On the recordOctober 25, 2001
I mention another important consumer protection included in the law. Questions have also been raised about the safety of supplements in the marketplace. In DSHEA, we added a fifth tool to FDA's arsenal--section 402(f)(1)(A), which deems that a dietary supplement is adulterated if it presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling. If no conditions of use are suggested or recommended in the labeling, then the FDA could act against a supplement that presented a significant or unreasonable risk of illness or injury under ordinary conditions or use. This safety standard was carefully developed in close consultation with Senator Kennedy and Congressmen John Dingell and Henry Waxman, all of whom worked with us to assure we had the strongest possible measure.
Source
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