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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:

(f) (1) If it is a dietary supplement or contains a dietary ingredient that—

  1. presents a significant or unreasonable risk of illness or injury under –

    1. conditions of use recommended or suggested in labeling, or

    2. if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;

  1. 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;

  2. 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

  3. is or contains a dietary ingredient that renders it adulterated under paragraph [402](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.

(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

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