Seventh Circuit Reverses an FDC Act Food Felony Conviction:
March 23, 2009By Riëtte van Laack & J.P. Ellison –
The Seventh Circuit’s March 12, 2009 decision in United States v. Farinella starkly shows what can happen when, as the court concluded, a prosecutor relies on bad facts for the government and combines that with no controlling law, an ineffective government expert witness, and questionable courtroom conduct. [link to decision]. In Farinella, this unfortunate combination resulted in an order directing a judgment of acquittal and a five-page broadside attack on the entire prosecution case.
Briefly, the case involved a criminal prosecution arising from a defendant changing the “best when purchased by” date on salad dressing by about 18 months before selling the salad dressing to discount stores. A jury convicted the defendant of wire fraud and introducing a misbranded food into interstate commerce with intent to defraud or mislead. The district court judge had earlier sentenced the defendant to five year probation, a fine, and forfeit of more than $400,000 for his “gain” from his sales of the relabeled product. The defendant appealed and the government cross-appealed. In a sharply worded opinion by Judge Posner, the Seventh Circuit reversed and directed an acquittal on all counts.
From reading the opinion, it seems that the appellate court was particularly disturbed by the lack of a record evidence to support the government’s theory of the case and by the lead prosecutor’s conduct. The opinion correctly observes that “best when purchased by” labeling is not required and neither the Food, Drug, and Cosmetic Act (“FDC Act”) nor FDA regulations address such labeling. Thus, the charge of misbranding could only stand if re-labeling of the product was false or misleading as a matter of law.
The Court concluded that a shelf stable product such as the salad dressing was edible for years after it has been manufactured. Without any evidence, the prosecutor implied that the product was deteriorated and tasted “foul [and] rancid” after the “best when purchased by” date. Moreover, the prosecution presented no evidence that consumers were misled by the change of the “best when purchased by” date or that there was a uniform food industry understanding of the meaning of “best when purchased by” date. Nevertheless, without any citation to a law or regulation or some written document, FDA’s expert witness offered testimony implying that a change of the “best by date” required FDA approval. As the Court of Appeals pointed out “to prove a person guilty of having made a fraudulent representation, a jury must be given evidence about the meaning . . . of the representation claimed to be fraudulent.” The appellate court found no such admissible evidence.
Presumably, because he was so distressed by the government’s case, Judge Posner’s decision does not provide much guidance about what may constitute criminal misbranding of a food. In this regard, it is worth noting that under section 201 (n) of the FDC Act, it states that “in determining whether the labeling . . . is misleading there shall be taken into account . . . the extent to which the labeling . . . fails to reveal facts material in light of such representations.”
According to FDA, “food can be safe forever from a foodborne-illness standpoint – but if shelf-stable food has been on the shelf for an extended period of time, you might not want to eat it because the quality may not be good . . . . FDA does not require an expiration date for shelf-stable foods, since the storage time for these foods is a quality issue, not a food safety concern.”
Judge Posner noted that there was no evidence that the re-labeling posed a threat to human safety. However, many food fraud adulteration and misbranding convictions have involved no threat to human safety. The decision also makes much of the fact that an FDA employee called at as an expert witness “was not just improper and inadmissible but incoherent.” The Court’s opinion excoriated the prosecutor by name. Its displeasure with the prosecutor’s tactics may well have dictated the outcome of the case.