More on Oats from Gluten Free Watchdog: Retrospective database analysis 2011- 2023

Tricia Thompson, MS, RD, Amy Keller, MS, RDN, LD

Summary

Gluten Free Watchdog has been testing food for gluten through the ISO/IEC 17025 accredited lab, Bia Diagnostics since 2011. For this retrospective GFWD database analysis, all labeled gluten-free products containing the word “oat” in the ingredients list were assessed for gluten levels. 213 products (i.e., individual packages) contained the word oat. Of these, 24 (11%) tested with quantifiable gluten greater than or equal to 5 parts per million. Only products with no extractions of less than 5 ppm (initial testing and/or after being reground or resampled) were included. For example, if a product tested at < 5 ppm and 12 ppm, it was excluded from this analysis.

Note: This is a preliminary analysis of the data. A final analysis will be submitted to a journal.

Percentage of oats testing with quantifiable gluten:

• 2011: 17% (April through December)
  • In 2004, purity protocol gluten-free oats arrived on the scene. Prior to this time, oats were not recommended in the US. Oats labeled gluten-free were considered synonymous with purity protocol oats.

• 2012: 5%
• 2013: 7%
• 2014: 0
  • The FDA gluten-free labeling rule took effect August 5, 2014.

• 2015: 22%
  • Sorted oats arrived in a big way via General Mills and gluten-free Cheerios in 2015. General Mills was very open about the fact that they were using sorted oats. The arrival of gluten-free Cheerios was the first time many in the gluten-free community heard of mechanical and optical sorting. Most folks were unaware that sorted oats had already been in the gluten-free food supply for at least a couple years including via the Canadian company, Grain Millers.

• 2016: 5%
• 2017: 0
• 2018: 11%
• 2019: 0
• 2020: 8%
• 2021: 0
• 2022: 35%
  • The drought in 2021 limited the availability of oats, including the availability of gluten-free oats and purity protocol oats.

• 2023: 25% (January 1 to May 1)       

Details By Year

2011: 3/18 individual products tested at a level of gluten at/above 5 ppm. The 3 products were all the same brand of certified gluten-free hot cereal with oats as the first ingredient. The products tested from 18 ppm to > 100 ppm (product 1: 28 to 30 ppm; product 2: > 100 ppm; product 3: 18 to 26 ppm). Oat source unknown.

2012: 1/21 individual products tested at a level of gluten at/above 5 ppm. The certified gluten-free hot cereal with oats as the first ingredient tested from 63 to 73 ppm of gluten. Oat source unknown.

2013: 1/14 individual products tested at a level of gluten at/above 5 ppm. The crumb mixture with oats as the first ingredient tested from 9 to > 80 ppm of gluten (9, 16, 22, > 80). The manufacturer was using regular oats. After testing by GFWD, the manufacturer changed their source of oats.

2014: 13 products containing oats were tested. No products tested at a level of gluten at/above 5 ppm.

2015: 5/23 products tested at a level of gluten at/above 5 ppm.

Product 1: The granola with oats as the first ingredient tested from 6 to 30 ppm. The clusters visibly containing the most oats were also tested. Results ranged from 17 to 23 ppm. After testing by GFWD, the gluten-free claim was replaced with a sticker with the statement, “using gluten-free ingredients.”

Product 2: The rolled oats with oats as the only ingredients tested from 72 to > 80 ppm. The manufacturer stated they were advised by their vendor that the oats were free of gluten.

Product 3: The ready-to-eat breakfast cereal with oats as the first ingredient tested from 6 to 7 ppm. The oats in this product were mechanically/optically sorted.

Product 4: The bar with oats as one of many ingredients tested from 12 to 15 ppm.

Product 5: The granola with oats as the second ingredient tested from 16 to 26 ppm when clusters with oats were tested. The oats used by the manufacturer were not gluten-free. After testing by GFWD, the manufacturer changed their source of oats.

2016: 1/21 products tested at a level of gluten at/above 5 ppm. The oat matzoh using purity protocol oats (according to their website) tested from 12 to 13 ppm.

2017: 12 products containing oats were tested. No products tested at a level of gluten at/above 5 ppm.

2018: 1/9 products tested at a level of gluten at/above 5 ppm. The cookie containing oats as the first ingredient tested from 10 to 15 ppm. According to the ingredients list, the oats were certified gluten-free.

2019: 4 products containing oats were tested. No products tested at a level of gluten at/above 5 ppm.

2020: 1/13 products tested at a level of gluten at/above 5 ppm. The bread mix containing oats as the first ingredient tested from 6 to 44 ppm. The manufacturer was using mechanically/optically sorted oats. They planned to change oat suppliers. After testing by GFWD, the product was recalled.

2021: 30 products containing oats were tested. No products tested at a level of gluten at/above 5 ppm.

2022: 9/26 products tested at a level of gluten at/above 5 ppm.

Product 1: The certified gluten-free, purity protocol flour with oats as the only ingredient tested from 7 to 22 ppm.

Product 2: The certified gluten-free, purity protocol flour with oats as the only ingredient tested from 6 to 14 ppm.

Product 3: The certified gluten-free, purity protocol flour with oats as the only ingredient tested from 12 to 16 ppm.

Product 4: The certified gluten-free, purity protocol flour with oats as the only ingredient tested from 9 to 32 ppm. A safety alert was issued for the flour (products 1 through 4) by the certifying organization.

Product 5: The certified gluten-free, purity protocol whole grain oats with oats as the only ingredient tested from 9 to > 80 ppm (9, 15, > 80).

Product 6: The rolled oats product with oats as the only ingredient tested from 6 to > 80 ppm (6, > 80, > 80).

Product 7: The bread product with oats as the first ingredient tested from 8 to 10 ppm. Based on information provided on the website, this bakery may be using standard oats in their products.

Product 8: The bread product tested from 6 to 13 ppm. Based on information provided on the website, this bakery may be using standard oats in their products.

Product 9: The certified gluten-free granola with oats as the first ingredient tested from 71 to > 80 ppm. A safety alert was issued for this product by the certifying organization.

2023: 2/8 products tested a level of gluten at/above 5 ppm.

Product 1: The certified gluten-free, purity protocol oat flour with oats as the only ingredient tested from 9 to 15 ppm of gluten.

Product 2: The oat flour sample with oats as the only ingredient tested from 7 to 14 ppm of gluten.

Nitty Gritty Q&A

Thank you to everyone who reached out over the past month with questions or comments about oats. Fingers crossed that most everything is covered in this Q&A. If you haven’t been following this issue, please see https://www.glutenfreewatchdog.org/news/gluten-free-watchdog-cannot-recommend-any-brand-of-gluten-free-oats/ and https://www.glutenfreewatchdog.org/news/brief-history-of-oats-gluten-free-watchdogs-evolving-opinion/.

How are products tested? Oat products are sent to the ISO-accredited lab Bia Diagnostics. They are tested using the sandwich R5 ELISA from R-Biopharm. This is one of two assays FDA says they use when products are tested as part of gluten-free rule enforcement.

Testing oats can be tricky. As R-Biopharm writes in their testing instructions for different food types:

“Oat samples: gliadin may not be distributed evenly, furthermore the samples are difficult to homogenize. Therefore, homogenize at least 200 g, then carry out the extraction with at least the fourfold amount of reagents: weigh 1 g of the homogenized sample and add 10 ml of the Cocktail (patented), close the vial and mix well.”

In other words, a larger amount of a food sample is ground by the lab and larger homogenized food samples are tested when the only or main ingredient is oats.

Why are test results sometimes different for the same product? As is mentioned above, any gluten in a sample of oats likely will not be evenly distributed within a product. It is hoped that by grinding a larger sample amount and testing larger homogenized sample amounts, any gluten in the sample will be detected. Sometimes despite the labs best efforts, gluten in a sample remains unevenly distributed.

Why are more oat products testing with quantifiable gluten? We can’t know for sure of course but the drought that occurred during the oat growing season of 2021 may be one factor.

Why would a drought cause an increase in gluten levels? The drought doesn’t cause oats to contain higher levels of gluten. However, we have been advised that the availability of good quality oats, including gluten-free oats and purity protocol oats was severely impacted by the drought.

A month ago, Gluten Free Watchdog issued a statement that read in part, “At this time, Gluten Free Watchdog cannot recommend any brand of gluten-free oats.” What does this mean exactly? It means exactly what it says—that we can’t recommend any brands. What this statement doesn’t say and what it doesn’t mean is that individuals with celiac disease or another gluten-related disorder should stop eating oats. What each person chooses to eat is entirely up to them.

Isn’t the statement issued by Gluten Free Watchdog alarmist? In our opinion, no (obviously). Based on what we are seeing with oats, it would have been irresponsible not to alert the larger gluten-free community versus only the Gluten Free Watchdog community,

Why can’t Gluten Free Watchdog recommend brands of certified gluten-free or purity protocol oats? Historically, we have been supportive of four carefully vetted suppliers of purity protocol oats, and by extension, the manufacturers that use these oats exclusively. We maintain a listing of these suppliers and manufacturers on GFWD. We also have been supportive of one brand of gluten-free sorted oats.

However, over the past several months, and based in part on testing data, we realized that we could not assume that the purity protocol suppliers supported by GFWD would inform us of any issues they were experiencing with oats. Along with additional testing of oats, new criteria must be developed for the purity protocol listing (and corresponding responsibilities to GFWD on the part of suppliers/manufacturers included in the listing).

What about multi-ingredient products containing oats? If there is gluten cross contact in a particular “lot” of oats, it makes intuitive sense that a single ingredient product using these oats may be more problematic than a product that contains these oats as only one of many ingredients. That said, at GFWD we can’t recommend any brand of rolled oats, oat flour, granola, cookie, etc.

This change in recommendation seemed to come about suddenly. Can you explain? We have had concerns about oats for a while now. Indeed, there are 50 articles on oats on GFWD. If you follow these articles, you can see the trajectory of increasing caution.

Why aren’t the brand names included in the information? There are a few reasons:

1. The information included in this report is less about the individual brands and more about oats and what happened with the gluten-free oat supply due to the drought.
2. Many of the brands tested prior to 2022 have since corrected the issue that caused products to test at/above 5 parts per million of gluten (e.g., the source of oats was changed).
3. Product reports for oats tested in 2022 with the highest test levels of gluten are publicly available on GFWD (see the homepage at www.glutenfreewatchdog.org).
4. We will be preparing this retrospective database analysis for submission to a journal. Generally speaking, brand names are not included in the peer-reviewed scientific literature.

Why do you include products that test below 20 ppm of gluten in this report? There are a few reasons:

1. We have found over the years that the vast majority of foods labeled gluten-free test below the lower limit of quantification for gluten using the sandwich R5 ELISA (in other words, they test less than 5 ppm).
2. Because of the spotty nature of gluten cross contact in oats, it is our view that where there is some gluten, there may be more gluten. Gluten in oats has been likened to looking for a needle in a haystack. OR as a dietitian colleague says about oats, “where there is smoke, there is fire.”
3. We have learned over the years that different folks have different standards when it comes to what they consider gluten-free. For some it is less than 5 ppm. For others it is less than 10 ppm. And for others it is less than 20 ppm.
4. Finally, this is a convenient way for us to analyze the data—looking at all products with quantifiable gluten.

Do you currently eat oats? Currently I (Tricia) am not eating oats. This is not much of a problem now but it will become one during the holidays or whenever my son is home. My son loves meatballs and oats are a staple in the recipe. AND we are huge fans of no bake cookies and it isn’t possible to make them without oats.  

Do you think this situation is permanent with oats or do you think it may get better as the drought resolves and supplies return to normal? We certainly hope the situation isn’t permanent! We don’t have a handle on how long oats that were packaged in 2022 from the 2021 growing season will remain on store shelves. Also, we are a bit concerned about some market reports we have seen, including that there has been a fall in oat prices and the potential for far fewer oats to be grown in 2023. We will continue to test oats at GFWD and we will provide periodic updates to the community at large.

What should I do if I believe a product containing gluten-free oats is making me sick? If you believe any gluten-free product is making you sick, it is very important to file a complaint with an FDA consumer complaint coordinator. For contact information see, https://www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinators.

If you made it to the end of this report, thank you for reading!