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  • Jefferson Adams
    Jefferson Adams

    General Mills Describes the Success of its Gluten Detection System

    Reviewed and edited by a celiac disease expert.

    General Mills uses a proprietary optical sorting process to make oats meet gluten-free standards.

    General Mills Describes the Success of its Gluten Detection System - Photo: CC--Bernard Sprague. NZ
    Caption: Photo: CC--Bernard Sprague. NZ

    Celiac.com 11/03/2017 - Talk about finding needles in a haystack. Imagine, if you will, sifting through rail cars full of oats and plucking out nearly every stray grain of wheat, barley or rye so that the final product tests at under 20 ppm, instead of the original 200 ppm to 1,000 ppm.

    Quite a challenge, yes? It's a challenge General Mills take on every day as it produces Gluten Free Cheerios from raw oats into the final product. According to their website, General Mills ships 500,000 cases of Cheerios each week.



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    To do this, General Mills uses a proprietary optical sorting process, for which it has filed a patent with the US Patent Office. That process sifts through those rail cars of oats, with stray gluten ranging from 200 ppm to 1,000 ppm, and "takes it down to less than 20" ppm, said Paul Wehling, principal scientist for General Mills.

    Mr. Wehling told audience members at the annual meeting of AACC International at Cereals 17 in San Diego on Oct. 9, that the General Mills sorting process achieves a "2- to 3-log reduction of the gluten."

    To verify their oat sorting results, General Mills uses enzyme-linked immunosorbent assay (ELISA) testing and visual inspection to spot and eliminate gluten-containing grains such as wheat.

    The company uses hand inspection in place of lateral flow testing, as they find that "hand inspection is much more efficient because we can look at quite a few more seeds," Mr. Wehling said.

    That process would seem to be validated by Laura K. Allred, regulatory and standards manager for the Gluten Intolerance Group, Auburn, Wash., which recommends companies use a combination of visual testing and ELISA testing.

    However, the General Mills process is not without critics. One of the more prominent voices in opposition to General Mills has been the Canadian Celiac Association (CCA).

    The CCA has made numerous statements questioning the process General Mills uses to create their Gluten-Free Cheerios, and other oat products.

    CCA statements, or statements attributed to the CCA include comments in an article published in October 26, 2017, in which Globalnews.ca writes "[CCA] expressed doubt in the company's mechanical sorting system and claim of 100 per cent removal of cross-contaminants."

    Candiangrocer.com reported in August 2016 that the CCA was, to paraphrase, "awaiting evidence showing the new line [of Gluten Free Cheerios] is 100% free of gluten." It is unclear what the CCA means by such terms as "100% gluten-free," "100 percent removal," and "100 percent safe for people with celiac disease."

    Is the CCA hinting that the standard for gluten-free products should be 0 ppm?

    Besides voicing fear and concerns, and citing alleged complaints by members, the CCA never actually provided any evidence that Cheerios failed to meet the US and Canadian standard of 20 ppm allowable gluten, and were, thus, not gluten-free.

    The CBC reported on August 31 2016, that the "Canadian Celiac Association is warning against gluten-free Cheerios products over concerns the cereal is not 100 per cent safe for people with celiac disease."

    Again, the CCA made this recommendation based not on independent product testing, or on any confirmed accounts of gluten-exposure in people with celiac disease who had consumed Cheerios, but on "fear" and "concerns" driven by anecdotal evidence. Moreover, they seemingly disregarded overwhelming anecdotal evidence provided by people with celiac disease who say they eat Cheerios safely. The CCA has yet to provide a satisfactory response for their warnings, or to provide any clarification of their position regarding the safety of products that test under 20 ppm gluten for people with celiac disease.

    The FDA recently announced that 99.5% of products tested came in under the 20 ppm standard set by the FDA for labeling a product "gluten-free." In fact, only one of 750 samples taken from 250 products tested above 20 ppm. That product was recalled and the manufacturer corrected the problem. There has been no indication the Cheerios tested outside the FDA's gluten-free standard.

    That means that even an ambitious sorting process like the one developed by General Mills seems to be working as designed. It means that consumers can trust the FDA, and American gluten-free labels, and that consumers of gluten-free foods can buy with confidence.



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    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

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    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

    "Less than 20 ppm is still too much gluten for sensitive celiacs." Please explain, as this level is considered safe by experts and governments, and any company can have issues with cross contamination (even the company you mentioned does not grow its grains, ship them, mill them, etc.).

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    I don't trust them. gluten-free Bisquik made me very ill. There can be cross contamination from the fields, in the air, and on the equipment. This is the second article concerning General Mills. What's the deal? Are they trying to convince us they are safe for their bottom line?

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    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

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    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

    Hopefully you understand that there is no testing that goes down to zero? If they made the labeling laws zero gluten, then no company would use the term on their packaging, and we would be right back where we were before there were labeling laws.

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    And yet... my local grocery has a section of freezers clearly labeled "GLUTEN-FREE" (along with a please read labels carefully CYA statement) that have 4 different non-gluten-free products planted right in the middle of a bank of 3 gluten-free-dedicated freezers. These are next to a longer section of "NATURAL LIVING" freezers with a wide range of both organic, diet-specific and gluten-reduced products. The non-gluten-free "blintzes" were reported to the store chain nearly 2 months ago, and followed up on 17 October 2017. And while there are now 2 freezer doors between the "Natural" and "gluten-free" freezers that are currently un-labeled, these blatantly non-gluten-free items still remain in the middle of the gluten-free freezers! When I brought this up tonight for the third time with the staff, the overnight freezer manager said he was aware of the complaints, and that the grocery chain had attempted to move the offending items to the other section of the freezers. But the company who sets the "floorplan" model for the section refused to let them do so! The outsourced management company is reputed to be called DPI. Research shows they are based in Canada. WHY IS A COMPANY IN CANADA TELLING A SMALL GROCERY CHAIN (BASED IN MD & PA) HOW THEY ARE TO ORGANIZE THEIR SHELVES??? THIS NONSENSE LEADS TO MANY PEOPLE GETTING SICK because no one seems to have any accountability within the immediate chain of command. IN ADDITION TO THIS PROBLEM of non-gluten-free product getting shelved beside gluten-free products GETTING FIXED... the paradigm of grocery chains outsourcing the floor plan management NEEDS TO STOP. There are local people who went to school for this sort of thing who can handle the floorplan (and within a general corporate framework) who can take responsibility for fixing these sorts of problems in short order... instead of it dragging on for months and months.

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    And yet... my local grocery has a section of freezers clearly labeled "GLUTEN-FREE" (along with a please read labels carefully CYA statement) that have 4 different non-gluten-free products planted right in the middle of a bank of 3 gluten-free-dedicated freezers. These are next to a longer section of "NATURAL LIVING" freezers with a wide range of both organic, diet-specific and gluten-reduced products. The non-gluten-free "blintzes" were reported to the store chain nearly 2 months ago, and followed up on 17 October 2017. And while there are now 2 freezer doors between the "Natural" and "gluten-free" freezers that are currently un-labeled, these blatantly non-gluten-free items still remain in the middle of the gluten-free freezers! When I brought this up tonight for the third time with the staff, the overnight freezer manager said he was aware of the complaints, and that the grocery chain had attempted to move the offending items to the other section of the freezers. But the company who sets the "floorplan" model for the section refused to let them do so! The outsourced management company is reputed to be called DPI. Research shows they are based in Canada. WHY IS A COMPANY IN CANADA TELLING A SMALL GROCERY CHAIN (BASED IN MD & PA) HOW THEY ARE TO ORGANIZE THEIR SHELVES??? THIS NONSENSE LEADS TO MANY PEOPLE GETTING SICK because no one seems to have any accountability within the immediate chain of command. IN ADDITION TO THIS PROBLEM of non-gluten-free product getting shelved beside gluten-free products GETTING FIXED... the paradigm of grocery chains outsourcing the floor plan management NEEDS TO STOP. There are local people who went to school for this sort of thing who can handle the floorplan (and within a general corporate framework) who can take responsibility for fixing these sorts of problems in short order... instead of it dragging on for months and months.

    What does this have to do with the article?

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    I don't trust them. gluten-free Bisquik made me very ill. There can be cross contamination from the fields, in the air, and on the equipment. This is the second article concerning General Mills. What's the deal? Are they trying to convince us they are safe for their bottom line?

    The issue is in the news lately. Also, the FDA just released their report on gluten-free product compliance. They tested hundreds of products, and found overwhelming compliance with gluten standards in food labeled gluten free. Overall, 99.5% of products tested were compliant. That means that American-made foods are likely not contaminated with gluten.

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    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

    I haven't seen any evidence to show that Bob's Red Mill products labeled "gluten-free"are contaminated with gluten. Where are you getting that? Also, the scientific evidence show that the vast majority of people with celiac tolerate gluten below 20 ppm, and that they experience gut healing and relief from symptoms. Remember, back in the days when there was no standard, there was simply no way to tell if anything was actually gluten-free or safe.

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    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

    Do you realize that if 0 ppm were used as a standard, then any trace of gluten could get a company sued. What company would claim to a product was "100% gluten-free?" How would you guarantee that standard? How would you test?

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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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    Jefferson Adams
    Celiac.com 04/24/2017 - The fallout continues from General Mills' recall of nearly 2 million boxes of Gluten Free Cheerios and Honey Nut Cheerios in 2015, which occurred after workers at a California plant accidentally loaded gluten-free oat flour into trucks that had been holding wheat flour, which contains gluten, and which then contaminated batches of "gluten-free" cereal produced with the grain from those trucks.
    In comments to the U.S. Ninth Circuit court, plaintiffs representing a proposed class of consumers claimed that a lower court had erred in dismissing their lawsuit on the grounds that the company's recall program made the claims baseless. They asked that the court allow their lawsuit against General Mills to continue. The suit is based on claims that the supposedly gluten-free Cheerios that had been made with the wrong flour, and that the cereal had sickened consumers.
    Lead plaintiff Christopher Hamilton told the panel that a refund program alone does not moot a claim for damages, as courts have held that, while refund programs do moot restitution claims, they do not moot claims for damages and injunctive relief, such as Hamilton's. "Indeed, in a case based on the exact facts present here, a court in California held that the Cheerios recall program did not moot a consumer's damages claim because the defendants did not satisfy the plaintiff's claims for statutory damages and injunctive relief," said Hamilton.
    Hamilton, who has celiac disease, brought his suit in March 2016 after buying the supposedly "gluten-free," wheat-contaminated Cheerios. One sample revealed 43 parts per million of gluten, more than twice the legal ceiling for the "gluten-free" label, Hamilton said in his complaint.
    Still, to the layperson, Hamilton's request for damages and injunctive relief invites questions. First, since the company issued a full product recall, what type of injunctive relief would they be seeking? Second, regarding damages, exactly what type of monetary damages would be claimed? Did these plaintiffs incur medical expenses, missed work or other costs? That is not made clear in these filings.
    When U.S. District Judge Michael McShane dismissed the original suit in July, he did so based on the fact that General Mills did issue a full product recall. In his statements on the matter, the judge wrote: "Rather than mitigate his damages by accepting General Mills' recall/refund offer, Hamilton is suing General Mills for false labeling, marketing and promotion of the product. Hamilton paints a discreet [sic] manufacturing mishap as a grand scheme of deceptive advertising, marketing and labeling." Judge McShane added, "I find this to be creative at best."
    But Hamilton says that he should be permitted to amend his complaint to include claims that the recall was delayed, and that the company was aware of complaints from sick consumers as early as July 2015. Hamilton also wishes to include allegations that General Mills deliberately ignored warnings from a dietitian that General Mills gluten-free testing was inferior.
    The case is Christopher Hamilton v. General Mills Inc. et al., case number 16-36004, in the U.S. Court of Appeals for the Ninth Circuit.
    Read more at Law360.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 10/27/2017 - Cereal maker General Mills has announced that it will no longer label their flagship cereal Cheerios as gluten-free in Canada.
    Has Canada Changed its Gluten-free Standards?
    No, the standard for labeling gluten-free foods in Canada remains same, at up to 20 ppm allowable gluten. Such foods are safe for the vast majority of people with celiac disease, according to both U.S. and Canadian regulatory agencies, the EU, celiac researchers and numerous celiac disease support groups. Health Canada, the agency responsible for setting food safety standards in Canada says that gluten levels below 20 ppm are safe for people with celiac disease. That is also the standard for gluten-free products in the United States and the EU.
    Have Cheerios Changed?
    No, the Gluten-Free Cheerios sold in the U.S. are the same Cheerios that are sold in Canada now, and the same Cheerios that will be sold in Canada after the labeling change. Cheerios routinely test below 20 ppm, and are currently labeled as gluten-free in both the U.S., and Canada. Cheerios has not been the subject of a mandated recall in with the U.S. or in Canada, which indicates that the product remains safe for the vast majority of people with celiac disease. So, Why is Cheerios Changing its Label in Canada?
    It comes down to a technicality over oat testing standards. Canadian labeling laws require manufacturers follow a specific testing requirement for products made with oats, such as Cheerios. Under that Canadian testing requirement, oat products with gluten levels above 5 ppm, but under 20 ppm are considered "Investigative," a status under which the agency "notifies the regulated party of the result." They then "follow up with the regulated party to determine the source of the gluten." Moreover, the agency advises "the regulated party, such as General Mills in the case of Cheerios, to review their Good Manufacturing Practices (GMPs) and process controls." The agency may require "corrective action."
    As a result, cereal maker General Mills has announced that it will no longer label their flagship cereal Cheerios as gluten-free in Canada.
    General Mills stands by its testing process and said Cheerios sold in the U.S. will continue to carry the gluten-free label. A statement by General Mills reads: GM: 
    "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." Comments made by both General Mills and the CFIA suggest the decision to remove the gluten-free labels from Cheerios stem from an issue around how products containing oats are tested for gluten in Canada.
    According to CBC News, the Canadian Food Inspection Agency confirmed that the move by General Mills to remove the gluten-free label was voluntary, and said the company had "informed" the agency of its plans in August.
    "This was a business decision made by the company and not a directive from the CFIA," the statement said.
    The statement from GM continues: "While Gluten-Free Cheerios products comply with the gluten-free standards in Canada and the United States, we have made the decision to remove the gluten-free label from our Cheerios products in Canada until the government agencies publish a consistent testing protocol for products containing oats. At this time the product is not changing, just the label on the box.
    For nearly a decade, General Mills has served consumers with Celiac disease and gluten sensitivities. Since Gluten Free Rice Chex was launched in 2008, General Mills has grown its portfolio of gluten-free products to more than 1,000 items. It is now the second largest provider of gluten-free foods, including seven varieties of Cheerios, in the U.S. The company has also introduced gluten-free products in more away-from-home food outlets like restaurants and schools, and in new regions such as Canada and Europe."
    GM spokesperson Mike Siemienas said the company was waiting for "Health Canada and The Canadian Food Inspection Agency (CFIA) [to] publish a consistent testing protocol for products containing oats," and that General Mills looks forward to labeling the Cheerios products as gluten-free once consensus is reached on a consistent testing protocol."
    So, while Cheerios will no longer carry a gluten-free label in Canada, Canadian standards for gluten-free products have not changed, and remain the same as American standards, at up to 20 ppm allowable gluten. The Cheerios sold in Canada are no different than Cheerios sold in the United States, where they will still carry a gluten-free label.
    So, only the Canadian label will change. Cheerios will remain the same. On either side of the border, people with celiac disease can continue to enjoy Cheerios with confidence.
    Those with oat sensitivity, or who react to high fiber levels, should use their own judgement about Cheerios, as with any other product.


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