Food Allergen Labeling and Consumer Protection Act

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The Food Allergen Labeling and Consumer Protection Act (FALCPA) is a United States law that requires all food labels in the United States to list ingredients that may cause allergic reactions and was effective as of January 1, 2006.Title II, {{USStatute|108|282|118|905|2004|08|02|S|741}}{{cite journal |last1=Thompson |first1=Tricia |last2=Kane |first2=Rhonda R. |last3=Hager |first3=Mary H. |title=Food Allergen Labeling and Consumer Protection Act of 2004 in Effect |journal=Journal of the American Dietetic Association |date=November 2006 |volume=106 |issue=11 |pages=1742–1744 |doi=10.1016/j.jada.2006.08.010 |pmid=17081820|url=https://zenodo.org/record/1259089 }} While many ingredients can trigger a food allergy, this legislation only specifies the eight major food allergens. This law was passed largely due to the efforts of organizations such as the Food Allergy & Anaphylaxis Network (FAAN).

The purpose of this act was to prevent manufacturers from using misleading, uncommon, or confusing methods to label their ingredients.Food Allergen Labeling and Consumer Protection Act of 2004, § 202(4), 118 Stat. 905, 906 (2004), (available at https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa). Someone shopping for a friend with a soy allergy might not know that lecithin is derived from soy. Now it must be labeled "lecithin (soy)" to help prevent consumers from consuming allergens.

Eight "major" food allergens

This law is in regard to the eight most common food allergens.21 U.S.C. § 321 (qq) (available at https://www.law.cornell.edu/uscode/text/21/321). These affect the most people and the proteins are commonly found in other ingredients. They account for about 90% of food allergies.{{cite web|last=Public Law|title=Food Allergen Labeling and Consumer Protection Act|url=http://www.foodallergy.org/document.doc?id=148|work=FARE|accessdate=3 July 2013|archive-url=https://web.archive.org/web/20140629083701/http://www.foodallergy.org/document.doc?id=148|archive-date=29 June 2014|url-status=dead}} The main eight are:

Any ingredient which contains proteins derived from these allergens must also be listed.{{cite journal|last=Bren|first=Linda|title=Food Labels Identify Allergens More Clearly|journal=FDA Consumer|date=March–April 2006|volume=40.2|issue=37–8}}

The specific type of nut, fish, or shellfish must be listed (e.g., walnut, catfish, blue crab).{{cite web|title=FAQ About the Food Labeling Consumer Protection Act (FALCPA)|url=http://www.kidswithfoodallergies.org/resourcespre.php?id=50|work=Kids With Food Allergies|accessdate=3 July 2013}}

Even minute amounts, such as coloring or spices, must be listed if they contain any proteins from these major allergens.{{cite web|title=Food Allergen Labeling and Consumer Protection Act|url=http://www.foodallergy.org/laws-and-regulations/falcpa|work=FARE|accessdate=2 July 2013}}

Manufacturers are given two ways in which to label food allergens. They may either state the food source name of a major food allergen in the list of ingredients, most often contained within parenthesis. (e.g. Casein (milk)) or they could instead use the word "contains" in the label, such as "contains peanuts".

They can choose either method, as long as it is clearly written. If they choose the second method and say an ingredient "contains" the allergen, they must be sure to list all allergens contained, such as by saying "contains pecans and soy".

Sesame

On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act added sesame as the ninth major allergen; the law took effect January of 2023.{{Cite web |last=Weese |first=Karen |date=11 April 2023 |title=To comply with a new sesame allergy law, some businesses add — sesame |url=https://www.washingtonpost.com/wellness/2023/04/11/sesame-allergy-law-consequences/ |website=The Washington Post}} The law backfired as major commercial bakers, unable to ensure their products contained no sesame, began adding sesame to their recipes.{{Cite web |last=Aubrey |first=Allison |date=30 August 2023 |title=A sesame allergy law has made it harder to avoid the seed. Here's why |url=https://www.npr.org/sections/health-shots/2023/08/30/1196640997/a-sesame-allergy-law-has-made-it-harder-to-avoid-the-seed-heres-why |website=NPR}}{{Cite web |last=Aleccia |first=Jonel |date=2022-12-21 |title=New label law has unintended effect: Sesame in more foods |url=https://apnews.com/article/sesame-allergies-label-b28f8eb3dc846f2a19d87b03440848f1 |access-date=2024-12-22 |website=AP News |language=en}}

Some bakeries, including Bimbo Bakeries, which makes Sara Lee, Entenmann's and Ball Park brands, attempted to comply with the law by listing sesame as an ingredient, even though it was not; the FDA said federal regulations forbid including sesame in the list of ingredients unless it is intentionally added.{{Cite web |date=26 June 2024 |title=FDA warns top U.S. bakery not to claim foods contain allergens when they don't |url=https://www.npr.org/2024/06/26/g-s1-6238/fda-warns-bakery-foods-allergens |website=NPR}}{{Cite web |date=9 October 2024 |title=Bakery That Makes Sara Lee and Entenmann's Pushes Back on FDA Sesame Warning |url=https://www.usnews.com/news/us/articles/2024-10-09/bakery-that-makes-sarah-lee-and-entenmanns-breads-pushes-back-on-fda-sesame-warning |website=US News & World Report}} The FDA typically requests recall of products containing unintended allergens.

Many commercial bakers found adding sesame to the recipes was the only feasible way to comply. As a result consumers have reported the availability of safe products has diminished profoundly.

Manufacturers introducing sesame into recipes that previously didn't include sesame include store brands Wegmans, Kroger, Walmart, and Target, brands Wonder, Thomas’, and Dave's Killer Bread, and restaurants Jack in the Box, Sonic, Chick-fil-A and Wendy's. Olive Garden initially announced the chain's suppliers were adding “a minimal amount of sesame flour” to their breadsticks recipe “due to the potential for cross-contamination at the bakery,”{{Cite web |date=2023-02-20 |title=New law causing unintended consequences for those with major food allergies |url=https://abc7chicago.com/sesame-allergy-faster-act-fda-food/12839602/ |access-date=2025-03-19 |website=ABC7 Chicago |language=en}} but in October of 2023, switched suppliers in order to reinstate sesame-free breadsticks, stating “It was always our intent to identify alternative sources to ensure our breadsticks did not contain sesame flour."{{Cite web |last=Mondello |first=Wendy |date=2023-10-25 |title=Olive Garden Hailed for Switch to Sesame-Free Breadsticks |url=https://www.allergicliving.com/2023/10/25/olive-garden-hailed-for-switch-to-sesame-free-breadsticks/ |access-date=2025-03-19 |website=Allergic Living |language=en-US}} United States Bakery announced it would add a small amount of sesame flour to recipes “to mitigate the risk of any adverse reactions to sesame products.” Pan-O-Gold Baking Company, which supplies bread to schools in the US Midwest, added sesame to recipes.

Some restaurants and brands were able to comply with the law without adding sesame to recipes. Jimmy John's removed sesame from its menus. McDonald's did not change its menu or recipes.

The FDA determined manufacturers adding sesame in order to comply with the law were not in violation of the law.{{Cite web |last=Aleccia |first=Jonel |date=26 July 2023 |title=Sesame is being newly added to some foods. The FDA says it doesn’t violate an allergy law |url=https://thehill.com/homenews/ap/ap-health/ap-sesame-is-being-newly-added-to-some-foods-the-fda-says-it-doesnt-violate-a-allergy-law/ |website=The Hill}} Food safety advocacy group Center for Science in the Public Interest petitioned the FDA to stop the new additions, but the FDA denied the request.

References

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  • H. Lemon-Mule, T.J. Furlong,S.H. Sicherer. Journal of Allergy and Clinical Immunology. Volume 119, Issue 1, Supplement, January 2007, Pages S74.