Thinking of Taking Supplements?
- Dietary supplements do not need FDA approval before they are marketed.
- The manufacturer, not the FDA, is responsible for determining safety.
- Manufacturers are also responsible for determining that label claims are accurate and truthful.
- The FDA requires that certain information appears on dietary supplement labels:
• A descriptive name of the product, stating that it is a "supplement"
• The name and place of business or the manufacturer, packer or distributor
• A complete list of ingredients
• The net product contents
• A "Supplement Facts" panel that identifies each ingredient in the product
- Manufacturers or distributors do not have to tell the FDA or consumers what proof they have about their product's safety or proof to back up any claims. (For information on claims that can be made for dietary supplements, see the following Web site: http://www.cfsan.fda.gov/~dms/hclaims.html). Dietary supplements come under the umbrella of the FDA's Center for Food Safety and Applied Nutrition (CFSAN).
- Because of limited resources, the FDA does not routinely analyze the content of dietary supplements.
On March 7, 2003, the FDA announced proposed rules to establish Good Manufacturing Practices for all dietary supplements. The intent is to reduce risks associated with adulterated or misbranded products. Different quality assessment programs have been developed to certify the content of dietary supplements. Some of these programs include the Dietary Supplement Verification Program (DSVP, run by the United States Pharmacopoeia), Consumer Lab, NSF International, and the Good Housekeeping Institute.
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These Web sites offer more information about dietary supplements:
FDA Dietary Supplement Questions and Answers available at cfsan.fda.gov/~dms/ds-faq.html
Tips for the Savvy Supplement User available at cfsan.fda.gov/~dms/ds-savvy.html
Tips for Older Dietary Supplement Users available at cfsan.fda.gov/~dms/dssavv2.html