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Celiac.com 01/07/2025 - The U.S. Food and Drug Administration (FDA) is tasked with safeguarding public health, but for those with celiac disease—a serious autoimmune condition triggered by gluten—the agency’s regulatory sluggishness is falling short. This gap in food safety policy has left millions of Americans, including children like 11-year-old Jax Bari, navigating the life-threatening challenges of celiac disease with inadequate protections. Celiac Disease: More Than a Dietary Restriction Celiac disease affects an estimated 3.3 million Americans and is far more than an inconvenience. It is a life-altering condition where ingesting even microscopic amounts of gluten, a protein found in wheat, barley, rye, and most oats, can trigger severe reactions. Symptoms range from gastrointestinal distress to neurological complications and long-term risks such as cancer, anemia, and malnutrition. Unlike other food allergies, there is no treatment or medication to counteract gluten exposure—strict avoidance is the only option. For individuals like Jax, everyday activities such as eating out, attending social events, or even choosing a career can be fraught with risk due to the prevalence of gluten and the lack of clear labeling on food products. The absence of mandatory labeling for gluten-containing grains other than wheat exacerbates this challenge, leaving celiac sufferers exposed to potentially life-threatening situations. A Simple Solution: Gluten Labeling In September 2023, Jax and his family founded Celiac Journey, an advocacy group pushing for change through a Citizen Petition submitted to the FDA. The petition calls for gluten to be designated as a major allergen and explicitly labeled on all packaged foods in the U.S. This step could be implemented under the FDA’s existing authority through the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). However, the FDA has yet to act decisively, even as 87 other countries already require gluten labeling as a priority allergen. At a January 2024 Food is Medicine Summit, FDA Commissioner Robert Califf acknowledged the petition but offered little in terms of action. The hesitation seems tied to institutional inertia and opposition from industry stakeholders, raising the question: Why should protecting public health take a back seat to commercial interests? The Impact of FDA Inaction The FDA’s failure to mandate gluten labeling has real consequences. Unlike many allergens, gluten contamination often goes unnoticed until it’s too late. A lack of clear labeling forces celiac patients and their families to decipher ingredient lists, cross-reference manufacturing processes, and rely on guesswork—all while knowing that even a small mistake can lead to severe health outcomes. Cross-contamination adds another layer of risk. Packaged foods that may seem safe could contain traces of gluten due to shared equipment or production lines. Without mandatory gluten disclosure, consumers have no way to make fully informed decisions about what they consume. Jax’s journey exemplifies the frustration and fear experienced by families dealing with celiac disease. Despite his young age, he has emerged as a passionate advocate, confronting FDA leadership and calling out the bureaucracy that prolongs critical decisions. The Science Supports Action Scientific evidence backs the need for gluten labeling. Both the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) recognize gluten as a significant allergen. Their findings align with the experiences of celiac patients who struggle with hidden gluten in foods labeled as safe. A single policy change—requiring gluten disclosure on all food labels—could dramatically improve the lives of millions. Yet, the FDA’s culture, described in a recent Reagan-Udall Foundation report as “sluggish and non-responsive to public health concerns,” has stalled this progress. Restoring Faith in Food Safety Jax’s Citizen Petition is more than a call for gluten labeling; it’s an opportunity for the FDA to demonstrate that it prioritizes the health and well-being of its citizens. Swift action could address the needs of 750,000 celiac patients and countless others with gluten sensitivities. The FDA’s Human Foods Program, led by Deputy Commissioner Jim Jones, has a chance to change the narrative and prove that the agency is capable of timely, meaningful action. By granting the petition, the FDA would take a critical step toward rebuilding trust and aligning the U.S. with global food safety standards. The Clock Is Ticking For families like Jax’s, every day without clear gluten labeling is another day of uncertainty, risk, and preventable harm. The FDA must act decisively to protect vulnerable populations, ensuring that no child—or adult—has to navigate a life-threatening condition without adequate support. It’s time for the FDA to show Jax and others that public health matters more than bureaucracy. Granting the Citizen Petition would send a powerful message: the agency is committed to safeguarding the well-being of all Americans, especially those most at risk. Jax Bari’s advocacy shines a spotlight on the urgent need for reform in gluten labeling policies. His story is a testament to the resilience of celiac patients and their families, who refuse to let institutional inertia dictate their futures. The FDA has an opportunity to act now and fulfill its mission to protect public health. The question is, will it rise to the occasion? Sign the FDA Citizen Petition at: regulations.gov Read more at: foodsafetynews.com Watch the video version of this article:

Celiac.com 04/04/2024 - Jon and Lexi Bari, co-founders of Celiac Journey, have penned an open letter to the editors of the Food and Drug Law Journal about their FDA citizen petition to require the labeling of gluten on all packaged foods. Here's the rundown. In a heartfelt plea for greater safety and transparency in the food industry, Jon and Lexi Bari, co-founders of Celiac Journey, have taken a significant step towards advocating for the rights of individuals living with Celiac Disease. Their impassioned open letter, featured in the Food and Drug Law Journal, sheds light on their FDA citizen petition aimed at ensuring the labeling of gluten on all packaged foods sold in the United States. Celiac Disease, a severe autoimmune condition triggered by the ingestion of gluten, poses significant challenges to those afflicted and their families. For the Bari family, the journey began in 2018 when their five-year-old son, Jax, was diagnosed with this life-altering condition. The sudden realization of the dietary restrictions and safety concerns associated with Celiac Disease thrust the Baris into a world of uncertainty and fear. Despite the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), significant gaps remain in the labeling requirements for gluten-containing grains such as barley, rye, and oats. This discrepancy exposes millions of Americans, including Jax, to the constant risk of accidental gluten ingestion due to incomplete and confusing food labels. The Baris' petition to the FDA aims to rectify this critical issue by advocating for the mandatory labeling of gluten on all packaged foods, aligning with international standards and the recommendations of leading health authorities. Their efforts have garnered support from esteemed institutions and organizations, further underscoring the urgency of their cause. With one crumb of gluten posing a serious threat to Jax's health and well-being, the Baris emphasize the imperative of preventive measures over remediation. Their courageous advocacy serves as a beacon of hope for the 3.3 million Americans living with Celiac Disease, urging policymakers to prioritize consumer safety and quality of life. As the Baris eloquently state, until a cure for Celiac Disease is found, the simple act of requiring gluten labeling has the potential to make a profound difference in the lives of those affected. In the spirit of compassion and accountability, they call upon health leaders to heed their plea and enact meaningful change for the Celiac community. In the pursuit of a safer, more inclusive food landscape, the Baris' citizen petition stands as a testament to the power of advocacy and the unwavering resilience of those impacted by Celiac Disease. Read more at FDLI.org

Celiac.com 04/01/2024 - Gluten-free doughnut enthusiasts should take heed as the US Food and Drug Administration (FDA) issues a recall notice for a product that contains wheat. Stonewall Kitchen of York, located in Maine, has voluntarily recalled its Gluten-Free Cinnamon Sugar Doughnut Mix due to concerns about potential wheat contamination. For individuals with celiac disease who must strictly avoid gluten, consuming contaminated products can lead to severe health complications. The recall encompasses doughnut mix units with specific details: Name: Stonewall Kitchen of York - Gluten Free Cinnamon Sugar Doughnut Mix Packaged in rectangular cardboard box Enjoy By Date: 03-09-2025 & 03-10-2025 (located on the bottom of the box) UPC: 711381313329 Item #: 553429 The recall was initiated following a reported reaction and subsequent investigation, which revealed that wheat-containing product was distributed in packaging that did not disclose the presence of wheat due to a packaging error. Consumers who have purchased the affected product are advised to discard it immediately. Stonewall Kitchen is offering full refunds to those who purchased the recalled doughnut mix. For further inquiries regarding the recall, individuals can contact Stonewall Kitchen Premier's Guest Services via email at guestservices@stonewallkitchen.com, or by phone at: 800-826-1735 (Monday to Friday, 8:00 AM ET to 5:00 PM ET). It is crucial for individuals with celiac disease and other gluten-related disorders to remain vigilant about product recalls to ensure their safety and well-being. Always check product labels and stay informed about any recalls that may affect gluten-free products in your household. Read more at: msn.com and fda.gov

Celiac.com 02/21/2024 - We get a lot of questions about the gluten-free status of numerous products and ingredients. Recently, one of the most common product questions we've seen is: Is modified food starch gluten-free and safe for people with celiac disease? The short answer, at least in the United States, is yes! Modified Food Starch and Celiac Disease For people with celiac disease, navigating food labels can feel like deciphering a complex code. One common ingredient that often raises questions is modified food starch. Let's delve into the intricacies of modified food starch to understand whether it is gluten-free and safe for those with celiac disease. Understanding Modified Food Starch Modified food starch is a widely used food additive with various applications in the food industry. It is derived from a variety of sources, including corn, potatoes, wheat, and tapioca. The modification process involves altering the starch's physical or chemical structure to enhance its functionality in food products. Modified Food Starch can go by many names, including: Modified Food Starch Modified Starch Food Starch Food Starch Modified Starch Is Modified Food Starch Gluten-Free? The primary concern for people with celiac disease is whether modified food starch contains gluten. The good news is that, in the U.S., most modified food starch is generally made from corn, potato, tapioca, or waxy maize. By federal law, the single word "starch" as an ingredient means cornstarch. In the U.S. all modified food starch not made with wheat, and labeled as such, is gluten-free. If modified food starch is derived from wheat, the Food and Drug Administration (FDA) mandates that it must be explicitly labeled as "wheat starch." So modified food starch containing gluten must be clearly labeled. This transparency allows people with celiac disease to easily identify and avoid products containing wheat-derived modified food starch. As a result, most modified food starches found in grocery stores are considered gluten-free and safe for individuals with celiac disease. Modified food starch appears on celiac.com's List of Safe Gluten-Free Foods. So don't worry if you see "modified food starch" as an ingredient. As long as there is no wheat or gluten warning, the product should be safe for people with celiac disease. Read Labels To ensure that modified food starch is gluten-free, it's crucial to become a vigilant label reader. Check the ingredient list on packaged foods, and if the source of modified food starch is not clear, reach out to the manufacturer for clarification. With the increasing awareness of gluten-related disorders, many manufacturers are responsive to consumer inquiries, and provide detailed information about their products. Certified Gluten-Free For an extra layer of assurance, look for products with gluten-free certifications. These certifications indicate that the product has undergone testing to meet specific gluten-free standards. However, it's important to note that not all gluten-free products carry certifications, so relying on a combination of label reading and certifications can be an effective strategy. The Takeaway on Modified Food Starch In general, modified food starch is often gluten-free, especially when derived from common gluten-free sources like corn or potatoes. However, due diligence in reading labels and, if necessary, contacting manufacturers is crucial. As always, when in doubt, it's best to consult with healthcare professionals or registered dietitians specializing in gluten-related disorders for personalized advice.

Celiac.com 08/19/2020 - The US Food and Drug Administration (FDA) has ruled that distilled foods and spirits made from gluten-containing grains can be labelled as ‘gluten-free.’ The FDA ruling covers fermented and distilled foods, or foods that contain fermented or distilled ingredients, which are made using gluten-containing grains such as rye, barley and wheat. The ruling changes the previous FDA requirement that distilled products labeled "gluten-free" must contain no gluten ingredients from start to finish. The change was hailed by Chris Swonger, president and CEO of the the Distilled Spirits Council of the United States (Discus), who said: “We commend FDA for this consumer-friendly ruling that will allow ‘gluten-free’ labelling claims to be included on distilled foods made from gluten-containing grains, and urge TTB to act swiftly to align policies allowing the same for distilled spirits products." Text of the new FDA ruling reads, in part: "[D]istillation is a process capable of separating gluten and other proteins from the remaining compounds...distillation must remove all protein (and thus gluten), regardless if the product has been distilled from gluten-containing grains. [Distillation] removes gluten because gluten does not vaporize. Therefore, there should not be any gluten remaining in the final distilled product. For this reason, a distilled product labeling may bear a “gluten-free” claim and should be safe for people with celiac disease to consume." The change means that manufacturers of distilled foods and beverages can now label their products as gluten-free without explanations about their gluten removal process. Gluten-free marketing has long been an issue of contention among regulatory bodies, people with celiac disease, and experts, with most scientists agreeing that the distillation process removes gluten from the final product. Health professionals and celiac support groups, like Celiac.com, and Coeliac UK, have long advised that distilled spirits are gluten-free and safe for celiacs on a gluten-free diet. Swonger said that “Allowing distillers to include a "gluten-free" statement on products made from gluten-containing grains will provide additional clarity for consumers to make informed choices about which products meet their dietary needs.” The rule will take effect on September 14, 2020. Read the full text at FDA.gov Read more at thespiritbusiness.com Resources: Here are some of the most common questions about gluten-free alcoholic beverages. Here's a helpful list of Gluten-Free Alcoholic Beverages

Celiac.com 02/04/2017 - Did you know that on August 2, 2013 the FDA published a regulation defining the term "gluten-free" for voluntary food labeling? According to that regulation, products labeled gluten-free must contain less than 20 ppm (parts per million) of gluten. The rule applies to all FDA regulated foods including dietary supplements. Manufacturers have until August 5, 2014 to bring package labels into compliance. After that, foods labeled 'gluten-free' that contain 20 ppm or more of gluten will be deemed misbranded and manufacturers will be subject to regulatory enforcement action. The Celiac Disease Foundation applaud the FDA for ensuring that food products labeled gluten-free will be safe for consumption. Ms. Geller, Chief Executive Officer of the Celiac Disease Foundation states that, "the celiac community, the CDF Medical Advisory Board, and our colleagues from the American Celiac Disease Alliance, Celiac Sprue Association/, Gluten Intolerance Group and National Foundation for Celiac Awareness, joined with CDF in a determined and collaborative effort for a federal gluten-free labeling standard." CDF Founder, Elaine Monarch, one of the first to advocate for a federal gluten-free standard stated "Congratulations to the FDA for acknowledging the dietary requirements of people with celiac disease with this important ruling. I am extremely pleased that the FDA has established a definition of gluten-free that will enable easier identification of appropriate foods for us." Ms. Monarch explains, "There is no pill for us, a gluten-free diet is the only treatment for celiac disease. That makes food both our drug and potentially our poison." Even though manufacturers have until August 5th of next year to comply with the new rule, the FDA is encouraging the food industry to come into compliance as soon as possible. Joseph Murray, MD, Professor of Medicine, Mayo Clinic and CDF Medical Advisory Board Member declared. "This long awaited regulation defining what a label saying 'gluten-free' means goes a long way to help build consistency in food labeling which will make it easier for people who need to be gluten-free to select food items. Manufacturers now know exactly what gluten-free means and will hopefully begin using this voluntary labeling standard immediately to provide safe food with clear information for consumers." If the Celiac Disease Foundation can applaud the FDA Food Labeling Rule defining "gluten-free" we can do the same. Then comes the Question, "What food products are covered by the FDA gluten-free labeling rule? Covered: All FDA regulated foods Dietary Supplements (vitamins, herbs, amino acids) Imported food products that are subject to FDA regulations Not Covered: Meat, poultry and unshelled eggs (and any other products regulated by the USDA). Distilled spirits and wines that contain 7% or more alcohol by volume ** Malted beverages made with malted barley or hops ** **These alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). The FDA says it will work with the TTB to " harmonize" gluten-free labeling requirements between the two agencies. AFTER August 5, 2014 What food products may be labeled gluten-free? A food product regulated by the FDA may be labeled gluten-free if: It does NOT contain wheat, rye, barley or their crossbred hybrids like Triticale (a gluten-containing grain) OR It contains a gluten-containing grain or an ingredient derived from a gluten containing grain that has been processed to less than 20 parts per million (ppm) of gluten May food products that are naturally gluten-free be labeled "gluten-free"? [YES - Food products that are naturally gluten-free, like bottled spring water or tomatoes may be labeled "gluten-free"] May oats be labeled gluten-free? Oats that contain less than 20 ppm of gluten may be labeled "gluten-free". Oats do not need to be certified gluten-free. AN ASIDE: This surprises me because the oat controversy and oat sensitivity battle has been going on for years. According to many experts in the field of gluten sensitivity the suitability of oats in the gluten-free diet is still somewhat controversial. Some research suggests that oats in themselves are gluten-free, but that they are virtually always contaminated by other grains during distribution or processing. According to Wikipedia, " Recent research, however, indicated that a protein naturally found in oats (avenin) possessed peptide sequences closely resembling wheat gluten and caused mucosal inflammation in significant numbers of celiac disease sufferers. Some examination results show that even oats that are not contaminated with wheat particles are nonetheless dangerous, while not very harmful to the majority. Such oats are generally considered risky for children with celiac disease to eat, but two studies show that they are completely safe for adults with celiac disease to eat. People who are merely "gluten sensitive" may be able to eat oats without adverse effect, even over a period of five years. Given this conflicting information, excluding oats appears to be the only risk-free practice for celiac disease sufferers of all ages. However, medically approved guidelines exist for those with celiac disease who do wish to introduce oats into their diet. Unless manufactured in a dedicated facility and under gluten-free practices, all cereal grains, including oats, may be cross-contaminated with gluten. Grains become contaminated with gluten by sharing the same farm, truck, mill, or bagging process. As mentioned in the Winter 2012 "Did You Know" article "grain standards for the United States and Canada allow a set percentage of foreign grains to be present in packages of particular grains. By definition then, oats may contain up to 25 percent of wild oats and other grains for which standards have been established under the United States Grain Standards Act. Research has shown, and the FDA acknowledges, that regular oats pose a risk to celiac consumers due to contamination." Today wheat is made to grow shorter and with bigger seeds to have a higher yield", explains Dr. Murray. "It is bred to be drought resistant, heat resistant, pest resistant and responsive to nitrogen fertilizer. All those things maximize the gluten content because it's important for its baking properties. To top it off, purified wheat gluten is added to foods such as high-fiber bread (because it helps the fibrous dough stick together and rise) and high protein bread, (because gluten is a protein). One survey reported people experiencing a potential trigger within six months prior to symptom onset, including severe stress (23%), a severe gastrointestinal infection (9%), a pregnancy (8%) and a major surgery (7%). Yet, according to the FDA oats that contain less than 20 ppm of gluten do not need to be certified gluten-free yet they may be labeled "gluten-free". Cross-contamination was the main reason why oats were considered unsafe in the past. Oats, wheat and barley are usually grown next to each other in farmers' fields, processed in the same grain elevators, milled with the same equipment, and transported using the same containers. Inevitably the grains co-mingle and the oats become contaminated with gluten grains. An excellent book entitled "Celiac Disease, Safe/Unsafe Food List and Essential Information" by Jaqui Karr, C.S.N., C.V.D. should be in your celiac library. First released in 2010, Karr does not recommend oats for celiacs. Karr states that "There are a handful of studies going back more than 20 years showing celiac patients reacting to rice and/or corn. Yet most medical communities are accepting rice and corn as safe. Several doctors and scientists still feel that all grains are harmful to celiacs. "Be careful as gluten-free standards are not absolute." Karr wrote the book to as a guide to help identify potential areas of danger. "We do not know yet know what the long term effects of continuous digestion of small amounts of gluten are, and we know that in most cases the person will be suffering internal damage with no external symptoms." We are not the only ones that are confused with the guidelines/rules and suggestions for the celiac. Different countries use different ingredients for the same food. Just one example is MSG. In the U.S. it is made from corn. Outside the U.S. it is usually made from wheat or soy. It is frustrating to read "Confirm with manufacturer" when you are expecting a list to tell you whether it is safe or unsafe. No list can truthfully claim to provide accurate information on every item without a few that require you to verify further. If you look at diningoutglutenfree.com you will find a large list of the fast food chains that carry separate gluten-free menus. If these are well-known restaurant chains they will probably be checked regularly by the Health Board to ensure that the foods are prepared in a separate area and no appliances or serving cutlery has been used in both preparation areas. You don't want someone flitting from regular food to gluten-free foods at the same counter with no glove changes or counter changes. It is a matter of 'buyer beware' isn't it? With two guests from England, we stopped for an afternoon tea at a well-known tea house in Victoria, Vancouver Island, Canada. It was a busy restaurant at 3:00 P.M., afternoon tea time. I broke another one of my rules: "Don't order during peak hours". I looked into the yummy dessert and pastry section of their glassed-in baked goods. I asked the young woman if they had any gluten-free items. She said, rather quickly, to look at the section on the top row on the left. She just pointed and went on her way. I 'ummed and haa'd', and when she came back I asked again if this strawberry dessert was gluten-free. That was when I noticed that she had an accent from another country. She again flew her hands over the top row on the left, so I bought my dessert, even though they were just labeled "sugar free". How stupid I was! Well, I did enjoy the dessert while I ate it. During the night I was sick and sure enough 24 hours later out came the dermatitis herpetiformis spots—scalp first, as usual. I complained to my husband as I itched, telling him that I had asked. He stated that he had noticed me asking the woman about gluten-free, "but", he said, "those baked goods only said, "sugar free" meaning they were made with a sugar substitute. After hearing that I had one of those thoughts about pausing and thinking. If it was twice the price as the other baked goods then it could be celiac-friendly, not just sugar free. The young woman's primary language was not English which should have registered with me. There should have been a bigger sign there saying, "Gluten Free". I itched my way through another three or four days of house-guests. When, eventually, I did call the restaurant (it is the only way we are going to get anywhere as a celiac community unfortunately, calling back and explaining what happened.) They apologized. They do not have gluten-free foods. They would mention it to the staff member. My fault or theirs? MY FAULT. I should have explained to the young woman. Not everyone knows what gluten-free means, nor do they realize how sick we can become ingesting items containing gluten. She must have thought I meant sugar free. Am I going to beat up the server, who was likely a University student, or beat myself up, a person who can read and should have asked further when seeing just the "Sugar-Free" sign. Better to be thought a dummy than to be sick again. Reminder; No matter what the front of the food package states, always, always read the back of the package. Yes, right to the bottom! Often they list ingredients by the volume used in the preparation of that food, and what is often at the very top is the largest proportion. But I have found the section they have not added in a lot of pre-packaged food—"May include" which can be an important listing for us, yet often it is in a little box by itself and not under ingredients at all. After all, it may not be included. But it could have been prepared with machines that process gluten. Looking back to the May 2011 "Living Without Magazine", in an article entitled "Research Roundup" 'Working With Wheat'. Did You Know that a lot of people are getting on the band wagon for eating gluten-free without being checked for celiac disease, because they have "heard" you can lose weight on the celiac diet. Four reasons not to go gluten-free (if you don't have to). It seems to be a popular thing to do these days. "Hey, go on a gluten-free diet and you will lose weight!" They talk about sugar belly, and having a bloated stomach, but they fail to realize that products on the market are much higher in sugar, fat and total calories than their gluten containing alternatives, says Shelley Case, a registered dietitian from Regina, and author of The Gluten Free Diet: A Comprehensive Resource Guide "Manufacturers use ingredients containing gluten to help the products stick together and taste better." Gluten-free products are frequently produced by small manufacturers who aren't required to add iron, B vitamins and other nutrients you generally find in gluten-containing products. "A lot of them use white rice flour, tapioca, and corn and potato starches, which are low in fiber and don't offer much in the way of nutrition," says Shelley Case. Gluten-free products are expensive. Dee Sandquist, a dietician who specializes in celiac disease states "In general, gluten-free packaged foods have added fat to make them look and taste better." Silly to go on a gluten-free diet to add more fats and receive a bad cholesterol overload! A 2008 study in the Canadian Journal of Dietetic Practice and Research found that gluten-free foods cost, on average, 242% more than conventional foods. If you add to that another five years of cost of living increases the percentage would be more today. The diet can interfere with your life. Eighty-one percent of the respondents to the Canadian Celiac Health Survey avoid going to restaurants and about 38 percent avoid traveling because of their eating restrictions. If you are wanting some foods to blame for your sugar belly or bloated belly, even if that bloated belly may be one sign of celiac disease, it can also be a sign of too many do-nuts, candies, or too much wine or beer. Some, should I say most? people who do not have celiac disease, are not aware of the nutritional deficits a celiac can have in their diet. The disease can have long-term and sometimes fatal health consequences because your immune system basically begins to treat gluten as a harmful invader. Your body's first line of defense is to launch a kind of overkill response that wears away the hair-like protuberances called villi (A shag carpet that lines your small intestine). These waving bits of shag carpet aid in the absorption of nutrients into the bloodstream, but in people with celiac disease it is more like a tile floor that lets nutrients slip by, often leading to rapid weight loss and eventual malnutrition. Now if someone has told you that the celiac diet is a way to lose weight you can tell them that it is the celiac with the 'tile floor' small intestine that could be causing them to lose weight, but it can also lead to malnutrition, hair loss, nail breakage and dental problems. To go from a bad idea to a life threatening disorder be aware that because celiac disease is an autoimmune disease (like lupus and Crohn's disease), as it evolves it can impact other body systems causing chronic poor health, infertility in both men and women, miscarriages, osteoporosis and cancers of the gastrointestinal tract. Unfortunately, because of the numerous ways it can manifest, celiac disease is devilishly hard to diagnose. A 2012 report from the Mayo Clinic estimated that about 1.8 million Americans had celiac disease, a dangerous immune response to gluten. Of those, 1.4 million are unaware they have it, says Joseph Murray, a gastroenterologist with the Mayo Clinic in Rochester, Minnesota. That means that in the USA, only 0.4 million people know they have celiac disease, and the other 1.4 million are going from doctor to specialist trying to find an accurate diagnosis for the baffling, often mysterious symptoms. Another U.S. statistic I was surprised to hear was that 1.6 million Americans are currently on a gluten-free diet despite never having been diagnosed with celiac disease. "It is safe to say many people are eating gluten-free for no reason" says Murray. Is it just another hipster food diet like the oat bran diet. Health Canada estimates some 300,000 people suffer from celiac disease in Canada and many of them don't know it. Have you noticed the mass influx of gluten-free foods in large food markets lately? Of course we are consumers, and we are a market that has not been fully served in the past. And they do not like to miss out on sales. A lot of the smaller stores do not realize how fastidious you have to be owning a restaurant or bakery selling foods that are gluten-free. If you are not preparing gluten-free foods in a separate area, under strict conditions that limit cross contamination, then you could be in a litigation line-up. Some people are severely allergic to gluten, and an outbreak of dermatitis herpetiformis is not a gift you want to give your customers. AN ASIDE: I just tore out a complete recipe section from the Canadian Living Magazine. Although they have a disclaimer with regards to you checking the ingredients carefully to ensure the products are gluten-free. Of the seven recipes listed, all of them stating gluten-free, rolled oats and vinegar are in the recipes. There is information on what type of vinegar. Do all celiac people realize that malt vinegar should be avoided? And do all people with celiac disease realize the controversy with regard to oats? I cannot tolerate oats, and why would you risk it when medical experts do not even know the long term effects of oat ingestion for the celiac? Don't forget that even the reason for the recent increase in celiac disease is unclear. As mentioned, Dr. Murray points out that gluten is being used more frequently and in purer forms than it was in the past. To top it off purified wheat gluten is added to foods such as high-fibre bread (because it helps the fibrous dough to stick together and rise! And high protein bread, (because gluten is a protein), "I think it could be overexposure at certain times and in this very purified state," states Murray. Shelley Case believes the theory that celiac disease and other conditions are being caused by junk diets and an overuse of antibiotics, which are changing the bacterial composition of the gut and killing off good bacteria. In either case, it seems likely that something activates the disease. About 47% of the respondents to the Canadian Celiac Health Survey reported experiencing a potential trigger within six months prior to symptom onset, including severe stress (23%—go figure), a severe gastrointestinal infection (nine percent), a pregnancy (eight percent) and a major surgery (seven percent). This is congruent with my condition of celiac disease and DH. I was living on the irritable bowel disease diet in the November prior to my daughter's wedding the following January. She was very slow with the invitations, ideas, and plans. Working full time I was a nut case, and by December had so many connect the dots dermatitis herpetiformis sores I was contemplating shaving my hair off and wearing a bathing cap to the wedding! Both Shelley Case and Murray urge patients to get diagnosed and treated for celiac disease before going gluten-free. In addition, without a diagnosis of celiac disease, patients are less likely to be monitored for celiac-associated conditions, such as cancer and osteoporosis, and are more likely to cheat. Murray warns, "Even if you have just a bit of gluten, you can cause damage." Did you know, that you should be tested for celiac disease if you experience one or more of the following symptoms: bloating, abdominal pain, diarrhea, weight loss, fatigue, weakness, anemia, depression, mood swings, bone or joint pain, easy bruising, constipation, lactose intolerance nausea, vomiting, mouth ulcers and/or migraines. You should also be tested if you have relatives who have been diagnosed with celiac disease. If you have a first-degree relative (parent, sibling, child) with celiac disease, you have about a 10 percent chance of having this condition. You should also be tested if you have type 1 diabetes. (Rates of celiac disease are higher in this group.) If you have been diagnosed with that common catch-all, irritable bowel syndrome, you should know that celiac disease can mimic irritable bowel syndrome and thus delay an accurate diagnosis. One physician at the hospital where I worked states that "irritable bowel" among gastroenterologists is the same thing as saying, "We don't know". If only I had known that when I had foregone the steak but ate the bun! Sources: Celiac Disease Foundation

Celiac.com 07/26/2022 - Previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? In people with celiac disease, gliadin-specific T cells drive an adverse immune response to gluten peptides, which can cause symptoms, long-term gut damage, and other related conditions. Currently, the only treatment for celiac disease is a gluten-free diet. A new drug, KAN-101, designed to treat celiac disease by inhibiting a key celiac disease biomarker, has received fast track status from the FDA ahead of Phase 2 Trials slated for the second half 2022. Designed by Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, KAN-101 has been found to be safe, well-tolerated, and to provide the proper immune responses. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. The Phase 1, randomized, double-blind, placebo-controlled trial enrolled a total of 41 individuals with celiac disease on a gluten-free diet in both single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts. Findings from the Phase 1 trial showed that treatment with KAN-101 was safe and tolerated, and successfully reduced T cell responses following gluten challenge. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of KAN-101, with secondary endpoints to assess KAN-101 serum concentrations and pharmacokinetics. Additional end points include the assessment of cytokines critical to both innate and adaptive immunity, T cell responses, and other serum cytokines and celiac disease symptoms. Patients who recieved KAN-101 experienced dose-dependent reductions of gluten-induced plasma IL-2, a cytokine that is elevated in celiac patients after gluten ingestion, and which reflects severity of acute symptoms. Patients who received the 0.6mg/kg dose experienced statistically significant reductions of IL-2, compared to other groups Administration of KAN-101 did not increase gut-homing CD8 T cell responses after gluten challenge, an indicator of immune response to gluten exposure in patients with celiac disease. Stories about new drugs designed to induce tolerance to gluten always cause great excitement within the celiac disease community. However, previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? Stay tuned for more as KAN-101 moves into its Phase 2 trial later this year. Read more at Businesswire.com

Celiac.com 07/04/2022 - The Food and Drug Administration (FDA) has issued a set of new guidelines for companies doing celiac disease drug trials. The agency noted that the guidance is intended only to provide clarity regarding existing requirements, and should be viewed solely as recommendations, unless they mention specific regulations or laws. The FDA directs sponsors of trials for clinical drugs to ensure the following regarding celiac disease patients on a gluten-free diet: Trial population Patients should undergo diagnostic esophagogastroduodenoscopy, with multiple biopsies to confirm celiac diagnosis. The biopsies should include one or two samples of the duodenal bulb and at least four samples of the distal duodenum. To avoid inclusion of patients whose symptoms are not celiac-related, patients should receive esophagogastroduodenoscopy screening with biopsy to ensure they meet histologic eligibility criteria at the time of trial enrollment. Patients should be symptomatic at baseline, based on enrollment criteria, to allow for evaluation of symptom improvement. Prior to trail enrollment and for the full duration, patients should follow to a strict gluten-free diet with input from trained dietitians. Trial design The FDA recommends using randomized, double-blind, placebo-controlled trial design. Before randomization of participants, sponsors should include a screening period to confirm histologic eligibility criteria, document clinical signs and symptoms, and train patients and/or providers in collecting clinical outcome assessment data. Trial duration and outcome assessments should be informed by the therapy goal, expected drug onset of action and the time frame in which clinical benefit is observable. The FDA recommends a placebo-controlled treatment period of at least 52 weeks for drugs intended for chronic use, with continued patient adherence to a gluten-free diet. Efficacy assessments for both clinical and histologic endpoints may be evaluated at week 24, and esophagogastroduodenoscopy with biopsy should be performed at week 52 to assess durability of response. Sponsors should make sure their patients follow a gluten-free diet for the complete treatment period. Efficacy and clinical outcome assessments Trails intended to support market approval should include coprimary endpoints to assess a drug’s effect on clinical signs, symptoms and related underlying mucosal condition. The FDA also recommends a pre-specified secondary endpoint to determine the number of patients who see improvement of clinical signs, symptoms and mucosal inflammation. Trial sponsors should seek FDA input early, when critical milestones are met, and throughout drug development. Sponsors should also identify disease and treatment burdens using patient input. To better assess symptom severity and event-related signs and symptoms, sponsors should ask patients to rate their worst experience and frequency of a specific sign or symptom over a 24-hour period. Statistical and safety considerations To be demonstrate efficacy, trial results should demonstrate statistical significance for both clinical and histological endpoints, and analyses should include all randomized patients. Sponsors should assess gluten-free diet adherence, which could alter efficacy data. Moreover, sponsors should talk with patients about the importance of following a strict gluten-free diet, since the benefit of the drug is still unknown. To assess the safety of drugs intended for long-term use, patients should be follow the intended market dosage for at least one year. The FDA recommends that sponsors include safety analyses to compare risk and confidence intervals in treatment groups. Read the full recommendations at FDA.gov

Celiac.com 06/16/2022 - The odyssey began four years ago with a one-page bill authored by New York Representative Nita Lowey. It ended on August 2, 2004, when President Bush signed the Food Allergen Labeling and Consumer Protection Act (FALCPA) into law. There have been many questions about when the new law goes into effect, and what it will mean for individuals with celiac disease. Beginning on January 1, 2006, food labels will be required to list the top eight food allergens. This date was the earliest that the law could go into effect. In order to minimize the burden on business, the Food and Drug Administration (FDA) sets periodic effective dates timed in two year cycles. This date also coincides with the labeling changes required for trans-fats. The top eight allergens account for 90 percent of all food allergic reactions. For individuals with celiac disease, it is estimated that 90 percent of food products contain wheat, or a wheat derivative. Of the remaining problematic grains—rye is almost never used as an additive. Barley is sometimes found as a main ingredient, or is listed as “barley malt,” or simply as “malt.” In addition to food ingredient labels, labels on dietary supplements or vitamins will also need to conform to the new FALCPA law. Further, institutional-sized food packaging— such as ten pound cans of tomatoes used by restaurants—must also conform to the new regulations. The bottom-line according to a spokesperson for the FDA, food packaged in any form will have to list the top eight allergens. The new law mandates not just labeling, but various other factors as well. Specifically, it requires: Food labels must list—in everyday language—any of the eight main food allergens (milk, egg, peanuts, tree nuts, fish, shellfish, soy, and wheat) that are in the product. Allergens in flavoring, coloring, or incidental additives to be labeled in accordance with these requirements. The U.S. Centers for Disease Control and Prevention to track food allergy-related deaths. An examination of how to eliminate unintentional contamination and cross-contact of foods. The FDA to consider revisions of the Food Code to provide allergen-free preparation guidelines for restaurants and foodservice establishments. An investigation of consumer preference pertaining to advisory food labeling such as precautionary “may contain” statements. Guidelines to be established for use of the term “gluten-free” on product labels. Again, the changes to food labels go into effect on January 1, 2006. Many food manufacturers have already begun listing allergens in some form or another, but don’t expect to see wholesale changes until then. What Happens Next? While we anxiously wait for the label revisions, there will be a lot happening at the FDA on another key provision of the law—setting standards for the use of the term “gluten-free” on food packages. These standards would be for companies which choose to label their products as gluten-free. The standards will be set out in regulations. Developing regulations is very time intensive. On average, it takes about a year to make a rule; some can take up to four years! The more specific, or detailed a law is, the easier it is to develop the rules for implementing, or putting that law into action. At a regulatory agency like the FDA, there is an annual priority-setting process. Things they want to do are put on a list, along with new laws passed by Congress, which have specific deadlines. Although it is not clear when the FDA will begin work on the regulations for using the term gluten-free on labels, the process is well established. According to sources at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), they will begin by assembling a multi-disciplinary team with experience in labeling, economics, and enforcement. Based on the law, the team will rough out what the rule should look like, and the issues that should be addressed. This first draft will be reviewed by leaders at CFSAN, and then by the FDA management. Depending on the complexity of the issues involved, it may take several drafts before the document is ready to go to the next step, called “clearance.” Regulations and policy statements are “cleared” through an administrative hierarchy beginning with the center (CFSAN) level, then moving up to the agency (FDA) level. After approval by the FDA, the draft rule must pass review at the Department level—Health and Human Services (HHS)—and the Office of Management and Budget. At any one of these stages the rule could be forced to go back for revision and have to start the process over. The draft rule must be open for public comment. The time allotted for such comments vary, but will be no less than 60 days. Under FALCPA, the proposed rule must be published by August 2, 2006. After the internal clearances are complete, the proposed rule is published in the Federal Register. Comments on the proposal will be requested from the public, interest groups, other government agencies, and members of Congress. The notice in the Federal Register will provide information for when comments are due, and how they must be submitted. We will be closely monitoring this process and any information published by the FDA regarding this rule will be posted to the ACTF website: www.celiaccenter.org/taskforce.asp. Those signed up for the E-Action List will receive a news alert (go to www.capwiz.com/celiac for more information). Once the comment period closes, FDA will review all the comments and the rule may be modified based on the feedback received. In some cases, re-drafting to address the concerns presented can take years. Luckily, FALCPA requires the final rule to be issued no later than August 2, 2008, which will prevent any extreme delays. The final rule, just like the previous draft, must be published in the Federal Register. For rules that have a significant economic impact, Congress has at least 60 days to register its objection. After this waiting period, the rule can take effect. The only way to undo the final rule is to start the process all over again. Many individuals have suggested that the FDA could speed up the process by adopting the proposed Codex Alimentarius gluten-free standard—20 ppm for naturally gluten-free foods, and 200 ppm for foods with ingredients that normally contain gluten but have had the gluten removed, such as Codex quality wheat starch. Others would prefer that it adopt the more stringent Canadian gluten-free standard of 20 ppm for all foods. The FDA is clearly aware of these existing standards. While it might be easy to accept either and just move on, it doesn’t work that way. The agency will review how, and when, these other levels were established. But, in order to set a gluten-free standard for the United States, the FDA will conduct a thorough, independent analysis of the science. Among other things, it will assess research on safe thresholds of gluten contamination for persons on a gluten-free diet; current testing methods for products, the availability and accuracy of such tests; and the impact of different standards on food manufacturers. The FDA has been very supportive of the need for gluten-free labeling for persons with celiac disease. The foremost issue will be the safety of those who will be relying on such labels. It is not possible to set the threshold at zero, in part, because there is no way to determine that level. No test has that level of sensitivity. In all probability, the FDA will settle somewhere between zero and 200 ppm. There is a lot of room in the middle, and our job is to help the FDA find the best possible point within that spectrum. Just as politics drive the legislative process, they also loom over the rulemaking process. Some will argue that these are “our” rules, and therefore the celiac community’s perspective should carry more weight. There are other interests which will need to be balanced against those of persons with celiac disease. If we are to be taken seriously, our views must be supported by science. Individual stories supported solely by anecdotal evidence, will receive little consideration. Reasonableness will also be a major factor in the FDA’s decision making. Demanding a standard which imposes significant burdens on the nation’s multi-billion dollar food industry will not be perceived as reasonable. One FDA staffer noted this could be a real opportunity for the celiac community because, through the rulemaking process, companies will get to see the real potential in developing products for a ripe and relatively untapped market. Thanks to an incredible effort we were instrumental in the passage of FALCPA. The development of the gluten-free rules provides another prime opportunity to demonstrate our collective strength. The same unity, along with strong, scientific-based research, will be necessary to achieve a safe gluten-free standard.

Celiac.com 04/20/2022 - The US Food and Drug Administration (FDA) is directing healthcare facilities and providers to transition to fully disposable duodenoscopes, and those with disposable components. The FDA made the announcement after an analysis of post-market surveillance studies supported the agency's concerns about the difficulty of fully cleaning fixed endcap duodenoscopes. Among other things, the agency noted that older reusable duodenoscope models had contamination rates as high as 6%, compared with just .5% for disposable models. The agency notes that disposable duodenoscopes and components reduce patient contamination risk "by half or more as compared to reusable, or fixed endcaps." The contamination concerns, coupled with the increasing availability of disposable duodenoscopes led the agency to update its April 2020 recommendations on the subject. Duodenoscopes are used in more than half a million medical procedures annually in the United States, and play an important part in evaluating and treating diseases and problems of the pancreas and bile ducts. While duodenoscope manufacturers no longer sell fixed endcap models in the United States, numerous healthcare facilities still use them. To decrease infections, the FDA now recommends that all fixed endcap models be replaced. The agency notes that some companies have programs in place to upgrade their old models with a disposable component at no cost. The FDA has approved two fully disposable duodenoscope models, along with five that use disposable components. Only four of the disposable components are currently available in the U.S. FDA-approved fully disposable duodenoscopes include: Ambu Innovation GmbH, Duodenoscope model aScope Duodeno Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope FDA-approved disposable duodenoscope components include: Fujifilm Corporation, Duodenoscope model ED-580XT Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V Pentax Medical, Duodenoscope model ED34-i10T2 Pentax Medical, Duodenoscope model ED32-i10 Read more at Medscape.com

Celiac.com 11/29/2021 - For anyone who has ever been confused about the labelling of gluten and other tops allergens, help may be on the way in the form of a comprehensive food labeling bill recently introduced in the United States Congress. The bill would make it easier to require labeling for additional food allergens in the future. FLMA Offers Major Progress on Gluten Labeling Under the Food Labeling Modernization Act (FLMA), introduced in the House and Senate on August 3 as HR 4917 and S 2594, respectively, regulators could add new allergens more easily, and gluten-containing grains would need to be declared. The bill improves food labeling laws, ingredients lists on packaged foods, and front-of-package food labeling and nutrition claims. The new bill requires the FDA to define claims made on packaging including “healthy” and “natural” and require more open disclosure of “gluten-containing grains" and ingredients. For example, the bill would require gluten-containing ingredients such as barley and rye to be overtly labeled, in the same way that wheat is now labeled. That means that gluten will no longer remain hidden in yeast, malts, and flavorings. Sponsored by Representatives Frank Pallone, Jr. (D-NJ) and Rosa DeLauro (D-CT) in the House, and Senators Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI), and Ed Markey (D-MA), in the Senate, the bill has won enthusiastic support from numerous celiac nonprofits and advocacy groups. Pallone told reporters that manufacturers must do more to properly disclose allergens. “The [FLMA] would allow FDA to act quickly to protect consumers by authorizing the agency to define major food allergens and ensure compliance,” he says. Read more in Allergic Living

Celiac.com 08/30/2021 - In August of 2020, the FDA issued a final rule regarding gluten-free labeling of fermented and hydrolyzed foods. The rule established a compliance date of August 13, 2021. The rule doesn't change the gluten-free definition established by the agency's original 2013 rule, which basically requires foods bearing a gluten-free claim to be made without gluten containing ingredients, or processed so that no more than 20 ppm of gluten remain in the final food product. But the FDA did decide that fermented and hydrolyzed foods required additional regulation to ensure compliance with the 2013 final rule, because currently the “FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins.” Therefore, the 2020 rule established a records-based system to ensure that fermented and hydrolyzed foods are gluten-free consistent with the definition established in 2013. The 2020 rule requires food manufacturers of foods that bear gluten-free claims are required to keep records that show that: The food is gluten-free before fermentation or hydrolysis; The manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; If necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process. Companies are required to keep records only for food ingredients for which there are no good analytical tests for gluten content, such as hydrolyzed and fermented foods. Records must be kept for at least 2 years after introduction of the food into interstate commerce, and must be reasonably accessible to FDA during inspection at each manufacturing facility. Starting on the compliance date, manufacturers of gluten-free foods should collect and review documentation from suppliers of any hydrolyzed or fermented food ingredients to ensure compliance with new the rule. Lastly, the rule applies to enzymes grown on media containing gluten, such as wheat, because gluten from the growth media may be carried over and hydrolyzed via fermentation, making it undetectable to current gluten tests. Read more at the National Law Review

Celiac.com 06/02/2021 - Under the FDA’s 2013 Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods, wheat starch is considered “an ingredient processed to remove gluten.” Wheat starch is an allowed ingredient in foods labeled gluten-free as long as its use does not result in the final food product containing 20 parts per million or more of gluten. The FDA clarified the rule to require food manufacturers to ensure that products containing fermented, hydrolyzed ingredients meet the definition of “gluten-free” before fermentation or hydrolysis. While fermented foods and ingredients made using gluten-free wheat starch as a starting material can be labeled gluten-free, wheat starch itself is not considered by FDA to be a fermented or hydrolyzed food. What Gluten Free Products Use Wheat Starch? Although gluten-free wheat starch has been approved by the FDA, there is still a great deal of skepticism about it. We recently reported that wheat starch is an ingredient in DiGiorno's Gluten Free Pizzas. Wheat Starch Long Used in Europe In Europe, the use of wheat starch in gluten free foods has been rigorously tested, with no evidence that foods made with gluten-removed wheat starch are harmful to people with celiac disease. Companies like Schär has been using it for over 20 years, with more than 90% of the wheat starch used by Schär testing below 5ppm, under ELISA. Wheat Starch Controversial in US However, because the use of wheat starch in gluten-free foods is still hotly debated in the US, even Schär only uses it in their Gluten Free Croissants, and a handful of other products in this country. Because wheat starch is controversial in the US, Celiac.com puts wheat starch on our Unsafe and Forbidden Foods and Ingredients list. Find more information on Celiac.com's Safe Gluten-Free Foods list. For the most part, wheat starch can be considered a safe ingredient for celiacs, as long as it is labeled gluten free. As always, read labels, avoid ingredients that disagree with you, and choose wisely.

Celiac.com 12/24/2020 - The U.S. Food and Drug Administration (FDA) says it has warned Amazon.com’s Whole Foods Market for failing to label some food products for known food allergens. As a result, Whole Foods has recalled over 30 food products in the last year after failing to list major food allergens on product labels, the agency said. Unlabeled food allergens, such as wheat, can pose a health risk for people with celiac disease or other gluten sensitivities. The recalled products came mainly from Whole Foods deli and bakery sections, the FDA letter said. A list of the products with unlabeled allergens appears on the FDA warning letter to the company, dated 16 December, 2020. According to the letter, it's up to Whole Foods is responsible investigate and assess the causes of the violations and for preventing future occurrences. The agency requested Whole Foods notify them in writing within 15 working days from receipt of the letter, with the specific actions it is taking to correct the violations. A statement by Whole Foods said that the company was “working closely with the FDA to ensure all practices and procedures in our stores meet if not exceed food safety requirements.” Read more at Reuters.com; and at the FDA.GOV.

Celiac.com 09/17/2020 - A recent "Advisory" issued on August 29, 2020 by the Canadian Food Inspection Agency (CFIA), followed by a product recall, has brought up an interesting question: Which food safety system works better, the USA's or Canada's? The alert was issued two weeks ago for President's Choice Brand "Gluten-Free" Chicken Strips, the text of which reads: "In response to several reported reactions from consumers, the Canadian Food Inspection Agency (CFIA) is recommending individuals with celiac disease, or others with gluten-related disorders, to not consume the product described below as it may contain undeclared gluten. " The advisory goes on to list the UPC number (0 60383 20488 4) and product code (2021 AL 20) of the chicken strips to avoid. What caught our eye about this particular alert was that it was an "Advisory," rather than a recall, and recalls are what we typically see issued by both the CFIA and the FDA. This raised the following question: What is the difference between a CFIA "Advisory" and a "Recall", and is it better to have both? On August 31, 2020 we sent an email to the the CFIA's media department where we asked several questions, and on September 2, 2020 we received the following responses from Christine: Q: What is the threshold minimum number of complaints required to trigger this type of public warning? Christine's Answer: "There is no set number of complaints required to issue a public warning. The CFIA issues public warnings on a case-by-case basis. In this case, the Agency had credible information from several sources that a particular product was the cause of several illnesses." Q: Did you test any of this company's products before issuing this warning? How did you determine that gluten was present in this product before issuing this warning? Christine's Answer: "In this case, the Agency acted on credible information from several sources that a particular product was the cause of several illnesses. It was affecting individuals with Celiac disease who normally show adverse reactions to the presence of gluten. Given the potential severity of reactions, the Agency chose to inform individuals with Celiac disease and other gluten related disorders based on a pattern of reactions." Q: Did you speak with any representatives at this company before issuing this warning? Christine's Answer: "Loblaw Companies Limited was contacted before issuing the consumer advisory and the recall warning." Q: Did any of the people who complained about the product run any tests for gluten? Christine's Answer: None of the complainants supplied test results for gluten to the Agency. After 25 years operating the Celiac.com Web site, including over 15 years of running our site's forum, one thing we've learned is that it can be very inaccurate to try to determine whether or not something has gluten in it just by someone's gut reaction to it. While some celiacs swear they can do this accurately, many celiacs, especially during the 1-2 year period following their diagnosis, can react in a similar way to all sorts of things like casein/milk, corn, eggs, soy, etc., possibly due to the "leaky gut" condition caused by the disease. Some celiacs swear they react to distilled alcohols made using gluten containing grains, even though scientists and the FDA have determined them to be gluten-free. Given the extremely high expenses that such an advisory could create for a food company, we were hoping to get a more specific answer to our first question, and were very surprised to discover that there is no threshold to trigger such an advisory. Could a single report from a celiac trigger an advisory to be issues? Below are examples of stories that ran in the press just one day following the advisory, which triggered Loblaw to voluntarily recall the product: Notice that none of these stories leave any doubt that there was gluten in the product, even though the CFIA made it clear in answering our first round of questions that the product never tested positive for gluten. At this point we were scratching our heads and wondering whether this system was working as planned, and whether it was doing a good job of keeping celiacs in Canada safe, or were advisories being issued without any real evidence that the product contained gluten? Since the CFIA indicated that there is no specific threshold for the issuance of such an advisory, we really had no idea if "several" complaints meant two or three, or two or three hundred. Directly following Christine's September 2, 2020 responses we sent a follow up question to her, but this time Patrick, rather than Christine, responded to it: Q: How can you be sure that the reactions that have been reported were not caused by a bacterial, chemical, or other issue with the product, rather than by gluten in the product? Patrick's Answer: "In this case, multiple individuals consumed the product and only those with celiac disease or allergies to wheat reported reactions. This points to gluten/wheat being the causative agent. In addition, some individuals reported anaphylactic shock. Those reactions are not associated with bacterial or chemical contamination in food. After the Consumer Advisory was issued, the food safety investigation was able to confirm that one of the ingredients contained gluten and a recall was issued by Loblaw Companies Limited." Patrick's response certainly makes this sound like an open and closed case of wheat contamination in a product that was labelled gluten-free. If true the CFIA's advisory system was very effective at detecting gluten in a gluten-free product, which is exactly what their advisory system was designed to do—protect its citizens as soon as possible from dangerous foods. Even though the CFIA's system appears to have worked well in this case, it also seems like it could easily result in costly errors. By not setting a threshold number of complaints, or verifying the presence of gluten in a product before issuing such an advisory, it's possible that a costly mistake could be made, and if so, such an error could severely damage a small company. In this instance the company was a large one, which means that the product was distributed more widely, and it was therefore more important to react quickly, especially for those with anaphylaxis. Many people in the USA have reported complaining to the FDA about the possibility of gluten in products that are labelled "gluten-free," for example certain General Mills cereals, however it appears that the FDA has a much higher threshold for issuing a product recall. At the time of writing this article we could not verify exactly how the warnings sent into the FDA are used to issue a recall, but we assume that they follow up by testing the reported batch and/or lot number of the reported products, and if gluten is found we assume they issue the recall. We wonder if the FDA's current system would have been able to detect gluten in these chicken strips and issue a recall as quickly as the CFIA's advisory system did? On one hand it makes perfect sense to verify complaints with positive testing for gluten before issuing any recall, if only to avoid costly errors that could harm companies, on the other hand it's possible that such delays could cause serious injury, or even deaths. Ultimately it's possible that both countries' systems could learn something from one another, and each could be improved. Tell us in the comments below which food safety system you like better, the FDA's possibly more conservative approach, or the CFIA's seemingly more aggressive approach? Read the original consumer alert at: healthycanadians.gc.ca

09/01/2020 - Fresh from an FDA ruling that distilled foods made from gluten-containing grains can be labelled as “gluten-free,” the Distilled Spirits Council (DISCUS), the trade body for America’s spirits, is now pressing the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) change their policies to align the the FDA, and to permit all distilled products to be labeled as "Gluten-Free." The FDA's new ruling says that the distillation process removes all gluten from the finished product, even if the original ingredients contained gluten. The ruling is consistent with the advice of numerous allergy and nutrition groups, including Celiac.com, and the National Celiac Association, which state that distilled spirits, even those made from a gluten-containing grain, such as wheat, rye or barley, are gluten-free and should be considered safe for people with celiac disease and gluten intolerance. The FDA ruling helps to pave the way for for distilled foods and beverages made from gluten-containing grains to be labelled as “gluten-free.” However, a few regulatory hurdles remain. Chief among them, TTB policy currently states that some people with celiac disease or gluten sensitivities could become sick from spirits made from grains such as wheat. The TTB rule means that only spirits made from non-gluten-ingredients such as grapes, corn or potatoes, or products specially treated to remove gluten, may be labeled as gluten-free. DISCUS president, Chris Swonger, says the ruling will allow "gluten-free" labelling claims on distilled beverages made from gluten-containing grains. Swonger says that his organization is now urging TTB “to act quickly to revise their 2014 interim policy on gluten content statements to align with FDA’s final rule and begin allowing "gluten-free" statements on distilled spirits products made from gluten-containing grains. A change by the TTB, says Swonger, will permit a "Gluten-Free" label on distilled products made from gluten-containing grains, and will “provide additional clarity for consumers to make informed choices about which products meet their dietary needs.” These developments are big news for people with celiac disease who drink distilled beverages, and also for drinkers, in general, who will have more clarity.

Celiac.com 08/24/2020 - The U.S. Food and Drug Administration has issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the "gluten-free" claim. The new rule requires food manufacturers to ensure that products containing fermented, hydrolyzed ingredients meet the definition of “gluten-free” before fermentation or hydrolysis. According to the rule "because gluten breaks down during [fermentation or hydrolysis] and currently available analytical methods cannot be used to determine if these products meet the 'gluten-free' definition." That means that products made with wheat or gluten ingredients cannot be labelled gluten-free, even if they test at gluten to levels below 20ppm after processing. The rule covers food fermented products including soy sauce, yogurt, sauerkraut, pickles, cheese and green olives, and vinegar. The rule will helps to "ensure that common products labeled 'gluten-free' really are gluten-free, and will help to protect individuals with celiac disease," said HHS Secretary Alex Azar. The new rule is very much in keeping with the original FDA rule on gluten-free labeling forbids products made with wheat or gluten ingredients to be labeled "gluten-free." Are Distilled Products Gluten-Free Under New FDA Rule? The ruling specifically states that distilled products like vinegar, whiskey, gin and vodka, are considered gluten-free and safe for people with celiac disease, even if these products are made with gluten ingredients. The ruling is in keeping with the positions of most allergy, celiac and dietary organizations, which have long considered distilled products to be gluten-free. The rule just means that distilled products made with wheat or gluten can now advertise as "gluten-free." Distilled products have long been regarded as gluten-free by EU standards. Anyone with celiac disease who wishes to avoid these products, or who cannot tolerate them well, should continue to avoid them. Anyone with celiac disease who tolerates distilled products made from wheat or gluten ingredients, including whiskey, gin or vodka, can continue to enjoy them. In either case, they are unlikely to contain gluten, and are likely safe for people with celiac disease. So, if you tolerate whiskey and other spirits made from gluten, cheers! Read more at FDA.gov