 Herbal Remedies: Cause or Cure of Ailments? . . . page 2 What Are the Regulations? Both the United States and Canada are grappling with the best way to regulate herbal products. The overall goal is to provide access to consumers while maintaining safety and ensuring truthful labeling that is not misleading. In Canada, regulations governing natural health remedies including herbal medicines have been delayed. The regulations, originally scheduled to become effective July 1, 1997 would have required establishments that manufacture or distribute drugs, including herbal remedies, to acquire annually an establishment license and pay establishment license fees. After an initial delay until January 1, 1998 for herbal remedies, traditional medicines, homeopathic preparations and vitamin and mineral supplements, the health minister called a halt to the regulations until a full and thorough public review could take place. While the review is underway, Health Canada continues to require that products meet standards of safety, efficacy, quality and cleanliness. In the United States, with the passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA), Congress amended the Food Drug and Cosmetic Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. The provisions of DSHEA define dietary supplements to include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet, or concentrates, metabolites, constituents, extracts or combinations of these ingredients. DSHEA also established a new framework for assuring safety. Like any other foods, it is the manufacturer's responsibility to ensure that the products are safe and properly labeled prior to marketing. As a result, dietary ingredients used in dietary supplements are no longer subject to premarket safety evaluations. This provision contrasts to drug regulations, which require premarket approval. The law also outlined guidelines for literature displayed where supplements are sold, provided for use of claims and nutritional support statements, required ingredient and nutrition labeling, and granted the Food and Drug Administration the authority to establish good manufacturing practice regulations. Finally, the law required the formation of a Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health . Critics of the law believe that DSHEA allows the sale of a broad range of dietary supplements without proof of safety, efficacy, or quality(10). They have also taken issue with DSHEA for allowing supplements to make health claims that foods containing the same nutrients cannot make(11). To remedy this situation, the Food and Drug Administration proposed rules in April 1998 that define certain permitted and prohibited types of labeling claims for dietary supplements. Unfortunately, there are few extensive, good information resources on dietary supplements. The United States Pharmacopeia is trying to fill this void by developing botanical monographs for health care professionals and leaflets for consumers. The following chart lists information about some of the more popular herbal remedies. Due to the paucity of studies on humans and the dearth of information on specific effects and interactions with other medications, use of herbal medicines in infants, children, pregnant and breast feeding women is not recommended. Idamarie Laquatra, Ph D, RD earned her degrees in applied nutrition from the Pennsylvania State University. A registered dietitian, Dr. Laquatra's background includes experience in the clinical, academic and business field s. Prior to earning her advanced degrees, she worked as a dietitian in hospital and nursing home settings. After receiving her Ph D, she completed a postdoctoral fellowship in Preventive Cardiology at the University of Medicine and Dentistry of New Jersey. During this period, she also worked as an adjunct faculty member at Montclair State University in Upper Montclair, New Jersey. Dr. Laquatra spent more than 10 years in the business sector, developing and executing nutrition and health programs. Her food industry experience includes eight years at the H. J. Heinz Company, first as a nutritionist for Heinz USA and then as a manager of nutrition services for the Weight Watchers Food Company. In these positions, Dr. Laquatra was heavily involved in nutrition labeling and worked closely with the marketing department on nutrition-oriented claims and education materials. In 1992, she joined Diet Centre, Inc. as Vice President of Scientific Affairs and Training. Dr. Laquatra has extensive training in nutrition counseling, has conducted research in this area, and authored and co-authored articles in peer-reviewed journals and chapters in texts. Frequently invited to add ress professional and industry audiences, Dr. Laquatra has lectured to health professionals across the United States. She has also give n numerous presentations to the public on nutrition and health issues. We were pleased to welcome Dr. Laquatra in 1998 as a member of the INI / HINS Advisory Council. |
