ISSN: 1391 - 0531
Sunday, December 03, 2006
Vol. 41 - No 27

Little check on never ceasing flow of hope

Offering solutions to weight problems, virility and much much more, dietery supplements are freely available over the counter, but with little regulation over their quality and health effects

By Ayesha Inoon and Smriti Daniel

They sell us hope. Men buy virility, women clear skin. Mothers buy strength and bolstered immune systems for their children – the elderly buy relief from their pain. Those who are overweight buy weight loss and stressed workaholics buy relaxation. The list is endless.

Dietary supplements are fast gaining popularity, not only in Sri Lanka, but the world over. Drawn by the colourful advertising, people are looking to these supplements as a quick and convenient way of getting healthier, stronger and even better looking.

What exactly is a dietary supplement? A dietary supplement is a product, that is intended to supplement the diet, that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, a herb, a dietary substance for use by man to supplement the diet, by increasing the total daily intake; or a concentrate, metabolite, constituent extract or combination of these ingredients. It is intended for use in pill, capsule, tablet or liquid form, and is not represented for use as a conventional food or as the sole item of a meal or diet and is labelled as a dietary supplement.

Despite the large numbers of these products now flooding the market, there are currently no laws or regulations in place to assess the quality or to control their importation and distribution. These items, which cannot be classified as either ‘food’ or ‘drugs’, are therefore not registered under the Cosmetic Devices and Drugs Act or the Food Act and are freely available over the counter.

According to the Nutritionist at the Police Medical Services, N.M.S. Hettigedera, dietary supplements are not an alternative to a healthy balanced diet, and, despite possible health benefits, often carry hidden risks – particularly when taken alongside other supplements or drugs.

“Dietary supplements can affect the action of therapeutic drugs,” he says. For example, if a patient suffering from cardiac disease is on the drug ‘digoxin’ and takes a supplement containing Ginseng, the level of the drug can rapidly increase in the body and become toxic. If taken along with diabetic medication, it can cause a severe drop in the blood sugar level. Some supplements can have an adverse effect on the anticoagulant properties of certain heart drugs, reducing their efficacy.

“Many supplements have high doses of vitamins, some of which can also become toxic if taken above a certain level,” he adds. Too much Vitamin A, for instance, can cause birth defects and liver problems while an excess of potassium can be dangerous to those suffering from renal disease.

Consumers should also be aware that even the better-known supplements have several contraindications, he cautions. The popular herbal supplement, ‘Evening Primrose Oil’, for example, is taken by people all over the world to reduce the symptoms of Pre- Menstrual Syndrome, psoriasis, eczema and attention deficit disorder. However, it can increase the risk of epilepsy, worsen the condition of schizophrenic patients and there is no data for the safety of its use during pregnancy or breastfeeding.

Slimming and energy supplements also carry their own health risks, he adds. Since the ‘energy boosters’ are usually taken by the young urban population who already have a diet high in proteins and carbohydrates, the frequent consumption of these supplements can increase their risk of obesity with all its negative health effects.

Countries all over the world are currently trying to bring in new regulations and guidelines to monitor these supplements. In many European countries food supplements can be sold only as long as they are safe and no medicinal claims are made. Health claims are permitted if they can be backed up by reliable evidence. There is a list of permitted claims and new ones are evaluated.

In Sri Lanka, a committee was appointed in 2005 by the Director General of Health Services Dr. Athula Kahandaliyanage, combining the food and drug authorities to oversee this issue. Since then, the committee appears to have put in a great deal of thought into forming the required regulations, but these are still many a step away from being successfully implemented.

“The delay is because the authorities have been busy with other issues,” says Dr. Kahandaliyanage, adding that they hope to bring these regulations into action as soon as possible.

“We have identified this as a problem,” says Assistant Director at the Food Control Administration Unit, Ministry of Health, P. Madarasinghe. “To overcome this problem, we have come out with a new procedure regarding dietary supplements which is still in the draft stage.”

According to Mr. Madarasinghe, the current problem is that of classification. At present there are two Acts – The Food Act and the Drug Act under which there are certain prohibitions, but which do not cover neutraceuticals and many of the newer products. A product isolated or purified from food that is generally sold in medicinal forms not usually associated with food, a neutraceutical is demonstrated to have physiological benefits or provide protection against chronic disease.

However, the committee has formulated a mechanism by which these supplements can be classified as either food or drugs.

“Dietary supplements which claim to be a treatment or cure for a specific condition – such as diabetes or cholesterol – will henceforth be considered drugs, and the manufacturers will have to submit dossiers backing their claim,” Mr. Madarasinghe says. The RDA (Recommended Daily Allowance) of a product will also be considered when designating a product as a food or a drug.

He adds that since there are currently no restrictions in place, certain substances which are banned in other countries, such as ‘kava kava’ may be among the ingredients in the supplements currently being sold in the country.

When the proposed regulations come into place, perhaps early next year, a food advisory subcommittee consisting of nutritionists, food technologists and other professionals will investigate such issues, and products will have to undergo a registration process before they can be released into the market.

Until then however, the responsibility lies with the consumer to understand the various implications of taking these supplements. “People should not believe everything they see on the labels,” says Mr. Hettigedera. He advises that one should carefully look at the ingredients as well as read and understand the possible side effects and contraindications of a product before buying it.

“The pharmacist also has a special role to play,” he says. While respecting the beliefs of those who want to take responsibility for their own treatment, the pharmacist should assist them in making the correct choices. Mr. Hettigedera also stresses on the importance of reporting adverse reactions, especially drug-herb interactions to the authorities.

It is always best to consult with a health care professional, such as a physician or nutritionist before taking these supplements, he says.

“It is very difficult to standardise these kinds of products so as a quality measure we must have a guarantee of the quality of the product,” says Mr. Hettigedera. “We must make sure they have the right manufacturing licence and that regular inspections are carried out in the relevant countries by the authorities to see if manufacturers are following good manufacturing procedures.”
However, in the U.S.A, it is the dietary supplement manufacturer who is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

Therefore, the fact that a product is sold in the U.S.A or some other country does not necessarily indicate that it is safe for consumption.

As the Ministry struggles to implement the proposed regulations, it seems the onus is on the consumers in more ways than one.
Consumers should report not only adverse reactions to any supplements but also draw the attention of the authorities to cases where marketers seem to be making unsubstantiated and grandiose claims. Such a strong consumer society might, in the end, be our best hope in the current situation.

Tips for consumers

The Food (Labelling and Advertising) Regulations 2005, under Section 32 of the Food Act No. 26 of 1980 lay down certain requirements. Since dietary supplements do not fall into the category of food this legislation does not curently apply to those products says Director General of Health Services Dr. Athula Kahandaliyanage. If food manufacturers make the following claims without receiving authorization from the Food Advisory Committee, however, the Ministry will take legal action against them, he says.

Some food experts claim that what applies to food may also apply to food supplements. Until these technicalities are sorted out by the authorities, the consumer is advised to be mindful of any products making the following claims.

  1. No label or advertisement relating to any food shall claim that dietary fats are a protection against heart diseases or of benefit to persons suffering from heart disease.
  2. No label or advertisement relating to any food shall indicate directly or indirectly that such food contains tonic, restorative or medicinal property or properties which make it beneficial for invalids or which will cure, alleviate or prevent any illness.
  3. No label or advertisement relating to any food shall indicate directly or indirectly that such food is a cure for any illness.
  4. No label or advertisement relating to any food shall claim such food to be an aid for slimming, weight control or weight reduction.


Safe for consumption

While some pharmaceutical companies say that they avoid importing dietary supplements because they are unable to substantiate the claims made and do not wish to assume the responsibility for guaranteeing the safety of such products, others say that they have no doubts about the safety or efficacy of the products they import.

“We have been importing these products for the past 18 years and we have to keep up our standards,” says Shurik Moulana, Brand Manager, Harcourts (Pvt) Ltd, who import supplements from countries such as USA, Thailand and India. When they choose a particular dietary supplement for importation, he says, they ask for a complete dossier on the product including WHO certifications and clinical trials, all of which have been done by the parent company, and thoroughly research its reliability.

Country Manager for Sri Lanka and Maldives, Novartis Medical Nutrition Madhu Siriwardana, also says that their products are completely drug free, and approved by both the FDA as well as the WHO and are therefore safe for consumption.

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Copyright 2006 Wijeya Newspapers Ltd.Colombo. Sri Lanka.