Allergen Advisory Statements for Wheat: NOT a Useful Predictor of Gluten Content

Allergen Advisory Statements for Wheat: NOT a Useful Predictor of Gluten Content

For Immediate Release (A pdf of this release is available at ejcnaaspressreleasesept15)

The full text of this article is available at

September 14, 2016

Allergen advisory statements for wheat on products not labeled gluten-free but appearing to be free of gluten-containing ingredients were NOT a useful predictor of gluten content.

Citation: Tricia Thompson, Trisha B. Lyons and Amy Jones. Allergen advisory statements for wheat: do they help US consumers with celiac disease make safe food choices? European Journal of Clinical Nutrition advance online publication, 14 September 2016 doi:10.1038/ejcn.2016.155

In the US, allergen advisory statements are voluntary and are not currently defined by any federal regulation. The FDA continues to state in recently updated guidance that allergen advisory statements must be truthful and not misleading.

There is very little published data on whether precautionary statements for wheat or gluten (for example, Made in a facility that also processes wheat) are helpful to consumers with celiac disease when deciding if a food is appropriate to eat.

In this analysis, labeling information compiled for 101 products tested for gluten content through Gluten Free Watchdog, LLC was retrospectively reviewed for an allergen advisory statement for wheat, gluten or both. Products reviewed for this analysis were not labeled gluten-free but appeared to be free of gluten containing ingredients based on a review of the ingredients list (that is, no wheat, barley, rye, malt, brewer’s yeast).

  • 87/101 products tested for gluten did NOT include an allergen advisory statement for wheat or gluten on product packaging.
  • Fourteen products tested for gluten DID include an allergen advisory statement for wheat or gluten on product packaging.
  • Of the 87 products that did NOT include an advisory statement, 13 contained quantifiable gluten at or above 5 ppm including 4 products that tested at or above 20 ppm of gluten.
  • Of the 14 products that DID include an advisory statement, only 1 contained quantifiable gluten at or above 5 ppm.

In this database review, precautionary labeling for wheat or gluten on products not labeled gluten-free but appearing to be free of gluten-containing ingredients was NOT a useful predictor of gluten content. In some cases, consumer reliance on precautionary statements for wheat or gluten could have resulted in choosing a product contaminated with gluten.

Ideally, allergen advisory statements should be used by manufacturers to help consumers make choices about which foods they can eat given their particular health constraints. The FDA should strongly consider regulating allergen advisory statements, especially in light of the Food Safety Modernization Act.

For more information about this study please contact:

Tricia Thompson, MS, RD

Founder, Gluten Free Watchdog, LLC

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Comments (13)


    Hello Tricia,

    We read your note about the passing of our dear Suzanne. All of us here at Everybody Eats and really sad.
    She helped us to develop our well know Multigrain Bread.

    Our breads have been tested recently at ELISA Technologies, Inc., and they have less than 5 ppm of gluten.

    718 369 7444

    September 15, 2016 at 3:42 pm
    • Carrie Ek, RD Reply


      Thank you for doing this research and for taking the time and energy to have it published. This is a HUGE problem in my practice and I am very frustrated by these “may contain” or “processed in a plant…..” statements.

      It gives the consumer absolutely no meaningful information , only doubts.

      September 20, 2016 at 9:53 pm
      • Tricia Thompson Reply

        My pleasure, Carrie. Thank YOU and all the supporters of Gluten Free Watchdog who help make this research possible.

        September 21, 2016 at 11:59 am
  • Matt RD Reply

    The first statement in your article is very misleading. As of 2004 the FDA requires food labels to declare allergens. Requires means not voluntary. Food manufacturers can have the allergen listed in the ingredient list or they can a “contains” statement. The contains statement is voluntary if the allergen is clearly stated in the ingredient list. Please see the Food Allergen Labeling and Consumer Protection Act.

    I’d also be interested in reading the article to see what testing methods were used because from what I’ve read 20 ppm was the lowest detectable level that is reliable.

    September 16, 2016 at 4:20 am
    • Matt RD Reply

      Am I misinterpreting something here? Why are you saying allergy declaration is voluntary? What are you considering an allergy advisory statement?

      September 16, 2016 at 4:50 am
      • Tricia Thompson Reply

        Please see response to your previous comment. Allergen advisory statements/may contain statements/precautionary statements are voluntary.

        September 16, 2016 at 1:11 pm
    • Tricia Thompson Reply

      Hi Matt,

      Please read the article in full. A link to a complimentary pdf is included at the beginning of the post and also pasted here (please cut and paste into your browser or click on the link in the post).

      Allergen advisory statements (also known as “may contain statements”) are not the same as FALCPA. Under FALCPA foods regulated by the FDA that include an ingredient that is or contains any of the top 8 allergens (including wheat) must include the name of the allergen in plain English either in the ingredients list or Contains statement. Allergen advisory statements (e.g., processed in a facility that also processes wheat) are voluntary and not currently regulated.

      Product testing is done using the fully validated R5 ELISA Mendez Method. This is one of the methods the FDA has stated they will use to assess compliance with the gluten-free rule when necessary. It is also a Type 1 method of Codex. The lower limit of quantification is 5 ppm. More information about testing is included in the article.

      Matt, are you an RD? If you are attending FNCE, please come to the session on Tuesday morning at 8 am (Hot Topic: FDA’s Proposed Rule for Gluten-Free Labeling of Hydrolyzed/Fermented Foods). Carol D’Lima (FDA) and I are presenting.

      September 16, 2016 at 1:10 pm
      • Matt RD Reply

        Thank you for the clarification. I didn’t realize allergen advisory statements were “may contain statements.”

        Do you know why FDA states 20 ppm is the lowest detectable limit that is reliable?

        I am an RD but won’t make it to FNCE this year. I have a family member that was diagnosed with Celiac’s and she introduce me to your website. Thanks for all your work!

        September 16, 2016 at 5:19 pm
        • Tricia Thompson Reply

          Let’s just say they have a difference of opinion with the developer of the assay–the late Dr. Enrique Mendez. If you are interested in learning more about testing, I am happy to send you the article I co-authored with Dr. Mendez before his passing.

          September 16, 2016 at 6:20 pm
          • Anne Fernandes

            Tricia, I am not an RD; however, I have Celiac Disease, and would, if you will allow, love to read the article that you co-authored with Dr. Mendez.

            September 21, 2016 at 5:48 pm
          • Tricia Thompson

            It is on the way to you, Anne.

            September 21, 2016 at 6:06 pm
  • Erin Reply

    Trisha thank you for your work! I have celiac disease and find the labelling frustrating and incorrect many times. I was at a GF expo and one of my friends with celiac disease got gluten poisoning. She is sensitive to even 3ppm. I would love to read the paper on the testing you did with Dr Mendez as well.
    Thank you!

    March 14, 2017 at 7:20 am

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