[切片] FDA OASIS Import Refusals — Veterinary Drug Residues & Unapproved New Animal Drugs (Animal Feed / Pet Food)

Topic Overview

Veterinary drug residues and unapproved new animal drugs represent a distinct violation category under the FD&C Act, specifically targeting food-producing animals and animal feed. These charges apply when pet food or feed ingredients contain prohibited pharmaceutical substances — including banned growth promoters, antibiotics, and unapproved animal pharmaceuticals — or when feed contains animal drugs lacking required approval.

> ⚠️ Data Note: Built from official charge code taxonomy (ACT_SECTION_CHARGES.CSV). Live refusal counts by country/date require Qlik Sense dashboard session. Charge codes are the authoritative violation taxonomy.

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1. Veterinary Drug Residues (VETDRUGRES)

Charge Code: VETDRUGRES Legal Basis: Section 402(a)(2)(C)(ii), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug... [or drug residue]..."

Why It Matters for Pet Food:

• Pet food ingredients derived from food-producing animals (chicken, beef, fish) can carry drug residues if the source animals were treated with unapproved substances
• Common violators: chloramphenicol, nitrofurans, fluoroquinolones, sulfonamides, melamine (historically)
• FDA monitors for both intentional doping (growth promoters in livestock) and environmental contamination
• Section 402(a)(2)(C)(ii) is specifically triggered when the drug is not approved for the species or use level

Snippet from official CSV: `` CODE: VETDRUGRES SECTION: 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION TEXT: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug... ``

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2. Nitrofurans (NITROFURAN)

Charge Code: NITROFURAN Legal Basis: Section 402(a)(2)(C)(i), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article appears to bear or contain a food additive, namely nitrofurans..."

Why It Matters:

• Nitrofurazone, furazolidone, nitrofurazone — FDA-prohibited antibiotics in food-producing animals since 1991
• Frequently detected in seafood and aquaculture products used in pet food (fish jerky, shrimp treats)
• No MRL (Maximum Residue Limit) established — any detectable level triggers refusal
• China, Vietnam, and India have historically been flagged for nitrofuran contamination in aquaculture

Snippet from official CSV: `` CODE: NITROFURAN SECTION: 402(a)(2)(C)(i), 801(a)(3); Adulteration TEXT: The article appears to bear or contain a food additive, namely nitrofurans (a prohibited substance in food-producing animals). ``

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3. Unapproved New Animal Drug (NEW VET DR)

Charge Code: NEW VET DR Legal Basis: Section 501(a)(5), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the article appears to be a new animal drug for which approval is required..."

Why It Matters:

• Any animal drug product without an approved New Animal Drug Application (NADA) or Abbreviated NADA (ANADA) is technically unapproved and subject to refusal
• This includes bulk active pharmaceutical ingredients (APIs) imported for pet food supplement formulations
• The 708NEWANIM code is a more specific variant targeting drugs lacking NADA specifically

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4. New Animal Drug Without Approved Application (708NEWANIM)

Charge Code: 708NEWANIM Legal Basis: Section 501(a)(5), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article has been determined to be a new animal drug without an approved new animal drug application."

Snippet from official CSV: `` CODE: 708NEWANIM SECTION: 501(a)(5), 801(a)(3); ADULTERATION TEXT: The article has been determined to be a new animal drug without an approved new animal drug application. ``

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5. Animal Feed with New Animal Drug (FEED & NAD)

Charge Code: FEED & NAD Legal Basis: Section 501(a)(6), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of §501(a)(6)..."

Why It Matters:

• This is the pet food / feed-specific drug charge — it targets feed products that contain animal drugs
• Key distinction from 501(a)(5): this applies to the feed itself, not just the drug ingredient
• A pet food or treat containing a drug-supplemented feed additive without proper approval falls here

Snippet from official CSV: `` CODE: FEED & NAD SECTION: 501(a)(6), 801(a)(3); ADULTERATION TEXT: The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 501(a)(6) of the FD&C Act. ``

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6. Chlorofluorocarbons in Animal Drugs (FLUOROCARB)

Charge Code: FLUOROCARB Legal Basis: Section 501(a)(5), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article appears to be a new animal drug containing chlorofluorocarbons in violation of 21 CFR 2.125."

Why It Matters:

• 21 C.F.R. § 2.125 bans chlorofluorocarbon (CFC) propellants in drug products
• Relevant for aerosolized pet medications or veterinary pharmaceutical aerosols imported for pet use

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7. Veterinary Drug Labeling Charges

VET LEGEND — Missing Caution Statement

• Code: VET LEGEND
• Basis: 502(a) & (f)(1), 801(a)(3); MISBRANDING
• Statement: "The article appears to be a veterinary drug without the 'Caution' statement as required by Section 503(f)(4)."

RXVETLACK2 — Missing Veterinary Caution

• Code: RXVETLACK2
• Basis: 503(f)(4), 801(a)(3)
• Statement: "The article appears to be a veterinary drug which requires but lacks the 'Caution' statement specified at Sec. 503(f)(4)."

708VETLGND — Veterinary Caution (variant)

• Code: 708VETLGND
• Basis: 502(a) & (f)(1), 801(a)(3); MISBRANDING

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8. Relevant Regulatory Framework

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Source: ACT_SECTION_CHARGES-20260721.csv (official charge codes, 306 entries)