[切片] FDA OASIS Import Refusals — Misbranding & Labeling Violations (Animal Feed / Pet Food)

Topic Overview

Misbranding charges under Section 403 of the FD&C Act are the second major category of import refusals after adulteration. For imported pet food, misbranding violations typically involve: (1) missing or incorrect allergen declarations, (2) foreign-language-only labeling, (3) missing manufacturer/distributor information, and (4) unapproved health claims. Unlike adulteration, misbranding can often be remediated (re-labeling in the U.S.) to allow entry.

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

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1. Major Food Allergen Declaration (ALLERGEN)

Charge Code: ALLERGEN Legal Basis: Section 403(w), 801(a)(3); MISBRANDING Charge Statement (verbatim from CSV):

> "The label fails to declare all major food allergens present in the product, as required by section 403(w)(1)."

The 9 Major Food Allergens (FAV): Milk · Eggs · Fish · Crustacean shellfish · Tree nuts · Peanuts · Wheat · Soybeans · Sesame

Why It Matters for Pet Food:

• Pet foods commonly contain chicken, beef, fish, dairy, soy, wheat — all major allergens
• Imported pet treats frequently fail allergen labeling requirements (undetected undeclared allergens)
• FARRP (Food Allergy Research & Resource Program) estimates ~$18B annual cost of food allergen non-compliance in the U.S.
• Section 403(w) requires ingredients to be declared by source name (e.g., "caseinate" must also declare "milk")

Snippet from official CSV: `` CODE: ALLERGEN SECTION: 403(w) 801(a)(3); Misbranding TEXT: the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). ``

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2. Labeling Not in English (NO ENGLISH)

Charge Code: NO ENGLISH Legal Basis: 21 C.F.R. 201.15(c)(1); 502(c), 801(a)(3); MISBRANDING Charge Statement (verbatim from CSV):

> "Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1)."

Why It Matters for Pet Food:

• All labeling for products sold in the U.S. must be in English
• Common issue with pet food/treats from China, Japan, Southeast Asia: labels in Chinese/Korean/Japanese only
• The importer of record is responsible for ensuring English labeling is present or accompanies the product

Snippet from official CSV: `` CODE: NO ENGLISH SECTION: 502(c); 801(a)(3);Misbranding TEXT: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1). ``

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3. Missing Manufacturer Information (LACKS FIRM)

Charge Code: LACKS FIRM Legal Basis: 502(b)(1), 801(a)(3); MISBRANDING (also 403(e)(1)) Charge Statement (verbatim from CSV):

> "The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor."

Why It Matters:

• FDA requires the domestic address or phone number of the responsible party on every label
• Many imported pet products list only a foreign address, violating 21 C.F.R. § 201.5 and § 502(b)
• Traceability requirement — FDA must be able to contact the responsible party

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4. Missing Net Contents (LACKS N/C)

Charge Code: LACKS N/C Legal Basis: 403(e)(2) and 502(b)(2), 801(a)(3); MISBRANDING Charge Statement (verbatim from CSV):

> "The article is in package form and appears to not bear a label containing an accurate statement of the quantity of the contents."

Why It Matters:

• Net weight statement must be in both imperial and metric units for U.S. sale
• Common violation in imported pet treats: weight declared in Chinese units only, or no metric conversion
• FPLA (Fair Packaging and Labeling Act) requires this specifically

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5. Other Relevant Misbranding Charges

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6. Misbranding vs. Adulteration — Key Distinction

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Source: ACT_SECTION_CHARGES-20260721.csv