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FDA Proposes New Health Claim Rules
By Jeffrey A. Babener
Excerpted from Network Marketing: What You Should Know, Jeffrey Babener, Legaline Publications
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And Congress Speaks Out

And, Congress itself made it very clear that the role of dietary supplements was to play an important role in our health care system, and in the dissemination of information.   In its preamble to the Act, Congress noted the following findings:

"(1)   improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;

 "(2)   the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;

 "(3)(A)   there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and (B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;

 "(4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;

 "(5)   preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;

 "(6)(A)   promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and (B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;

 "(7)   there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;

 "(8)   consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;

"(9)   national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;

"(10)   studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;

 "(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;

"(12)(A)   the nutritional supplement industry is an integral part of the economy of the United States; (B) the industry consistently projects a positive trade balance; and 8 the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;

"(13) although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;

"(14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and

"(15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and (B) a rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements."

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