In the USA, the Food, Drug, and Cosmetic Act defines a drug as : (1) a substance recognized in an official pharmacopoeia or formulary (2) : a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (3) : a substance other than food intended to affect the structure or function of the body (4) : a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device.
The FDA says: "The legal difference between a cosmetic and a drug is determined by a product's intended use."
In Canada, the Food and Drug Act defines a drug as:
“drug” includes any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals
The European Union DIRECTIVE 2001/83/E defines a 'medicinal product' as:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
What's wrong with this picture?
It seems to say that the difference between a drug, and a non-drug depends on the use. But if you read more carefully, that's not what it says. It really says, in simple English:
"The difference between a drug, and a non-drug is defined by the way the product is marketed." (intended for use, sold or represented for use in, presented as having properties for).
If it looks like a drug, and walks like a drug and talks like a drug - it makes no difference at all. It's not a drug until the paperwork is done.
But if the marketing paperwork to the government says:
in the USA: "a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"in Canada: "substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms"in the European Union: "presented as having properties for treating or preventing disease in human beings".
If the marketing department says it can be used to diagnose, cure, mitigate, treat or prevent disease, - it is a drug. That is the only requirement for a drug. Thus, everything and anything can be a drug - if it is marketed as a drug. Of course it must pass some significant paperwork hurdles - but these are easily managed by large corporations and their lawyers.
Note: to create a drug in any of these countries, it is not necessary for the drug to be particularly effective, nor for the scientific or medical community to believe that the drug is effective. Nor is it necessary for the drug to be safe in all situations. It is only necessary to pass the paperwork tests. Government offices cannot and do not pass judgement on the efficacy of any drug application. Governments pass judgement on the paperwork. Many new drugs cannot truly be tested for effectiveness, nor safety, on the general population until after they are in public use for many years, possibly even decades.
It is easily seen that one of the problems with the USFDA, Health Canada, and European Unions definition of a drug is that there is little said about what is 'not a drug'. Almost everything can be defined as a drug.
This has lead people to ask if water is a drug - because it can be marketed to prevent and cure dehydration (they failed due to the fact their the paperwork was not completed correctly). And it lead me to blog that the wind is my drug, because I claim it makes me feel better.
We need a different definition of a drug.
Wikipedia says: "A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage."
Webster's Dictionary says: "a substance used as a medication or in the preparation of medication".
We need a definition of DRUG, from a health viewpoint.
Is there a simple way to delineate between drugs and non-drugs from a health viewpoint. A definition not depending on a marketing department. Rather a definition that depends on science and facts about our health and healthiness.
The first thing we should recognize about drugs is that they are almost all toxic by design. Drugs are designed to throw your health system off balance, to counter the imbalance of your illness, not to create health. You need a prescription for drugs because they are toxic.
Can we define drugs in a useful fashion? Can we define non-drugs?
A healthicine is a substance that has a direct effect on the balances of healthiness. Healthicines are non-drugs. That effect might be positive, or if the healthicine is deficient or excessive - it will be a negative effect.
A drug is a substance that has an effect on illness. Drugs have an indirect, usually negative effect on the balances of healthiness. This negative effect is designed to throw the illness off balance and allow your body to heal. Or sometimes the illness is designed to simply trick your body into 'feeling healthy', by minimizing symptoms.
Water is not a drug. If you are dehydrated, water still cannot be a drug. Water cures dehydration, or it restores the balance of hydration - but it is not a drug. Water is necessary for healthiness. A deficiency or an excess results in an illness and possibly death.
Can we extend this distinction to other substances - it gets a bit more complicated. If you have a Vitamin C deficiency, taking Vitamin C to 'treat' the deficiency is not taking a drug - any more than eating oranges is taking a drug.
Vitamin C can also be used as an injection to treat a serious inflammation. In that case the Vitamin C is not addressing a normal Vitamin C deficiency, it is being used to tackle a health problem that is best treated by an excess of Vitamin C. Vitamin C has a negative effect on the problem - the inflammation - note, inflammation is normally a healthy response to stress. Administering an excess of Vitamin C, or any substance, for a therapeutic effect separate from the Vitamin C health balance, is administering a drug.
Is this a clear dividing line? Maybe, maybe not. The government definition of drugs for sale needs to be a clear, black and white, legal definition. But the definition of drugs for health, and for personal healthiness, has many shades of grey, ranging from black to white and every shade in-between, possibly even different colours.
A healthy definition of ''drug" needs to be open to dispute and discussion. The government definition is like a proclamation from God, there is not room for argument, not way to dispute the decision. This is not a healthy definition. It is not a democratic definition. It is not a 'freedom' definition. I believe in Personal Health Freedom. The freedom to differ.
All illness and disease are be caused by an imbalance, a deficiency or excess of genetics, nutrition, parasites, toxins, stress, growth (including healing and immune systems) - or a combination thereof.http://personalhealthfreedom.blogspot.com/2011/10/hierarchy-of-health-primary-and.html
A drug is always an excess. In most cases, if you are healthy, a drug is toxic to some aspect of your health. You need a prescription - a doctor must sign that you 'need the drug'. When you are ill, the drug may have a beneficial effect. By design. Drugs are not designed to fix health imbalances. Drugs are not nutrients. Drugs are not designed to cure - they are designed to create an 'opposing imbalance' so that your body can heal.
All drugs have 'side effects'. Why is that? Because all drugs are toxins - they have toxic effects. If they didn't have toxic effects, they would have no effect at all. In some cases, the toxic effects are intended. That's the 'design' of drugs. But in many cases the toxic effects are unintended, or even unknown. Generally unknown until many people fall ill or die. Mercola tells us that drugs kill more people than car accidents in the USA.
Are some drugs worthwhile? Are some drugs the 'best treatment'? Yes. Of course. If you have a bacterial infection, the best treatment might be a toxin that kills the bacteria, but has minimal effect on your health and healthy cells. An anti-biotic. However, most, possibly all antibiotics kill some healthy cells as well.
We need to search for health, not illness. We need to search for 'heals', not 'cures'. We need honesty and openness about treatments; to measure which treatments have the best effect on any illness, not which is the 'latest (untested on the public at large) drug'.
New drugs have the most potential for danger. We need a health paradigm, not an illness paradigm. We need a healthicine paradigm, not a drug paradigm.
Yours in health, tracy
Tracy is the author of two book about healthicine: