Generic Labeling Update
2017
Generic Labeling Update
1
1
2017
Agenda
2
I.
Introductions & Background
II.
Generic Eligibility
III.
Generic Compliance & Approval
IV.
Record Keeping & Enforcement
V.
Recommendations & Conclusion
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
2
2017
FDA vs USDA: Label Approval Ask for Forgiveness Surveillance catches errors Warning Letter or Recall Ask for Permission US law requires USDA to preapprove ALL labeling Due to high volume, USDA created “Generic” approvals Generic labels MUST be in compliance with all regulations and are therefore approved without USDA viewing them 3
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
3
2017
USDA Label Approval – Two Types 1. LPDS reviews “sketch” labels & stamps approval
When labels are finalized with all artwork complete, the actual label is attached to approved sketch application & is “generically” approved (no changes to sketch)
Sometimes approved labels can be rescinded if they were approved in error
2. Generic Labels which comply with ALL regulations are approved without LPDS viewing them (by virtue of regulatory compliance to all acts, laws, directives, etc.)
4
If there is an error, they are not considered approved and the local inspector can stop production or request a recall
A temporary approval may be granted if the proposed labeling would not misinterpret the product; the use of the labeling would not present any potential health, safety, or dietary problems to the consumer; denial of the request would create undue economic hardship; and an unfair competitive advantage would not result from the granting of the temporary approval.
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
4
2017
Generic Labels must be in compliance with all sources of USDA Regulations . . . ①
Congressional Acts
②
Code of Federal Regulations (CFR) Title 9: Meat & Poultry Title 7: Eggs, Organic, CN
5
③
Food Standards & Labeling Policy Book
④
Policy Memos
⑤
Directives & Notices
⑥
Guidance Documents
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
5
2017
Generic Eligibility
© Copyright 2014 by Prime Label Consultants, Inc. 6
6
2017
NOT ELIGIBLE for Generic Label Approval: Four categories of labels require LPDS review
Temporary Approval Product produced under religious exemption Product for export only with U.S. deviations Labels with special statements & claims
All other labels DO NOT REQUIRE LPDS review
9 CFR 412 7
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
7
2017
Temporary Label Approval Granted for final labels with a regulatory deviation
With no safety or dietary risk economic advantage, or product misrepresentation
Never acceptable as a generic approval;
Reviewed by LPDS on a case-by-case basis
Granted for a maximum of 180 days
Extension of temporary may be granted if labels have not all been used
8
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
8
2017
Religious Exemption Religious Exempt Product (poultry)
Does not receive a mark of inspection
Can never be generic
i.e. Confucian style poultry (not eviscerated)
Different from ritually slaughtered meat or poultry which does receive a mark of inspection
i.e. Kosher or Halal
Which may be a generic approval unless the name/acronym of certifier is present (special statement / claim)
9
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
9
2017
For Export Only with Label Deviations Labels marked for export only with deviations from U.S. regulations must be reviewed by LPDS
With the exception of:
Net Weight Statement
Foreign Language
These deviations may be generically approved
Provided the deviations do comply with regulations of the country of import
10
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
10
2017
Special Statements & Claims: Not Eligible for Generic 9 CFR 412.1(e)
“Claims, logos, trademarks, and other symbols…not defined in the Federal…meat and poultry regulations or FS&LPB”
“Natural and negative claims (e.g. gluten free, uncured)”
“Ingredient and processing method claims (e.g. highpressure processing)”
“Health claims…structure-function claims, claims regarding the raising of animals, organic claims”
“Logos and symbols include graphic representations of hearts and geographic landmarks”
11
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
11
2017
Special Statements & Claims - Examples 3rd Party Certifications
Organic Statements
Animal Production Claims
Natural Claims
Breed Claims
Negative / Free Claims
Gluten Free
Omega 3/6 statements
Uncured
Whole Grain Claims
Health Claims
Front of Pack Nutrition
Structure Function Claims
Non-GE statements
Implied Nutrition Claims
Additional Claims not defined in FSIS regs or FS&LP Book
Instructional Statements related to pathogens
Use of FDA Format NFP These label features require LPDS review 12
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
12
2017
Special Statements & Claims complexities Undefined Serving Size Appetizer RACC can be generic, if ad copy is consistent Meals “Serves #” – “Serving Size 1/# package” Uncured Not generic even though 9 CFR 317.17 defines requirements Front of pack nutrition Blanket Approvals (as long as every icon is represented) Undefined nutrient claims Modifications to existing approvals Impact on Special Statements / Claims Establishment transfers Animal production claims Generic Approval does not apply to eggs, exotic species, or voluntary inspection
14
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
13
2017
Modifications to previous LPDS approvals 9 CFR 412 removed 9 CFR 317.4 / 381.132
Removed all provisions for generic modifications No new regulations on acceptable generic changes
Current guidance is that modifications that do not affect the approved statement or claim are acceptable as generic changes Gluten-Free Claim New seasoning blend added to the product?
14
Change to the net weight?
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
14
2017
Generic Compliance & Approval
15
© Copyright 2014 by Prime Label Consultants, Inc.
15
2017
Your Label may be Generic Eligible but NOT Compliant Generic Eligibility According to the criteria in 9 CFR 412: a) The label must be reviewed by LPDS OR
b) The label is eligible for Generic Approval
Generic Compliance If the label is Generic Eligible: A Generic Approval exists only when all labeling features are in compliance with FSIS regulations and the Food Standards and Labeling Policy Book
16
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
16
2017
LPDS Top Ten Reasons for Label Refusal
* source: Generic Final Rule Nov 2013
Generic Reason
Eligible
Compliant
1. Illegible label records
✔
✖
2. Missing required features
✔
✖
3. Incomplete application form
✔
✖
4. Lack of formulation/processing support
✔
✖
5. Standard is not met
✔
✖
6. Incorrect product name
✔
✖
7. Ingredient statement errors
✔
✖
8. Nutrition Facts Panel errors
✔
✖
9. Non-compliant nutrient content claims
✔
✖
10. Undefined nutrient content claims (must be approved by LPDS)
✖
✖
37% industry-wide refusal rate* (after resubmissions) 17
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
17
2017
Mandatory Label Features - Errors Principal Display Panel - Product Name - Handling Statement - Establishment Legend - Net Weight Statement
Raw Frozen Garlic Breaded Chicken Nuggets Inaccurate Handling Statement
Wrong Inspection Legend
Frozen Keep Refrigerated
Information Panel - Ingredients Statement - Signature Line - Nutrition Facts
No Dual Declaration NET WT 24 OZ (1.5 LBS)
P-5555
Incorrect Serving Size
Any Label Panel - Safe Handling Instructions
Wrong order of Predominance Missing address information 18
May not comply with FSIS standard
4 OZ
INGREDIENTS: CHICKEN BREAST, WATER, SALT, MODIFIED CORN STARCH. BREADED WITH: WHEAT FLOUR, CORN FLOUR, GARLIC WATER, SUGAR Distributed by: Chicken Nuggets LLC Washington DC 20001
Incomplete SHI ©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
18
2017
Generic Claims & Special Statements Claims 100%, Pure Fresh Geographic Claims Grading Green/Environ Claim “Hand” Production Claim New Claims Nutrition Claims (Defined) Religious Uncertified
Special Statements Ad Copy Allergen Statement Country of Origin Cooking Instructions Flavor Profiles Foreign Language Guarantees Prep/Cook Time Stmts Statement of Limited Use Child Nutrition Labels
These label features may not require FSIS first priority review 19
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
19
2017
Generic Case Study
20
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
20
2017
Determining Compliance for Label Approval How do we know if our label is compliant?
21
In-house
Many common label regulations will be well understood by the regulatory team
askFSIS
Useful for simple questions
Consultant
A third-party expert can review your label if you prefer to stay “under the radar”
LPDS
All labels may be sent to LPDS for review; second priority review will take longer
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
21
2017
Record Keeping
22
© Copyright 2014 by Prime Label Consultants, Inc.
22
2017
Label Lifecycle: FSIS Directive 7221.1
Label Design
Sketch Label Approval
Final/Generic Approval
Compliance Verification
Approval by LPDS
Final Label added to Records
IPP via PHIS Labeling Tasks
Generic Approval via LPDS
FSIS Market Surveillance
Enforcement / Remediation Recall
New Label
Generic Modifications to Sketch Approved Label
3rd Party Audit
Generic Approval via Company
(allergen ingredient omission)
NR
Consumer Complaints
(Noncompliance Record) - Pressure sensitive sticker - Temporary approval by LPDS
3rd Party Audit
Company must maintain records of all label approvals
23
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
23
2017
FSIS Directive 7221.1 All approved labels must be produced upon request for authorized USDA personnel within 24 hours. Each labeling record should include: 1. a copy of the final label that is in use, 2. the product formulation, 3. the processing procedure for the product, and 4. any supporting documentation needed to show that the label is consistent with the Federal meat and poultry regulations and policies on labeling as described in 9 CFR 412.1 24
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
24
2017
Establishing Records – Core Elements
Label records should always include: The label sketch/proof
A record of the approval (7234 Form)
The product formulation
Processing procedures
Generic:
25
1.
Who approved: signature
2.
Date of approval
3.
Entire previous stamped label application with note of changes (if applicable) ©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
25
2017
Establishing Records – Other Documentation
Mandatory Purchased Ingredients
Certifications (unexpired)
Claim Support
Recommended Previous label approvals
Eligibility Support
1. Spec Sheets
1. Stamped 7234
2. Meat/Poultry: Actual Label
2. Actual Label 3. Supporting Docs
26
Compliance Support
Regulation citations - examples in Appendix
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
26
2017
Updating Records 1. Formula Changes: • New label + Temporary if needed
2. Ingredient Substitutions: • Temporary (extraordinary circumstances) • Recommended: establish an in-house approval process
3. Processing Changes: • New label + Temporary if needed
4. Other situations … • Different establishment • New regulations (Nutrition Panels in 2-5 years) • Expired certificates • More? 27
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
27
2017
Enforcement & the Local Inspector
28
© Copyright 2014 by Prime Label Consultants, Inc.
28
2017
IIC Inspector Roles in Labeling 1. Compare manufacture of product with paperwork detailing formulation & processing procedures 2. Verify final label via Labeling Tasks in PHIS 3. Issue NR (Noncompliance Record) when problem exists & hold product until rectified
29
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
29
2017
Public Health Information System Labeling Tasks From PHIS IIC Inspector Training Manual… 1. General Labeling Task 2. Product Standards Task 3. Child Nutrition / Grade Labeling / Declared Count / Vignette Task 4. Net Weights Task
30
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
30
2017
From PHIS Local Inspector Training Manual… When noncompliance is found, take the appropriate regulatory control actions, such as retention of product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of specifically identified product (9 CFR 500.1(a)), if it is determined that misbranded or economically adulterated product would otherwise enter commerce or be shipped from the establishment. Additionally, FSIS may rescind or refuse approval of false or misleading marks, labels, or sizes, or forms of any container for use with any meat or poultry product per 9 CFR 500.8. If it is determined that economically adulterated or misbranded product has entered commerce, FSIS will expect establishments to implement recall procedures.
31
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
31
2017
Noncompliant Labels The Inspector Finds a Noncompliant Label
A friendly warning is given
Update labels at next printing
Noncompliance Report is issued
Apply for a Temp if necessary
Apply for an Emergency Temp
32
Sticker/Inject labels for Compliance
Appeal the NR to an IPP supervisor
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
32
2017
Recommendations & Conclusion
33
© Copyright 2014 by Prime Label Consultants, Inc.
33
2017
Labeling Rules are Complex 1. USDA has very precise, strict requirements for labeling 2. There are many sources of labeling regulations 3. USDA decisions can be subjective & follow unwritten rules 4. USDA has final authority
34
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
34
2017
Mistakes Can Be Costly 1. Risk of non-compliance could mean product prohibited from leaving plant until label is corrected – production holds & reprinting costs 2. Risk of product being stopped at border 3. Risk of recall if product leaves plant with serious error (undeclared allergens, etc.) 4. Risk of lawsuit if competitor alleges misbranding
35
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
35
2017
Recommendations to Reduce Risk 1. Record keeping is your friend! Document, document, document …Update, update, update
2. For high risk labels, get a second opinion with LPDS (if not time sensitive) or consultant High volume product
Complex/gray area labeling
Extensive ad copy
High geographic distribution
Co-packer
Assertive marketing
High printing costs
Customs border support
3. Get the resources you need Software, training, experts on call
36
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
36
2017
Recommendations to Reduce Risk 4. Proactively change your organization to mitigate risk New Quality Control labeling processes More & tighter communication with production, vendors, suppliers, IPP Educate R&D & Marketing up front in labeling regulations Use technology like WebEx to get everyone on same page
5. Develop: Labeling Checklists QC program of audits & reviews
Do the Inspector’s job before they do it themselves…
37
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
37
2017
Conclusion Faster time to market with Generic approvals, BUT… YOU are now responsible for getting it right “with great freedom comes great responsibility…”
Compliance mistakes come with a price tag! Retained product ($$) or Recall ($$$$$)
38
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
38
2017
Biography
39
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
39
Generic Labeling Update
1
1
2017
Agenda
2
I.
Introductions & Background
II.
Generic Eligibility
III.
Generic Compliance & Approval
IV.
Record Keeping & Enforcement
V.
Recommendations & Conclusion
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
2
2017
FDA vs USDA: Label Approval Ask for Forgiveness Surveillance catches errors Warning Letter or Recall Ask for Permission US law requires USDA to preapprove ALL labeling Due to high volume, USDA created “Generic” approvals Generic labels MUST be in compliance with all regulations and are therefore approved without USDA viewing them 3
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
3
2017
USDA Label Approval – Two Types 1. LPDS reviews “sketch” labels & stamps approval
When labels are finalized with all artwork complete, the actual label is attached to approved sketch application & is “generically” approved (no changes to sketch)
Sometimes approved labels can be rescinded if they were approved in error
2. Generic Labels which comply with ALL regulations are approved without LPDS viewing them (by virtue of regulatory compliance to all acts, laws, directives, etc.)
4
If there is an error, they are not considered approved and the local inspector can stop production or request a recall
A temporary approval may be granted if the proposed labeling would not misinterpret the product; the use of the labeling would not present any potential health, safety, or dietary problems to the consumer; denial of the request would create undue economic hardship; and an unfair competitive advantage would not result from the granting of the temporary approval.
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
4
2017
Generic Labels must be in compliance with all sources of USDA Regulations . . . ①
Congressional Acts
②
Code of Federal Regulations (CFR) Title 9: Meat & Poultry Title 7: Eggs, Organic, CN
5
③
Food Standards & Labeling Policy Book
④
Policy Memos
⑤
Directives & Notices
⑥
Guidance Documents
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
5
2017
Generic Eligibility
© Copyright 2014 by Prime Label Consultants, Inc. 6
6
2017
NOT ELIGIBLE for Generic Label Approval: Four categories of labels require LPDS review
Temporary Approval Product produced under religious exemption Product for export only with U.S. deviations Labels with special statements & claims
All other labels DO NOT REQUIRE LPDS review
9 CFR 412 7
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
7
2017
Temporary Label Approval Granted for final labels with a regulatory deviation
With no safety or dietary risk economic advantage, or product misrepresentation
Never acceptable as a generic approval;
Reviewed by LPDS on a case-by-case basis
Granted for a maximum of 180 days
Extension of temporary may be granted if labels have not all been used
8
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
8
2017
Religious Exemption Religious Exempt Product (poultry)
Does not receive a mark of inspection
Can never be generic
i.e. Confucian style poultry (not eviscerated)
Different from ritually slaughtered meat or poultry which does receive a mark of inspection
i.e. Kosher or Halal
Which may be a generic approval unless the name/acronym of certifier is present (special statement / claim)
9
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
9
2017
For Export Only with Label Deviations Labels marked for export only with deviations from U.S. regulations must be reviewed by LPDS
With the exception of:
Net Weight Statement
Foreign Language
These deviations may be generically approved
Provided the deviations do comply with regulations of the country of import
10
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
10
2017
Special Statements & Claims: Not Eligible for Generic 9 CFR 412.1(e)
“Claims, logos, trademarks, and other symbols…not defined in the Federal…meat and poultry regulations or FS&LPB”
“Natural and negative claims (e.g. gluten free, uncured)”
“Ingredient and processing method claims (e.g. highpressure processing)”
“Health claims…structure-function claims, claims regarding the raising of animals, organic claims”
“Logos and symbols include graphic representations of hearts and geographic landmarks”
11
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
11
2017
Special Statements & Claims - Examples 3rd Party Certifications
Organic Statements
Animal Production Claims
Natural Claims
Breed Claims
Negative / Free Claims
Gluten Free
Omega 3/6 statements
Uncured
Whole Grain Claims
Health Claims
Front of Pack Nutrition
Structure Function Claims
Non-GE statements
Implied Nutrition Claims
Additional Claims not defined in FSIS regs or FS&LP Book
Instructional Statements related to pathogens
Use of FDA Format NFP These label features require LPDS review 12
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
12
2017
Special Statements & Claims complexities Undefined Serving Size Appetizer RACC can be generic, if ad copy is consistent Meals “Serves #” – “Serving Size 1/# package” Uncured Not generic even though 9 CFR 317.17 defines requirements Front of pack nutrition Blanket Approvals (as long as every icon is represented) Undefined nutrient claims Modifications to existing approvals Impact on Special Statements / Claims Establishment transfers Animal production claims Generic Approval does not apply to eggs, exotic species, or voluntary inspection
14
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
13
2017
Modifications to previous LPDS approvals 9 CFR 412 removed 9 CFR 317.4 / 381.132
Removed all provisions for generic modifications No new regulations on acceptable generic changes
Current guidance is that modifications that do not affect the approved statement or claim are acceptable as generic changes Gluten-Free Claim New seasoning blend added to the product?
14
Change to the net weight?
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
14
2017
Generic Compliance & Approval
15
© Copyright 2014 by Prime Label Consultants, Inc.
15
2017
Your Label may be Generic Eligible but NOT Compliant Generic Eligibility According to the criteria in 9 CFR 412: a) The label must be reviewed by LPDS OR
b) The label is eligible for Generic Approval
Generic Compliance If the label is Generic Eligible: A Generic Approval exists only when all labeling features are in compliance with FSIS regulations and the Food Standards and Labeling Policy Book
16
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
16
2017
LPDS Top Ten Reasons for Label Refusal
* source: Generic Final Rule Nov 2013
Generic Reason
Eligible
Compliant
1. Illegible label records
✔
✖
2. Missing required features
✔
✖
3. Incomplete application form
✔
✖
4. Lack of formulation/processing support
✔
✖
5. Standard is not met
✔
✖
6. Incorrect product name
✔
✖
7. Ingredient statement errors
✔
✖
8. Nutrition Facts Panel errors
✔
✖
9. Non-compliant nutrient content claims
✔
✖
10. Undefined nutrient content claims (must be approved by LPDS)
✖
✖
37% industry-wide refusal rate* (after resubmissions) 17
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
17
2017
Mandatory Label Features - Errors Principal Display Panel - Product Name - Handling Statement - Establishment Legend - Net Weight Statement
Raw Frozen Garlic Breaded Chicken Nuggets Inaccurate Handling Statement
Wrong Inspection Legend
Frozen Keep Refrigerated
Information Panel - Ingredients Statement - Signature Line - Nutrition Facts
No Dual Declaration NET WT 24 OZ (1.5 LBS)
P-5555
Incorrect Serving Size
Any Label Panel - Safe Handling Instructions
Wrong order of Predominance Missing address information 18
May not comply with FSIS standard
4 OZ
INGREDIENTS: CHICKEN BREAST, WATER, SALT, MODIFIED CORN STARCH. BREADED WITH: WHEAT FLOUR, CORN FLOUR, GARLIC WATER, SUGAR Distributed by: Chicken Nuggets LLC Washington DC 20001
Incomplete SHI ©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
18
2017
Generic Claims & Special Statements Claims 100%, Pure Fresh Geographic Claims Grading Green/Environ Claim “Hand” Production Claim New Claims Nutrition Claims (Defined) Religious Uncertified
Special Statements Ad Copy Allergen Statement Country of Origin Cooking Instructions Flavor Profiles Foreign Language Guarantees Prep/Cook Time Stmts Statement of Limited Use Child Nutrition Labels
These label features may not require FSIS first priority review 19
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
19
2017
Generic Case Study
20
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
20
2017
Determining Compliance for Label Approval How do we know if our label is compliant?
21
In-house
Many common label regulations will be well understood by the regulatory team
askFSIS
Useful for simple questions
Consultant
A third-party expert can review your label if you prefer to stay “under the radar”
LPDS
All labels may be sent to LPDS for review; second priority review will take longer
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
21
2017
Record Keeping
22
© Copyright 2014 by Prime Label Consultants, Inc.
22
2017
Label Lifecycle: FSIS Directive 7221.1
Label Design
Sketch Label Approval
Final/Generic Approval
Compliance Verification
Approval by LPDS
Final Label added to Records
IPP via PHIS Labeling Tasks
Generic Approval via LPDS
FSIS Market Surveillance
Enforcement / Remediation Recall
New Label
Generic Modifications to Sketch Approved Label
3rd Party Audit
Generic Approval via Company
(allergen ingredient omission)
NR
Consumer Complaints
(Noncompliance Record) - Pressure sensitive sticker - Temporary approval by LPDS
3rd Party Audit
Company must maintain records of all label approvals
23
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
23
2017
FSIS Directive 7221.1 All approved labels must be produced upon request for authorized USDA personnel within 24 hours. Each labeling record should include: 1. a copy of the final label that is in use, 2. the product formulation, 3. the processing procedure for the product, and 4. any supporting documentation needed to show that the label is consistent with the Federal meat and poultry regulations and policies on labeling as described in 9 CFR 412.1 24
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
24
2017
Establishing Records – Core Elements
Label records should always include: The label sketch/proof
A record of the approval (7234 Form)
The product formulation
Processing procedures
Generic:
25
1.
Who approved: signature
2.
Date of approval
3.
Entire previous stamped label application with note of changes (if applicable) ©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
25
2017
Establishing Records – Other Documentation
Mandatory Purchased Ingredients
Certifications (unexpired)
Claim Support
Recommended Previous label approvals
Eligibility Support
1. Spec Sheets
1. Stamped 7234
2. Meat/Poultry: Actual Label
2. Actual Label 3. Supporting Docs
26
Compliance Support
Regulation citations - examples in Appendix
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
26
2017
Updating Records 1. Formula Changes: • New label + Temporary if needed
2. Ingredient Substitutions: • Temporary (extraordinary circumstances) • Recommended: establish an in-house approval process
3. Processing Changes: • New label + Temporary if needed
4. Other situations … • Different establishment • New regulations (Nutrition Panels in 2-5 years) • Expired certificates • More? 27
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
27
2017
Enforcement & the Local Inspector
28
© Copyright 2014 by Prime Label Consultants, Inc.
28
2017
IIC Inspector Roles in Labeling 1. Compare manufacture of product with paperwork detailing formulation & processing procedures 2. Verify final label via Labeling Tasks in PHIS 3. Issue NR (Noncompliance Record) when problem exists & hold product until rectified
29
©2016 Prime Label Consultants, Inc. All rights reserved. Contents may not be reproduced by any means without expressed permission of PLC
29
2017
Public Health Information System Labeling Tasks From PHIS IIC Inspector Training Manual… 1. General Labeling Task 2. Product Standards Task 3. Child Nutrition / Grade Labeling / Declared Count / Vignette Task 4. Net Weights Task
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2017
From PHIS Local Inspector Training Manual… When noncompliance is found, take the appropriate regulatory control actions, such as retention of product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of specifically identified product (9 CFR 500.1(a)), if it is determined that misbranded or economically adulterated product would otherwise enter commerce or be shipped from the establishment. Additionally, FSIS may rescind or refuse approval of false or misleading marks, labels, or sizes, or forms of any container for use with any meat or poultry product per 9 CFR 500.8. If it is determined that economically adulterated or misbranded product has entered commerce, FSIS will expect establishments to implement recall procedures.
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2017
Noncompliant Labels The Inspector Finds a Noncompliant Label
A friendly warning is given
Update labels at next printing
Noncompliance Report is issued
Apply for a Temp if necessary
Apply for an Emergency Temp
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Sticker/Inject labels for Compliance
Appeal the NR to an IPP supervisor
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2017
Recommendations & Conclusion
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© Copyright 2014 by Prime Label Consultants, Inc.
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2017
Labeling Rules are Complex 1. USDA has very precise, strict requirements for labeling 2. There are many sources of labeling regulations 3. USDA decisions can be subjective & follow unwritten rules 4. USDA has final authority
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2017
Mistakes Can Be Costly 1. Risk of non-compliance could mean product prohibited from leaving plant until label is corrected – production holds & reprinting costs 2. Risk of product being stopped at border 3. Risk of recall if product leaves plant with serious error (undeclared allergens, etc.) 4. Risk of lawsuit if competitor alleges misbranding
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2017
Recommendations to Reduce Risk 1. Record keeping is your friend! Document, document, document …Update, update, update
2. For high risk labels, get a second opinion with LPDS (if not time sensitive) or consultant High volume product
Complex/gray area labeling
Extensive ad copy
High geographic distribution
Co-packer
Assertive marketing
High printing costs
Customs border support
3. Get the resources you need Software, training, experts on call
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2017
Recommendations to Reduce Risk 4. Proactively change your organization to mitigate risk New Quality Control labeling processes More & tighter communication with production, vendors, suppliers, IPP Educate R&D & Marketing up front in labeling regulations Use technology like WebEx to get everyone on same page
5. Develop: Labeling Checklists QC program of audits & reviews
Do the Inspector’s job before they do it themselves…
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2017
Conclusion Faster time to market with Generic approvals, BUT… YOU are now responsible for getting it right “with great freedom comes great responsibility…”
Compliance mistakes come with a price tag! Retained product ($$) or Recall ($$$$$)
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2017
Biography
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