Is the Government Entitled to Deference in FDA Criminal Cases?

February 27, 2014

By John R. Fleder

In litigation brought by or against FDA, the agency frequently seeks to avoid a “jump-ball” by arguing that FDA’s position is entitled to deference by the court.  That argument is consistently made in civil cases and has been made in some criminal cases.  A Supreme Court ruling on February 26, 2014, raises a serious question regarding whether a deference argument is available to the government in certain criminal cases.

In United States v. Apel, the Supreme Court (Chief Justice Roberts) stated that the Court has “never held that the Government’s reading of a criminal statute is entitled to any deference.”  Slip Op. at 9.

One wonders what this means in the context of the FDC Act.  Is the suggestion that the government’s position regarding the meaning of a criminal statute is not entitled to deference applicable at all to the FDC Act?   If so, is Chief Justice Roberts’s conclusion limited to criminal, rather than civil, cases decided under the FDC Act?  If Justice Roberts conclusion is applicable to the FDC Act, it would surely be applicable to FDA’s interpretation of 21 USC 333(a), 333 (b)(1), 333(c), 333(d) and 333(e).  Perhaps a court would rule that FDA’s interpretation of other provisions of the FDC Act are not entitled to deference when those other provisions are being interpreted in a criminal case.

Time will tell if criminal defendants choose to rely on Apel and whether they are successful.

Categories: Enforcement