Frequently Asked Questions about Voluntary Allergen Advisory Statements
- Allergen advisory statements or “may contain” statements are sometimes printed on product labels. Examples you might see on a product include:
- “Processed in a facility that also processes wheat”
- “May contain wheat”
- “Processed on shared equipment with wheat”
- Allergen advisory statements are different than regulated allergy statements such as “Contains Wheat.” See FALCPA question below.
- While allergen advisory statements might be concerning, it’s important to know that these these statements are VOLUNTARY on the part of the manufacturer
- Manufacturers may choose not to include these voluntary allergen advisory statements on food labels even if their products are processed using shared equipment or facilities.
- Products with allergen advisory statements are not necessarily contaminated and products without them are not necessarily free of contamination.
- All food is required to be processed using current Good Manufacturing Processes (GMP), a regulation set by the FDA, to prevent unintentional ingredients, such as allergens, from ending up in a product.
TAKE HOME MESSAGES
- Allergen advisory statements are voluntary and unregulated.
- These statements are related to manufacturing practices.1
- Allergen advisory statements do not appear reliable for determining whether foods labeled gluten-free or not labeled gluten-free are contaminated with gluten.1, 5, 6, 7
- Under the FDA’s labeling rule, food labeled gluten-free must contain < 20 ppm of gluten from ingredients and cross-contact regardless of whether the label includes an allergen advisory statement for wheat.
- Thompson, T. ADA Pocket Guide to Gluten-Free Strategies for Clients with Multiple Diet Restrictions. Academy of Nutrition and Dietetics. Chicago, IL, 2016.
- U.S. Food and Drug Administration. Food Labeling: Gluten Free Labeling of Foods. Updated January 24, 2018. Accessed July 12, 2018.
- 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. Accessed July 12, 2018.
- NIAID-Sponsored Expert Panel. Guidelines for the Diagnosis and Management of Food Allergy in the United States. Report of the NIAID Expert Panel. J Allergy Clin Immunol. 2010;126(6Suppl):S1-S58.
- 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.
- Thompson T, Lyons, T, Jones A. Allergen advisory statements for wheat: do they help US consumers with celiac disease make safe food choices? Eur J Clin Nutr.2016;70(12):1341-1347.
- Thompson T., Keller A., Lyons T. When foods contain both a gluten-free claim and an allergen advisory statement for wheat: should consumers be concerned? Eur J Clin Nutr.2018;72(7):931-935.
Revised August 3, 2018
Author: Melinda Dennis, MS, RDN, LD
Editors: Amy Keller, MS, RDN, LD and Jocelyn Silvester, MD, PhD