Is it safe for human consumption?

How do we test new foods and medicines to determine they are safe for consumption?

How can I be sure the food I buy is really safe for human consumption?

In this section we look at how foods and medicines are actually tested and authorised, banned or even withdrawn from consumption. The system is not perfect and with millions of dollars at stake, is constantly fighting corruption but it works well most of the time.

We'll look at a few examples where it has broken down.

Because of the enormous costs involved in testing, most food certification is done through one organisation, usually the US Food and Drug Administration (FDA). The amount and preparation of foods varies greatly from person to person and culture to culture. Many foods are healthy in moderation but may pose a health risk if consumed in large quantities. This information need to be communicated to the consumer, so the effectiveness of the system also relies on food labelling, us reading and understanding the meaning of the labels. That's not easy when preservatives are all number coded and compounds may have several different scientific names for the same compound.

But there's a simple no-nonsense way to identify the safest foods on the shelf. We'll show you how.

How the global system works

The US Food and Drug Administration or FDA examines and tests foods for toxicity. Most Western countries take the FDA recommendations very seriously. Once the FDA has approved a substance as safe for human consumption, it is very easy to get that substance approved in other countries. From the international point of view, it makes sense for one organisation to test all food to see if it is harmful. It's a lengthy, complex and expensive process involving many trials and studies to test not only if a substance is harmful in our foods but at what concentrations it becomes harmful. Almost every substance can be toxic in sufficient concentrations – take water; in extremely high concentrations, you drown in it!

Is it really possible to determine if something is safe to eat?
The truth is – No.
There is no way of determining something is truly safe to eat, for a variety of reasons:

What reactions are there with other ingredients?
Many substances may be totally harmless or even beneficial but can undergo a reaction in the presence of other compounds. It is impossible to test for every combination so even though extensive tests over several years, some mistakes do happen. One example is the drugs for blood pressure treatments. In their properly prescribed dosages, they are highly beneficial and in some cases are life saving. Years after they were prescribed it was discovered that in the presence of grapefruit, they can undergo a dangerous reaction. It wasn't a problem at first because people only ate grapefruit in small quantities. Later however, the fruit juice industry began to market grapefruit juice and it became popular. Now people were consuming enough grapefruit to react with their blood pressure medication and we began seeing admissions into hospitals as a result of blood pressure medication failure.

It's difficult to factor in all other substances that it may react with, like prescription medicines

How should it be stored and handled?
Substances can change with storage conditions. The FDA doesn't simply supply a yes or no answer to it's testing, it releases an in-depth report that describes:

• where the substance can be used,
• what purity the substance should be (eg. contaminants)
• how it is transported (eg, refrigerated at or below 50C),
• in what quantities it can be used (eg. cannot be present in more than 50ppm or parts per million)
• at what temperatures the resulting product should be stored
• how long the substance can be kept for, or the product containing the substance can be stored for (eg. Use by date).
• the recommended daily intake (RDI) or in the case of drugs, the Recommended Daily Dose (RDD).

What is the common usage?
Common usage varies from person to person.
Here in Australia we have a sandwich spread that is very high in Vitamin B group vitamins, called Vegemite. Australian families can use a jar of Vegemite a week but in the USA, people would never use it.

Vegemite is unique to Australia

Most Americans find it distasteful (rather like Australians find the US concept of Ice Cream and Peanut Butter – Totally Gross Man! . . . but then again you fellas voted for George W Bush! ;-p.

For this reason, the FDA's results may apply in the USA and be quite safe but in another country (or even a sub culture within the USA) they might be approaching the level of being toxic.

Concentrations
People can react to substances in their foods in certain concentrations but show no reaction at at slightly lower levels. One example is a glycol derivative that is used as an aerator in baked goods, especially bread. It is also used in the suspension of aircraft landing gear and is toxic. In baked goods, it is used in minute quantities and some of it evaporates in the baking process. The remainder is present in such low concentrations that it is deemed as not harmful, according to the FDA.

Many baked goods contain an aerator that is actually toxic but present
in such low concentrations that it is considered safe for human consumption.

Bias and conflict of interests in the testing process
The FDA does not do it's own testing. It relies on the clinical trials results supplied by the manufacturer of the products. This seems to be biggest flaw in the system - the manufacturer has a billion dollar incentive to skew the results, making their product look better than it is. Of course there are reviews and checks for this but sometimes one sneaks through the system.

There are manufacturers who fake the results or conveniently overlook some negative results of their tests. Avandia, a diabetic pharnaceutical is an example or this. When GlaxoSmithKline submitted their test results for their new diabetic medicine the results of their clinical trials all pointed to it being safe.

According to the clinical trials, Avandia tablets seemed to be an effective
and harmless treatment for diabetics to control their blood sugar but . . .

It all seemed straight forward so the medicine was passed for human consumption with a medical prescription. After a few prescribing physicians noticed their patients developing heart conditions, a few questions were asked and the FDA conducted a review.

The FDA reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in the clinical trials where patients taking Avandia appeared to suffer serious heart problems but these were not counted in the study’s tally of adverse events.
Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he reported.

Developing research may uncover unforeseen side effects
There are also cases of substances that have seemed perfectly harmless and have later been proven to be toxic. Aspartame, one such example, is an artificial sweetener approximately 200 times sweeter than sucrose, or table sugar. It is marketed under the names of Nutrasweet, Equal and Canderel and is a common sweetener in most soft drinks (or soda as you call them in the USA). In diabetic or low sugar (low calorie) soft drinks it is the main sweetener usually with saccharin. Most people don't realise that it is also used in normal soft drinks as well. It is a common sweetener in almost any food that is not cooked or is alkaline, two environments that cause aspartame to rapidly break down.

Not only diabetic drinks contain aspartame. It's common in most fizzy drinks.

When it was clinically trialed, it was found to be harmless. Since then we have established that one of the compunds that it breaks down into, in the body, is linked to an increase in cancer. There is also a rare genetic condition, phenylketonuria (PKU) that prevents some people from metabolizing the naturally-occurring essential amino acid phenylalanine, one of the byproducts that Aspartame breaks down into.

Several people who have raised official concerns against Aspartame have moved on to marketing positions elsewhere, giving rise to conspiracy theories. Debate still rages about the side effects and the validity of the original testing that claimed aspartame had no harmful side effects. The whole conspiracy theory issue has become an urban myth.

Here at Kitchen Headquarters we don't buy into hearsay so, as far as who is right or wrong, we leave that up to you to decide . . . and it's really not important. What is important is that the whole debate has not been disproved one way or the other, so while there is any doubt, the safest option is to avoid aspartame and any foodstuffs that contain it. For more information on Aspartame, saccharine, sucralose and the debate, see the Artificial Sweeteners page.

Technological developments – What does the future hold?
GM Foods
Recently we have moved into genetics to modify the genes of some of our foods both in plants and animals. This is a whole new area and we are currently investigating this in more detail. This is a new science and even the experts admit we don't really know the full consequences of gene modification. See our page on GM Foods for more detail. Because we live in the grain growing area of Australia, we see the side effects of GM crops daily. No matter how strict the laws are in your state and country, you currently consume GM product. Once created they are almost impossible to prevent from entering the natural food chain, even when they are sterile mutations. For more information, see our page on Gene Modified Foods

Nano-Technology
Most compounds occur in large clumps of molecules, rather than single molecules. Nano-technology relies on breaking these clumps up into single molecules and this alters the some of the behavioural properties of the compounds.

Scanning electron microscope image of a nano-bot reacting with a bacterium

Titanium Dioxide is a good example of how nano-technology works. Titanium dioxide is a white powder long used as the pigment for titanium white paint by artists for the most stable and brilliant white colour because it reflects most light. In an effort to reduce the ultraviolet degradation to both paints and plastics, it was added as a pigment, with significant results. As technology improved and titanium dioxide was available in a finer grade of powder, it was added to cosmetics as a sun block, reducing the amount of ultraviolet radiation that penetrates the skin. Today titanium dioxide is available as nano-particles and is used in a whole range of goods.

In the fine ground powder, the particles are too big to enter through the outer membrane of most cells, so it is harmless in cosmetics. In it's nano-particle form the particles are small enough to pass through a cell wall into the inside of the cell, in some instances and we are not sure what effect it will have on the cells in the long term.

It is possible that nano-particles could act as a catalyst in genetic reactions within cells, causing mutations. They are so small that they can be added to compounds that they would not normally absorb or mix with. They can fit between normal molecules in most compounds, adding new properties without decreasing the structural integrity of the original compound. This can also occur in cells, passing through the cell wall inside the cell where the genetic reactions take place. With over a billion gene combinations in a cell, it is impossible to predict the effects this could have.

It is illegal to use nano-particles in foodstuffs but it is only a matter of time before an application is filed. The danger is we will tend to regard the nano-particles as harmless because they will be familiar substances probably already used as an ingredient and feel quite comfortable allowing their use. The problem is in nano-particle form, they will be reacting at different levels to the normal reactions. It is easy to quote an analysis of seemingly harmless compounds and omit the fact that they are in nano-particle form, which could give them entirely different behavoural properties.

A further complication arises when we dispose of waste containing nano-particles. Because they do not occur in the natural environment, in this form naturally, we have no idea what will happen when they enter the food chain. They might be harmless to us but can we say the same for the plants, insects and other animal life?

So . . . Is it safe to eat?
Because the United States Food and Drug Administration does not actually do it's own testing but relies on the manufacturers to test their products and supply their results, the testing system is open to manipulation. Considering the billions of dollars at stake, I am surprised we don't have more faked tests and poisonous foodstuffs on supermarket shelves. In addition , most of the clinical trials are done in the USA. As long as the manufacturer has control over the testing process, we have a situation where the “fox is guarding the hen house”. It could also be argued that because the testing is primarily USA based, there could also be a high degree of ethnic bias as well.

I heard a brilliant little guideline for identifying the healthiest foods on your supermarket shelf:

“If your Grandmother would not recognise it, it is probably not healthy to eat.”

Test it for yourself next time you are at the supermarket. Look at the ingredients and nutrition label of the items in your shopping basket. Compare the 'new' items with the things that old granny would recognise and you will be amazed at the difference. Granny's diet will usually have a lot less "additives", "flavourings", "preservatives" and "enhancer". 

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