’s how science improves public health.

The science is clear: there is no consistent and coherent association between hyperactivity and FD&C colors. Based on my review of the literature, it is clear that statistically significant associations between FD&C colors and hyperactivity in children are false positive results and are most likely statistical noise. In addition, due to the small sample sizes, these results are not generalizable to any population.

Part of the difficulty with finding an association between FD&C colors and hyperactivity is due to changes regarding how hyperactivity is clinically defined over time, the purely subjective nature of the definition, the lack of objective biomarkers, and an inability to consistently and coherently quantitate what an adverse effect is.

I have found that there is insufficient evidence to suggest that FD&C colors are associated with hyperactivity in children. I am not alone in this conclusion.

The US FDA, the European Food Safety Authority (EFSA), Health Canada, and the FAO/WHO Joint Expert Committee (JECFA) on Food Additives have reviewed the data on the association of FD&C color ingestion by children and hyperactivity. All of these organizations have reached the same conclusion that I have: the science is clear, and there is insufficient evidence to suggest that FD&C colors are associated with hyperactivity in children.

Thus, the science is clear: FD&C colors are not associated with hyperactivity in children.

Europe, Food Labeling, Hyperactivity, and Colors

Many advocates will point out that EFSA requires labeling of foods that use artificial dyes. It is important to note that this is not entirely true.

The European Parliament actually requires the labeling of foods that use certain artificial dyes that were used in the “Southampton Study” by McCann et al. (2007) [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)61306-3/abstract].

EFSA was, and still is, against this labeling on scientific grounds, as EFSA does not believe that these artificial dyes are associated with hyperactivity in children. However, the European Parliament directed this labeling, despite EFSA’s protests.

Is It True That Europe Bans Ingredients That the US Authorizes?

This isn’t quite right. Europe and the US both have food regulatory laws that require food ingredient companies to ask for permission and approval to sell foods that contain ingredients, colors, etc. So, Europe doesn’t ban ingredients, colors, and the like so much as food companies haven’t really asked for permission.

Why doesn’t a company use food colors in a European product, but they do in the US? It’s really about consumer preferences.

We have completely different histories and preferences around our foods. Just like in much of Asia, consumers have very different attitudes around food colors.

For instance, FD&C Red 3 is allowed in Europe (ya know, the one that FDA was compelled to ban in foods, despite FDA saying there was no evidence it would ever cause cancer in humans…because the Delaney Clause is ridiculous and forces FDA to do things that are completely unscientific). Companies asked for permission to use it to dye canned cherries. Anyone who cans knows that foods lose their color in the canning process. Thus, companies asked for permission for candied cherries of various types and uses to be allowed to be colored.

But generally speaking, most European consumers do not want brightly colored food. This food preference goes back centuries.

In many parts of Asia, food is art. The bright colors and the interplay of textures is important culturally. These bright colors and the spice in some parts of Asia, are also signals that the food is safe to eat, as they contain ingredients that tend to traditionally make them inhabitable by microbes that might make us sick.

What is striking, through, is that Europe allows all kinds of food colorings, including Red Dye No. 40 and Red Dye No. 3, among many others (including FD&C Yellow No. 10 which the US has not approved for food use). If you want to see the full list of colorings and where companies have asked they be allowed to use them, you can find it here.

No, Titanium Dioxide Will Not Cause Cancer In Your Body When Used As Approved and Directed

With respect to titanium dioxide, the science is clear: titanium dioxide is safe when used as approved and directed by the US FDA. There have been concerns raised based on scientific studies that titanium dioxide may cause cancer. I am here to tell you that I have studied this topic extensively, and titanium dioxide is safe when used as approved and directed by the US FDA.

I published my analysis of the papers that EFSA relied upon to conclude that titanium dioxide may cause cancers at my blog, the Toxic Truth Blog. I demonstrated that all of the papers are fatally flawed, and in many cases should be retracted. In fact, one of the papers was published in a highly questionable journal.

However, if we take EFSA’s conclusion at face value, you would need to eat 4,080 skittles – each and every day – for over 9 years – to achieve the genotoxic dose in someone’s spleen (the organ where titanium dioxide resides the longest) in order to see the same DNA damage that concerned EFSA.

If I were to purchase that many skittles at my local Target, it would cost over $13,700 every year in just skittles. Although my 12 year old son has said he welcomes this challenge, I remind him that if he were to save that $13,700 across 9 years, he would have enough money to buy a nice sports car, including a used McLaren MP4, or a new Porsche 911. I’m pretty sure he still would rather have the skittles.

I can assure you that by eating 4,080 skittles – each and every day – for over 9 years – you will have far larger problems than DNA damage and possible cancer. I am fairly certain that the diabetes, extreme weight gain, gastrointestinal distress from overeating, and other adverse physiological effects will take a very severe toll on one’s body, to the point that they will likely die before they ever have any risk of developing cancer.

Thus, the science is clear: titanium dioxide is safe when used as directed and approved by the US FDA.

Labeling Safe Ingredients Leads to Unnecessary Harms (i.e., It Is Unethical)

We have a long history of using and studying the FD&C colors and titanium dioxide. Labeling products that contain FD&C colors and titanium dioxide could unnecessarily alarm consumers, despite clear scientific evidence that FD&C colors and titanium dioxide are safe when used as directed and approved by the US FDA. The California Department of Public Health has noted that such labeling could lead to increased anxiety without improving health outcomes. Since FD&C colors and titanium dioxide are approved for use by the US FDA and have been extensively studied for safety, introducing this type of labeling risks creating confusion and harm without a corresponding public health benefit.

Regulatory Agencies Use the Science to Protect Us

Keep in mind – regulators have every reason to act – if the science supported it. US FDA and EFSA are not afraid of regulating FD&C colors, titanium dioxide, or other food ingredients. US FDA is tasked with protecting public health. If there were credible evidence that FD&C colors, titanium dioxide, or any other food ingredient caused harm, they would be obligated to act. In fact, We The People could sue the FDA for not acting on our behalf!

And US FDA has acted quickly on other substances when evidence has emerged. The fact that FD&C colors, titanium dioxide, and other food ingredients remain approved means that the evidence just isn’t there.

Also, let’s chat for a moment about Generally Recognized As Safe (GRAS) ingredients. The US Congress put into place within the Food, Drug, and Cosmetics Act, a mechanism for scientific experts to identify ingredients that are GRAS. All of the data that are used by these panels of experts must be in the public domain, as the law specifies “[a]n additive may be shown to be safe either by means of scientific procedures (including a review of the existing scientific literature) or, in the case of substances in use prior to January 1, 1958, also by means of experience based on common use in food.”

Let’s be clear here — GRAS is not a loophole, as some would lead us to believe. Nor is GRAS a means to put lipstick on a pig. Any food ingredient that is shown to be GRAS, is GRAS because scientific experts have examined the literature. What if someone cooked the books and lied? Well, that’s why we have courts. If someone lies about an ingredient being GRAS, you better believe they will get sued.

This is also why the US FDA recommends companies send their GRAS notices to the US FDA — because US FDA will examine the GRAS notice and let a company know if they do not agree that an ingredient is GRAS.

Also, little known fact — did you know that colors cannot be GRAS? That’s right — colors are called “color additives”, and there is no GRAS provision for color additives. All colors are subject to testing prior to their approval. Companies that want to use colors in the US must file a Color Additive Petition.

Fight the Fear!

It is completely understandable to worry – but the science on FD&C colors, titanium dioxide, and other approved food ingredients provide reassurance.

Have some companies chosen to remove FD&C colors, titanium dioxide, and approved food ingredients because of public perception? Yes – not because of scientific evidence of harm. This is a business decision, not a health decision.

FD&C colors, titanium dioxide, and food ingredients are among the most extensively studied chemicals in the world. That’s why regulators across the world, including the US FDA and EFSA, continue to approve their use based on consistent safety data. The science supporting their safety is well established.

And remember — Europe allows all kinds of food ingredients and colors. Consumer preferences are what drive what ingredients and colors companies will ask for permission to use. And if you want that link again for the full list that can be used in Europe, well, here ya go.

Fear Is Their Business

Remember — fear is big business. Fear is a powerful emotion. Fear shuts down our brains and prevents us from acting and thinking rationally. That’s the whole point of fear — to get us to act quickly and without thinking.

Why does fear stop us from thinking? Because if we are in danger, we don’t have time to think!

Marketers, the media, lobbying organizations, and many so-called “consumer protection non-profits” use the same tools perfected in used car sales. You sell the emotion — not the data. You sell how something will make you feel. You sell the sizzle, not the steak. How else are you going to drive big money donations and sales when you don’t have a winning product or idea? You sell people on emotion.

And fear is one of the biggest emotions of all.

Fight the Fear! Decide Smarter!