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FAQ About the Food Allergen Labeling Consumer Protection Act (FALCPA)

May 2013



FREQUENTLY ASKED QUESTIONS ABOUT THE FOOD ALLERGEN LABELING AND CONSUMER PROTECTION ACT OF 2004 (FALCPA)


fda The Food Allergen Labeling and Consumer Protection Act (FALCPA) was passed by Congress to ensure that there would be clearer labeling of food for the millions of people with food allergies. As of January 01, 2006, all food products regulated by the FDA must be labeled in a specific way to identify the eight major food allergens: milk, egg, fish, crustacean shell fish, tree nuts, wheat, peanuts and soybeans. Further, the specific type of nut (e.g. almond, pecans, walnut, coconut), fish (e.g. bass, flounder, pollack), and crustacean shellfish (e.g. lobster, shrimp, crab) must also be indicated. Molluscan shellfish (e.g. oysters, clams, mussels, or scallops) are not considered a major food allergen.

These 8 major food allergens identified by FALCPA account for over 90 percent of all documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.
For a look at the complete law, vist:  http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106187.htm



1. How must labels declare food allergens?

Labels on foods regulated by the FDA must list ingredients which contain one or more of the major food allergens in one of two ways:

1) The common or usual name of the major food allergen must be followed by the food source in parentheses in the list of the ingredients. This will occur the first time the major food allergen is listed and does not have to be repeated each time the name of the specific food allergen appears.
Examples: "lecithin (soy)," "flour (wheat)," and "whey (milk)"

2) There may be a section after or near the ingredient list called “Contains”. After the word “Contains”, there must be listed the name of the food source from which the major food allergen is derived.
Example: "Contains Wheat, Milk, and Soy."

Note that there does not always have to be a “Contains” section and that the food source for one of the major eight allergens may only be listed in the “Contains” section (rather than specified in the ingredient area), so that you must read both lists carefully.


2. What types of foods does the FDA regulate?

The FDA has control over packaged foods, conventional foods, vitamins and dietary supplements, infant formula and infant foods, and medical foods (those items produced for people with particular diseases such a phenylketonuria and those people requiring a particular feeding method, such as tube feedings). This includes items produced in the United States and those items produced outside the U.S. (imported) but intended for sale in the U.S.  

FALCPA labeling applies to all retail and food-service establishments that package, label, and offer products for human consumption (e.g. vending machines and all packages labeled “for individual sale”).

It is possible that locally made foods may not be in full compliance with FALCPA labeling, so continue to read all labels carefully and contact the manufacturer.


3. Are there any food exemptions to the law?

Yes, FALCPA does not cover fresh fruits and vegetables in their natural state nor any highly refined oil derived for a food specified in the major eight allergen group and any ingredient derived from such a highly refined oil. There are clinical studies demonstrating that highly refined oils can be safely eaten by food allergic individuals, due to the fact that those oils contain extremely small levels of allergenic protein.1


4. Are there any other areas not covered by FALCPA?

Yes, there are quite a few areas where the law does not apply:

a) Any prescription drug, over-the-counter drug, cosmetic, or health and beauty aids, such as shampoo, mouthwash, toothpaste or shaving cream.

b) Any food product regulated by the USDA, which includes meat, poultry, or certain egg products.

c) Any product regulated by the Alcohol, Tobacco Tax and Trade Bureau (ATTB), which would include alcoholic drinks, spirits, beer and tobacco products.

d) Any restaurant foods or foods that are placed in a wrapper or container in response to a person's order for that food (for example street vendors, festival foods, fast food restaurants).

e) Kosher labeling

f) Pet foods, supplements, and supplies


5. Are flavors, colors, and food additives subject to the allergen labeling requirements?

Yes, any flavoring, spice, coloring, or processing aid that is or bears one of the eight major food allergens must list the allergen in plain English. Processing aids are those items which help in the making of the food product but may not present a major ingredient. They are used, for example, to keep food from sticking to the baking pans or as a carrier for a certain flavor, spice or vitamin. Such a product might be soy lecithin or wheat starch and may have not been labeled as present before FALCPA took effect.


6. If a new ingredient containing one of the major eight allergens appears on a revised label of a food I have been using, can I just assume that it was there all along and the food is safe to eat?

No, that creates a false sense of security. It may indeed be a new ingredient in a reformulated product with the revised label or it may be a previously unlabeled processing aid. You will need to check with the food company as before.


7. Are advisory statements, such as “May contain...” required?

No, FALCPA does not require such advisory statements nor does it require statements containing any information about possible cross-contamination of the food item.


8. Does FALCPA change how the term “non-dairy” is used?

The FDA regulations authorize the use of the term “non-dairy” and this terminology will continue to appear on foods that contain caseinates (milk-derivatives) as ingredients. The caseinates must be listed in the ingredient section followed by a parenthesis and “milk”. However, the FDA does not specifically address the term “dairy-free”, so that is not affected by FALCPA.


9. How does FALCPA affect gluten and “gluten-free” labeling in food?

FALCPA requires the FDA to issue a proposed rule to define and permit the voluntary use of the term “gluten-free” on labeling of foods by August 2006 and a final rule to be issued no later than August 2008. As of July 2011, however, the FDA has not yet ruled on the use of the term “gluten-free”. For information on the FDA's response to public comments on the draft report “Approaches to Establish Thresholds For Major Food Allergens and For Gluten in Food”, click on the link: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106108.htm.


10. Is there a way that food manufacturers can ask to have a food product exempted from FALCPA labeling??

Yes, anyone can petition the Secretary of Health and Human Services to request an exemption to the labeling requirement, provided that scientific evidence is submitted that such a food ingredient (with a particular production method) does not cause an allergic response that poses a risk to human health. An inventory of notifications received for exemptions from FALCPA can be found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm076656.htm
The site is updated periodically.


Reference:
1) Crevel, RWR, Lerkhoff, MAT; Koning, MMG, "Allergenicity of refined vegetable oils", Food Chem Toxicol 2000; 38:385-393



This article was first published in 2006, and was updated in 2007 and most recently in August 2011 and May 2013, and was approved by KFA's Medical Advisory Team.





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Page last updated 7/29/2012

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