If you answered YES, you answered correctly; if you answered NO, you also answered correctly.  The reason both answers are correct is due to the confusing legal language of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which is the law that governs the sale of dietary supplements. Sponsored by Sens. Hatch and Harkin, the law is seen by its detractors as a law that was bought by the dietary supplement industry and exposes consumers to unnecessary risks. Within four years of its passsge, annual sales of dietary supplements jumped from $4 to $12 billion. The reason is that manufacturers no longer need approval from the Food and Drug Administration to market a new dietary supplement.


 While it is perfectly legal for a dietary supplement manufacturer or retailer to claim that a product can make a person beautiful, it is illegal for a company to claim on the label of a product that taking a dietary supplement can "cure, treat or prevent a disease." While that may seem intuitive, there are many health claims made about dietary supplements that are more complex and vague.

   This area of law becomes particularly gray when it comes to pamphlets, books and magazine articles that are written to promote sales of dietary supplements. This literature is known as third-party literature, and is often used to make unsubstantiated health claims about dietary supplements.

    For example, a pamphlet that claims "Vitamin E can help prevent heart disease," is making what is called a disease claim.  This is illegal under DSHEA because there is no conclusive evidence that Vitamin E prevents heart disease, and it is not one of the three health claims that have been approved by the FDA for dietary supplements. However, if another pamphlet claims "Vitaman E promotes a healthy heart," it is not making a disease claim and is legal under DSHEA. The question facing consumers is, "Is there really a difference in these two claims, and if so, how can one be distinguished from the other?

 That question will likely be settled when a prominent court case regarding another health claim is settled. The claim in question is: "Red-yeast rice promotes healthy cholesterol levels." The company making that claim, Pharmanex, originally claimed that its product CHOLESTIN "reduces cholesterol levels." However, because of the clear connection between elevated cholesterol levels and heart disease, the FDA made Pharmanex change the wording from "prevents high cholesterol levels" to "promotes healthy cholesterol levels." Even then, the FDA ruled Cholestin is an illegal drug and impounded several tons of Red-yeast rice. The case is still in court.

 As a consumer, you need to understand why you read many types of disease claims in books, newspapers and magazines.  Most of these claims are not based on peer-reviewed scientific evidence, and in many cases, do not present the possible bad side effects and drug interactions of many dietary supplements. Certain companies, Web sites and authors are more responsible than others in this area, but the larger problem is that many of the side effects and interactions are not known because many substances have not been scientifically studied. Some companies are trying to standardize dietary supplements, but without patent protection, most companies will not invest the necessary funds to perform the proper studies on these products. It is still very much a "buyer beware" market.

 This Web site will give you a better understanding of DSHEA and how it affects what manufacturers claim on dietary supplement labels, or in ads on television, or in books, magazines and pamphlets. Hopefully, it will aid you in making good decisions about your health.

   A Brief History Of Dietary Supplements

   The use of herbs and animal glands as medicines dates back to the origins of civilized man. The earliest known written records of herbal medicines were inscribed on six-thousand-year-old clay tablets written by the Sumerians, who lived on the banks of the Tigris and Euphrates Rivers in what is now Iraq. The tablets showed use of many medicinal plants including opium poppy, thyme, licorice and mustard plant.  Moreover, the Asian cultures, particularly in the Sichuan province of China, have a long recorded history of herbal use dating back more than three thousand years.

  The United States has a much shorter history of medicinal herbal use. Native American Indians and early European settlers certainly used herbs and glands as medicines, but not to the extent of the Asians. And although several important drugs are derived from herbs, notably Aspirin from the Willow Bark tree, and Digoxin, a potent heart drug, from the Digitalis plant, most Americans shy away from herbal preparations when synthetic ones are available.

 However, it is interesting to note that the use of herbs and alternative medicines is more popular in the United States now than ever before. But there remains a vast gap in our knowledge about which constituents in a particular herb are the active ones. Even when scientists know what active substthe ances are, critics say that because whole plants act in synergy, it is fruitless to try and isolate the active ingredients. Moreover, the legal history of dietary supplements in the United States is a long and twisted tale. Due to space restrictions, only recent history will be included here.

     Prior to 1990, all dietary supplements were tightly regulated by the FDA and only included essential nutrients such as vitamins, minerals and proteins. In 1990, the Nutrition Labeling and Education Act expanded the category to include "herbs or similar nutritional substances," but the FDA maintained control over pre-market approval.  However, in 1994, a law was passed that drastically changed the dietary supplement marketplace. That law is the landmark Dietary Supplement Health and Education Act (DSHEA), and it expanded the category of dietary supplements further to include substances such as: "Ginseng, fish oils, enzymes, glandular products such as hormones and steroids, and mixtures of these."

 More important to the consumer, DSHEA also removed much of the FDA's control over dietary supplements and created what is considered by many health officials to be a virtually unregulated industry. There is no law to prevent you from chopping up some potent herbs, putting them in a bottle, and making claims for those herb's effects. All that is necessary is to send a letter to the FDA stating that you don't "expect any negative side effects from the product." The FDA has no authority to deny your product entry into the marketplace! Once again, the term is, Buyer Beware.

  Dietary Supplements Under DSHEA

  DEFINITION: A product intended to supplement the diet that contains one or more of the following ingredients: A vitamin, a mineral, an herb or other botanical, an amino acid, organ tissues, or a concentrate or extract of these ingredients. It cannot be represented for use as a food.

  FORMS INCLUDE: Tablets, capsules, powders, softgels, liquids and teas.

  WHERE SOLD: Health food stores, grocery stores, drug stores, national discount chains,   mail-order and Internet.

  ALLOWABLE CLAIMS: Statements about how a product affects the structure or a function of   the human body.  Example: "Calcium builds strong bones."

  NOT ALLOWED: Statements that say a supplement can cure or treat a disease.                                 Example: "Ginkgo Biloba prevents dementia."

  SOURCE: The Dietary Supplement Health and Education Act of 1994 (DSHEA).

 Disclaimer: This Web site has no commercial relationships with any other Web sites that may be linked to it. The author is a professional journalist who obtained the majority of the data for this site from interviews with leading industry professionals. The purpose of the data presented and the links made available is strictly educational. Copyright April, 2000. Paul A. Kimpel

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