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The Dietary Supplement Health and Education Act: A Legislative History and Analysis.
The most important piece of legislation affecting the regulatory status of herbs and related products in the last several decades is the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law has created a new regulatory category called "Dietary Supplements" which includes vitamins, minerals, amino acids, herbs, and other botanical preparations. In addition, provisions of the Act declare that these substances are not "food additives" nor are they drugs. Further, DSHEA allows manufacturers to publish more complete directions for use than previously allowed, which include warnings, contraindications, and side effects -- information that was previously reserved only for approved drug products. A very interesting and somewhat controversial section of the Act allows manufacturers to publish limited information regarding the benefits of dietary supplements in the form of "Statements of Nutritional Support" as well as so-called "Structure and Function Claims." The Act al so requires the development of a new level of good manufacturing practices (GMPs), the creation of a Presidential Commission on Dietary Supplement Labels to advise and recommend to the Food and Drug Administration (FDA) appropriate policy on the labeling and various claims for these products, the creation of the Office of Dietary Supplements at the National Institutes of Health, charged with developing and coordinating research in this area. The authors of this book are emminently qualified to present the most complete information on this landmark legislation available in one publication. Both are attorneys representing the National Nutritional Foods Association (NNFA), a trade association of manufacturers, distributors, and retailers in the health food and dietary supplement industry. Both authors were directly involved in the various meetings and negotiations that occurred over a two- to three-year period culminating in the passage of DSHEA. The book is divided into 11 chapters. Chapter 1 deals with a summary of the Act. Chapter 2 gives a brief history of regulations dealing with dietary supplements in the United States. Chapter 3 discusses several previous Acts that were introduced in Congress in 1992 that dealt with attempts to reform dietary supplement regulation. Chapter 4, one of the most important aspects of this book, deals with the passage of Senate Bill 874, later known as DSHEA, and the various issues that were discussed in Senate hearings, an in-depth comparison of the House and Senate diversions of the bill, and various attempts to effect passage of the final legislation. Chapter 5 deals with the legal definition of dietary supplement as it finally evolved in the Act. Chapter 6 deals with the issue of "New Dietary Ingredients," the term which refers to ingredients that were not commonly sold in the U.S. marketplace prior to the passage of the Act in October, 1994. This section also covers procedures with which companies must comply in order to market a new dietary ingredient as well as additional enforcement power granted to FDA. Chapter 7 covers another more controversial aspect of the bill -- transfer of the burden of proof of the safety of a dietary supplement from the marketer to the FDA. Chapter 8 discusses an important aspect of the Act which helps to increase the quantity and quality of educational information on dietary supplements, including so-called "third party literature" and reform of labels under DSHEA. Chapter 9 deals with what is probably the most interesting area of the Act relative to its effect on the explosion of supplement, especially herb, sales in the marketplace, i.e., the statements of nutritional support and structure and function claims, an area of increasing interest and activity to both the FDA and the Federal Trade Commission. Chapter 10 discusses the new label for dietary supplements under DSHEA which includes the ability of industry to provide warning s and directions, nutrient content claims, and a redefined nutrition facts box. Finally, Chapter 11 covers the Commission for Dietary Supplement Labels and the Office of Dietary Supplements at NIH. The book also provides numerous appendices, including copies of the original Senate versions of the bill, the Acts that were proposed in 1992, and the Amendment to the Senate Act, as well as the Nutrition Labeling and Education Act of 1990 (NLEA), an important piece of legislation upon which the dietary supplement debate in Congress and the passage of DSHEA is predicated. This is a useful and indispensable book for every U.S. company currently selling any form of dietary supplements. In addition, this book will also provide considerable value to food, pharmaceutical, and foreign companies which manufacture ingredients and/or advanced products intended for sale in the U.S. Finally, this book will provide considerable value to attorneys, regulatory affairs consultants, and any researchers in the nutrition and botanical fields who would like to have a better understanding of the legal and regulatory landscape in which these increasingly important consumer products are being sold. Article copyright American Botanical Council. ~~~~~~~~ By Mark Blumenthal">by I. Scott Bass and Anthony L. Young. 1996, Washington D.C.: Food and Drug Law Institute. Softcover. 319 pp. ISBN #C:\Inetpub\wwwroot\Data