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Allergen Labeling

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... use/consumer preferences, FDA food inspection findings, & voluntary food recalls ... whole wheat flour, buttermilk, eggs, peanut butter. AND ... – PowerPoint PPT presentation

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Title: 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

2
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)

3
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

4
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

5
Major Provisions of Public Law 108-282
  • Specifies a petition and notification process to
    exempt certain food ingredients from food
    allergen labeling requirements

6
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)

7
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

8
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

9
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)

10
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

11
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)

12
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

13
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.

14
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

15
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.

16
Accompanying House Report
  • Expects FDA to conduct inspections of food
    manufacturers without increasing the number of
    inspections of food facilities

17
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

18
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

19
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

20
FDA Food Allergen Information
  • http//www.foodsafety.gov
  • Click on Industry Assistance
  • Click on Information about Food Allergies

21
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

22
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

23
Trans fat declaration
  • Separate line
  • No Daily Value

24
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

25
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

26
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.

27
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.

28
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.

29
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.

30
Qualified Health Claims
  • Walnuts Heart Disease
  • Eligible Foods Whole or chopped walnuts

31
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.

32
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.

33
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

34
Qualified Health Claims
  • http//www.cfsan.fda.gov/dms/lab-qhc.html
  • http//www.fda.gov/bbs/topics/news/2004/NEW01115.h
    tml
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