Stricter Supplement Labeling Rules Needed: FDA
December 1998; Volume 1: 143
Source: Rheinstein PH, Tsai VW. Keeping abreast of new drug approvals and labeling changes. Am Fam Physician 1998; 58:995-998.
On April 29, 1998, the FDA proposed a rule that would define criteria for the structure and function claims permitted by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the disease claims prohibited by it. Permissible claims include "promotes regularity," "helps maintain cardiovascular health," or "supports the immune system." Prohibited disease claims include "protects against cancer," "antiseptic," "lowers cholesterol," and "reduces nausea associated with chemo-therapy." Adverse events associated with dietary supplements should be reported to MedWatch at www.fda.gov/MedWatch.
Comment
Currently, supplements are sold without government screening. Consumers must rely on companies’ good names, on the assurances of brand names, or on the recommendations of friends or relatives. There is no guarantee that supplements contain what the label says they do because there are no federally required standards for their composition. Major pharmaceutical firms are entering the market and are likely to add quality improvement and perhaps standardization to the field.
Recommendation
The proposed DSHEA rule is a start—a stricter rule would be better. Standardized preparations from German companies are probably most reliable, until public standards and high quality make themselves known. Given their activity, some supplements should be reclassified as medications.
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