Allergen advisory statements for wheat do NOT appear to be useful predictors of the potential for quantifiable gluten in database reviewsTricia Thompson
For Immediate Release April 4, 2018
Allergen advisory statements for wheat do NOT appear to be useful predictors of the potential for quantifiable gluten in database reviews 1,2
A pdf of this release is available at FINAL EJCNAAS2018PressReleaseApril4
In the U.S., allergen advisory statements are voluntary and are not currently defined by any federal regulation. The FDA continues to state that allergen advisory statements must be truthful and not misleading. Precautionary labeling may include language such as, “May contain wheat,” “Processed in a facility that uses wheat,” and “Produced on equipment that also processes wheat.” This terminology is allowed to be included on foods labeled “gluten-free.” For consumers, such statements are understandably confusing and concerning. Adding to the confusion is the lack of understanding of the difference between Contains statements regulated under the Food Allergen Labeling and Consumer Protection Act and May contain statements that are not currently regulated.
There is very little published data on whether precautionary statements for wheat or gluten on food labels provide any indication about whether a food contains quantifiable gluten. However, the body of available data is increasing.
In a recently published 2018 analysis (1), labeling information was retrospectively reviewed from 328 products labeled gluten-free and tested for gluten through Gluten Free Watchdog, LLC.
297/328 products tested for gluten did NOT include an allergen advisory statement for wheat or gluten on product packaging.
31/328 products tested for gluten DID include an allergen advisory statement for wheat or gluten on product packaging.
Of the 297 products that did NOT include an advisory statement, 39 contained quantifiable gluten at or above 5 ppm, including 12 products that tested at or above 20 ppm of gluten.
Of the 31 products that DID include an advisory statement, 3 contained quantifiable gluten at or above 5 ppm, including 2 products that tested at or above 20 ppm of gluten.
In a 2016 analysis (2), labeling information was retrospectively reviewed from 101 products tested for gluten content through Gluten Free Watchdog, LLC. 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.
87/101 products tested for gluten did NOT include an allergen advisory statement for wheat or gluten on product packaging.
14/101 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 (it tested at a level of gluten at or above 20 ppm of gluten).
Combining the data from both studies:
4/45 (9%) products that DID include an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten.
52/384 (14%) products that did NOT include an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten.
The FDA should strongly consider regulating allergen advisory statements, especially in light of the Food Safety Modernization Act.
Citation 1: Tricia Thompson, Amy Keller, Trisha B. Lyons. When foods contain both a gluten-free claim and allergen advisory statement for wheat: Should consumers be concerned? European Journal of Clinical Nutrition, advance online publication, 26 March 2018. doi:10.1038/s41430-018-0141-y.
Available at http://rdcu.be/JRM0 Summary available at https://www.glutenfreewatchdog.org/news/wp-content/uploads/2016/10/2016-FNCE-AAS-flyer.pdf
Citation 2: 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.
Available at http://rdcu.be/kl1j Summary available at https://www.glutenfreewatchdog.org/news/wp-content/uploads/2018/03/2018-AAS-FINAL-one-pager.pdf
For more information about these studies please contact:
Tricia Thompson, MS, RD
Founder, Gluten Free Watchdog, LLC
I am a very sensitive Celiac. I have learned the hard way not to buy any processed food which does not have the seal of the Celiac Foundation. This means forgoing many foods that I like. And it means preparation of foods in my strictly gluten free kitchen that I might otherwise buy in the gluten free ? section.
It is a sad fact that we cannot depend on the FDA for “truth in advertising” and protection from foods that will trigger health issues related to manufactured foods. Thank you Tricia for fighting the good fight for us. The hard work and the information that you and your colleagues are providing for us is very much appreciated.
Thanks for taking the time to post, Joanna. It is good to hear that you find the information useful.
Is there anything we can do about this? How do we change the FDA laws?
I’ve learned the hard way that the ‘GF Certified’ label unfortunately doesn’t mean I can eat the product, but what I find even more frustrating is that when company’s do ‘voluntary’ list allergens that the manufacturer will choose to leave off wheat when they are selling a GF certified product. So the label will read “May contain milk. Processed on shared equipment with soy, tree nuts, and milk.” This certainly makes it seem that if they’re choosing to list processing allergens that they’d list them ALL…but NO. I’ve researched and written countless companies and 90% of the time I find out that yes they do process that product on shared equipment with wheat but choose to not list that particular allergen on the label. I find it highly deceptive to mark a product GF Certified and then choose to list every other shared equipment ingredient except gluten when it is present. It honestly seems intentional, as though they’re tying to not scare off the GF consumer, but in doing so they make many of us very sick. I’d absolutely love a law that states that all allergens run on shared manufacturing equipment must be listed, regardless of cleaning or sanitizing between runs. And that they must specify whether the actual equipment is shared, or just the facility. They can tell me on the label if they’d like that they clean between runs, but they should still be required to list the allergen if it’s ever present so that I can make an informed decision about whether I feel safe eating it or not. Thanks for posting about this issue.