Dear General Mills’ Cheerios Team,

Your recent recall of 13 lots of Honey Nut and 4 lots of Yellow Box Cheerios and subsequent explanation of how these products made it to market has raised many questions. One of the biggest concerns is the apparent discrepancy between what you told the community about your testing protocols and what you were actually doing. It is important that you provide a thorough and honest explanation.

What you were actually doing

You stated to me in an email on October 6th, “We tested the oat supply – and the oat supply tested as gluten free. We tested the oat flour being used – and our oat flour supply also tested as gluten free on all of the recall code dates. Unfortunately, an amount of wheat flour was introduced into our otherwise gluten free production system through human error, and finished product was not tested on these run dates.” Emphasis mine.

What you told Gluten Free Watchdog you were doing

As you know, when we met at Medallion Labs on July 15th, you provided me with the following information:

Data Collection and Test Results for Yellow Box Cheerios Provided by General Mills

General Mills has four plants producing gluten-free Cheerios using what they term “validated gluten-free flour.” At the time of my visit to General Mills (July 14 to 16) they had 88 production dates or “lots” of testing data. Each data point represents a “lot mean.”

General Mills defines a “lot” as a 24-hour production cycle. To arrive at a lot mean, the following protocol is followed:

Twelve to eighteen boxes of cereal are pulled during a production cycle The contents of each individual box are ground A sub-sample of ground product is taken from each box The sub-samples are composited—meaning they are combined The combined sub-samples are subject to additional grinding Twelve extractions are taken from this combined, ground sample Extractions are tested using the Ridascreen Fast Gliadin (R7002) and cocktail extraction solution

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In an email sent on July 21st you responded to a series of questions. One Q&A was:

Is General Mills basing their decision on the safety of a “lot” of boxed Cheerios on the lot mean or do individual extractions above 20 parts per million raise alarm bells?

With all the learning we have done on our journey to bring gluten-free Cheerios to market, we know that looking only at a single data point does not represent the entire picture. As we shared with you, we conduct a minimum of 12 tests on any given sample of Cheerios. In doing so, we look first at the lot mean to give us an initial indication of safety. However, we also look at the confidence interval around the lot mean to tell us about the variability of the individual extractions. It is through a thorough assessment of all the data, we can have confidence around the safety of any given sample or lot.

What you told the gluten-free community you were doing

On August 4th you sent some members of the gluten-free community, including Gluten Dude (http://glutendude.com/celiac/gluten-free-cheerios-update/) the following email (included here with permission from Gluten Dude):

“I just wanted to share an update with you on Gluten Free Cheerios, in the interest of continuing the dialogue with you. We know there have been some concerns in the celiac community, and one of the ways we want to address those concerns is through increased transparency. I know you’ve seen Tricia’s recent post on Cheerios, and we continue to work directly with her to address her concerns. The below is new data of our first month of production that we have not published yet but will continue to be part of our transparency journey with the celiac community. I wanted to share it with you immediately to help alleviate any concerns you may have about the safety of our product for your community.

We have 34 days of Original Cheerios production across our 4 Cheerios plants. Each of those run days has at least 12 samples that we pull.

– The mean ppm of those samples is 7.

– 30 days had an average < 10ppm – 2 days = 11ppm; 2 days = 12ppm Furthermore, we have some data on some of the other flavors (that run less frequently due to size of business). – Multi-Grain Cheerios: 2 run days across 2 plants — Mean <5ppm – Apple Cinnamon Cheerios: 1 run day across 1 plant –Mean <5ppm As always, if you have any questions please don’t hesitate to reach out. We are likely talking to Tricia on the 12th or 13th and would be happy to update you on some of the specifics of that dialogue once we land on the date. Thank you!”

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You produced a graphic about your “rigorous” testing protocol.” The description on the graphic for Test #4 reads, “Finished Product: Our oat flour is then shipped to our cereal plants in dedicated rail cars and trucks to be made into Cheerios. The finished product is tested for safety a final time.” Emphasis mine

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As reports of consumer illness were posted on Cheerios’ Facebook page your response as late as September 30th was, “Cheerios are gluten-free and every single box & serving are < 20 ppm.” Emphasis mine.

What are you doing now?

At Gluten Free Watchdog we are left shaking our heads. While we took issue with your testing methodology and protocol, at least you were testing finished product Cheerios (or so you said). Can you please tell this community how without ANY testing on finished product of the lots involved in the recall you had confidence that these 1.8 million boxes were gluten-free? And can you please provide the Gluten Free Watchdog community with an honest and detailed description of your current testing methodology and protocol for finished product Cheerios? Until you do, it will remain the position of Gluten Free Watchdog that individuals with gluten-related disorders should not eat gluten-free labeled Cheerios.

Thank you.

Tricia Thompson, MS, RD

Owner/Founder Gluten Free Watchdog, LLC

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UPDATE October 9: Response from General Mills to the Gluten Free Watchdog Community

Tricia: In your letter, you ask two questions. Here’s our answer to each:

Can you please tell this community how without ANY testing on finished product of the lots involved in the recall you had confidence that these 1.8 million boxes were gluten-free?

We had tested the oat supply, and we had confirmed that it met the standard for gluten free. That has been subsequently reconfirmed. There was no issue with the oat supply.

We had also tested the oat flour prior to use, and had confirmed that our oat flour also met the FDA gluten free standard. That has also been subsequently reconfirmed.

As your questions have consistently been focused on the oat supply, hopefully you will appreciate knowing that the oat supply was not the issue. Both the oat supply and the oat flour were tested and confirmed as meeting the gluten free standard – and both our oats and our oat flour have been subsequently retested and reconfirmed as meeting the gluten free standard.

This issue came when our Lodi facility lost rail service, and our gluten-free oat flour was off-loaded from rail cars to trucks. All current evidence points to one truck – that had previously carried wheat flour for a different customer – inadvertently introducing an amount of wheat flour into the gluten free oat flour system at our Lodi facility.

That shouldn’t have happened – and we’ve acknowledged that.

We’ve also acknowledged that for a number of days finished product testing was not done. We are testing finished products – and that was and had been true before this issue was discovered. But finished product was not done on these run dates, and therefore the problem was not discovered at the time of production.

It has since been done, and that is how the specific dates included in the recall were determined.

And can you please provide the Gluten Free Watchdog community with an honest and detailed description of your current testing methodology and protocol for finished product Cheerios?

As we’ve discussed with you in the past, we test the oat supply – and confirm that our oats meet the gluten free standard. We then mill the oats – and test the resulting oat flour to confirm that our oat flour also meets the gluten free standard. We are also testing finished products – to confirm that our finished products also meet the gluten free standard. And we had been testing finished products prior to discovering this issue. But we’ve also acknowledged that for a number of days finished product testing was not done, and therefore the problem was not discovered at the time of production.

It has since been done, and that is how the dates included in the recall were determined.