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[切片] FDA OASIS Import Refusals — Diseased Animals, Unapproved Food Additives & Miscellaneous Violations (Animal Feed / Pet Food)

fda_oasis_refusals_diseased_animals_unapproved_additives_and_miscellaneous_2026

us-2026 800 tok en 2026-07-21

Topic Overview

This topic covers remaining Animal Feed-relevant violation categories not addressed in prior topics: (1) products from diseased animals, (2) unapproved food additives and color additives, and (3) miscellaneous procedural/timing violations. These represent a smaller but still significant portion of import refusals for animal feed and pet food.

> ⚠️ Data Note: Built from official charge code taxonomy. Live refusal counts by country require Qlik Sense dashboard session.

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1. Products of Diseased Animals (DISEASED)

Charge Code: DISEASED Legal Basis: Section 402(a)(5), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The food appears to be, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter."

Why It Matters for Pet Food:

  • Rendered animal proteins (chicken meal, meat meal, bone meal) sourced from animals that died by disease or non-slaughter causes are adulterated under 402(a)(5)
  • This charge is distinct from 402(a)(3) (unfit for food) — it specifically addresses the source animal's condition
  • Common in rendered protein ingredients from regions with limited veterinary oversight
  • The related *** code appears to be a secondary Diseased animal charge with the same legal basis

Snippet from official CSV: `` CODE: DISEASED SECTION: 402(a)(5), 801(a)(3); ADULTERATION TEXT: The food appears to be, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter. ``

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2. Unapproved Food / Color Additives

YELLOW #5 — Undeclared FD&C Yellow No. 5

  • Code: YELLOW #5
  • Basis: 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING
  • Statement: "The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 C.F.R. Part 74."
  • Pet food relevance: Many pet treats and wet foods contain artificial colors; undeclared colors violate both adulteration and misbranding provisions

COLOR LBLG — Color Additive Labeling Violation

  • Code: COLOR LBLG
  • Basis: 602(e), 801(a)(3); MISBRANDING
  • Statement: "The color additive appears to not have its packaging and labeling in conformity with requirements under Section 721(b) of the Act."

NO TAG — Electronic Product Certification Violation

  • Code: NO TAG
  • Basis: 536(a),(b); NOT CERTIFIED
  • Statement: "The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act..."

COLOR LBLG — Undeclared Artificial Coloring (Food)

  • Code: COLOR LBLG
  • Basis: 403(k), 801(a)(3); MISBRANDING
  • Statement: "The article appears to contain an artificial coloring and it fails to bear labeling stating that fact."

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3. Dietary Supplement Violations

NO EXP DAT — Missing Expiration Date

  • Code: NO EXP DAT
  • Basis: 402(g), 801(a)(3); ADULTERATION
  • Statement: "The article appears to be a dietary supplement and lacks an expiration date and it has been prepared, packed, or held under insanitary conditions..."
  • Pet supplement relevance: Pet vitamins, joint supplements, and functional treats classified as dietary supplements

UNSFDIETUS — Significant/Unreasonable Risk (Dietary Supplement)

  • Code: UNSFDIETUS
  • Basis: 402(f)(1)(D), 801(a)(3); ADULTERATION
  • Statement: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement which presents a significant or unreasonable risk of illness or injury..."

UNSFDIETLB — Significant Risk from Dietary Ingredient

  • Code: UNSFDIETLB
  • Basis: 402(f)(1)(A), 801(a)(3); ADULTERATION

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4. Unapproved Drugs (Human/Veterinary)

NO LICENSE — Unapproved Drug / Misbranded / PHS Act

  • Code: NO LICENSE
  • Basis: 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT
  • Statement: "The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act..."

FALSEDRUG — Misbranded Drug

  • Code: FALSEDRUG
  • Basis: 502(a)(1), 801(a)(3); MISBRANDING

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5. Other Miscellaneous Charges

CodeViolationBasisPet Food Relevance
EXPIREDProduct past expiration501(c); 801(a)(3)Pet treats/foods with old lot codes
STERILITY (501(a)(1))Filthy, putrid substance501(a)(1); 801(a)(3)Ingredient contamination
BUTTEROleo from filthy materials402(e); 801(a)(3)Fat ingredients from rendered stock
DIRSEXMPTDrug lacking adequate directions502(f)(1); 801(a)(3)Veterinary pharmaceuticals
IMITATIONImitation food without disclosure403(c); 801(a)(3)Extended shelf-life products

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Source: ACT_SECTION_CHARGES-20260721.csv

Sources

  • ACT_SECTION_CHARGES-20260721.csv (official CSV)