There is an increasing trend in developing countries to follow the patterns and life-styles of populations in the western developed World and the latest is the case of increasing popularity in the use of what are termed as Nutraceuticals. They are also known as Nutritional and Food Supplements as non-prescription, Over The Counter (OTC) products for healthcare.
Perceptions vary a great deal as to what constitutes these products, their precise role in healthcare and the importance of regulating their use to ensure that they do contribute towards improving healthcare as complementary or alternate systems to modern medicine without causing any damage to the consumers.
Even though, in the Indian context, products of Indian Systems of Medicine (ISM) had always claimed that their efficacy for promoting health (not merely for curing diseases), is due to the potentiation of immunity in the patient, thereby building resistance of the body against diseases, the modern concept of use of Nutraceuticals is a concept imported from the West.
These class of products range from Vitamins, Minerals and Trace elements, Herbal products and Amino Acids and Proteins to replacement therapy for various diseases due to deficiencies of essential nutrients. In fact, many of the Vitamins were discovered through their correlation to diseases such as Xerophthalmia & Keratomalacia (Vitamin A), Beri-Beri (Vitamin B1), Scurvy (Vitamin C), Rickets & Osteomalacia (Vitamin D), Pellagra (Niacin), RBC hemolysis & Creatinuria (Vitamin E) Glossitis, Peripheral Neuropathy & Lymphopenia (Vitamin B6), Megaloblastic Anaemia (Folic Acid & Vitamin B12), etc.
Same is the case of various minerals and trace elements, with around a dozen of them identified as essential for maintenance of the vital functions of the various mammalian tissues. Some of the more important are Iron, Iodine, Calcium, Copper, Manganese, Magnesium, Zinc, Cobalt, Molybdenum, Selenium, Chromium, Fluorine and Silicon. In addition to all these, herbal products have recently attained great importance and have become part of the complementary or alternate systems to modern medicine, as therapeutics and as prophylactics.
Majority of these products have one thing in common. They are all naturally occurring, whether from plants, animals or minerals, even though many of them are today produced through synthetic or fermentation routes.
Safety of Nutraceuticals
The belief that since they are natural products, they are devoid of adverse reactions or chronic toxicity is a myth. Even overuse of Vitamins result in Hypervitaminosis-related reactions, particularly in the case of fat soluble Vitamins, A, D and E. Products of herbal, animal or mineral origin used as Nutraceuticals also pose problems of toxicity and unexpected side reactions in humans due to their inherent toxic properties or due to contaminants from pesticides etc. Recently Nutraceuticals containing Ephedra have been banned in the U.S.A.
Problems of willful adulteration of several botanical drugs with steroids, anti-histamines, anti-diabetics etc to ensure or enhance their therapeutic usefulness are common. Very recently, the FDA found that some of the herbal preparations which led to several side effects including seizures, high blood pressure and skin rashes in a number of consumers contained diphenhydramine and dextromethorphan. It is illegal as per FDA rules to incorporate any drug in dietary supplements even if they are approved as OTC drugs.
Due to the fact the majority of products rely on natural products and also due to sometimes poor manufacturing standards, there have many quality problems associated with Nutraceuticals. In a recent survey by the U.S. FDA of 18 Soya products, it was found that in as many as 5, the content of Isoflavones was only 50-80 % of the declared levels.
Antioxidants
Among the wide spectrum of Nutraceuticals, the ones which have gained enormous markets are the class of products called antioxidants. While fruits and vegetables, notably, Spinach, Carrots, Tomatoes and others are good sources of antioxidants, reliance on packaged antioxidants with Vitamins C and E, Spirulina, Carotenoids, Curcumin etc, as well as semi-synthetic products such as Alpha Lipoic acid , Coenzyme Q 10 etc are getting increasingly popular as dietary supplements. The rationale behind their use is based on their role in the prevention of effects on body tissues of free oxygen radicals, by-products formed during the process of cellular metabolism. These radicals are capable of damaging most of the tissues of the human body such as the heart, lungs, liver, kidney etc.
Thus, in addition to slowing the degenerative process itself due to age or disease, antioxidants have the capacity to ward off heart diseases, cancer, cataract, maturity onset diabetes etc. Antioxidants work by binding to the free radicals thereby converting them into benign products.
Nutraceuticals Markets
Estimates of the global Nutraceuticals market vary a great deal, partly due to the ambiguities in the definition of what constitutes Nutraceuticals per se. If all categories including health foods, health beverages and nutritional supplements are included, the market size could be over $ 75 billion per year. It has been reported that during the period 1998 to 2003, this market had grown by 37.7%, but during the last 2/3 years the growth has leveled off.
Among the positive aspects responsible for growth in the earlier years could be mentioned consumers' interest to lead a life based on sensible health diet and life styles and the desire to have a say in the management of ones health without external inputs. The scientific rationale, however meager they are, also contribute to adoption of their use on a day-to-day basis. More recently, there has been a major re-look at these products by the consumers assisted by various groups of health professionals.
On the negative side are mentioned the lack of convincing evidence for their usefulness even as food supplements, reports of adverse reactions and the proliferation of unsubstantiated claims. Severe competition with too many products in the market and increasing regulatory hurdles through stricter implementation of legislative controls, have further affected the market growth for these products.
The U.S. sales of Herbal/Botanical products have been reported at around $ 4.3 billion in 1999, while sales in Europe were around $ 6.5 - 7 billion. In Europe two thirds of the sales are in France and Germany. Even though Asian countries have been in the forefront of use of Traditional Medicines which primarily use plant material, sales of modern Nutraceuticals are not more than $ 4.5 billion.
Global Regulatory Standards For Nutraceuticals
In the U.S., both herbal and non-herbal Nutraceuticals which have not been developed as drugs through an NDA route, can be marketed only as food supplements. The Federal government taking into account these factors enacted the Dietary Supplements Health Education Act (DSHEA) in 1994. It was emphasized that no unreasonable regulatory barriers will be imposed which will affect the flow of these products. DSHEA considers it important to disseminate appropriate information linking nutrition and long-term good health. The U.S.FDA allows food manufacturers to list health claims on labels even before they are scientifically proven, but will crack down on false or misleading claims. The purpose is to enable consumers make better choices when selecting foods. With estimated annual sales of $ 18 billion and 29000 products in the market and another 1000 added every year, the problem of monitoring them has become very complex.
In April 2004, the acting FDA Commissioner Lester Crawford outlined a new Science-based plan for Dietary Supplements enforcements, with the purpose of ensuring consumer protection under DSHEA. During the last six months, FDA inspected 180 U.S. dietary supplement manufacturers and sent out 118 warning letters for non-compliance with DSHEA. The agency refused entry of 1171 foreign shipments of dietary supplements and ordered destruction of products worth over $ 18 million (for mislabeling or for adulteration). The regulatory requirement is that the labels can make claims about the impact of a supplement on the structure of the body, but the claims must be truthful and not misleading. An example of misleading claims is in the case of Obesity claims where 16 Companies were sent warning notices. A draft global model for functional claims prepared by the industry association, IADSA states that statements such as 'Calcium helps build strong bones', 'Vitamin A is important for vision', 'Plant sterols can help lower cholesterol' 'Product Y helps enhance body's natural defenses' should be allowable claims for dietary supplements. The Association further recommends that food supplements may be placed on the market without the requirements of notifications as long as the ingredients, claims and labels adhere to the standards set for dietary supplements and the products are manufactured according to cGMP standards. They may be allowed to be marketed and sold through retail trade, direct sale or by mail order.
In Europe, particularly in France & Germany, the track record of safe use is often the yardstick for approval. The German Federal Health Office insists that the manufacturing process and the concerned products are standardized. The principles of Hazard Analysis and Critical Control Points (HACCP) shall be observed in the manufacturing of dietary supplements. England too uses the experience of prior use as a valuable indicator of safety and efficacy.
In China and India, traditional preparations are very widely used as complementary systems for management of healthcare. While in China the Traditional Chinese Medicines (TCM) are some what integrated with the Modern system of Medicine, in India, the two systems function as separate disciplines practiced only by those trained in the particular system.
It is thus obvious that in the global scenario, Nutraceuticals are treated as functional foods or as food supplements and the relatively thin line of distinction between these products and drugs are based on the specific claims made for their use as healthcare products.
Next Week: Nutraceuticals - Regulatory Concerns - Indian Scenario
-- The author is a leading scientist and industry observer