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  • Jefferson Adams
    Jefferson Adams

    General Mills Gluten-Free Oats Patent Could Be a Game Changer

    Reviewed and edited by a celiac disease expert.

    General Mills patent application No. US 20180236453 A1 details a method for producing oat grains with gluten levels below 20 parts per million (ppm) and, more preferably, below 10 ppm. 

    General Mills Gluten-Free Oats Patent Could Be a Game Changer - Image: CC--Steve McLaughlin
    Caption: Image: CC--Steve McLaughlin

    Celiac.com 09/25/2018 - In a patent application that could have a huge impact on the gluten-free industry, General Mills, Inc. has described its method and system for removing foreign, gluten-containing grains to establish gluten-free oats. Current FDA guidelines require all products labeled gluten-free to have a maximum gluten content of 20 parts per million (ppm). 

    Published August 23rd, patent application No. US 20180236453 A1 details a method for producing oat grains with gluten levels below 20 ppm and, more preferably, below 10 ppm. 



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    Natural oats generally do not contain gluten, but after harvest, transport and storage, large batches of raw oats may contain small amounts of gluten-containing grains, such as wheat, barley, rye and triticale. These can sometimes occur at levels exceeding 20 ppm.

    The General Mills patent application describes a method of arranging mechanical oat sorting operations in series, or in both series and parallel operations. The multi-step process best includes width grading, multiple length grading steps, along with a potential de-bearding step.

    The resulting oats will be gluten-free to under 20 ppm, and possibly to under 10 ppm, and are suitable for the production of  gluten-free oat food products, including cereals and granolas.

    To receive a patent, General Mills will have to prove that their process does what they say it does. A successful patent for General Mills could have a huge effect on the gluten-free oat foods industry. For one, it may allow General Mills to become a major supplier of gluten-free oats for other manufacturers. 

    The benefits of larger scale, more economical gluten-free oat production could include more, and more readily available, gluten-free oat products, along with lower prices for both manufacturers and consumers. Stay tuned for more developments on this and related stories.

    Read more at Justicia.com



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    Interesting.  However, will the oats they use be Non-GMO? I think not, and given the recent information releases and lists of Oat brands contaminated with Roundup (and the known damage it causes), the oats and products made of them will still be damaging to out bodies.....my opinion 

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  • About Me

    Jefferson Adams

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,500 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.


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  • Related Articles

    Jefferson Adams
    Celiac.com 08/17/2016 - Cereal-maker General Mills is looking to patent method and system for manufacturing gluten-free oats.
    The application for patent protection covers numerous mechanical separation processes on a variety of grains, including oat grains and gluten-containing grains, using, among other things, width grading steps, multiple length grading steps, aspirating steps and a potential de-bearding step.
    Federal labeling regulations require products labeled 'gluten-free' to have gluten levels below 20 ppm. The process allow the production of oat grains with gluten levels below 20 parts per million, and optimally at 10 ppm.
    The resulting oats are gluten-free oats and suitable for use in a variety of gluten-free oat food products, including cereal and granola products, according to the patent US 2016/0207048 A1, filed on July 21st 2016.

    Mechanical separation techniques, such as these covered by the patent application, have the potential to be highly efficient and economical. The patent does not mention more expensive optical systems.
    Oats are naturally gluten-free, but, according to the patent, "oats cultivated in North America, Europe and other parts of the world commonly are contaminated by gluten-containing grains such as wheat, barley, rye and triticale."
    Contamination can result from rotating grains on the same crop land, and from harvesting, transporting, storing and merchandising.
    General Mills experienced problems with wheat contamination of gluten-free products last year, when they were forced to recall an estimated 1.8 million boxes of gluten-free Cheerios and Honey Nut Cheerios at its Lodi, Calif., plant. The product was contaminated with gluten. However, the company has maintained that the gluten contamination was due to an employee processing error, not any defect in their grain sorting equipment covered under the patent protection.
    Stay tuned to find out if General Mills receives their patent, and if their process has a significant impact on the quality, availability and cost of gluten-free oats.


    Jefferson Adams
    Celiac.com 09/01/2017 - A recent story by Buzzfeed does little to answer the question of whether Cheerios and other General Mills cereals are actually gluten-free and safe for people with celiac disease.
    There are a number of folks in the gluten-free community who complain that General Mills is making people sick by selling Cheerios that they know to be contaminated with gluten due to a faulty sorting process. Because General Mills uses a flawed sorting process, the story goes, their boxes of Cheerios are subject to gluten "hot spots," which is making some gluten-sensitive folks sick, thus the complaints.
    They point to regular complaints logged by the FDA to argue that Cheerios are clearly not gluten-free, and thus not safe for people with celiac disease. Comment sections on articles covering this topic show that plenty of people claim that Cheerios makes them sick, and triggers gluten-related symptoms.
    But, one useful measure of the basic scope of an issue is numbers. What kind of numbers are we talking about? How many complaints? How many boxes of Cheerios?
    It's important to realize that General Mills produces huge numbers of Cheerios each week. How many exactly? Well, according to their website, General Mills ships 500,000 cases of Cheerios each week. At about 12 boxes per case, that's about 6 million boxes each week, or 24 million boxes each month.
    We know that the FDA received a number of consumer complaints in 2015, when a mix-up at a Cheerios plant in California led to mass gluten contamination, and eventually to a full recall of 1.8 million boxes by General Mills.
    During that three month period, after the gluten contamination but prior to the recall, when many consumers were eating Cheerios made with wheat flour, the FDA says it received 136 complaints about adverse reactions to the product. So, during the 90 days when we know there was gluten contamination in nearly 2 million boxes of Cheerios, when people were definitely having gluten reactions, the FDA got 136 complaints. During that time General Mills shipped about 72 million boxes, and later recalled nearly 2 million of those due to gluten contamination. That's a complaint rate of about one complaint per 529,411 total boxes, and about one complaint for every 5,000 people with celiac disease; if each person with celiac ate 1 box, and the complaints came only from people with celiac disease. (Obviously this is simplified assumption for discussion purposes).
    Let's imagine another 2 million gluten-contaminated boxes got to consumers. Again, imagine that 1% of those buyers were celiac, so that 20,000 boxes of the 2 million went to celiacs—one box each. 146 complaints for 20,000 boxes is about 1 complaint per 140 boxes, give or take, for each person with celiac disease. That seems like a substantial complaint rate. So, how does that rate compare to the current rate, after the recall?
    Since the beginning of 2016, the FDA has received 46 reports of people with celiac disease or sensitivity to gluten or wheat linking their illness to General Mills cereals, including Cheerios and Lucky Charms.
    Let's forget about Lucky Charms for a minute, let's focus on Cheerios. During the 18 months from January 2016 to July 2017, General Mills has shipped something like 450 million boxes. That's about one complaint for every 10 million boxes of Cheerios, or about one complaint for every 100,000 people with celiac disease.
    And those numbers don't include Lucky Charms, which account for some portion of the 46 complaints since early 2016. If General Mills is having an issue with sorting oats, then why have complaint ratios gone down so sharply?
    Also, General Mills uses its optically sorted gluten-free oats for other products. The FDA is certainly taking all of this into account. When they get complaints, they look at large amounts of data to help them put things into perspective. Has the FDA seen corresponding numbers of complaints for different General Mills products made from the same oat sorting process? It doesn't seem so.
    Celiac.com has covered the gluten-free Cheerios story from the beginning, and will continue to do so. We stand on the side of science, and accurate information.
    Beyond the obvious gluten-contamination that led to the recall, we have been skeptical of claims that General Mills' sorting process is flawed, and that their products, including Cheerios are routinely contaminated with gluten.
    If this were true, we think the numbers would be very different, and that the pattern of official complaints would reflect that reality. We also feel that General Mills would be facing down lawsuits from hungry trial lawyers looking to put a big trophy on the wall.
    We have simply not seen any good evidence that supports claims that Cheerios and other General Mills products are contaminated with gluten "hotspots" that cause reactions in people with celiac disease. We have also not seen evidence that rules out adverse oat reactions as the cause of many of these claims.
    If someone out there has different numbers, or better information, we are all ears. However, until we see convincing evidence to the contrary, Celiac.com regards Cheerios and other General Mills products as safe for people with celiac disease and gluten-sensitivity. We do offer the caveat that people should trust their own judgement and avoid any food they think makes them sick.
    Stay tuned for more on this and other stories on gluten-free cereals and other products.
    Read more at BuzzFeed.com and GeneralMills.com.


    Jefferson Adams
    Celiac.com 10/31/2017 - A press release by the Canadian Celiac Association announcing a label change for General Mills' Cheerios is drawing confusion and questions from numerous corners of the gluten-free community.
    The press release is also drawing pushback from General Mills, which called the CCA press release "inaccurate," and said it was "not based on facts."
    General Mills spokesman Mike Siemienas says that "the only thing the CCA got right is that General Mills is changing its label in Canada." Everything else, Siemienas, claimed, was based on opinion, not facts.
    Siemienas added that General Mills has made efforts to work with the CCA, but that the organization "had its opinions formed" in advance, and seemed unmoved by facts.
    Regarding Cheerios, a statement by General Mills reads: 

    "Each serving of Cheerios products in Canada are gluten free, as defined by the current regulatory standard of containing less than 20 ppm of gluten. General Mills Canada has made the decision to voluntarily remove the gluten-free label from our Cheerios products in Canada until Health Canada and The Canadian Food Inspection Agency (CFIA) publish a consistent testing protocol for products containing oats. At this time the product is not changing, just the label on the box. We look forward to labeling the Cheerios products in Canada as gluten free once consensus is reached on a consistent testing protocol for products containing oats."
    The full text of the original CCA press release appears below, but since this article was written: "The CCA retracts its statement of October 20, 2017 and replaces it with this statement due to errors in the original statement.":

    October 20, 2017 (Mississauga, ON) The Canadian Food Inspection Agency (CFIA) has made an announcement that the words "gluten-free" will be removed from all Cheerios package sold in Canada by January 1, 2018.
    The Canadian Celiac Association first objected to the claim in August 2016 and strongly recommended that people with celiac disease not consume the cereal, even though the box was labelled "gluten free".
    The announcement came in a letter addressed to a Canadian consumer who was one of many customer complaints to be filed against the products.
    "We are delighted to hear that the regulators have determined that the claim must be removed from the packages", said Melissa Secord, Executive Director of the Canadian Celiac Association. "Based on the advice of the members of our Professional Advisory Board, the experts of the Gluten-Free Certification Program, and other professionals working in the field, we believe that there is not adequate evidence to support the claim. When added to many reports from consumers with celiac disease reacting to eating the cereal, we believe this is the safe recommendation for Canadians."
    The CCA will follow up closely with the CFIA and Health Canada to continue to monitor this decision along with other products sold in Canada to ensure access to safe foods for people with celiac disease and gluten sensitivities.
    The CCA is currently working on a grant from Agriculture and Agrifood Canada to examine the scope of gluten contamination in oats grown in Canada, and to determine where the contamination occurs as the oats a processed (field, harvest, transport, processing). The project is scheduled to be completed in March 2018.
    Celiac disease is a medical condition in which the absorptive surface of the small intestine is damaged by a substance called gluten. This results in an inability of the body to absorb nutrients: protein, fat, carbohydrates, vitamins and minerals, which are necessary for good health.
    Gluten is a protein found in wheat, rye, triticale, barley. In the case of wheat, gliadin has been isolated as the toxic fraction. It is the gluten in the flour that helps bread and other baked goods bind and prevents crumbling. This feature has made gluten widely used in the production of many processed and packaged foods.
    The Canadian Celiac Association, the national voice for people who are adversely affected by gluten, is dedicated to improving diagnosis and quality of life.


    Jefferson Adams
    Celiac.com 12/18/2018 - Evidence compiled by Quaker Oats shows that 4% of the purity protocol oats the company uses to make "gluten-free" oatmeal products are contaminated with trace amounts of gluten. Overall, these batches may contain under 20 ppm gluten, and thus be considered gluten-free. But somehow, isolated kernels of wheat, barley or rye flakes were making their way into the final oatmeal products and onto store shelves.
    Because these kernels were rolled flat the same way as the oats, it was possible for one of these flakes to find its way into a bowl of otherwise gluten-free oats, and to render the bowl over the 20 ppm standard, meaning it is technically not gluten-free, according to FDA standard.
    Quaker found a solution in a stricter testing method. The testing method used by Quaker mirrors the testing method recently adopted by the CFA. Under that method, "oat groats are collected from gluten-free oat production following a robust attribute-based sampling plan then split into 75-g subsamples, and ground. R-Biopharm R5 sandwich ELISA R7001 is used for analysis of all the first 15-g portions of the ground sample.
    A less than 20-ppm result disqualifies the production lot, while a greater than 5 to less than 20-ppm result triggers complete analysis of the remaining 60-g of ground sample, analyzed in 15-g portions.
    If all five 15-g test results are less than 20 ppm, and their average is less than 10.67 ppm (since a 20-ppm contaminant in 40 g of oats would dilute to 10.67 ppm in 75-g), the lot is passed.
    Most oatmeal is made from rolled whole oats. That means that, even with just 4% gluten contamination, products made with whole oats, even rolled oats, can contain pockets of gluten that might render a given serving over the 20 ppm standard. Because Quaker, or their oat supplier, lacks a sorting process for eliminating or reducing gluten-contamination in its raw purity protocol oats, and because its oatmeal is minimally processed, the problem of loose individual flakes of wheat, barley or rye remains unsolved at the manufacturing level. This is true for Quaker in a way that is not true for General Mills.
    No matter how much Quaker mixes rolled oats, a single wayward flake of wheat, rye or barley will remain intact and eventually turn up in a serving portion. That's true, even if it's just an isolated flake. That means that Quaker must look for a solution in its supply chain.
    So, Quaker's approach makes sense for products made with whole oats. However, the challenges faced by Quaker in making gluten-free oatmeal are substantially different than the challenges faced by General Mills in making a product like Cheerios. That's because of differences in the processes used to make the two products.
    Because General Mills uses a process to sort its raw oats to below 20 ppm allowable gluten, and because it then grinds the raw oats into oat flour, there is no danger that intact flakes of wheat, rye or barley will make their way into any given serving. The flour is mixed thoroughly, and, thus, any flour from the wayward oat flake is now blended evenly into the rest of the batch. The oat flour is then mixed further with other ingredients to become the raw material for making Cheerios.
    So, it's extremely unlikely that Cheerios would suffer from the types of gluten "hotspots" that Quaker found in their supposedly gluten-free purity protocol oats. The process greatly increases the likelihood that any gluten would be evenly distributed into the final product, and thus be gluten-free below 20 ppm at the serving level.
    Essentially, the two studies by scientists at Quaker show a couple of things. First, whole oats, and products made with whole oats, even those labeled gluten-free, even those which are harvested as "purity protocol," can contain isolated pockets or "hotspots" of gluten. This may mean that these products can cause symptoms in people with celiac disease. People with celiac disease should be vigilant about these products. Trust your gut and eat accordingly. Second, the data gathered, and the conclusions reached, by the Quaker scientists regarding Quaker's efforts to produce gluten-free oatmeal, have little or no connection to General Mills and the process used to make Cheerios.
    It would be a mistake to project Quaker's challenges onto General Mills. For its part, it seems that General Mills has actually solved the challenges of removing wheat, rye and barley from oats to reach levels below 20 ppm, and to manufacture products that reflect that gluten-free status. General Mills has solved the challenge at the manufacturing level in a way Quaker has not.
    For all its refined testing procedures, Quaker is still reliant on its suppliers to deliver gluten-free oats. Somewhere, somehow the problem of quantifying the gluten content of raw oats and rendering that level to be within gluten-free standards still has to be solved.
    Quaker is relying on oat growers and suppliers to solve the problem, to develop a way to quantify and reduce the gluten contamination levels of raw "purity protocol" oats. Perhaps Quaker might benefit from optical sorting technology, or other processes that allow them to exert more control over their finished product at the manufacturing level?
    Celiac.com is not alone in saying that optically sorted oats likely safe. That view is also held by the Gluten Intolerance Group.
    Read articles on the original studies by scientists at Quaker Oats at Food Chemistry, and the International Journal of Food Science Technology.
    Sources:
    Food Chemistry. Volume 240, 1 February 2018, Pages 391-395 Int J Food Sci Technol, 52: 359–365.  DOI: 10.1111/ijfs.13288 http://onlinelibrary.wiley.com/doi/10.1111/ijfs.13288/full General Mills Describes the Success of its Gluten Detection System


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