21 U.S.C. § 335
Section 335 · Hearing before report of criminal violation
This is the Federal Food, Drug, and Cosmetic Act
Amended 1 time on record
Applied in 23 court decisions — leading case Helco Products Co. v. McNutt (1943)
Most recently applied in Pfizer Inc. v. Teva Pharmaceuticals U.S.A., Inc. (July 2012)
How often courts cite this section
Court decisions citing this, by year.Markers show enactment, consequential amendments, and circuit splits over this section — watch for a citation surge after a change or a disagreement. The dip in the last several years is a data-coverage gap, not a real trend — our corpus holds fewer opinions from the most recent years, so recent citations are undercounted.
Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.
Editorial notes U.S. Code · Office of the Law Revision Counsel
Transfer of Functions
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see note set out under section 41 of this title.