Labeling of dietary supplements: Consumer awareness and industry compliance

The Dietary Supplement Health and Education Act (DSHEA 1994) provides for the use of label statements on dietary supplements. In the "Dietary Supplement Strategy: The Ten Year Plan" (Jan. 2000) and "Better Health Information for Consumers Initiative" (Dec. 2002), the FDA placed emphasis on improving consumer labeling information and strengthening enforcement of DSHEA rules. The purpose of this research project was to (1) gain insight into consumer's awareness and understanding of nutritional claims on dietary supplements using focus groups and (2) evaluate industry's compliance with selected labeling requirements by conducting product surveillance at retail establishments. Thirty-four individuals (17 men and 17 women) participated in the focus groups. Slightly more women (88%) than men (76%) indicated that they were familiar with nutritional claims on dietary supplements. While most consumers remain skeptical about the efficacy of dietary supplements and truthfulness of corresponding labeling, it does not preclude their use. The use of a scientific ranking system, similar to what's proposed for qualified health claims, for structural/function claims would provide a standard for claim substantiation and for consumers to judge their credibility. Five hundred thirty-five supplement products, manufactured and/or distributed by 238 companies, were evaluated for their compliance to selected labeling requirements. The majority (83%) of products screened, had labeling consistent with recent regulations. Having no or incomplete disclaimer with a structural/functional claim was the most common issue, occurring in 65% of the noncompliant products. The proportion of compliant and noncompliant products was not significantly different between retail categories.