KEY POINTS:

  • Allergen advisory statements (may contain/made in a facility) are voluntary and unregulated.
    • The Food and Drug Administration (FDA) states that such statements "should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading." 1
    • Some manufacturers use allergen advisory statements; many do not.
  • The National Institutes of Health (NIH) recently released, "Guidelines for the Diagnosis and Management of Food Allergy in the United States." 2
    • These guidelines recommend that products with allergen advisory statements be avoided by individuals with allergies to the allergens named in the allergen advisory statement.
    • For example, if there is an allergen advisory statement for wheat, the expert panel suggests that individuals allergic to wheat should avoid that product.
    • The guidelines do not address allergen advisory statements for wheat for individuals with celiac disease.
  • Under FDA rules, foods labeled gluten-free that include an allergen advisory statement for wheat must contain less than 20 parts per million (ppm) of gluten regardless of whether gluten comes from ingredients or contamination. 3
  • In the study, "Gluten contamination of grains, seeds, and flours in the United States: A pilot study," 22 naturally gluten-free products were assessed for gluten contamination. 4
    • Thirteen of 22 products contained less than 5 ppm gluten; 3 of these products, nonetheless, included an allergen advisory statement for wheat on product packaging.
    • Nine of 22 products contained between 8.5 and 2,925 ppm gluten; only 4 of these 9 products contained an allergen advisory statement for wheat. Seven products contained 20 or more ppm gluten; three of these 7 contained an allergen advisory statement for wheat.
  • Allergen advisory statements for wheat do not appear too reliable for determining whether a food not labeled gluten-free is contaminated with gluten. 4,5

TAKE HOME MESSAGES:

  • While allergen advisory statements remain voluntary and unregulated, the FDA states that they must be truthful and not misleading.
  • The NIH has no recommendation for whether individuals with celiac disease should avoid foods whose labels contain an allergen advisory statement for wheat.
  • Under FDA rules, food labeled gluten-free must contain less than 20 ppm of gluten regardless of whether gluten comes from ingredients or contamination.
  • Based on the grain contamination study, allergen advisory statements do not appear reliable for determining whether a food not labeled gluten-free is contaminated with gluten.

RESOURCES FOR YOU:

Guidelines for Diagnosis and Management of Food Allergies in the United States. National Institutes of Health.https://www.niaid.nih.gov/sites/default/files/faguidelinespatient.pdf . Accessed October 27, 2011.

Gluten contamination of grains, seeds, and flours in the United States: A pilot study. Journal of the American Dietetic Association. http://www.ncbi.nlm.nih.gov/pubmed/20497786 . Accessed October 27, 2011.

Contamination of Naturally Gluten-Free Grains. Gluten-Free Dietitian.http://www.glutenfreedietitian.com/newsletter/contamination-of-naturally-guten-free-grains/ . Accessed October 27, 2011.

Contamination of Naturally Gluten-Free Grains: Part 2. Gluten-Free Dietitian.http://www.glutenfreedietitian.com/newsletter/contamination-of-naturally-gluten-free-grains-part-2/ . Accessed October 27, 2011.

US Food and Drug Administration. Food Allergies: What You Need to Know. Update October 25, 2011.http://www.fda.gov/food/resourcesforyou/consumers/ucm079311.htm .

References:

  1. US Food and Drug Administration. Food Allergies: What You Need to Know. Update October 25, 2011.http://www.fda.gov/food/resourcesforyou/consumers/ucm079311.htm . Accessed October 27, 2011
  2. 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.
  3. U.S. Food and Drug Administration. Federal Register Proposed Rule—78 FR 150 August 5, 2013. Food Labeling: Gluten Free Labeling of Foods.
  4. 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.
  5. Thompson, T. ADA Pocket Guide to Gluten-Free Strategies for Clients with Multiple Diet Restrictions. American Dietetic Association. Chicago, IL, 2011.

Revision Date: 12-18-13 
Author: Tricia Thompson, MS, RD 
Editors: Melinda Dennis, MS, RD, LDN and Daniel Leffler, MD, MS

CeliacNow Disclaimer