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![]() By: Daniel Gastelu
A series of news segments produced by CBS Evening News featured an author who wrote a sensationalized book about the dietary supplement industry. The news segments were only a few minutes long and also featured representatives from health product trade organizations to provide their positions about the critical comments. But these representatives only had seconds to state their positions; not much time to review such a comprehensive and important subject. A significant health topic like this deserves lengthy coverage by the media, because the real news is about how dietary supplements benefit health. The health benefits of dietary supplements are well established. There are thousands of studies published in support of the numerous health benefits dietary supplements have to offer. For example, the International Bibliographic Information on Dietary Supplements (IBIDS) is a database of such scientific studies. The IBIDS database contains over 730,000 citations on the topic of dietary supplements from four major database sources:
The Scope Of IBIDS Includes:
Dietary supplements are especially well suited for athletes, who as a group have special nutritional requirements that are typically not being met by food alone. In addition to promoting good health, certain supplements are research proven to improve muscle, strength and endurance. For example there are about 200 studies that prove the effectiveness of creatine; refer to my Creatine Super-Feature for a review of the recent research studies, then there is carnitine with a range of health and athletic performance benefits, which is now considered a conditionally essential nutrient by the National Institutes of Health.
You can also review my 10 section Sports Nutrition Guide for an overview of more research proven sports nutrition products and approaches.
When it comes to researching the potential health benefits of foods, drugs or dietary supplements a range of results is expected. In other words, a substance or product may be beneficial for some uses but not necessarily for others. For example, the author mentioned that a study for a botanical, St. John's Wort, did not show any improvements for severe depression. What the author failed to mention was that many other studies have reported that St. John's Wort is effective in treating mild to moderate depression. But keep in mind that technically this is considered a drug claim, and even though this use for St. John's Wort has scientific substantiation, dietary supplements cannot be sold to treat a disease; drug use approval would be needed for this, as reviewed below.
Regulatory distinctions aside, here is a press release from the Council for Responsible Nutrition to get a flavor about how these news shows were portrayed. Note that on the first news segment about herbal supplements a representative from CRN appeared to convey that dietary supplements are safe and effective for many uses.
From viewing the news segments and other previous coverage of dietary supplements in the media, there appears to be some perpetually confused issues about what dietary supplements actually are and what they are supposed to do. For example, dietary supplement products are not drugs, and technically cannot be sold to treat diseases. However, consumers often self prescribe dietary supplement products on their own or in conjunction with their health professional as supportive treatment of certain diseases. On the other hand, dietary supplements can be sold to prevent diseases, in particular nutritional deficiency related diseases. But also other types of diseases, under the health claim provisions of the regulations. These types of claims are approved by the Food and Drug Administration (FDA). Like foods and drugs, dietary supplements are a highly regulated, as I wrote about in a previous article. See my "FDA Authorized Claims That Can Be Made for Foods and Dietary Supplements" article for details about this.
The Natural Products Association provides an independent overview of some of the issues regarding the regulation, substantiation and safety of dietary supplements. So while the research about how nutrients and other legal ingredients used in dietary supplements and foods can be effective in treating a variety of diseases, products for these types of uses would have to be pre-approved by the FDA, and sold as drugs. And because the drug approval process in the USA is very expensive, there is a lack of incentive to get supplement type products approved as drugs. With all of the research supporting the use of dietary supplements for the treatment of diseases, there is a need for a new category of natural drug type products. Looking outside the USA for examples, Canada recently created the Natural Health Product category of products, which includes the use of vitamins, minerals, botanicals, amino acids, and metabolites for approved uses to treat a variety of diseases. You can visit their website to review the monographs for the currently approved Natural Health Products. When you review these monographs you will discover that based on the Canadian Government's expert review, here are some examples of Natural Health Product approved ingredients and their approved uses/claims.
Like foods, depending on the ingredients being used, dietary supplement products do not require pre-marketing approvals. Like foods, the ingredients for use in dietary supplements are already considered to be safe by the Food and Drug Administration. Before a new ingredient is used in a dietary supplement product, safety data must be submitted to the FDA under the New Dietary Ingredient requirements of the dietary supplement regulations. Based on the safety data submitted, FDA can permit the use of the new ingredient or deny the use of the new ingredient. This follows the similar process for new ingredients to be used in conventional foods. It is important to realize that aside from this starting point of using ingredients already considered to be safe, the FDA does have that authority to remove an ingredient or product from the market if there is an adverse health concern. The FDA has this authority for all of the products it regulates, such as foods, dietary supplements, drugs, medical devices, cosmetics, and veterinary products.
The dietary supplement regulations are the way they are because this is what American citizens wanted. Members of Congress passed the Dietary Supplement Health and Education Act of 1994 based on both scientific support and overwhelming public support. As with all aspects of society, there will be reevaluation and refinements along the way. For example, in December 2006 President Bush signed into law the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER bill"), S. 3546. The legislation amends the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration (FDA). Keep in mind that companies manufacturing FDA regulated products have been required to keep track of even the most minor health related customer complaints, before this new law. As an industry insider, I see an emerging opportunity to create a claims approved category for dietary supplements. Currently, each company creating dietary supplement products and foods relies upon their own evaluation of the scientific evidence to determine ingredients, ingredient combinations, product claims and dosages; except for health claims, which are approved by the FDA. While this approach is working well, sometimes lines get crossed in the market place. For example, the benefits of ginkgo are well established in promoting mental wellness, and there are some high quality, research tested products on the market. But, there are also a variety of unstandardized ginkgo products, and while these are lawful products, they may not have the potency to produce the same health benefits as the standardized, research proven ginkgo products.
Then there is the opportunity to create an entirely new product category similar to Canada's Natural Health Products. In this way, we can enjoy the many benefits that natural products offer for treatment of diseases, in most cases in ways that conventional drugs cannot.
For the sake of our health, it is time to put publisher and media driven confusion and self motivated controversy aside. It is time to focus on promoting the proven health benefits that dietary supplements have to offer, and continue research in this regard. After you spend time reviewing the research summaries stored in the IBIDS searchable database, the vast health benefits dietary supplements and related products has to offer is conceivably limitless. Yes, Hippocrates, the Father of Modern medicine, was correct when he said; "Let food be thy medicine, and medicine be thy food." The updated version of this famous quote could be,
"Let food and dietary supplements..."
You can visit Awesome Muscles to hear about the latest and greatest information about training and nutrition for sports, fitness and health. This is a Podcast seminar series, which you can also listen to online or download on to your computer.
Copyright © 2007 SUPPLEMENTFACTS International LLC. All Rights Reserved. Notice and Disclaimer: This article is not intended for use as a substitute for consultation with a qualified medical practitioner. If you have symptoms of any illness or injury, it is essential that you see your doctor immediately for proper treatment. This information is for education and entertainment purposes only. We strongly recommend that you consult for matters of health.
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