Safety Standards for Dietary Supplements as Established by DSHEA
Section 4. Safety of Dietary Supplements and Burden of Proof on FDA.
DSHEA amends § 402 (21 U.S.C. 342) by adding the following:
presents a significant or unreasonable risk of illness or injury under –
conditions of use recommended or suggested in labeling, or
if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code to affirm or withdraw the declaration; or
is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
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.
SOURCE: FDCA, P.L. 75-717 § 402, as amended 21 U.S.C. § 342(f) (2001).