The 1994 Dietary Supplement Health and Education Act (DSHEA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) provided a regulatory framework to allow marketing of vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Now, more than 15 years later, a vast array of dietary supplements in different combinations and amounts are available to United States patients/consumers. Sales of dietary supplements are approaching $25 billion/year, with about $4 billion of this amount representing sales of botanicals. While DSHEA was instrumental in providing consumers with easy access to dietary supplements, a recent U.S. Government Accountability Office (GAO) report stated that consumers of dietary supplements are not adequately protected under current U.S. law and regulations.1 Pre-market oversight and registration of products are recommended in the GAO report.2 Outside the United States, dietary supplements are frequently considered as traditional medicines with few standards and conformity assessments to these standards. In this white paper, USP’s Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements provides background information on the topic and advances proposals for consideration by the Convention membership to further improve the quality of dietary supplements.