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How Safe Are Unregulated Drugs or Supplements

This article gives you some information on the safety issues of Over-the-Counter (OTC) supplements and herbal remedies.

Are Unregulated Over-the-Counter Supplements and Herbal Remedies Safe?

There is an increasing concern on the use of Over-the-Counter (OTC) supplements and Herbal Remedies because these products are not regulated by the Food and Drug Administration (FDA). The use of OTC supplements and herbal remedies by Americans is becoming a part of the daily household purchasing. According to Tufts University, the Hartman Group (a Washington-based marketing research firm) reported its findings that Americans spent $1 billion a year on Vitamin E supplements and close to $1 billion a year is spent on Calcium supplements. Because these products are unregulated by the FDA, the accountability on their safe use is non-existent.

The FDA, is a U.S. Government regulatory agency, which safeguards the use of drugs or supplements not only by mandating their release and safe dosage, but also ensures accountability. The FDA allows prescription and OTC drugs to be sold on the market only after passing rigorous testing. OTC supplements and herbal remedies on the other hand, do not go through this route, therefore, they have no pre-market Government approval. As a health care professional, I would caution everyone on the use of OTC supplements and herbal remedies. Because it is non-regulated, suppliers of these products can use "miraculous" words on the labels. These tactics can virtually entice shoppers to willingly spend dollars to buy these products without realizing the danger involved. Many of these products claim significant levels of vitamins, other nutrients or elements indicating miraculous power to cure illness or boost health status. Because we (as humans), believe that "a lot is better", and "having more is powerful" - we easily get carried away when we read these claims. How do you know these suppliers are telling you the truth that the product is pure and free of harmful substances?

The Tufts University -Health & Nutrition Letter, reports that ConsumerLab.com is an independent company that acts as a watchdog over the supplement industry. According to Tufts, ConsumerLab.com investigated and tested several products for their contents to prove the industry’s claim. Products that were investigated and tested included Ginkgo biloba (an herb supplement believed to improve memory), Glucosamine and Chondroitin (used for pain and stiffness of osteoarthritis), calcium supplements, and Ginseng (an herb believed to cure fatigue and stress). Their findings included many of the products failed to show content of the amount of substance claimed on the label. "At least two ginseng products for instance, harbor potentially cancer-promoting pesticides at more than 20 times the acceptable levels. And at least two contain unacceptable levels of lead, a harmful metal that’s toxic to the nervous system." Likewise, many of these products have no scientific basis to prove its claim.

ConsumerLab.com lists the supplements that made it through their "Pass List." Nevertheless, their "Pass List" is not a guarantee of the product, but a quality approved product that passed their independent review. To get your money’s worth when you buy a product without knowing its purity, reliability, effectiveness and safety, a good start would be to look at the ConsumerLab.com's "Pass List" for quality approved products.

Once again, let me emphasize that the best source of vitamins and minerals, which are preferably absorbed by the body, is from food. Foods give many nutrients that are "naturally built-in" to enhance health. The best way to start is to eat 3 well-balanced meals daily to get the adequate nutrients that your body needs. To find out how much you should eat to get a well-balanced meal, let the Food Guide Pyramid guide you with the daily recommended servings.

-- Ofelia B. Mutia, M.S.,R.D.,L.D.

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Thursday, August 2, 2001