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Dietary Supplements: A Framework for Evaluating Safety
ported link of more frequent dietary supplement use among Americans with one or more health problems (Bender et al., 1992), with specific diseases such as breast cancer (Newman et al., 1998), with higher alcohol consumption (Radimer et al., 2000), and with obesity (Radimer et al., 2000). Evidence suggests that supplement use may not be associated with better food intake in all populations and may differ by ethnicity and across income strata (Kraak et al., 2002; Pelletier and Kendall, 1997).
Consumer Expectations About Dietary Supplement Safety
Surveys have suggested that many Americans may assume dietary supplements are subject to existing government regulations similar to those required for over-the-counter (OTC) drugs sold without a prescription (Blendon et al., 2001). When consumers purchase OTC drugs, such drugs have typically undergone an FDA review that has deemed them to be safe and effective as labeled. Most OTC drugs have been through FDA’s OTC Drug Review, in which the agency assesses the safety and effectiveness of the active ingredients of OTC drugs and then issues detailed monographs restricting the labeling and formulation of products containing these ingredients. Other OTC drugs have been specifically approved by FDA under its rigorous new drug application (NDA) process and then have been reviewed by the agency again before being changed from prescription to OTC status.
Only a few national surveys exploring the views and perceptions of Americans regarding the safety of dietary supplements have been conducted. One compilation was based on four national opinion surveys conducted from 1996 to 1999 by the Roper Center for Public Opinion; however, supplement users were not differentiated from nonusers, thereby limiting the usefulness of the findings (Blendon et al., 2001). The Sloan Survey explored general patterns of medication use in the ambulatory adult population from 1998 to 1999 and examined use of vitamins, minerals, botanicals, and other dietary supplements, in addition to drugs. Conducted among 2,590 U.S. consumers, it reported that 16 percent of prescription drug users also took one or more “herbal or other natural supplements” (Kaufman et al., 2002). A more recent telephone survey, conducted by the Princeton Survey Research Associates for Prevention Magazine, used a nationally representative sample of 2,000 U.S. adults. The results suggested a high degree of consumer confidence in supplements based on the finding that nearly two-thirds of respondents believed that herbal supplements were either safe or completely safe (Prevention Magazine, 2001).
Another analysis was based on two separate data sources that compared the views of dietary supplement users with those who were nonusers (Blendon et al., 2001). In the first survey reviewed, which was designed collaboratively by researchers at National Public Radio, the Kaiser Family