The Food Safety and Inspection Service (FSIS) recently published an updated FSIS Compliance Guideline for Label Approval (guideline). The purpose of the revised guideline is to provide establishments clarity on which labels require the Labeling and Program Delivery Staff (LPDS) approval, or qualify for generic approval. The comment period on the revised guideline closed Oct. 17.
The revised guideline includes several important modifications from the previous version.
First, the guideline provides updates to include new examples of “special statements and claims” that must be submitted to the LPDS for formal approval under 9 C.F.R. § 412.1. Special statements and claims include logos, trademarks, claims and other symbols on labels that are not defined in FSIS regulations or the Food Standards and Labeling Policy Book, as well as “natural” and negative claims. Some of the new statements/claims that are considered “special” include, but are not limited to, “family farmed raised,” implied nutrient content claims (e.g., “baked not fried,” “made with olive oil”), free from allergen claims, fruit claims, safety claims, “minimally processed,” trans fat declarations in the nutrition facts statement for the first time, the term “uncured” in the product name or ingredient statement and sample labels bearing special statements and claims.
Second, the guideline provides new examples of factual statements and claims that are considered generically approved and need not be submitted to the LPDS. These include, but are not limited to, allergen warning statements carried over from FDA products, “certified by SQF quality supplier,” “extra” and “more” claims, “lightly seasoned,” “Contains: [Ingredients],” “made in the USA” or “processed in the USA” and claims indicating the product was processed with high-pressure processing or subject to X-ray for bone detection.
Third, the guideline clarifies when changes to labels need or do not need additional LPDS review. FSIS recognizes there are some changes to a label — already approved by the LPDS — that do not require resubmission to LPDS, specifically if the change is unrelated to the special statement or claim. Examples given in the guideline include removal of an ingredient in a product formula that was previously approved with a negative claim, and changing from “GE” to “GMO” on certified organic or other third-party certified labels. Alternatively, when changes to previously approved labels could affect special statements or claims, they require establishments to resubmit to LPDS for approval. For instance, if a negative claim label was approved and the product has undergone reformulation that includes the addition of ingredients, LPDS would need to review the revised label to ensure the negative claim is still accurate.
Fourth, the guideline now indicates that certain special statements or claims only need initial LPDS approval to ensure compliance and after initial approval, the claims can be generically approved. These include “certified” claims (e.g., “certified Kosher”) where documentation was provided in the original label approval showing that the establishment had the appropriate certification documents. The establishment could then generically approve other product labels bearing the “certified” claim.
Finally, the document clarifies when establishments can request a “blanket approval” for a special claim for an entire line of products or multiple products instead of submitting each individual label bearing the claim to the LPDS. Examples provided in the guideline include changing the organic certifier on an approved label, adding a new supplier for an approved animal raising claim, and adding a front-of-pack nutritional statement to multiple products. In these situations, an establishment need only submit one label for approval and indicate all the other products that would bear the special claim.
The guideline continues to provide information from the previous version on label approval for religious exempt products (9 C.F.R. § 412.1(c)(1)), export labels with deviations from domestic labeling requirements (9 C.F.R. § 412.1(c)(2)), and temporary label approval (9 C.F.R. § 412.1(c)(4)). The guideline also refers establishments to FSIS Directive 7222.1, Prior Labeling Approval, for information on the agency’s verification activities at establishments. Also discussed are the establishment responsibilities regarding labeling as detailed in 9 C.F.R § 320.1(b)(11), 381.175(b)(6), and 412.1. NP