Questions and Answers Concerning the Recently Published Generic Labeling Final Rule
- General Information
- Label Review Process and Recordkeeping
- Food Standards and Labeling Policy Book
- Temporary Label Approval
- Religious Exempt Labels
- Export Labels
- Special Statements and Claims
- Special Statements and Claims: Nutrition
Q1. What exactly is “generic approval”? How does the process work?
FSIS’s meat and poultry regulations permit certain labels, including those that are not likely to present significant policy issues that have health or economic significance, to be “generically approved” without having to be submitted to the Agency’s headquarters-based labeling staff, as long as the labels comply with the regulations. Although not submitted to FSIS, generically approved labels are approved by FSIS by being in compliance with applicable regulations.
Q2. What has changed as a result of the new Generic Labeling Final Rule?
On November 7, 2013, FSIS published a final rule that amended the meat and poultry products inspection regulations to expand the circumstances under which the labels of meat and poultry products would be deemed to be generically approved by the Agency. Effective January 6, 2014, FSIS regulations only require four categories of labels to be submitted to LPDS for approval, as described in 9 CFR 412.1. FSIS will require the submission of labels: 1) intended for temporary approval, 2) for products produced under religious exemption, 3) for products for export with labeling deviations, and 4) with special statements and claims as described in 9 CFR 412.1(c). All labels that do not fit into one of the four categories are eligible for generic approval.
The Final rule also amended FSIS regulations to combine the previous regulations that provided for labeling approval (9 CFR 317.4 and 381.132) and generically approved labeling (9 CFR 317.5 and 381.133) for meat and poultry products into one new section. The new label approval regulations for meat and poultry products are now in 9 CFR 412.1; approval of generic labels is now in 9 CFR 412.2
Q3. Do the new generic labeling regulations (9 CFR Part 412) completely replace all of 9 CFR 317.5 and 9 CFR 381.133? Will this change be reflected in future editions of the CFR?
Yes, all of the previous generic regulations will be removed from future printed editions of the Code of Federal Regulations and replaced with Part 412 for both meat and poultry products. Both the 2014 online electronic version of the CFR (accessible at www.eCFR.gov) as well as the printed version (available at www.gpo.gov) currently reflect this change.
Q4. When did the rule take effect?
The rule took effect on January 6, 2014.
Q5. What is meant by the terms “sketch” and “sketch approval”?
A “sketch” label is defined in 9 CFR 412.1(d). The regulations state a “sketch” label is the concept of a label. It may be a printer’s proof or equivalent that is sufficiently legible to clearly show all labeling features, size, and location. FSIS will accept sketches that are hand drawn or computer generated, or other reasonable facsimiles that clearly reflect and project the final version of the label. A “sketch” label is the concept of a label, while a “final” label is the label that is applied to product before distribution in commerce.
All sketch labels approved by LPDS will be marked as “sketch approved” or “sketch approved as modified.” When LPDS determines that a label submitted for sketch approval requires a minor modification for compliance with FSIS labeling requirements, LPDS may approve the label with modifications by stating on the form or through LSAS that it is “sketch approved as modified.” Establishments do not need to resubmit to labels that are sketch approved as modified. Establishments need to ensure that the final labels printed are consistent with the modifications noted in the sketch approval and need to maintain a copy of the label approval in their labeling records.
Q6. What are the mandatory features on meat and poultry labels?
The mandatory features on a meat or poultry label remain unchanged. There are up to eight features required on most meat and poultry labels. The required features include: (1) the product name; (2) an ingredients statement; (3) the manufacturer’s, packer’s, or distributor’s name and place of business; (4) a net weight for product sold at retail; (5) the USDA mark of inspection, including the official establishment number; (6) a handling statement if the product is perishable (e.g., “Keep Frozen” or “Keep Refrigerated”); (7) nutrition labeling for applicable meat and poultry products; and (8) safe handling instructions if the product is not ready-to-eat.
Q7. Do multi-ingredient products require LPDS Sketch approval?
The fact that a product has multiple ingredients has no bearing on whether or not the label requires sketch approval. A multi-ingredient meat or poultry product may be generically approved provided it does not fall into one or more of the four categories of labels requiring approval in 9 CFR 412.1(c): temporary approval, labels for export with labeling deviations, religious exempt, or labels bearing special statements or claims.
Q8. Do non-standardized products still require LPDS Sketch approval?
A non-standardized meat or poultry product may be generically approved provided it does not fall into one or more of the four categories of labels requiring approval in 9 CFR 412.1(c): temporary approval, labels for export with labeling deviations, religious exempt, or labels bearing special statements or claims.
Q9. Does this rule apply to egg products?
No. FSIS is considering expanding the generic labeling criteria to egg products in a separate rulemaking.
Q10. Does this rule apply to processed labels for exotic species slaughtered or processed under voluntary inspection by FSIS?
No. Expanding the generic labeling criteria for exotic animals slaughtered or produced under voluntary FSIS inspection (9 CFR Part 352) is not part of the generic final rule.
Q11. Are products containing both amenable species and exotic species (as an ingredient), such as “Bison and Beef Jerky,” eligible for generic label approval?
Yes, provided that the label is not included in one of the four categories requiring label approval in 9 CFR 412.1(c).
Q12. May the establishment number be changed from one establishment number to another in the case of a label bearing a special statement or claim without being submitted to LPDS for approval? For example, may Establishment B use an approved label from Establishment A and simply change the establishment number from establishment number A to establishment number B and not submit the label to LDPS for prior approval?
Yes, under certain circumstances and for some claims other than organic claims. Establishment B would need to obtain a complete copy of the original label application from Establishment A, including all documentation that was submitted to support any special statements or claims on the application. With this information, Establishment B would have a complete label record on file and would be permitted to change the Est. number on the label from Establishment A to Establishment B. Establishment B would have to meet all of the same procedures and maintain records consistent with Establishment A (e.g., same HACCP category, product formulation, and processing procedures for the labeled product).
However, changing the establishment number without submitting the label application to LPDS is not an option for all labels with organic claims because the approval from the National Organic Program (NOP) is specific to the establishment to which the organic certificate is issued. In this case, the supporting NOP documentation for Establishment A is not transferable to Establishment B, because the supporting documents are specific to Establishment A.
Q13. May labels for products that include substances that are considered to be processing aids, and therefore are not listed in the ingredients statement, be generically approved?
Yes. The generic labeling regulations did not change the criteria for determining whether a substance is a processing aid. Labels for products with formulations that include processing aids may be generically approved provided that they do not need to be submitted to LPDS for prior approval under 9 CFR 412.1 and display all mandatory features in compliance with FSIS regulations. More information about processing aids is available on the FSIS website at: http://www.fsis.usda.gov/wps/wcm/connect/9a34e8d9-997a-4c58-bd5e-d87cc371ecda/Determination_of_Processing_Aids.pdf?MOD=AJPERES.
Q14. What types of labels will FSIS’s headquarters-based labeling staff continue to review?
FSIS will require the submission of labels: 1) intended for temporary approval, 2) for products produced under religious exemption, 3) for products for export with labeling deviations, and 4) with special statements and claims as described in 9 CFR 412.1(c).
Q15. If a label requires LPDS review, will LPDS review all information on the label, or will it just review the elements of the label that require sketch approval, as required by 9 CFR 412.1?
LPDS will review all labels submitted for approval in their entirety. Applicants are required to submit documentation to support all special statements and claims on the label (9 CFR 320.1(b)(11) for livestock, 9 CFR 381.175 for poultry). However, for statements and claims that do not require LPDS approval and that can be generically approved, establishments are only required to maintain supporting documentation in the in-plant label record and are not required to submit such documentation to LPDS as part of the review process. For example, a label for Mongolian Style Beef with an American Heart Association (AHA) claim would require LPDS sketch approval for the AHA claim. “Mongolian Style” may be approved generically provided documentation supporting this claim by a third party authority, e.g. a culinary institute or a recognized expert on the cuisine from the referenced region, is included as part of the establishment’s labeling record. However, this supporting documentation for the undefined geographic style does not need to be submitted to LPDS as part of the approval process.
Q16. Will LPDS still review my labels if the labels qualify for generic label approval?
Yes, LPDS will continue to review meat and poultry labels that are generically approved under 9 CFR 412.2(b) at a company’s request. However, such labels will receive lower priority than those requiring Agency approval and may take longer to be reviewed.
Q17. If an establishment voluntarily submits a generically approved label to LPDS for approval, should the establishment indicate this somehow on the label application?
Yes. It is unnecessary to submit a generically approved label to LPDS for approval. However, if an establishment chooses to voluntarily submit such a label, the applicant can facilitate the label review process by adding “generic” to the claims list in block 10 of FSIS Form 7234-1. Similarly, when applicants are requesting voluntary review of a generically approved label submitted through LSAS, the applicant should type “generic” in the box entitled “Other claim description” in Step 3: Special Claims Information.
Q18. When LPDS completes a voluntary label review on labels that do not require submission to LPDS and that can be generically approved, will the labels be stamped with the “Sketch Approved” stamp if they meet all of the regulatory labeling requirements?
Yes. As part of the voluntary LPDS label review process for labels that can be generically approved, such labels that meet all of the applicable regulatory requirements will be stamped “Sketch Approved.” Labels that require minor modification in order to comply with applicable regulations will be stamped “Approved as Modified” and “Sketch Approved” and required modifications will be noted on the label application. Labels sketch approved as modified by LPDS staff are not required to be resubmitted to LPDS.
Q19. If during a voluntary review on a label which does not fall into one of the four categories of labels requiring sketch approval, LPDS determines that the label must be returned to the establishment and is not granted sketch approval, must the establishment resubmit the label to LPDS for approval?
No. Any label that is submitted for a voluntary review but returned to the establishment by LPDS because it is not compliant with FSIS regulations or policies, will have attached to it comments from an LPDS staff officer noting why the label is not acceptable. The comments will enable the establishment to make the necessary changes to achieve compliance. Establishments may contact LPDS if they have questions or require clarification on comments made on any returned labels. If the establishment voluntarily resubmits such labels with corrections, LPDS will place the labels in the second priority review queue on the day they are received. It is important to note that labels that are voluntarily submitted that meet the requirements for generic approval in 9 CFR 412.2 may be used by the establishment while they are awaiting review provided that they meet all applicable labeling regulations. Furthermore, this placement will ensure that labels that require approval under 9 CFR 412.1 always receive the highest priority for review. As a reminder, first priority labels that need to be modified will be handled the same as prior to the implementation of the generic rule. Most importantly, FSIS does expect a shorter turnaround time for label review as more labels are now eligible for generic approval under the new generic label approval regulations in 9 CFR 412.2.
Q20. Are there any circumstances under which labels that are eligible for generic approval may be submitted as an extraordinary circumstance and receive an accelerated review?
No. Any label that may be generically approved does not require LPDS review and, therefore, does not meet LPDS’s criteria for an extraordinary circumstance. Labels that may be generically approved that are voluntarily submitted for evaluation and approval will be reviewed as part of a second or lower priority review process.
Q21. What are the record keeping requirements for a generically approved label?
Establishments are required to keep records of all labeling, both generically approved and sketch approved by FSIS, along with the product formulation and processing procedures, as prescribed in 9 CFR 320.1(b)(11), 381.175(b)(6), and 412.1. The final rule added the requirement that any additional documentation needed to support that the labels are consistent with the Federal meat and poultry regulations on labeling also be kept. For example, in a situation where an establishment makes a “no MSG” claim, documentation would include a sketch approval from the Agency and the product formulation to establish that the product is absent of the ingredient, which substantiates the validity of the claim. Companies must provide labeling records to FSIS personnel upon request as described in 9 CFR 412.1(a).
Q22. Is the establishment required to use FSIS Form 7234-1, Application for Approval of Labels, Marking or Device as part of the labeling record for labels that are generically approved?
No. However, because FSIS Form 7234-1 contains space to record the product formula and processing information, both of which are required to be included in the labeling record for generically approved labeling, many establishments voluntarily choose to use this form to document their product formula and processing procedures in their labeling record.
Q23. Will FSIS Form 7234-1 be changed so that the establishment may include the reasons that the label cannot be generically approved? For example, the label includes a third party logo.
No. FSIS does not plan to modify FSIS form 7234-1. The form provides several reasons that applicants can check off to indicate why the label can not be generically approved in block 10 of the form: labels for religious exempt product, labels for products for export with deviations from domestic requirements, temporary label applications, and labels with several special statements and claims such as “Natural/Organic.” If applicants have a label with special statements and claims not listed on the form, they should check “Other Claims” on the form, with a notation regarding the claim.
Q24. Do FSIS Inspectors generically approve labels?
No. FSIS inspectors do not generically approve labels. Labels will be generically approved by FSIS, without submission to LPDS, if they meet the criteria listed in 9 CFR 412.2(b).
Q25. I have heard that FSIS IPP do not approve labels, but I have also heard that FSIS IPP will verify labels. What is the difference between these two activities?
All meat and poultry product labels need to be approved by the Agency for compliance with 9 CFR 412.1(a). Any label that is not included in one or more of the four categories of labels that requires submission to the Agency in 9 CFR 412.1(c) is generically approved without the need for it to be submitted to LPDS under 9 CFR 412.2, provided that the label displays all mandatory label features in compliance with applicable Federal regulations. FSIS IPP perform a General Labeling Task in the Public Health Inspection System (PHIS) as part of their regular label verification activities. FSIS IPP verify that final labels applied to product are in compliance with applicable regulations by reviewing information in the establishment’s labeling record and the label that is applied to the product (e.g., to verify that the ingredients statement on the label matches the product formula).
Q26. What should I do if I believe that my label is generically approved, but FSIS Inspection Program Personnel (IPP) believe that my label requires LPDS sketch approval?
The establishment should follow up directly with the IPP to clarify any questions or concerns that have been raised. If an establishment or FSIS IPP has questions about specific labeling regulations and requirements, they may contact LPDS by phone (800-233-3935) or through askFSIS: http://askfsis.custhelp.com
Q27. Does the establishment generically approve its own label?
No. Establishments do not generically approve labels. Although not submitted to FSIS, generically approved labels are approved by FSIS by being in compliance with applicable regulations in 9 CFR 412.2(b).
Q28. Will FSIS update the Generic Labeling Advisor (GLA) in LSAS to reflect changes to the generic regulations?
Yes. The GLA is a tool to assist establishments in determining whether a label is eligible for generic approval. FSIS is updating the GLA in LSAS to reflect the new generic labeling regulations in 9 CFR 412.2.
Q29. Will FSIS continue to update the Food Standards and Labeling Policy Book with new policy guidance?
No. FSIS has decided to stop adding policy guidance to the Food Standards and Labeling Policy Book. FSIS will continue to amend or remove items in the book, as necessary; however, it will no longer add new material to the book.
Q30. How will FSIS convey new labeling policy if the Food Standards and Labeling Policy Book is no longer updated?
The Agency will convey new labeling policy and clarify existing policy by other means, such as compliance policy guides.
Q31. May statements on labels that are defined in FSIS’s regulations or the Food Standards and Labeling Policy Book be generically approved?
Yes, with the exceptions of “natural” and negative claims (e.g., “gluten free” and “no milk”), statements defined in the Food Standards and Labeling Policy Book may be approved generically.
Q32. Will FSIS allow generic approval of any temporary label approvals and extensions?
No. FSIS regulations are not specific enough to assist establishments in determining when a temporary label may be granted. For this reason, the final rule did not expand the scope of generic labeling approval to include temporary label approvals and extensions of temporary approval.
Q33.If an establishment receives temporary approval for a label with deficiencies may the label, once the noted deficiencies are corrected, be generically approved?
No. Temporary approval only provides for the use of final labels that are deficient in some particular, as described in 9 CFR 412.1(f)(1). A label may only be generically approved if it meets the criteria for generic approval in 9 CFR 412.2(b) and displays all mandatory features in compliance with FSIS regulations.
Q34. If a pressure sensitive sticker is used to correct a label issue (e.g., nutrition facts panel error, allergen advisory declaration, etc.), may the sticker be applied generically or would the manufacturer be required to submit a temporary label approval in order to apply this sticker?
If a pressure sensitive sticker is applied to a label in order to correct a label error or deficiency, the label may be used with the sticker indefinitely. However, if the sticker is used to add information to a label but does not correct the label to be fully compliant (e.g. adding an ingredient of public health concern but not placed in its proper order of predominance), then the establishment will need to correct it’s label or submit the label for a temporary approval to be able to keep using the incorrect label until the label can be replaced.
Q35. May I generically approve a label with a religious exemption claim?
No. Generically approved labeling is not appropriate for the labeling of religious-exempt product because such product does not receive the mark of inspection and, therefore, deviates from the general labeling requirements for meat and poultry products.
Q36. Are labels for animals slaughtered under ritual slaughter required to be sketch approved by FSIS?
Ritually-slaughtered meat and poultry products receive the mark of inspection (Kosher, Halal) and may be approved generically provided that they don’t meet one of the other labeling categories required to be submitted for approval under 9 CFR 412.1(c).
Q37. What is the difference between “Certified Halal” and “Halal”? Do both require LPDS sketch approval?
The use of the term “Halal” on labeling requires certification by an appropriate third party authority. However, when “Halal” is used on the label without referencing a specific certifying authority, the label may be eligible for generic approval. When the label states that the food has been "Certified Halal,” the name of the organization providing the certification also needs to appear on the label and "certified" acts as a special claim that requires submission to FSIS LPDS. The label application must include documentation that demonstrates that the certifying organization's standards are met. For example, Company AZ submits a label for a Halal product labeled as "IFANCA Certified." FSIS would require Company AZ to submit confirmation from the Islamic Food and Nutrition Council of America (IFANCA) that Company AZ's product meets the IFANCA requirements for certification. Supporting documentation should be current within the past 12 months and specific to the establishment submitting the label.
Q38. Why are labels marked “for export only” with labeling deviations required to be submitted to FSIS for sketch approval?
Exports of U.S. meat and poultry products occur in the context of U.S. government-foreign government agreements. These agreements require U.S. government approval of labels on meat and poultry products to be exported. One aspect of this approval is ensuring that any changes made to labels on meat and poultry products are done in accordance with the importing country’s laws. Therefore, labels marked “for export only,” whose labels deviate from FSIS regulations, cannot be generically approved.
Q39. Under the New Generic Labeling Final Rule, would ALL product labels for export that are generically approved need to be submitted to LPDS for approval before they are exported?
No. Only sketch labels for products for foreign commerce whose labels deviate from FSIS regulations (with the exception of printing labels in foreign language or printing labels that bear a statement of the quantity of contents in accordance with the usage of the country to which exported as described in Sec. 317.7 and part 381, subpart M, which are deviations that do not require submission) need to be submitted to LPDS for approval. If a label for export bears any other deviations from domestic requirements, then the label must be submitted for review and approval.
Q40. What are some examples of labeling deviations that might appear on labels marked “for export only”?
Common labeling deviations on such labels include the absence of Safe Handling Instructions on products that are not fully cooked and nutrition facts panels in formats varying from those in the FSIS regulations.
Q41. What constitutes a “special statement or claim”?
A special statement or claim is a statement on labeling that is required to be submitted to the Agency for approval. Labels with special claims cannot be generically approved. These claims are usually those that are not defined in 9 CFR, in published label guidance, or defined in the Food Standards and Labeling Policy Book. Examples of labeling claims and special statements that must continue to be submitted for evaluation and approval are:
- claims relating a product’s nutrient content to a health or a disease condition;
- statements that identify a product as “organic” or containing organic ingredients;
- claims regarding meat and poultry production practices, e.g., claims regarding the raising of animals, such as “no antibiotics administered” or “vegetarian fed”;
- claims that are undefined in FSIS regulations or the Food Standards and Labeling Policy Book
- “natural” and negative claims; or
- instructional or disclaimer statements concerning pathogens, such as “for cooking only” or “not tested for E. coli O157:H7.”
Q42. Is there a comprehensive list or guide available that outlines what statements or claims require prior approval?
FSIS has compiled a list, which will be periodically updated, of statements or claims that require prior approval: Labeling that Needs to be Submitted to the Labeling and Program Delivery Staff for Evaluation and Approval.
The list is extensive; however, because of the wide variety of possible claims that may be submitted, the absence of a claim from this list does not necessarily indicate that a claim does not require prior approval. If establishments need clarification on whether or not a claim requires sketch approval by LPDS, they may submit a claim inquiry via the online question and answer forum askFSIS.
Q43. Is the child nutrition (CN) box on a meat or poultry product considered a special statement or claim and require sketch approval?
No. The CN information in CN boxes is reviewed and evaluated for approval by the Agricultural Marketing Service (AMS) and is not a special statement or claim. Therefore, under this final rule a meat or poultry product label with a CN box is generically approved and does not have to be submitted to FSIS for approval after approval by AMS.
Q44. Are labels with special statements or claims that have been reviewed by other Government agencies eligible for generic approval?
Except for meat and poultry product labels that bear child-nutrition (CN) boxes, which are reviewed and approved by the Agricultural Marketing Service (AMS), at this time, no other labeling that may be placed on meat and poultry products is actually reviewed by another Government agency. While agencies such as FDA and AMS may have extra-regulatory processing, marketing, or verification programs, the labels applied to meat and poultry products as part of these programs are not reviewed and approved by the other agencies. Rather, these agencies are verifying the documented production, manufacturing, or service delivery processes of suppliers of agricultural products or services. Therefore, because only the production, manufacturing, or service delivery process is being verified by these agencies, and not the label itself, they are not generically approved under the Agency’s regulations. In addition, the statements on the labels are considered special statements or claims that may not be approved without submission to and evaluation by FSIS.
Q45. Are Child Nutrition (CN) labels with an AMS extra regulatory marking or verification program symbol on them required to be submitted to LPDS?
Yes. The addition of an AMS extra regulatory marking or verification symbol (e.g. “USDA Process Control Certification Program”) would require the label to be submitted to LPDS for review and approval.
Q46. When introducing a new product in which the label bears no special statements or claims but does state “NEW” on the label, is this label required to be submitted to LPDS for sketch approval?
No. Product labels bearing the statement “NEW” that are not included in one of the four categories of labels that must be submitted for approval (9 CFR 412.1) may be generically approved. If a label bearing a “NEW” claim is used beyond six months from the date that the product was introduced in commerce, then the label would need to be submitted to LPDS to request a temporary approval because the use of the term “NEW” is limited to a period of six months as described in the Food Standards and Labeling Policy Book.
Q47. Are “more” claims about a food (e.g., “10% more meat sauce” or “20% more food”) eligible for generic approval?
Yes, “more” claims about a food component (e.g., 10% more pepperoni) can be generically approved, provided that the establishment has documentation in its labeling record to support the claim that is made (e.g., documentation showing the new product formula contains 10% more protein as compared to the previous product formula).
Q48. Are labels bearing State endorsement programs with a geographic landmark (e.g., Pride of New York, which includes a map of the State of New York) required to be submitted to LPDS for sketch approval?
Yes. 9 CFR 412.1(e) stated that LPDS would continue to review labels with geographic landmarks. Labels bearing State endorsement programs with an emblematic representation of the state (map of the state, state flag, iconic item from that state, etc.) need to be submitted to LPDS for review and approval. However, labels bearing State endorsement programs without an emblematic representation of the State would be eligible for generic approval, provided that the label does not fall into any of the categories listed in 9 CFR 412.1.
Q49. Do State endorsement programs that include “certified” as part of the logo require LPDS sketch approval?
Yes. A State endorsement program that includes “certified” as part of the logo that appears on the label requires LPDS approval, while a logo that does not reference the term “certified” and does not include a geographic landmark may be generically approved.
Q50. What is a geographic landmark or logo, as referenced in 9 CFR 412.1. Under this provision, labels with a geographic landmark or logo need to be submitted to LPDS for approval?
A geographic landmark or logo is a map (state, country, or region), flag, or some other geographically significant symbol, such as the Statue of Liberty. If companies add geographic landmarks or logos of this type, they need to submit the label to LPDS for review and approval.
Q51. Is “Certified Cajun” considered a special statement or claim that requires submission to LPDS for review and approval?
No. Unlike other types of certified claims that need to identify the certifying entity on the label and be submitted to LPDS for approval, “Certified Cajun” is a claim that the Agency has historically approved for any products produced in Louisiana. Therefore, the claim “Certified Cajun” is not considered a special statement or claim and is generically approved, provided that the product is produced in Louisiana.
Q52. Labels for uncured products that contain naturally-occurring nitrate, nitrite in celery powder, and other natural sources must bear the statement “No nitrates or nitrites added except for those naturally occurring in (name of ingredient, e.g., celery salt).” May these labels be approved generically since the “no nitrates/nitrates” statement is required by FSIS regulations in 9 CFR 317.17?
No. The labeling of uncured products is prescribed in 9 CFR 317.17. However, “uncured” is also a negative claim that highlights the absence of a specific ingredient (i.e., a curing agent). Therefore an uncured negative claim required by 9 CFR 317.17 is a special statement or claim under 9 CFR 412.1(c)(3).
Q53. May labels bearing COOL (Country of Origin Labeling) statements as required by the Agricultural Marketing Service (AMS) be approved generically?
A COOL statement, as required by 9 CFR 317.8(b)(40) and 381.129(f), is not considered a special statement or claim. As long as labels bearing COOL statements do not meet any of the criteria requiring sketch approval (temporary approval, export labels with deviations, religious exempt product, or special statements or claims), they may be approved generically.
Q54. Will allergen statements require approval by LPDS staff?
No. FSIS does not view the addition of an allergen statement (e.g., “contains soy”) applied in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) as a special statement or claim that requires sketch approval. An allergen statement of this type is generically approved as described in 9 CFR 412.2(b).
The use of factual statements about a product's manufacturing environment, e.g., "Produced in a plant that uses peanuts," and the use of “may contain” statements, e.g., "may contain peanuts," may only be used in cases where establishments show that adequate SSOPs cannot effectively eliminate the cross contact issue. Statements of this type are considered a special statement or claim under 9 CFR 412.1(c)(3), which requires sketch approval. Additional information on voluntary allergen labeling statements can be found at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/ingredients-guidance/allergens-voluntary-labeling-statements.
Q55. Will labels containing foreign languages on products for sale in the US that do not have special statements or claims require prior approval by LPDS staff?
No. While the previous generic labeling regulations did not permit the generic approval of a label adding or deleting a direct translation of the English language into a foreign language for product sold in the U.S., this final rule does. These types of labels do not fall into any of the categories of labels that must be submitted to FSIS for evaluation and review.
Q56. Under the new generic regulations, what types of changes are permitted to a label approved with a special statement or claim without resubmitting the label for sketch approval through LPDS? Do the permitted changes include the changes referenced in the previous generic regulations (9 CFR 317.5(b)(9) and 9 CFR 381.133(b)(9)) that were removed when the new generic regulations were added to the Code of Federal Regulations?
FSIS regulations in 9 CFR 317.5(b)(9) and 381.133(b)(9) used to prescribe the types of changes that could be made to labels previously approved by LPDS (e.g., change in brand name, net weight changes, updating the values in the nutrition facts panel). Although these regulations were eliminated, these types of label changes may continue to be made generically for labels previously approved by LPDS with special statements and claims provided the change is unrelated to the special statement or claim (e.g., the addition of a new special statement or claim not on the previously approved label). For example, an establishment may change the address line and net weight on a label submitted and approved with a “natural” or “gluten free” special statement or claim because these changes would be unrelated to the claims. In comparison, if the establishment modified the formula to include a new ingredient not included in the previously approved label’s formula, the label would need to be resubmitted for approval because a formulation change of this type could affect the special statement or claim.
Q57. If there is a formulation change to a label that was previously approved with a special claim such as "natural" or “gluten free,” will the label need to be re-submitted for approval?
In this case, the label would need to be resubmitted if the change involved the addition of a new ingredient not listed in the formula of the previously approved label. LPDS would need to evaluate the addition of a new ingredient to verify whether the product continues to qualify for the natural or gluten free claim. If no new ingredients are added and ingredients in the formula are only being removed or changing in order of predominance, the label does not need to be resubmitted and may be generically approved.
Q58. Labels with negative claims must be submitted to FSIS for approval. How does FSIS define “negative claims” and why do they require FSIS approval?
“Negative” labeling claims are defined in the Food Standards and Labeling Policy Book. Negative claims refer to statements highlighting the absence of an ingredient or another constituent of the food, an example of which, “gluten free,” has been codified in 9 CFR 412.1(e). “No milk” is another example of a negative claim that highlights the absence of an ingredient or another constituent of a food. A negative claim may also identify the absence of certain types of ingredients, e.g., “no preservatives” or “no artificial coloring,” based on the product formulation. Consequently, negative claims can vary greatly, from a specific ingredient to a class of substances, making it difficult to determine whether a label bearing this type of claim complies with the regulations. Therefore, such claims require submission to FSIS for approval as noted in preamble to final rule (78 FR 66826).
NOTE: Nutrient content claims (e.g. fat free, cholesterol free) are defined in FSIS regulations (9 CFR 317, Subpart B and 381, Subpart Y) and are eligible for generic approval. Defined nutrient content claims are not negative claims as defined in the Food Standards and labeling Policy Book entry for “Negative Claims.”
Q59. Why do “organic” claims require FSIS approval?
The Agricultural Marketing Service (AMS) is responsible for developing national standards for organically-produced agricultural products (7 CFR Part 205). “Organic” is not defined in FSIS’s regulations. Consequently, establishments may not be familiar with the Agency’s requirements for the support of label applications with this claim, which could result in increased labeling errors and misbranded products. While industry is familiar with the requirements for mandatory label features, as noted in the proposed rule, the Agency believes that it needs to continue to provide pre-market evaluation and approval of “organic” claims because they present significant and evolving policy issues. Evidence that the product has been approved as “organic” by the USDA National Organic Program (e.g., a certificate from the certifying entity) will be considered sufficient support for FSIS to approve the claim.
Q60. Why does the use of the word “natural” require LPDS review?
“Natural” is also a claim that is undefined in FSIS’s regulations, but is defined in the Food Standards and Labeling Policy Book. However, “natural” is a controversial claim which has come under great scrutiny in the last several years and for which FSIS is considering rulemaking. Therefore, “natural” was not included in the final rule as a claim eligible for generic approval as noted in preamble to the final rule (78 FR 66826).
Q61. The regulations require that certain pork products be treated to destroy trichinae. Must establishments submit at least one label to LPDS for sketch approval if they elect the labeling in lieu of certified pork option permitted by FSIS instead of the trichinae treatments described in 9 CFR 318.10(c)?
No. Labels for uncooked pork products that are prepared in such a manner that the product might be eaten rare or without thorough cooking because of the appearance of the finished product or otherwise (9 CFR 318.10(b), and that bear required labeling features to convey that the products require thorough cooking, do not require a sketch approval from LPDS. All of the required features of the labeling in lieu of certified pork option (validated cooking instructions with endpoint temperature, a statement such as “uncooked” on the principal display panel, and safe handling instructions) may be generically approved in accordance with 9 CFR 412.2. Therefore, an establishment is not required to have an LPDS sketch approved label on file.
Q62. Do claims that may not present public health or economic concerns, such as marketing promotions, logos from recognized third parties, and general wellness claims qualify for generic approval?
No. Labels such as these are subject to Agency evaluation and review. As with some of the temporary labels for which generic approval is sought, whether a label presents a food safety issue or not, requires an assessment of the public health risk presented by the label. It is appropriate that FSIS, not establishments, conduct such an assessment. In addition, the generic approval of labels that include marketing promotions, logos from recognized third parties, general wellness claims, and other similar features that, in the opinion of industry, do not present consumer confusion issues, would still be problematic because these labels may include claims that are not addressed in the meat and poultry regulations. Some of these labels might also fall into the category of implied nutrient content claims as defined in 9 CFR 317.313(b)(2) and 381.413(b)(2), e.g., a claim that suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made with an explicit claim or statement about a nutrient. Because FSIS does not have any regulations that cover the application of implied claims to meat and poultry labels, establishments would have great difficulty determining whether such labels are generically approved. For these reasons, these labels must continue to be submitted to FSIS for evaluation and review under this final rule.
Q63. What is the difference between the Nutrition Facts Panel and a Nutritional Claim?
The nutrition facts panel is the panel on the label that provides information about the nutrients present in the product. An example of such a panel can be see in 9 CFR 317.309(d)(12) and 9 CFR 381.409(d)(12). The presence of the nutrition facts panel does not require sketch approval. Nutritional claims are claims relating to some aspect of the product, i.e., excellent source of protein, which corresponds to the grams and percent daily value of protein in the nutrition facts panel. Nutritional claims that are defined in the regulations do not require sketch approval.
Q64. What are nutritional claims that are defined in the regulations and eligible for generic approval?
Some examples of claims that can be generically approved are:
- Low or free (9 CFR 317.313 (e) and 9 CFR 381.413 (a))
- Relative Claims (9 CFR 317.313 (j) and 9 CFR 381.431 (j) (1))
- Good, High, More (9 CFR 317.354 and 9 CFR 381.454)
- Light (9 CFR 317.356 and 9 CFR 381.456)
- Calories (9 CFR 317.360 and 9 CFR 381.460)
- Sodium (9 CFR 317.361 and 9 CFR 381.461)
- Fat (Lean and Extra Lean), Fatty Acid (9 CFR 317.362 and 9 CFR 381.462), Cholesterol (9 CFR 317.362 and 9 CFR 381.462)
- Healthy (9 CFR 317.363 and 9 CFR 381. 463)
- Reducing Weight- Low calorie, Reduced Calorie, Sugar free or No-Added Sugar (9 CFR 317.380 and 9 CFR 381.480).
Q65. Are statements such as “97% fat free,” “excellent source of protein,” “lower sodium,” and “good source of iron,” eligible for generic approval?
Yes. Nutrient content claims that are defined in FSIS’s regulations are eligible for generic approval and are not required to be submitted for review.
Q66. Does the location (principal display panel or informational panel) of a statement such as “97% fat free,” “excellent source of protein,” and “good source of iron,” affect whether or not a label may be generically approved?
No. The location of the nutrient content claim does not affect whether or not the label may be generically approved. Nutrient content claims that are defined in FSIS’s regulations are generically approved and are not required to be submitted for review.
Q67. Is LPDS sketch approval still required for changes to the serving size on the Nutrition Facts Panel?
No. A change in serving size that is in the regulations (9 CFR 317.309 (b) (2) and 9 CFR 381.409 (b)) may be generically approved. However, if the serving size is changed to one that is not in FSIS’s regulations, the label must be submitted to LPDS for evaluation and approval.
Q68. The appetizer (Reference Amount Customarily Consumed) RACC of 85g is not a RACC defined in FSIS’s regulations (9 CFR 317.309 (b) (2) and 9 CFR 381.409 (b)), yet it has been used by establishments for years. May this RACC be applied to a label generically?
Yes. Although not formally defined in FSIS regulations, the appetizer RACC has been used regularly for 20 years. FSIS believes that the length of time that the appetizer RACC has been utilized by establishments is significant enough to permit its generic approval if the product is an appetizer, and the labeling record indicates that the product is an appetizer. Note that nowhere on the label can it suggest that the product may also be used as a main dish or entree.
Q69. Do front-of-package labeling statements that meet the requirements for nutrient content claims, including statements of quantity, qualify for generic approval?
No. FSIS considers certain front-of-pack (FOP) labeling statements, such as those highlighting select nutrients from the nutrition facts panel placed on the principal display panel, to be nutrient content claims. However, unlike traditional nutrient content claims, such as “low fat,” that are defined in FSIS regulations, there are no guidelines for the multiple types of FOP labeling statements on labeling. Therefore, FSIS needs to continue to require prior evaluation and approval by the Agency to ensure these statements are truthful and not misleading.
However, the addition of an FOP labeling system to a line of products an establishment produces may be the subject of a blanket approval whereby the company only submits one complete application bearing the FOP for approval and indicates in its request that the establishment intends to apply the FOP format to other products it produces. The FOP statement could then be added to other products without having to submit each individual label bearing the FOP statement for approval. The establishment would be responsible for updating the individual nutrient values within the FOP statement generically to match the nutrient values displayed in the nutrition facts panel
Q70. What are front of package (FOP) nutrition statements?
An FOP nutrition statement refers to a specific type of nutrient content claim and not the location of the statement. FOP nutrition statements are used on labeling to highlight and convey certain nutrition information in a manner that is simple and consistent with the Nutrition Facts panel. The statements “10g of protein” and “25% DV Calcium” placed on the principal display panel of a food, consistent with information for these nutrients in the Nutrition Facts panel, are examples of FOP nutrition statements. These FOP statements consist of the amount and name of a nutrient, for example, 10g protein or 25% DV calcium.
Q71. May I do a blanket approval for front of pack (FOP) information on my label?
If front of pack information (FOP) is included on a series of labels in the same product line or by the same company, you may submit an application for a blanket approval for the various nutrient categories. A blanket approval refers to an approval that would cover multiple products or product lines that is submitted to LPDS for approval because it falls under one or more of the four categories of labels described in 9 CFR 412.1. An application for a blanket approval would include a completed application form 7234-1, a copy of at least one of the product labels bearing the FOP information, and an attachment that would indicate the products or line of products that you intend to apply the same FOP nutrition. The blanket approval allows the FOP information to be added to other products without having to submit each individual label bearing the FOP information for approval. The establishment needs to update the individual nutrient values within the FOP statement generically to match the nutrient values displayed in the nutrition facts panel. However new nutrients cannot be added generically to the FOP information that was approved by LPDS.
Note: Other nutrition information on the front of pack, e.g., “0 grams Trans fat per serving” or “fat free” must kept separate from the FOP to prevent it from being considered an implied claim, e.g., healthy.
Q72. What is the difference between a front of package (FOP) nutrition statement and a claim like “97% fat free?”
FOP nutrition statements are considered nutrition claims and are not defined in FSIS’s regulations. Therefore, FOP nutrition statements are considered special statements and claims that require approval under 9 CFR 412.1(c)(3). In comparison, “97% fat free” is considered a nutrient content claim that is defined in FSIS’s regulations. Establishments electing to make a defined nutrient content claim on their label may do so generically.
Q73. If values in the nutrition facts change may the values in the FOP be changed generically?
Q74. May nutrients be added or removed generically from the approved FOP?
The specific nutrient categories in the FOP may be removed generically, but none may be added generically. Additionally, no other nutrition information or claims may be added contiguous to the FOP. For example, the nutrition statement “0 grams Trans fat per serving” or the claim “fat free” must be separated from the FOP information to prevent it from being considered an implied claim, e.g., healthy.