Allergen Labeling

1
Allergen Labeling

• Allergen Labeling Initiatives
• by the
• Food and Drug Administration
• Felicia B. Satchell
• Office of Nutritional Products, Labeling and
  Dietary Supplements
• Center for Food Safety and Applied Nutrition

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Labeling Requirements Prior to Food Allergen
Labeling Law

• Food Drug and Cosmetic Act requires declaration
  of ingredients by their common or usual names
• Common or usual names do not always include the
  source of the ingredient
• There are two exemptions to ingredient
  declaration
• Flavorings, spices, and colors (Statutory)
• Incidental additives (Regulatory)

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Major Provisions of Public Law 108-282

• Amends the Federal Food, Drug, and Cosmetic Act
• Section 201 Definitions Adds (q)(q)
• Section 403 Misbranded Food Adds (w)(1)
  -(w)(7) and (x)
• Defines the term Major Food Allergen
• Defines term name of the food source from which
  the major food allergen is derived

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Major Provisions of Public Law 108-282

• Requires food allergen labeling for packaged
  foods that are not raw agricultural commodities
  by 1-1-06
• States that DHHS Secretary can
• Publish a Federal Register Notice to allow
  required information to appear in labeling vs.
  the label, if still protects the public health
• Modify certain labeling requirements, if needed
  to protect the public health
• Require, via a rulemaking, the label/labeling for
  other food allergens found in a spice, color,
  flavor, or incidental additive

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Major Provisions of Public Law 108-282

• Specifies a petition and notification process to
  exempt certain food ingredients from food
  allergen labeling requirements

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Petitions

• Any person may petition to exempt a food
  ingredient that contains protein derived from a
  major food allergen
• Petitioner provides scientific evidence
  (including an analytical method) that
  demonstrates that the food ingredient does not
  cause an allergic response that poses a risk to
  human health
• The petition shall be approved in 180 days or it
  is deemed denied (extensions possible)

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Notifications

• A person need not file a petition to exempt a
  food ingredient from the allergen labeling
  requirements, if the person files a notification
  that contains
• scientific evidence that the food ingredient does
  not contain allergenic protein
• OR
• a determination by the Secretary that the
  ingredient does not cause an allergic response
  that poses a risk to human health under a
  pre-market approval or notification program under
  section 409

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Major Provisions of Public Law 108-282

• Requires DHHS Secretary to
• Submit a report to Congress by 2-2-06 on
  allergen cross-contact/GMP issues, may contain
  labeling use/consumer preferences, FDA food
  inspection findings, voluntary food recalls
• Conduct food allergen inspections of food
  manufacturers/processors/packers/holders

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Major Provisions of Public Law 108-282

• Requires DHHS Secretary to
• Publish a proposed rule by 8-2-06 a final rule
  by 8-2-08 on gluten-free labeling
• Work with the Conference on Food Protection to
  provide guidance in the Food Code on how to
  prepare allergen-free foods in food
  establishments (e.g., restaurants, school
  cafeterias, grocery store delicatessens
  bakeries)

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Definition of Major Food Allergen

• Milk, egg, fish, Crustacean shellfish, tree nuts,
  wheat, peanuts and soybeans
• A food ingredient that contains a protein derived
  from one of these foods, except
• A highly refined oil derived from one of these
  foods or an ingredient derived from such oil
• Food ingredient exempt under a petition or
  notification process specified in the law

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Definition of Food Source of a Major Food
Allergen

• Same as the names for the major food allergens
  milk, egg, wheat, peanuts soybeans
• Types of tree nuts (e.g., almonds, pecans,
  walnuts)
• Species of fish (e.g., bass, flounder, cod)
• Species of Crustacean shellfish (e.g., crab,
  lobster, shrimp)

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When Food Allergen Labeling Is Required

• When a major food allergens CUN does not already
  identify its food source, e.g.
• whole wheat flour, buttermilk, eggs, peanut
  butter
• AND
• When that major food allergens food source is
  not already identified elsewhere in the statement
  of ingredients for another allergenic ingredient,
  e.g.
• nonfat dry milk, whey, albumen, egg whites

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Two Ways to Label Products Containing Major Food
Allergens

• Within the statement of ingredients
• CUN of a major food allergen is immediately
  followed parenthetically by the name of its food
  source, e.g., natural flavor (peanuts), whey
  (milk).
• In a separate summary statement at the end of or
  immediately adjacent to the statement of
  ingredients in the same size type
• Word Contains is followed by the names of the
  food sources of all major food allergens present,
  e.g., Contains peanuts and milk.

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Ingredients Subject to Laws Labeling
Requirements

• All ingredients, except those exempted by law,
  (or through the petition or notification process)
  that either are or contain a major food allergen,
  including
• Incidental Additives
• Flavors
• Colors

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Accompanying House Report

• Expects, consistent with the November 30, 1987
  MOU, that the Department of Treasury will
  pursuant to the Federal Alcohol Administration
  Act determine how, as appropriate, to apply
  allergen labeling of beverage alcohol products
  and the labeling requirements for those products.
  The Committee expects that the TTB and the FDA
  will work together in promulgation of allergen
  regulations, with respect to those products.

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Accompanying House Report

• Expects FDA to conduct inspections of food
  manufacturers without increasing the number of
  inspections of food facilities

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CFSAN 05 Priorities

• Implement the provisions of the Food Allergen
  Labeling and Consumer Protection Act of 2004,
  including training, guidance and outreach
  activities to 1) assist industry and 2) provide
  the appropriate information to FDA field staff.  
  A
• Obtain expert consultation on gluten-free
  labeling in response to the Food Allergen
  Labeling and Consumer Protection Act of 2004. A
• Develop for publication in FY 2006 a proposed
  rule for gluten-free labeling in response to the
  Food Allergen Labeling and Consumer Protection
  Act of 2004 (FALCPA). A

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CFSAN 05 Priorities

• Publish a proposed rule to require the
  declaration of carmine/cochineal extract, a color
  additive, on the ingredient statement of food,
  drug, and cosmetic products containing it. A
• Issue draft guidance on the use of test kits to
  detect the presence of peanut protein for
  regulatory purposes. A
• Complete an Association of Official Analytical
  Chemists (AOAC) interlab study for immunochemical
  peanut protein test kits following the
  AOAC-harmonized validation protocol. A

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CFSAN 05 Priorities

• Initiate Association of Official Analytical
  Chemists (AOAC) performance and harmonized
  validation of egg and milk test kits. A
• Issue allergen Compliance Program and implement
  enforcement strategy. A
• Issue report on allergen inspections. A
• Develop a comprehensive food allergen strategy to
  address considerations such as cross-contamination
  problems. B

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FDA Food Allergen Information

• http//www.foodsafety.gov
• Click on Industry Assistance
• Click on Information about Food Allergies

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Other Labeling Initiatives

• Trans Fatty Acids in Nutrition Labeling, Nutrient
  Content Claims, and Health Claims
• Final rule
• http//www.cfsan.fda.gov/dms/lab-cat.htmltransfa
  t
• Qualified Health Claims
• Interim guidance

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Trans fat declaration

• Final rule published July 11, 2003
• Effective date January 1, 2006
• Separate line under saturated fat
• Not required to be listed if the total fat is
  less than 0.5 g per serving and no fat or
  cholesterol claims are made
• No Daily Value

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Trans fat declaration

• Separate line
• No Daily Value

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Qualified Health Claims Interim Guidance

• Issued July 10, 2003
• Claims must go through FDA review process
• Claim will include language that accurately
  conveys amount of scientific evidence that
  supports the claim based on FDAs scientific
  ranking level

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FDAs Scientific Ranking Level

• First level (A) Significant scientific
  agreement
• Second level (B) Some scientific evidence
  but not conclusive
• Third level (C) Some scientific evidence
  but limited and not conclusive
• Fourth level (D) Very limited and preliminar
  y, little scientific evidence supporting claim

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Qualified Health Claims

• Nuts Heart Disease
• Claim Statement(s)Scientific evidence suggests
  but does not prove that eating 1.5 ounces per day
  of most nuts such as name of specific nut as
  part of a diet low in saturated fat and
  cholesterol may reduce the risk of heart disease.
  See nutrition information for fat content.

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Qualified Health Claims

• Nuts Heart Disease
• Eligible Foods
• (1) Whole or chopped nuts listed below that are
  raw, blanched, roasted, salted, and/or lightly
  coated and/or flavored any fat or carbohydrate
  added in the coating or flavoring must meet the
  101.9(f)(1) definition of an insignificant
  amount.
• (2) Nut-containing products other than whole or
  chopped nuts that contain at least 11 g of one or
  more of the nuts listed below per RACC.

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Qualified Health Claims

• Nuts Heart Disease
• Eligible Foods (cont)
• (3) Types of nuts eligible for this claim are
  restricted to almonds, hazelnuts, peanuts,
  pecans, some pine nuts, pistachio nuts, and
  walnuts. Types of nuts on which the health claim
  may be based is restricted to those nuts that
  were specifically included in the health claim
  petition, but that do not exceed 4 g saturated
  fat per 50 g of nuts.

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Qualified Health Claims

• Walnuts Heart Disease
• Claim Statement(s)
• (1) Supportive but not conclusive research shows
  that eating 1.5 ounces per day of walnuts, as
  part of a low saturated fat and low cholesterol
  diet and not resulting in increased caloric
  intake, may reduce the risk of coronary heart
  disease. See nutrition information for fat and
  calorie content.

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Qualified Health Claims

• Walnuts Heart Disease
• Eligible Foods Whole or chopped walnuts

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Qualified Health Claims

• Omega-3 Fatty Acids Coronary Heart Disease
• Claim Statement(s)Consumption of omega-3 fatty
  acids may reduce the risk of coronary heart
  disease. FDA evaluated the data and determined
  that, although there is scientific evidence
  supporting the claim, the evidence is not
  conclusive.

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Qualified Health Claims

• Omega-3 Fatty Acids Coronary Heart Disease
• Claim Statement(s)Supportive but not conclusive
  research shows that consumption of EPA and DHA
  omega-3 fatty acids may reduce the risk of
  coronary heart disease. One serving of name of
  food provides x grams of EPA and DHA omega-3
  fatty acids. See nutrition information for total
  fat, saturated fat and cholesterol content.

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Qualified Health Claims

• Omega-3 Fatty Acids Coronary Heart Disease
• Eligible foods
• Conventional Foods that meet the criteria
  described in FDAs letters of enforcement
  discretion.
• http//www.cfsan.fda.gov/dms/ds-ltr37.html
• http//www.cfsan.fda.gov/dms/ds-ltr38.html

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Qualified Health Claims

• http//www.cfsan.fda.gov/dms/lab-qhc.html
• http//www.fda.gov/bbs/topics/news/2004/NEW01115.h
  tml