Patients' understanding of the regulation of dietary supplements.

The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their own choices, free from governmental restriction. Yet, little is known about the public's understanding of the supplement regulatory process. We undertook a study to assess patients' knowledge regarding governmental oversight of product marketing and advertising. A survey of 300 adult patients from the Baltimore Metropolitan area was administered after showing participants an advertisement for a dietary supplement. Patients were asked questions regarding their understanding of federal regulation of the advertised product. A total of 52% of respondents were unaware that the dietary supplement had not been approved by the government while 63% were unaware that the advertisement for that supplement had not been pre-approved. Factors associated with a lack of understanding of the product approval process included lower education level (OR 2.52; 95% CI 1.52-4.19) and non-Caucasian race (OR 1.99; 95% CI 1.17-3.36). Lower education level was also associated with confusion regarding the advertisement approval process (OR 2.60; 95% CI 1.48-4.57). Based on these results, patients seem unclear about the government's role in the regulation of dietary supplements. Educational efforts should be geared towards clarifying these issues.