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.


  • 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.


  1. Thompson, T. ADA Pocket Guide to Gluten-Free Strategies for Clients with Multiple Diet Restrictions. Academy of Nutrition and Dietetics. Chicago, IL, 2016.
  2. U.S. Food and Drug Administration. Food Labeling: Gluten Free Labeling of Foods. Updated January 24, 2018. Accessed July 12, 2018.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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