FDA needs sales information on dietary supplements in order to perform its regulatory mission under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Provisions of DSHEA define dietary supplements and ingredients and set forth new labeling requirements whereby manufacturers must notify FDA of new dietary ingredients prior to marketing. Under the DSHEA, the Secretary of Health and Human Services is authorized to regulate dietary supplements and to prescribe good manufacturing practices (GMPs) for the industry. FDA contracted with RTI to conduct a survey on dietary supplement products according to a statistical sampling plan and to provide a database containing information on dietary supplement products. The report entitled Dietary Supplement Sales Information documents the procedures used to select a sample of approximately 3,000 dietary supplements sold in the United States through retail establishments, mail-order catalogs, and the Internet. It also describes the Dietary Supplement Product Database, which contains information collected for each of these products and provides a summary of the information in the database.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Clark Nardinelli, 202-205-8702
PIC ID: 7082
PERFORMER: Research Triangle Institute, Research Triangle Park, NC