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United States of America, Libellant-Appellant v. 1,500 Cases More or Less, Tomato Paste Case Brief
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Case Brief Summary & Legal Analysis
tl;dr: The government seized tomato paste as “adulterated.” The court held that an informal FDA enforcement tolerance for mold sets the legal standard for adulteration, but the government failed to prove adulteration from other alleged filth or from the general conditions of the canning facility.
Legal Significance: This case demonstrates how courts may give legal force to an agency’s informal administrative tolerances to interpret a broad, absolute statutory prohibition. It establishes that such tolerances can function as the binding legal standard for what constitutes an “adulterated” product under the FDCA.
United States of America, Libellant-Appellant v. 1,500 Cases More or Less, Tomato Paste Law School Study Guide
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Case Facts & Court Holding
Key Facts & Case Background
The United States government filed four libels to seize and condemn approximately 10,370 cases of tomato paste, alleging it was “adulterated” under the Federal Food, Drug, and Cosmetic Act (FDCA). The government’s claims were twofold. First, under 21 U.S.C.A. § 342(a)(3), the paste allegedly consisted in part of a “filthy, putrid, or decomposed substance,” specifically decomposed tomato material (rot), insect fragments, and fly eggs. Evidence for this claim was based on microscopic analysis, including the Howard Mold Count. The Food and Drug Administration (FDA) had an informal administrative tolerance, announced to the industry, that it would not seize paste for mold unless the count exceeded 40%. Second, under 21 U.S.C.A. § 342(a)(4), the paste was allegedly prepared under “insanitary conditions whereby it may have become contaminated with filth.” Evidence for this claim included testimony and photographs of a nearby labor camp, unscreened openings in the factory, and accumulated tomato material on machinery. The trial court found for the claimant on all but a small portion of the paste, and the government appealed.
Court Holding & Legal Precedent
Issue: How should a court apply the broad statutory definition of “adulterated” under the Federal Food, Drug, and Cosmetic Act where the enforcing agency has established an informal administrative tolerance for one type of impurity but not for others?
Affirmed in part and reversed in part. The court held that the Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut eni
IRAC Legal Analysis
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IRAC (Issue, Rule, Analysis, Conclusion) is the exact format professors want to see in your exam answers. Our exclusive Flash-to-Full briefs combine holding, analysis, and rule statements formatted to match what A+ students produce in exams. These structured briefs help reinforce the essential legal reasoning patterns expected in law school.
Legal Issue
How should a court apply the broad statutory definition of “adulterated” under the Federal Food, Drug, and Cosmetic Act where the enforcing agency has established an informal administrative tolerance for one type of impurity but not for others?
Conclusion
The case is significant in administrative law for demonstrating judicial willingness to Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim a
Legal Rule
A food product is adulterated as a matter of law under 21 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, su
Legal Analysis
The court first addressed the interpretation of § 342(a)(3), which deems a Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercit
Flash-to-Full Case Opinions
Flash Summary
- Food is adulterated under FDCA § 342(a)(3) if it contains any