Section 4. Safety of Dietary Supplements and Burden of Proof on FDA.
DSHEA amends § 402 (21 U.S.C. 342) by adding the following:
(f) (1) If it is a dietary supplement or contains a dietary ingredient that—
In any proceeding under this paragraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a violation of the paragraph (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.
SOURCE: FDCA, P.L. 75-717 § 402, as amended 21 U.S.C. § 342(f) (2001).
In contrast to reacting based on detecting a signal, FDA may decide to proactively initiate a review of a dietary supplement ingredient due to high prevalence of use in the general population, high level of use by a particularly vulnerable population, or other factors.
One of the requirements of the study was to develop a framework that would include criteria for how the review of safety of dietary supplements