As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that
- is intended to supplement the diet;
- contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
- is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
- is labeled on the front panel as being a dietary supplement.
The FDA regulates dietary supplements as foods, and not as drugs. The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.
- is intended to supplement the diet;
- contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
- is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
- is labeled on the front panel as being a dietary supplement.
The FDA regulates dietary supplements as foods, and not as drugs. The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.
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Last Updated: Sep 2009
Last Updated: Sep 2009
What are Dietary Supplements?
What are Dietary Supplements?
