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Found 4 results

  1. Celiac.com 06/17/2017 - Hello, my name is Gerry. I am a certified Medical Technologist currently working as a Clinical Systems Analyst. I was diagnosed with celiac disease in 2006 by blood/biopsy. I have two wonderful children, 1 of whom has screened positive for a celiac gene pair. My strong background in Medical Technology assured a quick diagnosis once symptoms appeared. Since then, I have been living a strict gluten-free life. I have gone through nutritional counseling at Mayo Clinic and have an enhanced background with my understanding of the world of gluten. I use my experience and knowledge to accurately base my decisions on whether a product is safe for me. To prove my diet to be effective, I have had my TTG levels measured every 6 months since 2006—all were negative. Also, I have had 3 biopsies after beginning my gluten-free life and all were negative for villous atrophy. I do understand that my medical follow-ups do not prove that I am not ingesting small amounts of gluten; they simply indicate that I am not reacting. As for me, I view the gluten-free life to be much simpler and cheaper than it once was, and fear that strict gluten labeling guidelines have the potential to negatively shape the gluten-free life that I know and live today. Within the last few years, I have been receiving emails to ask my support regarding the FDA's gluten-free labeling rule. At first, I was a supporter as I wanted to support the celiac community since I was part of it. However, after I sat down and really thought about it, I am questioning the benefits of a strict gluten labeling act. In fact, I am predicting a negative impact if gluten labeling guidelines are too strict. When I started my gluten-free life in 2006, my grocery bill was atrocious. I was paying very high prices for the simplest of things. Tortilla chips $3.89 for a 6 oz bag. $3.99 for 8 oz of mustard. $5.99 for gluten-free mayonnaise. As the years moved on I noticed two changes that positively impacted my life as a celiac. The first is that many manufacturers have a list of their gluten-free products on their website along with explanations of how their company handles gluten. The second is the fact that many generic/in-store-brand companies are now labeling their products as "Gluten Free" or "Naturally Gluten free". Because of these two advancements, my life is so much easier and much more cost effective. This makes it easy to stick with my diet and keep my health safe and spirits up. Currently, if a product is made without gluten, it can be labeled as "gluten-free". Many products are available at a fraction of the cost and they are safe. Now that my family eats gluten-free, I have noticed that in today's world my grocery bill seems much more normal and realistic: gluten-free mustard $1.29; gluten-free mayonnaise $1.59;20 oz bags of tortilla chips labeled gluten-free $2.59; 8 oz bag of gluten-free cheese $1.99. You see, living a gluten-free life with today's rules is easy and I believe it to be safe if we are careful and make educated decisions. At this time we have many inexpensive non-brand/in-store brand name products that are widely available. I know of some stores that have 20+ pages of gluten-free items on an excel spreadsheet for their own brand of products, including medications. There are stores that update these lists quarterly, and most are listed by bar-code number. I can simply print the list and buy all of my products safely and inexpensively. I could easily make a phone call to clarify items that I may disagree with, or inquire about cross-contamination. Are these products that I speak of above tested for gluten? I don't believe so. Are these products free of gluten ingredients? I trust that they are. Is there cross-contamination? Maybe. It is easy for me to call and ask about their product lines. Are these products safe for me? I believe so, as I have the blood tests to prove they have been safe for me. Phone calls to companies on products that are not labeled as "gluten-free" are still the norm even though they are getting less frequent. As an expert, I am able to screen who I am talking to and the company's knowledge about gluten. I have been able to make accurate judgments on these products as well as deciding whether I believe them to be safe. In many of the cases, the company claimed their product to be free of gluten and I felt comfortable consuming the product. Yes, there were companies that didn't have acceptable knowledge/quality control and I didn't feel these products were safe so I didn't consume them. My first question to the celiac community is this. Do we need a strict gluten-free labeling act when we already have companies testing for gluten and providing safe products? If we want our products batch tested for gluten, we can simply purchase the ones that are currently available as there are many. If we want to know the threshold that the company considers as gluten-free, we can call them and they will tell us. Are there currently batch tested gluten-free products on the market? Absolutely. Many companies state on their packaging that they have been tested to under 20 or 40 ppm. If a company is testing, they make it known on the label and in the price of the product. My next question is what will a strict gluten-free labeling act do for us? I believe that it will ensure that a product is safe for celiac patients defining what a product needs to be in order to be labeled as gluten-free. Simple-yes. How do we suppose a company is going to know if their product is gluten-free? Well, if you ask me, it will NEED to be tested. Who will pay for this testing? I believe that the celiac community (the consumers) will be paying for this in higher food prices. If a company has to test a product to label it gluten-free, the price will need to go up in order to pay the cost of the testing and the quality control program for the company. We know this to be true as these products are already accessible. I see a possible negative impact of this labeling act if it were to be made too strict. I believe that manufacturers that do not test for gluten may need to pull their "gluten-free" labeling from the package. This could eliminate most of the inexpensive safe products that I currently purchase today. We know there are many manufacturers out there that label products as gluten-free as they simply do not use gluten ingredients. I believe these products may recede. I am not so sure a company will be able to label these products as gluten-free without first testing them. Even if they are allowed, I am not so sure they will take the risk. Therefore negatively impacting our pricing/availability. Will Gluten free lists on websites go away too? I believe these could fade or be at risk as well. If there is a law/act that dictates the amount of gluten in a product, I would think that a company would not create gluten-free lists of products without proving them to be gluten-free by some form of testing in an attempt to avoid legal action against them. What about our phone calls to companies asking if their products are gluten-free? Will they have a gluten-free list to review? I would tend to think that they may not be provided with a gluten-free list to reference. I have a hunch they may say, "We do not test any of our products for gluten and therefore are unable to tell you whether the product is gluten-free". I know that reply will complicate my life in many ways. The first thing that comes to my mind, in this regard, are the calls to pharmaceutical companies regarding medications. I feel that there are better ways to change the labeling as we know it that would offer a more positive effect on the celiac community. Maybe just changing the package labeling to force companies to list wheat, oats, rye, and barley on the packaging. How about requiring mandatory labeling of products that share lines with "gluten" containing ingredients? When we look at the big picture, I think it is safe to theorize that the impact of strict gluten labeling guidelines goes far beyond just providing safe products. In conclusion, I ask these questions. Will a strict gluten labeling act have the potential to negatively impact the celiac community by increasing prices and decreasing availability? And lastly, have we looked at the possible outcomes from all angles?
  2. Celiac.com 08/02/2011 - The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (celiac disease) and invites comment on these additional data. One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries. People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the United States population is estimated to have the disease. “Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.” The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities. The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days. To submit your comments electronically to the docket go to www.regulations.gov 1. Choose “Submit a Comment” from the top task bar 2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space 3. Select “Search” To submit your comments to the docket by mail, use the following address: The Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Include docket number FDA-2005-N-0404 on each page of your written comments. For more information Federal Register Notice (scroll to FDA--temporary link will update when document publishes on Aug. 3): http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1 Gluten-Free Portal (scroll to Gluten-Free): http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/default.htm#gluten FDA’s Proposed Rule on the Gluten-Free Labeling of Foods: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm Questions and Answers on the Gluten-Free Labeling Proposed Rule: http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/ucm265309.htm Consumer Update on the Gluten-Free Labeling Proposed Rule: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265838.htm
  3. This update comes to us from Frederik Willem Janssen, The Netherlands: fwjanssen@WXS.NL About a week ago I promised to post info about agenda item 4 (Gluten Free Food) as dealt with at the meeting of Codex Alimentarius NFSDU (Nutrition and Food for Special Dietary Uses) which was held in September in Berlin Germany. As usual this meeting starts on Monday and continues till Wednesday, Thursday is a day off (time for the secretariat to draw resolutions) and on Friday these draft resolutions are discussed. Unfortunately I wasnt able to stay till Friday. However, the resolutions as discussed on Friday were handed to me afterwards however and I pass them with some corrective changes accepted during that day. For those of you who have no interest in reading this clerical stuff I summarize: The proposed limits (20) for food gluten-free by nature and 200 for food "rendered gluten-free" will stay between square brackets (so no decision has been made). The same holds for oats, awaiting further toxicological data about its celiac-toxicity it should be considered as toxic. The main obstacle for finalizing the standard is the lack of an appropriate method of analysis. Progress has been made but still not to that extent that enforcing agencies can be satisfied. Maybe we will see some progress in the next 2 years! Proposed Revisions: Alinorm 99/26, Draft Revised Standards for Gluten-Free Foods (Agenda Item 4): 31. The Committee recalled that the Twenty-second Session of the CAC adopted the Proposed Draft Standard for Gluten-Free Foods at Step 5 while recommending that comments on methods of analysis and on amounts of gluten in gluten free foods should be taken into account when finalizing the standard. The Committee noted that without an appropriate method of analysis it was not scientifically justified to advance the Draft further. 32. The Delegation of Sweden introduced their recent study on gluten determination in foods by an enzyme immunoassay using a monoclonal antibody against omega-gliadin (CRD 33), noting that the detection limit of the method (ref. AOAC 991.19) was about 20 - 40 ppm and the repeatability was acceptable. Some Delegations pointed out that the method presented raised some technical concerns: it was performed only on wheat and due to this, uncertainty exists as regards its applicability to other cereals. There were also concerns about the reproducibility of the method. It measured only omega-gliadin and other gliadins should also be taken into account. The need of further improvement was raised. Spain expressed concern about setting units where no method of analysis is available and not all the different types of gliadins can be detected. 33. The Committee noted that in some cases a proprietary method was the most specific way to detect an analyte, such as in the case of gluten detection. Since Codex had not endorsed these techniques as methods of analysis of Codex, the CCMAS (Codex committee on Methods of Analysis and Sampling) should consider this problem. 34. Several delegations suggested that the Committee should ask FAO and WHO to convene an Expert Consultation to address the issue of the level and the method of analysis. Other delegations proposed to consult the CCMAS on this issue. The Secretariat informed the Committee that on the request of the CCFL (Codex committee on Food Labeling), JECFA (Joint expert committee on Food Additives) was prepared to consider the question of hypersensitivity at its 53rd Session (June 1999) and the intolerance to gluten might be discussed in this context. The Secretariat recalled that the role of the CCMAS was to endorse methods of analysis proposed by specialized Committees and the CCNFSDU needed to specify the method. 35. Several delegations and the Observer from the AAC (Association des Amidonneries Cooperative) proposed that the discussion of this draft should be adjourned until a reliable method of analysis became available. Other delegations were in favor of continuing work on it in order to meet the urgent need of the patients suffering from coeliac disease and proposed to advance the proposed draft for a single level of 200 ppm to step 8. Taking into account the absence of an appropriate and accurate method of analysis, it was proposed to maintain the gluten free level at 200 ppm for all foods and to include a new preamble suggesting the a revision of the standard when a method of analysis or new scientific evidence became available. 36. While concerning the proposed definition of "gluten-free" foods, several delegations wanted to point out that the current approach was confusing and misleading the consumer and that the level should be uniform for all foods. However, other delegations and the Observer from AOECS stressed the need for two levels with regard to the naturally gluten free foods and the products which had been rendered gluten free. The Committee noted that the proposed term "gluten-free" might mislead the consumer and recognized that the term "low or reduced in gluten" should be considered. 37. The Observer from AOECS, supported by some delegations, expressed the view that the level of 200 ppm for all gluten-free foods was too high to protect coeliacs and the gluten level should refer only to the end product for better consumer protection. 38. The Delegation of Finland proposed to remove the oats from the list as scientific studies showed that oats can be tolerated by celiacs and allows to provide dietary fibers for coeliacs. The Observer from AOECS, supported by some delegations, stressed that the square brackets on oats should be removed as oats might have negative impact on the health of coeliacs and that the medical experts had not reached consensus on this issue. 39. The Committee recognized that the development of reliable method of analysis of gluten was the key point of this discussion and that the development of the method should be encouraged by all means. Status of the Draft Revised Standard for Gluten-Free Foods 40. The Committee agreed to leave the text of the draft as it was in CX/NFSDU 98/4 and to return it to Step 6 for further consideration. The Committee also agreed that the question regarding the proprietary techniques should be raised to the CCMAS as a general matter. The following documents were discussed during the meeting: CX/NFSDU 98/4 - Add 1 (Comments from Australia, Spain, UK, AAC, ISDI); CX/NFSDU 98/4 - Add 2 (AOECS); CRD 3 (Uruguay, ISDI); CRD 13 (USA); CRD 21 (Spain); CRD 33 = CRD 42 (Sweden); CRD 44 (India); CRD 51 (Norway).
  4. This 11/29/98 update comes to us from Frederik Willem Janssen, The Netherlands: fwjanssen@WXS.NL About a week ago I promised to post info about agenda item 4 (Gluten Free Food) as dealt with at the meeting of Codex Alimentarius NFSDU (Nutrition and Food for Special Dietary Uses) which was held in September in Berlin Germany. As usual this meeting starts on Monday and continues till Wednesday, Thursday is a day off (time for the secretariat to draw resolutions) and on Friday these draft resolutions are discussed. Unfortunately I wasnt able to stay till Friday. However, the resolutions as discussed on Friday were handed to me afterwards however and I pass them with some corrective changes accepted during that day. For those of you who have no interest in reading this clerical stuff I summarize: The proposed limits (20) for food gluten-free by nature and 200 for food rendered gluten-free will stay between square brackets (so no decision has been made). The same holds for oats, awaiting further toxicological data about its celiac-toxicity it should be considered as toxic. The main obstacle for finalizing the standard is the lack of an appropriate method of analysis. Progress has been made but still not to that extent that enforcing agencies can be satisfied. Maybe we will see some progress in the next 2 years! Proposed Revisions: Alinorm 99/26, Draft Revised Standards for Gluten-Free Foods (Agenda Item 4): 31. The Committee recalled that the Twenty-second Session of the CAC adopted the Proposed Draft Standard for Gluten-Free Foods at Step 5 while recommending that comments on methods of analysis and on amounts of gluten in gluten free foods should be taken into account when finalizing the standard. The Committee noted that without an appropriate method of analysis it was not scientifically justified to advance the Draft further. 32. The Delegation of Sweden introduced their recent study on gluten determination in foods by an enzyme immunoassay using a monoclonal antibody against omega-gliadin (CRD 33), noting that the detection limit of the method (ref. AOAC 991.19) was about 20 - 40 ppm and the repeatability was acceptable. Some Delegations pointed out that the method presented raised some technical concerns: it was performed only on wheat and due to this, uncertainty exists as regards its applicability to other cereals. There were also concerns about the reproducibility of the method. It measured only omega-gliadin and other gliadins should also be taken into account. The need of further improvement was raised. Spain expressed concern about setting units where no method of analysis is available and not all the different types of gliadins can be detected. 33. The Committee noted that in some cases a proprietary method was the most specific way to detect an analyte, such as in the case of gluten detection. Since Codex had not endorsed these techniques as methods of analysis of Codex, the CCMAS (Codex committee on Methods of Analysis and Sampling) should consider this problem. 34. Several delegations suggested that the Committee should ask FAO and WHO to convene an Expert Consultation to address the issue of the level and the method of analysis. Other delegations proposed to consult the CCMAS on this issue. The Secretariat informed the Committee that on the request of the CCFL (Codex committee on Food Labeling), JECFA (Joint expert committee on Food Additives) was prepared to consider the question of hypersensitivity at its 53rd Session (June 1999) and the intolerance to gluten might be discussed in this context. The Secretariat recalled that the role of the CCMAS was to endorse methods of analysis proposed by specialized Committees and the CCNFSDU needed to specify the method. 35. Several delegations and the Observer from the AAC (Association des Amidonneries Cooperative) proposed that the discussion of this draft should be adjourned until a reliable method of analysis became available. Other delegations were in favor of continuing work on it in order to meet the urgent need of the patients suffering from coeliac disease and proposed to advance the proposed draft for a single level of 200 ppm to step 8. Taking into account the absence of an appropriate and accurate method of analysis, it was proposed to maintain the gluten free level at 200 ppm for all foods and to include a new preamble suggesting the a revision of the standard when a method of analysis or new scientific evidence became available. 36. While concerning the proposed definition of gluten-free foods, several delegations wanted to point out that the current approach was confusing and misleading the consumer and that the level should be uniform for all foods. However, other delegations and the Observer from AOECS stressed the need for two levels with regard to the naturally gluten free foods and the products which had been rendered gluten free. The Committee noted that the proposed term gluten-free might mislead the consumer and recognized that the term low or reduced in gluten should be considered. 37. The Observer from AOECS, supported by some delegations, expressed the view that the level of 200 ppm for all gluten-free foods was too high to protect coeliacs and the gluten level should refer only to the end product for better consumer protection. 38. The Delegation of Finland proposed to remove the oats from the list as scientific studies showed that oats can be tolerated by celiacs and allows to provide dietary fibers for coeliacs. The Observer from AOECS, supported by some delegations, stressed that the square brackets on oats should be removed as oats might have negative impact on the health of coeliacs and that the medical experts had not reached consensus on this issue. 39. The Committee recognized that the development of reliable method of analysis of gluten was the key point of this discussion and that the development of the method should be encouraged by all means. Status of the Draft Revised Standard for Gluten-Free Foods 40. The Committee agreed to leave the text of the draft as it was in CX/NFSDU 98/4 and to return it to Step 6 for further consideration. The Committee also agreed that the question regarding the proprietary techniques should be raised to the CCMAS as a general matter. The following documents were discussed during the meeting: CX/NFSDU 98/4 - Add 1 (Comments from Australia, Spain, UK, AAC, ISDI); CX/NFSDU 98/4 - Add 2 (AOECS); CRD 3 (Uruguay, ISDI); CRD 13 (USA); CRD 21 (Spain); CRD 33 = CRD 42 (Sweden); CRD 44 (India); CRD 51 (Norway).
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