On Monday, the USDA will release a proposed rule to substantially change generic label approval. Prime Label is pleased to provide you with an initial overview of the rule below.
In the rule titled “Prior Label Approval System: Expansion of Generic Label Approval,” FSIS proposes to expand the circumstances under which labels of meat, poultry, and egg products are eligible for generic approval, as well as discontinue evaluating labels submitted to LPDS that can be generically approved. The agency estimates that these changes would reduce the amount of label submission to LPDS by one third.
Key Proposed Changes:
- Cease FSIS review of labels submitted to LPDS that are eligible for generic approval
- Expand generic eligibility to include labels on products for export that deviate from FSIS requirements
- Permit generic approval of products that receive voluntary FSIS inspection, including exotic species such as bison and rabbit under 9 CFR part 352
- Allow for generic approval of labels with the following statements and claims:
- Listing ingredients in the ingredients statement as being certified “organic”
- Geographic landmarks, such as a foreign country's flag, monument, or map
- “Negative” claims identifying the absence of certain ingredients or types of ingredients, including statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”
Notably, all animal production claims and GMO statements, including negative declarations, would still require LPDS review. Third party certification is also planned to still require LPDS review as well
The expected publication date in the Federal Register is Monday, September 14, 2020, and comments should be submitted by mail or online within 60 days of publication. No compliance or potential enforcement dates have been provided yet.
Update to FSIS Egg Inspection:
FSIS also issued a final rule entitled “Egg Products Inspection Regulations” earlier this week. As the first update to Egg Products Inspection Acts since 1970, it will more closely align food safety, labeling, and import requirements for egg products with those for meat and poultry products. Key changes include the expansion of generic eligibility to egg products and FSIS’s assumption of authority over egg substitutes and freeze-dried egg products. See USDA's Press Release here.
We will continue to monitor developments with our contacts at the USDA for late-breaking news and notify our Label Alert subscribers as soon as new information is available.
PLC Regulatory Consultants are available today to help determine whether your labels are eligible for generic approval under the current guidelines. In addition, our Generic Compliance Report service reviews your generic label and gives detailed feedback on whether it is compliant with USDA regulations, directives, policy memos and FSIS unwritten rules. For more information, go to our Services Order form or contact us at email@example.com or (202) 546-3333.
Jesse Zuehlke, PhD