# Presentation: 127676

##  Food Industry Perspectiveson Food Allergen Advisory Statements 

**Regina Hildwine**
**Senior Director, Food Labeling & Standards**
**Grocery Manufacturers Association**
**FDA Public Hearing**
**September 16, 2008**

## GMA

- The Grocery Manufacturers Association (GMA) represents the world’s leading food, beverage and consumer products companies.
- The association promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence.

## Food Allergen Advisory Statements

- Two segments to presentation:
- Background:  Food Allergen Labeling Guidelines of Food Allergy Issues Alliance (2001)
- Factors influencing use of food allergen advisory statements

## Food Allergen Labeling Guidelines(Food Allergy Issues Alliance)

- Food Allergy Issues Alliance (collaboration of food associations, consumer group representing food allergic patients, public health interests, academic community)
- Coordinated by food industry association  (NFPA → GMA)
- Food Allergen Labeling Guidelines developed 2000 - 2001
- Published in 2001 (pre-FALCPA)
- Reviewed post-FALCPA

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Four main elements:
- Identify Major Food Allergens
- “Plain language” food allergen labeling
- Major Food Allergens declared for ingredients otherwise exempt by law/regulation (e.g., in flavors, incidental additives)
- Principles for appropriate use of “supplemental” food allergen labeling  (i.e., “may contain”-type statements)

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Elements incorporated into FALCPA:
- Big 8 Major Food Allergens (foods and classes)
- “Plain language” food allergen labeling
- Presentation within or adjacent to ingredient declaration
- Options for presenting food allergen information
- Major Food Allergens in processing aids, flavors, colors are declared

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Principles for “may contain”-type allergen  statements
- “Supplemental” = “Advisory”
- Four criteria and related rationales
- Overarching consideration:  labeling is _**not**_ a substitute for GMPs

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- 1.  The presence of a Major Food Allergen is documented through visual examination or analytical testing of the processing line, equipment, product, or other means.
- Affirm the Major Food Allergen is in the environment
-  If the allergen is not in the environment, can “may contain” be true?

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- 2.  The risk of presence of a Major Food Allergen is unavoidable even when current GMPs are followed.
- Even with best feasible allergen controls and optimal practices, some risk remains that Major Food Allergen may be present in a food where it is not intended.

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- 3.  Major Food Allergen is present in some, but not all, of the product where it is not intended to be.
- Occasional or sporadic presence of allergen supports truth of “may contain”
- Reflects assessment of production environment, reevaluation of risks

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- 4.  The presence of a Major Food Allergen is potentially hazardous
- Anticipated circumstances when an insignificant level of a Major Food Allergen in food might be deemed non-hazardous

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- If all 4 criteria are met, consider labeling with “may contain”-type allergen statement
- “Consider” does not mean proceed automatically
- Labeling applied after robust evaluation process
- Concern about proliferation of “may contain”-type food allergen statements

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- Placement of statement in proximity to ingredient declaration
- Clear
- Accurate
- Specific
- Conspicuous

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- Continue to be useful principles for considering food allergen advisory labeling
- Labeling not a substitute for GMPs
- Recent FDA warning letters reinforce this concept that labeling is not a substitute for GMPs

## Food Allergen Labeling Guidelines (Food Allergy Issues Alliance) 

- Criteria for “Supplemental” food allergen labeling
- Intended to help food allergic consumers make clear decisions on whether or not food is appropriate for them to eat
- “May contain” food allergen labeling should mean: **“If you are allergic to this allergen, do not eat this food.”**

## Factors for Food Allergen Advisory Statements

- For the intended audience –  food allergic consumers and their caregivers:
- Food allergen advisory labeling presents challenges
- “May contain walnuts”
- How to assess risk communication?
- What are credible messages?
- What will support appropriate eating behavior?

## Factors for Food Allergen Advisory Statements

- For the food manufacturer:
- Consumer confidence and consumer protection are vitally important
- Supply chain requires careful control
- Labeling strategies to meet customers’ requirements need to be based on sound scientific principles

## Factors for Food Allergen Advisory Statements

- For the food manufacturer:
- Need for consistent high-standard in-plant food allergen controls
- Need for careful allergen risk assessment
- Quantification of risk needs to be considered (food allergen thresholds)

## Food Allergen Advisory StatementsSummary

- Criteria in 2001 Food Allergen Labeling Guidelines are useful principles for considering advisory labeling
- One of the criteria implies quantitative element
- Labeling does not replace GMPs
- Allergen advisory statements can be valuable for both food manufacturers and food allergic consumers – if applied and interpreted properly

## Food Allergen Advisory Statements

- Thank you.