DIETARY SUPPLEMENTS

In 2000 it was estimated that Americans spent 17 billion dollars on a wide array of over-the-counter (OTC) products known collectively as dietary supplements.  These nonprescription products are legally described as:

·         Products (other than tobacco) that are intended to supplement the diet, including vitamins, amino acids, minerals, glandular extracts, herbs, and other plant products such as fungi

·         Products that are intended for use by people to supplement the total daily intake of nutrients in the diet

·         Products that are intended to be ingested in tablet, capsule, softgel, gelcap, and liquid form

·         Products that are in themselves to be used as conventional foods or as the only items of a meal or diet

Unlike prescription medications, dietary supplements have been available in the market place for years almost without restriction.  However, dietary supplements now must be deemed safe for human use on the basis of information supplied to the FDA by the manufacturers.  In addition, the labels on these products cannot make a direct claim, with the exception of calcium and folic acid supplements, that they can cure or prevent illness.  However, other material with such claims may be displayed close to the dietary supplements themselves.  Further, the labels on dietary supplements must remind consumers that the FDA has not required these products to undergo the rigorous research required of prescription medications and so the FDA cannot attest to their effectiveness.  Beyond this, consumers are left to themselves to decide whether to purchase and use dietary supplements.

Probiotic products, dietary supplements with live bacteria, are gaining in popularity.   Probiotics are “good bugs” and they by making the environment in the digestive system inhospitable for harmful bacteria.  The U.S. sales of probiotic supplements have increased 10 to 15% over the past 5 years, reaching $170 million in 2002.  Actimel is one of the biggest sellers, claiming to “help to strengthen your body’s natural defenses” and enhance your immune system.  Yogurt is another way to get your daily dose of probiotics as it contains lactobacillus bulgaris.

Easily accessible to anyone, over 15,000 different dietary supplements can be purchased in grocery stores, drugstores, and discount stores, through mail-order catalogs, and over the Internet.  Because of the great demand for these products, major pharmaceutical companies are now entering the dietary supplement field.  Whether this trend leads to the development of more effective products, or to a greater effort on the part of the FDA to demand proof of effectiveness, remains to be seen.  By definition, supplements are not foods, but simply “supplements.”  Therefore they remain free from requirements to substantiate their claims of effectiveness (as now required for functional foods).