USDA Food Safety and Inspection Service: Labeling of FSIS-Regulated Foods
The USDA Food Safety and Inspection Service provides strict guidelines regarding the Labeling of FSIS-Regulated Foods. According to Required Information on a Label (9 CFR 317.2/381 Subpart N), there are up to 8 required features that must be included on food packaging.
The following table outlines the mandatory information required for compliance:
| Feature Number | Required Label Feature |
|---|---|
| 1 | Product name |
| 2 | Inspection legend and est. number |
| 3 | Handling statement |
| 4 | Net weight statement |
| 5 | Ingredients statement |
| 6 | Address line |
| 7 | Nutrition facts |
| 8 | Safe handling instructions |
Criteria for Misbranding
A Food is Misbranded if its labeling is false or misleading in any particular. Furthermore, it is considered misbranded if it is offered for sale under the name of another food or if it is an imitation of another food without proper labeling.
Label Approval Processes
Prior Approval: Traditionally Required For All Product Labels meant that meat and poultry plants submit labels for approval. Under this system, Labeling “Policy Book” precedents become de facto regulation.
Sketch and Temporary Approvals
A Sketch approval occurs when a company submits a printer’s proof showing all labeling material (including graphics). This process avoids unnecessary expense of printing incorrect labels. In some cases, Temporary approval of noncomplying labels may be granted under extenuating circumstances, for up to 6 months, but only if:
- The label is not misleading
- The label does not pose a health, safety or dietary problem
- Approval would not give an unfair competitive advantage
- Denial would cause undue economic hardship
Generic Approvals
Following the July 1996 Labeling Regulation, FSIS returned all label files to plants. Under the rules for Generic approved labels, plants are not required to submit certain types of labels for approval. As a result, FSIS only approves sketch and temporary labels. Generic Approvals - New Labels (9 CFR 317.5/381.133) apply to:
- Standardized products without special claims, guarantees or foreign language
- Single ingredient products without special claims, guarantees or foreign language
- Products with contract specification for Federal Government agencies
- Shipping containers
- Inspection legends
Generic Modifications
Companies are permitted to make Generic Modifications to labels without specific submission. These modifications include Proportionate enlargement or reduction, Abbreviations for unit of measurement, and changes to the Address of packer, manufacturer or distributor. Other allowed changes involve Net weight statement, Handling statements, Safe handling instructions, and Open dating information.
Company Responsibilities
Regarding Company Responsibilities - Labeling, firms must maintain labeling records and create a record of all final labeling including sketch approved labels. It is essential that modifications per sketch approval are made to label before final printing. The FSIS inspection force monitors label usage and product formulation to verify presence of mandatory label features and ensure label is accurate representation of product.