§7.4 De Novo Judicial Review

• Jurisdiction: United States
• Publication year: 2022

§7.4 De Novo Judicial Review

If all administrative methods of review have been exhausted, and the end result is unfavorable, judicial review may be undertaken.

§7.4.1 Basis for De Novo Review

Section 4 of DSHEA sets forth that a court shall decide the adulteration of a new dietary ingredient, based on the provision, on a de novo basis.³⁰ As the FDA in its communication asserts that a new dietary ingredient is adulterated under the section, de novo review may be had of this communication.

§7.4.2 Ripeness for De Novo Review

Judicial review may be had based on pre-enforcement of an FDA threatened action. In Fmali Herb v. Heckler,³¹ the court questioned whether the case, brought to obtain a pre-enforcement review of an FDA regulation, was "ripe" for adjudication.³² In holding the regulation reviewable, the court followed the precedent of Abbott Laboratories v. Gardner.³³ As the introduction of an adulterated article into interstate commerce is prohibited,³⁴ the article subject to seizure,³⁵ and the person who commits the act subject to imprisonment and/or fine,³⁶ it is apparent the petitioner will be "adversely affected" in the future because the dietary supplement has been determined adulterated by the FDA.

§7.4.3 Scope of De Novo Review

Regarding the scope of de novo review, the court in Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford noted that both the petitioners and the FDA agreed that de novo review allowed the examination of the FDA's factual determinations. However, the court did not address whether de novo review of FDA statutory construction (conclusions).³⁷

The de novo standard, in comparison to the "substantial evidence" standard and the "arbitrary and capricious" standard, may be considered the most generous form of review.³⁸ Under the "substantial evidence" standard, the evidence used by the FDA in creating the order, rule, or regulation is reviewed.³⁹ If there is substantial evidence on the record supporting the FDA's conclusion, and it is within statutory and conclusion limitations, the FDA's conclusion is controlling.⁴⁰

§7.4.4 Jurisdiction

The place for filing for review should be where the petitioner resides or has his, or its principal place of business.⁴¹ However, in the event an import of a dietary supplement is seized, jurisdiction may be the locale of the port where seizure occurred.

§7.4.5 Judicial Progression

Before a judicial review of an FDA determination can be had, all FDA administrative remedies (for the...