Page 25 - CTPA Annual Report 2011

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22.
It is the area of ‘medicine by function’ that has been causing
some confusion recently. A product is a medicine if it functions
as a medicine, even if no specific claims are made. It has been
said repeatedly and erroneously that cosmetic products must not
have a physiological effect otherwise they would be medicines.
This is quite wrong. Cosmetic products can and do have
physiological effects, but could still be classed as medicines if
those effects are brought about by specific mechanisms, which
are described later.
What is Physiology?
Physiology is the study of nature (from the Greek
φύσις
- physis
and
λογία
- logia) or, more specifically, the science of how the
normal body functions. It studies, for example, why our normal
body temperature is 37°C whether we are in the arctic or the
tropics and how we maintain that temperature by creating heat
through shivering or cooling ourselves through sweating.
Consider then a typical antiperspirant: by stopping sweating,
it has a significant effect on physiology, yet no one seriously
proposes that antiperspirants should be anything other than
cosmetic (toiletry) products.
Of course, many medicines also have physiological effects:
we have medicines to reduce blood pressure, to reduce stomach
acid, to supress coughing, to induce sleep, to deaden pain, etc.
Indeed, virtually all pharmacologically active medicines, i.e. drugs,
act on the physiology of the body to some extent. To establish
whether the physiological effect of a product is cosmetic or
medicinal requires knowledge of how that effect is brought
about; what is the mechanism of action? If the mechanism is
pharmacological, immunological or metabolic, and is significant,
the product is usually deemed a medicine.
These terms require further explanation.
Pharmacological activity
Pharmacological activity is, essentially, a drug action. An active
agent or drug is bringing about a change in the body’s activity.
The effect requires the presence of the drug and the effect
normally ceases when the drug is no longer present, although
not exclusively so as some drugs may have long-lasting effects.
But one might ask whether this is not also true of our
antiperspirant since it only works when present on the skin.
Immunological activity
Immunological activity is unlikely to concern cosmetics and the
discussion over borderline products since cosmetic products do
not act by altering or engaging with the immune system.
However, some ingredients used in cosmetics may have soothing
effects on the skin and any inflammatory reaction inevitably
involves the immune system so a link might be drawn.
Metabolic action
Metabolic action is, at first sight, also unlikely to involve cosmetic
products since this mechanism is concerned with the internal
functioning of individual cells and cosmetics do not set out to
change that. Or do they?
One of the most basic cosmetic products is the moisturiser.
Whether a cream or lotion, at its simplest, it is a mixture of
humectants to hold water, emollients to soften and lubricate
the skin and water itself, made into an emulsion. When used
on dry skin, the benefit is immediate and visible but with
repeated use, there is a general improvement in the condition
of the skin. Research has led to understanding how this benefit
has been achieved and has shown that there is indeed a change
in the metabolism of the skin cells as they mature and age,
leading to the increased production of natural moisturising
factor, increased water retention in the skin and reduction in
the dry, flaky, scaly look of dry skin. This comes about through
changes in the metabolism of the skin cells where different
genes are expressed and different enzymes produced. But again,
no one would expect a moisturiser to be classed as a medicine.
What does this mean for our ability to reliably differentiate
between a cosmetic and a medicine? Whilst we have seen
that cosmetics can and do have physiological effects that are
significant, and indeed must be significant to be efficacious,
we had thought that the mechanisms by which medicines act,
namely pharmacological, immunological and metabolic,
were not likely to be directly invoked by cosmetics and certainly
not to a significant degree.
However, the picture is perhaps not so clear and research has
established that even the most basic cosmetic products might
well lead to metabolic changes, might be deemed to act through
pharmacological mechanisms and, who knows, might even have
an impact upon our immune systems. Although the advice given
by MHRA recognises this possibility and states that minimal
pharmacological, immunological or metabolic effects would not
automatically lead to a product being classed as a medicine, as
we enter into exciting new areas of research in skin science,
future cosmetic products may well come under closer scrutiny as
borderline products. If we are to ensure that common sense
prevails and that safe, effective and high quality cosmetics can
bring innovations to market in a rapid and cost-effective fashion,
we ought to remind ourselves that, in essence, medicines take
the diseased and return them to normal whereas cosmetics take
the normal and make further improvements.
Cosmetic products contribute to our well-being and self-esteem.
Without them we could well suffer from lack of confidence in social
situations, in business, and in our health generally. But innovation
is about the unknown and the exciting new developments still to
be discovered. If those benefits are to be brought to the public,
the level of regulation must be appropriate.
Cosmetic products contribute to our well-being and
self-esteem and without them we would all suffer from
lack of confidence in social situations, in business and
in our health generally.
Photograph courtesy of John Frieda
®
- Kao Corporation