2018
American Journal of Humanities and Social Sciences Research (AJHSSR) American Journal of Humanities and Social Sciences Research (AJHSSR) e-ISSN : 2378-703X Volume-02, Issue-05, pp-01-08 www.ajhssr.com
Research Paper
Open Access
Analyzing the Dietary Supplement Health and Education Act and other related regulation relevant FDA approval. Chihiro Iizawa International University of Health and Welfare Graduate School December 30th 2017 ABSTRACT: The research introduces the policy of Dietary Supplement Health and Education Act (DSHEA) and relevant regulations and backgrounds with quantitative data analysis. Studying case studies of Dietary Supplement Health Educational Act (DSHEA) might address Food and Drug Administration (FDA) accountabilities and improvements.
I.
INTRODUCTION
According to the Department of Health Human Services, dietary supplements were used by 70 % of the U.S. population in 2004. Vitamin and mineral products were accounted for $7.7 billion of the U.S. retail sales and 48% of entire sales in the dietary supplement category. (Brackett, 2004, p. 51). Dietary supplements cause increasing infringement trade over the online, illegal import drugs, qualitative and labeling issues. For instance, the FDA enforcement has refused 1,500 foreign shipments of potentially unsafe dietary supplements offered for the United States (Dickinson, 2004, p. 127).
II.
THE HISTORY AND BACKGROUND OF THE DIETARY SUPPLEMENT AND HEALTH EDUCATION ACT According to Larsen, Berry (2003), the FDA in early 1900s. Over 100 peoples died after taking Elixir Sulfanilamide encouraged passing the Food Drug, and Cosmetic Act (FDCA) in 1938. The guidelines established protecting consumers from false claims in later 1940s and 1950s. The Nutritional Labeling and Educational Act (NLEA) established in 1990. “The Nutrition Labeling and Education Act of 1990 (NLEA) provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., 'high fiber', 'low fat', etc.) and health claims be consistent with agency regulations. Regulations implementing the NLEA labeling provisions issued on January 6, 1993, with technical amendments published on August 18, 1993”(U.S. Food and Drug Administration, 2009). Food Additive Amendment included FDCA for ensuring labeling regulations in 1958. The drug law amendment was passed relevant the FDA approval for prescription drug in 1962. The U.S. congress passed the DSHEA in 1994. The regulation stimulated consumer purchasing power to purchase supplemental drugs. The DSHEA obligated continuing the researcher、and observing new drug entry to the Office of Dietary Supplements in the National Institution of Health (NIH) (Schweizer, 2007, p. 283). The FDA proposed GMPs in March 2003 (GAP research, 2000).
III.
THE DEFINITION OF THE DSHEA IS A REGULATION OF OVER THE COUNTER DRUGS, WHICH CONTAIN HERBS, VITAMINS, AND MINERALS EXCEPT TOBACCO.
“In 1994, DSHEA created a unique regulatory framework for dietary supplements in the United States. Its purpose was to strike the right balance between providing consumers access to dietary supplements that they use to help maintain and improve their health and giving the Food and Drug Administration (FDA or the Agency) the necessary regulatory authority to take action against supplements that present safety problems, have false or misleading claims, or are otherwise adulterated or misbranded…As a summary of the previous testimony, I would like to point out that the DSHEA regulatory framework for dietary supplements is primarily a postmarket program, as is the case for foods in general. Should safety problems arise after marketing, the adulteration provisions of the statute come into play”(U.S. Food and Drug Administration,2009). The DSHEA was established in 1994, which regulates over the counter drugs, which contain vitamins, minerals, herbs, botanicals, amino acids, and concentrates, metabolites, constituents, extracts, combination of any of above products except Tobacco by the FDA (Berry, 2005, p. 670).
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