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Today, USDA published a final rule expanding the criteria of generic label approval for inspected meat, poultry, and egg products. The Expansion of Generic Labeling Rule is largely consistent with the proposed rule published in late 2020. Read on for a quick summary of changes, regulatory impacts and compliance deadlines.
Final Rule: Expansion of Generic Label Approval
FSIS has finalized regulations which discontinue review of generically approved labels and expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products. This rule becomes effective on March 20, 2023.
Key changes of the final rule include:
- FSIS will no longer evaluate labels submitted to FSIS that are eligible for generic approval. The second priority review queue will be discontinued March 20, 2023.
- The following labels will no longer need to be submitted to FSIS for approval:
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Labels that make “negative” claims identifying the absence of certain ingredients or types of ingredients (e.g., statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”). Critically, the rule does not include negative animal raising claims (e.g. “no antibiotics administered”)
- Labels that display geographic landmarks, such as a foreign country's flag, monument, or map
- Labels on products for export that deviate from FSIS requirements
- Labels that list ingredients in the ingredients statement as being certified “organic” (e.g., organic garlic) under the Agricultural Marketing Service (AMS) National Organic Program
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Labels of products that receive voluntary FSIS inspection (e.g., exotic species under 9 CFR part 352)
FSIS has updated the FSIS Guideline for Label Approval and intends to update and reissue FSIS Directive 7221.1. FSIS will continue to answer questions and provide labeling support to industry.
Regulatory Impact
This rule does not eliminate the requirement to comply with USDA's complex labeling regulations, but instead shifts the full burden of compliance for generic labels onto the manufacturer. According to the USDA's Inspector General Audit Report of June 2020, 74% of generic labels reviewed by FSIS required revisions. The report went on to conclude, "Consumers expect product labels to be accurate when they choose products to purchase. If FSIS is not verifying a sample of generic labels, the agency runs the risk of inaccurate or unsupported product labels being in commerce." While the expansion of generic eligibility creates opportunities to increase speed to market for some products, manufacturers will need to balance the complexity of label compliance with the risk of Inspection Program Personnel issuing Noncompliance (NR) Records.
How to Navigate the New Environment
Fortunately PLC has been developing tools and services for this shift:
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USDA Label Audit - using our automated Label IQ technology, which has been in development over the past 2 years, PLC's USDA experts check over 1,700 data points to produce a detailed audit report identifying errors and required USDA approval path.
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USDA Compliance Report - PLC's regulatory consultants provide a full service, in-depth report on your label, identify risk areas, suggest remediation alternatives and walk you through any nuances during a one-hour consulting session.
Learn more about this new regulation:
Not sure where to start? Schedule a 30-minute introductory call with a member of our Team to discuss how your company has been impacted by the USDA’s new final rules, and ways PLC can help with your compliance needs. We’ll provide you with information on company services and explore eligible discount opportunities. Contact our team at labels@primelabel.com or (202) 546-3333 today.
What's Next?
Tomorrow, AMS will publish a final rule strengthening enforcement of organic regulations. PLC continues to monitor anticipated rule makings on updates to the Nutrition Facts Panel for USDA foods, using “Product of USA” and similar statements, and possibly a proposed rule to change the label requirements for cured and uncured products that contain nitrate or nitrite. PLC will notify our Label Alert subscribers as soon as new information or industry guidance is available.
Best,
Jesse Zuehlke PhD
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