## Facts

- The United States filed four in rem seizure actions in the Northern District of Illinois seeking condemnation of about 10,370 cases of tomato paste shipped in interstate commerce from Utah to Chicago.
- The tomato paste was canned by Smith Canning Company in Clearfield, Utah, and seized in Chicago by the United States Marshal.
- The government alleged adulteration under the Federal Food, Drug, and Cosmetic Act (FDCA), primarily:
  - Under 21 U.S.C. § 342(a)(4), that the paste was prepared, packed, or held under insanitary conditions whereby it may become contaminated with filth.
  - Under 21 U.S.C. § 342(a)(3) (in two actions as amended), that the paste consisted in whole or in part of a filthy, putrid, or decomposed substance, identified as decomposed tomato material and, in one action, insect parts.
- The government relied on microscopic examinations showing mold and insect fragments; the asserted defects were not visible to the naked eye.
- There was no claim that the paste was injurious to health or unfit for consumption in the ordinary sense.
- The FDA had not set a specific quantitative tolerance or regulatory standard for mold or insect fragments in tomato paste.
- After a lengthy evidentiary hearing (approximately 1,700 pages of record), the district court ordered release of all seized paste except a small portion in one action, which was condemned.
- The United States appealed the adverse judgments.

## Issues

1. Whether the government proved that the tomato paste was adulterated under 21 U.S.C. § 342(a)(3) because it consisted in whole or in part of a filthy, putrid, or decomposed substance (including decomposed tomato material and insect parts).
2. Whether the government proved adulteration under 21 U.S.C. § 342(a)(4) by showing the paste was prepared, packed, or held under insanitary conditions whereby it may become contaminated with filth.
3. Whether, absent an agency quantitative tolerance, microscopic mold and insect fragments shown by contested expert proof required condemnation on this record.

## Decision

- The Seventh Circuit affirmed the district court’s judgments.
- The court upheld condemnation only of the small portion condemned in one case and affirmed release of the remainder.
- The court treated the district court’s determinations as fact-intensive findings based on conflicting scientific evidence and declined to overturn them absent clear error.
- The court held the government’s evidence did not compel a finding that the bulk of the seized paste met the statutory definitions of adulteration under § 342(a)(3) or § 342(a)(4).

## Legal Principles

- In FDCA condemnation actions, the government bears the burden to prove by the evidence that the seized food is “adulterated” within the statutory definitions invoked.
- Under 21 U.S.C. § 342(a)(3), proof of some microscopic mold or insect fragments does not necessarily compel a finding that food “consists in whole or in part” of a filthy, putrid, or decomposed substance; the statutory determination remains fact-dependent.
- Under 21 U.S.C. § 342(a)(4), the relevant question is whether the food was prepared, packed, or held under insanitary conditions whereby it may become contaminated with filth; less-than-ideal practices are not enough if the government’s proof does not establish the statutory condition.
- Appellate review is deferential to the trial court’s resolution of conflicting expert testimony and other evidentiary disputes in a scientific record; reversal is unwarranted where the findings are supported by the record.

## Conclusion

The Seventh Circuit affirmed the district court’s release of most seized tomato paste because the government’s proof, largely based on microscopic findings and disputed expert testimony without a governing quantitative tolerance, did not compel a determination that the product was adulterated under the FDCA’s “filthy or decomposed” or “insanitary conditions” provisions.


United States v. 1,500 Cases More or Less, Tomato Paste, 236 F.2d 208 (7th Cir. 1956)