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ment ingredients in the general population can be estimated from two types of data. One type is industry estimates of production or sales. Dietary supplement industry publications, such as the Nutrition Business Journal, provide such data. Additionally, manufacturers and distributors collect production data, unit sales data, and total sales information in dollars as a normal component of business operations. The industry may be willing to make this information available.

The second type of data about prevalence of use is that collected in surveys about supplement usage. Such surveys ask respondents about patterns of use and can provide data on prevalence of use in the general population as well as in specific population subgroups.

National surveys that have traditionally collected information from a large number of persons regarding health issues and conventional food consumption information are increasingly also collecting valuable information about specific supplement use. An example is the expanded monitoring efforts of the National Health and Nutrition Examination Survey (CDC, 2004). Although it may be 2 to 3 years before the collected information is available, the planned expanded data collection will provide more detailed and useful information than is currently available in the older national survey data sets.

There are inherent limitations to many of the older survey data sets. They are often deficient in reporting frequency of use information and brand-specific information on ingredients and concentration, and they contain limited information on the collection and interpretation of data on products or ingredients that are typically used in combination (in addition to formulation and sales of single-ingredient products).

In summary, when setting priorities for which dietary supplements warrant attention first, it is not only appropriate to consider use by subpopulations that may be at risk for adverse effects, but also the extent of use by the general population, assuming that other information about risk is equivalent or comparable. Ingredients that are widely used by the general population should be given higher priority for critical safety evaluation than less widely used ingredients with similar degrees of safety concerns. These concepts are consistent with the FDA’s mission of protecting the public health.

REFERENCES

Brown AK. 1968. Bilirubin metabolism in the developing liver. In: Assali N, ed. Biology of Gestation. Vol 2. New York: Academic Press.

Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. 2001. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 345: 1583–1592.



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