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Food Allergens

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Congress enacted the Food Allergen Labeling and Consumer Protection Act in 2004 mandating that food product labels indicate when the food contains one of the eight major food allergens.  This page provides an overview of the rules and practices for labeling food products containing a major food allergen.

Legal references

 

Food & Drug Administration

The Food & Drug Administration (FDA) is responsible for overseeing the labeling of many food products, including the labeling of food allergens. The following FDA web pages provide information on the topic. 

FDA Information for Consumers
1) FDA Food Facts. “Food Allergens – What you need to know” at http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/ucm079311.htm (web page last updated: 05/15/2014). 

  • Congress enacted a statute in 2004 mandating that food product labels indicate when the food contains one of the eight major food allergens. 
  • Major food allergens are defined as “milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and as “a food ingredient that contains protein derived from these foods.” 
    • The definition of major food allergen excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.
  • The law requires that food labels must clearly identify the food source names of all ingredients that are a major food allergen, or that contain any protein derived from a major food allergen.

 

2) “Food Allergen Labeling and Consumer Protection Act of 2004 -- Questions and Answers”. December 12, 2005; updated July 18, 2006 at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106890.htm (web page last updated: 08/15/2013).

3) Links to information about Food Allergens: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm 

 

FDA Industry Guidance

4) Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm059116.htm  Page Last Updated: 07/07/2014

  • The food allergen labeling law applies to all packaged foods sold in the United States that are regulated under the Federal Food, Drug, & Cosmetic Act (that is, food in interstate commerce), including both domestically manufactured and imported foods.
  • FDA regulates all foods except meat products, poultry products, and egg products; USDA regulates meat, poultry and egg products.
  • The food allergen labeling law does not apply to raw agricultural commodities, such as fresh fruits and vegetables in their natural state.
  • If a "Contains" statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. For example, if "sodium caseinate," "whey," "egg yolks," and "natural peanut flavor" are declared in a product's ingredients list, any "Contains" statement is required to identify all three sources of the major food allergens present (e.g., "Contains milk, egg, peanuts").
    The "Contains" statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food.

 

  • The food labeling law does not apply to major food allergens that are unintentionally added to a food as the result of “cross-contact” that occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment.  FDA expects that advisory labeling such as "may contain [allergen]" should not be used as a substitute for good manufacturing practices.  Any advisory statement such as "may contain [allergen]" must be truthful and not misleading.
  • The food labeling law does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in resulting from the manufacture of ingredients.

 

  • The FDA may at some point consider establishing a threshold level for one or more food allergens in the context of reviewing a petition or a notification submitted to request that an ingredient be exempt from food allergen labeling requirements.  See below.

 

  • Federal law generally does NOT apply to retail food establishments.  State and local governments play an important role in oversight of these food establishments.
  • The food allergen labeling requirement extends to foods packaged by a retail or foodservice establishment that are offered for human consumption (assuming the product or its ingredients are in interstate commerce). The food labeling law does not apply to foods provided by a retail food establishment that are placed in a wrapper or container in response to a consumer's order - such as the paper or box used to convey a sandwich that has been prepared in response to a consumer's order.
  • FDA's Food Code, however, is a model (suggested) code available for adoption by local and state jurisdictions to apply to retail food establishments that provide food directly to consumers, including restaurants, grocery stores, supermarkets, hospitals, nursing homes, child care centers, and temporary food establishments.  The Food Code now states that the person in charge of a food establishment shall understand foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual.
  • The food labeling law does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the preparation and packaging of the food in a retail or food service establishment.



5)  Food Labeling Guide, Chapter 6, Ingredient List at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064880.htm#label Web page dated January 2013; last updated 07/03/14

 

 

6)  Links to FDA “Food Allergens Guidance Documents & Regulatory Information” at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/default.htm

7) Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications. May 2014; Page Last Updated: 07/07/2014 at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm395494.htm

  • In some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein.  In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses a risk to human health.  Therefore, the food allergen labeling law provides two mechanisms through which such ingredients may become exempt from the labeling requirement. 
  • An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health”.  The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.
  • Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process that the ingredient “does not cause an allergic response that poses a risk to human health.”
  • The risk for food allergic individuals is a function of multiple factors.  The factors that are relevant for evaluating petitions are the amount of allergenic protein present in a food and the amount of that food consumed in a single eating occasion.  Therefore, a petition should include information on the expected consumer exposure from consumption of the final food product(s) containing the ingredient.  FDA suggests the following information be included in a petition for exemption.
    • Information on actual consumption levels for each intended food or food use at the mid-range, and at the 90% and 95% levels for consumers of that food;
    • For ingredients that might be used in multiple foods, an estimated integrated consumption level at a single eating occasion (such as a complete meal); and
    • Information on differential consumption patterns for consumers of different ages, genders, or ethnicity.

If necessary, the submitter should consider several different consumption scenarios, such as different consumption patterns in children and adults for some foods or different exposure levels from multiple uses of an ingredient.



USDA Food Safety Inspection Service 
USDA Food Safety Inspection Service (FSIS) is responsible for regulating the safety of meat, poultry and egg products.  This regulatory oversight includes assuring that the food is properly labeled.  The law mandates that food allergens are declared on the label.  The FSIS has prepared documents intended for several audiences.

 

Intended for Consumers

8) “Allergies and Food Safety” at http://www.fsis.usda.gov/wps/wcm/connect/1e98f24c-d616-443f-8490-f7372476d558/Allergies_and_Food_Safety.pdf?MOD=AJPERES

  • The food allergens labeling law does not apply to products regulated by USDA FSIS, that is, meat, poultry and egg products.
  • USDA regulations require an ingredient list, but the agency recommends a “Contains” statement. 

Intended for Meat, Poultry and Egg Processing Businesses

9) “Allergens and Ingredients of Public Health Concern:  Identification, Prevention and Control, and Declaration through Labeling.”  FSIS Compliance Guidelines, April 2014 at http://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES

  • FSIS pre-approves product labels (FDA does not follow that same practice)
  • FSIS supports the voluntary addition of allergen statements (e.g. “contains” statements) on meat and poultry product labels immediately following the ingredients statement.
  • FSIS has suggested measures for controlling the presence of undeclared allergens in product that may be included in an establishment’s HACCP system. Measures may also be included within an establishment’s Sanitation SOPs or other prerequisite program that sufficiently and effectively prevent the presence of undeclared allergens in product.
  • FSIS does not recognize a threshold of any allergenic ingredient that does not require declaration.
  • Only in limited situations does FSIS allow the use of factual labeling statements about a product’s manufacturing environment (e.g. “Produced in an establishment that uses wheat”). Statements of this type may only be used where good manufacturing practices cannot reasonably eliminate the unintended presence of ingredients of public health concern. In this case, the HACCP plan, Sanitation SOP, or other prerequisite program procedures should be implemented by the establishment to control this issue.
  • All the ingredients in a “may contain” or “produced in a facility” statement of a purchased ingredient should carry forward that statement EXCEPT if the FSIS’ inspected establishment: 1) contacts the supplier and confirms in writing that the statement is a cautionary statement, and no such ingredient is in the product; and 2) includes a written statement in its hazard analysis documentation to support why the “may contain” or “produced in a facility” statement is not carried forward to the finished meat or poultry product label.

Intended for USDA Meat, Poultry and Egg Inspectors

10) “Targeted Verification of Product Formulation and Labeling for the Eight Most Common (“Big 8”) Food Allergens.” USDA FSIS Notice 29-13, 4/30/13 at http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/29-13.pdf 

 

 

FDA Gluten-Free Labeling of Foods

On August 2, 2013, FDA issued a final rule defining “gluten-free” for food labeling, which will help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content. 

11)  “Gluten-Free Labeling of Foods” at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362510.htm (web page last updated: 08/05/2014).

  • As of August 5, 2014, any food product bearing a gluten-free claim labeled on or after this date must meet the rule’s requirements.
  • In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA now allows manufacturers to label a food "gluten-free" if the food does not contain any of the following:
    • an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
    • an ingredient derived from these grains and that has not been processed to remove gluten
    • an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled "gluten-free" if they inherently don't have any gluten.

  • Some restaurants use the term “gluten-free” in their menus. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition. State and local governments play an important role in oversight of restaurants. FDA will work with partners in state and local governments with respect to gluten-free labeling in restaurants.

 


Other Food Allergen Information
USDA National Agriculture Library (NAL) compiles documents on a range of food and agricultural topics, including food allergens; for example, see http://fnic.nal.usda.gov/diet-and-disease/allergies-and-food-sensitivities.

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Email David.Saxowsky@ndsu.edu

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