USDA
Label and Content Review
Fee: $349 / product
In the United States, meat, poultry and certain processed egg products are regulated by USDA FSIS rather than FDA. The label of these imported products states the country of origin with the phrase "Product of" together with the foreign establishment number. As a rule, the label goes through FSIS approval; labels that contain the mandatory elements and carry no special claims can be used under generic approval. Only approved establishments in countries whose inspection system FSIS has found equivalent may export these products to the United States.
Who Is Obligated?
Approved establishments in countries FSIS deems eligible to export, and companies importing these products. Separate denaturing rules apply to animal products not intended for use as food.
What We Do
- We determine whether your product is regulated by FDA or FSIS.
- We check your country’s and your establishment’s FSIS export eligibility.
- We review the label against FSIS rules and determine whether it needs approval or qualifies for generic approval.
- We prepare the corrected English label text.
What You Receive
- Jurisdiction and eligibility assessment
- Review report
- Corrected label text
US Meat, Poultry and Egg Product Label (USDA FSIS) Review Application
Product, establishment, claim and label details for reviewing your meat, poultry or egg product labels against USDA FSIS rules.
Frequently Asked Questions
- Is my product regulated by FDA or USDA?
- Meat, poultry and certain processed egg products are regulated by USDA FSIS rather than FDA. We determine which agency your product falls under as the first step.
- Can every country export these products to the United States?
- No. Only approved establishments in countries whose inspection system FSIS has found equivalent may export. We check your country’s and your establishment’s eligibility.
- Does the label always go through approval?
- As a rule, it goes through FSIS approval. Labels that contain the mandatory elements and carry no special claims can be used under generic approval.
Sources: FDA: Producing a food product regulated by FDA; FSIS Directive 9900.5; 9 CFR 327.14; 9 CFR 381.205; 9 CFR 412.1; 9 CFR 412.2; FSIS: Eligible foreign establishments; FSIS Directive 9510.1.
