I have received a very important message from Martin Seychell, B.Pharm.Tech. (Hons.) of the Malta Standards Authority. As consumers we must be aware of the following information:
Legal Notice 239 of 2003 regulates the composition of food supplements. A variety of food supplements exist on the market, but these can be subdivided into the following main categories:
a) Vitamin and mineral supplements, such as supplements containing vitamin C, calcium or iron, for example;
b) Supplements containing other types of nutrients, such as proteins, amino acids, fatty acids; and
c) Herbal supplements, such as plant extracts.
Food supplements are generally concentrated forms of the above nutrients and substances, presented as tablets, pills, capsules, powders and similar dosage forms. Despite their similarity in appearance, food supplements are not medicines but are a special category of foodstuffs.
Therefore, all aspects of food legislation are applicable to the labelling, composition and marketing of supplements. This includes the prohibition of any claim that a supplement may cure, prevent or alleviate a disease. Any such claim would lead to the product being classified as a medicinal product and not as a food supplement.
Consumers should be aware of this very important distinction between medicinal products and food supplements. Different criteria are applied in determining the safety of products in each of these cases. Medicines are intended for treatment of specific abnormal conditions and therefore a certain degree of undesirable effects may be tolerated, provided that the benefit to the patient is greater than the risk.
This risk-benefit analysis is an integral part of the authorisation procedure that medicines have to undergo before being placed on the market. Furthermore, medicinal products are intended for use during as part of a treatment, and always under the supervision of a medical professional.
On the other hand, foods are intended for the general population, as part of their overall diet. All foods, including food supplements, are placed on the market by the manufacturer on his/her own responsibility, subject to control by the health authorities. In the case of food supplements, manufacturers must ensure that these do not present any risk of toxicity to consumers. This is done through a process known as risk assessment, where the effects of the substance at specific dosage levels on various body organs and functions is studied.
A safe level for use is then established, including an appropriate margin of safety. If there is any risk to certain categories of vulnerable consumers, such as children, the elderly, pregnant women or persons suffering from specific conditions, this risk must be clearly indicated on the label or information accompanying the product and the necessary advice must be provided to eliminate this risk to the greatest extent possible.
As mentioned earlier, food supplements are not subject to the authorisation/permit procedure used for medicines. This does not mean that they are not regulated. LN 239/2003 requires that all food supplements placed on the Maltese market be notified to the Malta Standards Authority.
This notification has two main aims. First, it ensures that the Authority is continuously updated about supplements present on the market and is thus in a position to monitor them, request data on their safety wherever this is considered necessary, as well as follow trends in consumption and formulation which may need to be studied more closely.
Secondly, the notification procedure ensures that whoever is marketing a food supplement assumes responsibility for it. It is important to emphasise that the notification procedure is not an authorisation procedure and those who make the respective notifications cannot claim that their products have been 'approved' by MSA or anybody else.
Unlike most other foodstuffs, the point of sale of food supplements is also regulated so as to ensure that a qualified person is present to answer any questions and advise consumers on any risks.
Consumers often ask whether food supplements are necessary. The simple answer is that a healthy person eating a balanced diet should be obtaining all his/her nutritional requirements from other foods. This is not to say that supplementation may not have a role in the diet.
A number of beneficial effects are claimed for various substances and, although not all can be easily substantiated, it is clear that some benefits exist, provided appropriate doses are used.
It should also be remembered that, unfortunately, many people, for various reasons, may not have a balanced diet or may require supplementation for other reasons. The important thing to remember is that one should always read the instructions carefully and consult with a doctor or pharmacist when medical conditions exist, when taking medication or when any side effect or reaction is noted.
Yet again, I thank Mr Seychell for his co-operation. As a regular guest (on Mondays) in the programme Mill-Box hosted by Valerie Vella on TVM, I invited him to give you some more useful information, on Monday, January 26.