- Allergen advisory statements 1 or "may contain" statements are sometimes included on product labels. Examples include:
- "Processed in a facility that also processes wheat."
- "May contain wheat."
- These statements:
- Address manufacturing practices.
- Are voluntary and not defined by any federal regulations.
- Are used by some manufacturers but not by others.
- Do not necessarily mean a food is safe or unsafe for people with celiac disease. Under FDA rules, foods labeled gluten-free must contain less than 20ppm of gluten regardless of whether they include an allergen advisory statement for wheat.
- Are not reliable in and of themselves for determining whether a food is contaminated with gluten.1,2
- Are not the same as the Food Allergen Labeling and Consumer Protection Act (FALCPA).
- Under FALCPA 3 if an ingredient in a food regulated by the Food and Drug Administration (FDA) contains protein from wheat, the word "wheat" must be included on the food label either in the ingredients list or Contains statement. Visit the section on Simple Label Reading for detailed information on FALCPA.
- FALCPA does not address wheat protein that may be in a food product unintentionally due to cross contact.
- In other words, these foods may still be contaminated with gluten.
- BUT, if a food is labeled gluten-free 4 it must contain less than 20 parts per million (ppm) of gluten from ingredients and cross-contamination (under the FDA's gluten labeling rule) regardless of whether the food label includes an allergen advisory label for wheat. Visit the section on Simple Label Reading for detailed information on gluten-free labeling.
TAKE HOME MESSAGES:
- Allergen advisory statements are voluntary and unregulated.
- These statements are related to manufacturing practices.
- Allergen advisory statements are not the same as FALCPA.
- Labeled gluten-free food must contain less than 20 ppm of gluten (under the FDA's proposed labeling rule) regardless of whether the label includes an allergen advisory statement for wheat.
RESOURCES FOR YOU:
Food Allergies: What You Need to Know. U.S. Food and Drug Administrationhttp://www.fda.gov/food/resourcesforyou/consumers/ucm079311.htm . Accessed October 27, 2011.
Food Allergies: Reducing the Risk. U.S. Food and Drug Administration.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm089307.htm . Accessed October 27, 2011.
Allergen Advisory Statements. Gluten-Free Dietitian. http://www.glutenfreedietitian.com/newsletter/dietcom-blog-gluten-free-allergen-advisory-labeling/ . Accessed October 27, 2011.
Thompson T, Case S. Food Labeling in the United States and Canada. In Real Life with Celiac Disease: Troubleshooting and Thriving Gluten-Free. Eds. Dennis M, Leffler D. AGA Press. Bethesda, MD, 2010.
- Thompson, T. ADA Pocket Guide to Gluten-Free Strategies for Clients with Multiple Diet Restrictions. American Dietetic Association. Chicago, IL, 2011.
- Thompson T, Lee AR, Grace T. Gluten contamination of grains, seeds, and flours in the United States: A pilot study. J Am Diet Assoc. 2010;110:937-940.
- US Food and Drug Administration. Center for Safety and Applied Nutrition. Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282). August 2004. http://www.fda.gov/food/labelingnutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm. Accessed October 13, 2011.
- U.S. Food and Drug Administration. Federal Register Proposed Rule—78 FR 150 August 5, 2013. Food Labeling: Gluten Free Labeling of Foods. http://www.gpo.gov/fdsys/pkg/FR-2013-08-05/pdf/2013-18813.pdf. Accessed November 19, 2013.
Revision Date: 12-18-13
Author: Tricia Thompson, MS, RD
Editors: Melinda Dennis, MS, RD, LDN and Daniel Leffler, MD, MS