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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 11/30/2024 - Gluten is a protein found in wheat, barley, and rye that can cause severe health issues for individuals with celiac disease or gluten sensitivity. Most people are aware of the obvious sources of gluten in foods like bread, pasta, and baked goods, but gluten can also hide in less obvious places. From processed foods to personal care products, gluten can sneak into your daily routine in ways you might not expect. Let's explore some of the hidden sources of gluten that you need to watch out for, and some practical tips on how to avoid them. Sneaky Gluten in Processed Foods Gluten is often used as a thickening agent or filler in a wide range of processed foods, making it difficult to avoid unless you carefully check ingredient labels. Below are some common food categories where gluten may be lurking: 1. Sauces and Condiments Many sauces and condiments contain gluten as a thickening agent or as part of flavor additives. Soy sauce, for example, is typically made from fermented wheat, making it a major gluten offender. Barbecue sauces, salad dressings, marinades, and gravy mixes may also include gluten, even if they don’t taste like wheat-based products. To be safe, look for products labeled "gluten-free" or opt for tamari as a gluten-free soy sauce alternative. 2. Processed Meats Gluten can be hidden in processed meats like sausages, hot dogs, deli meats, and pre-packaged burger patties. These products may contain breadcrumbs or other gluten-based fillers that help bind the meat. Always read labels carefully and choose brands that specifically state they are gluten-free. 3. Spice Blends and Seasonings It’s easy to assume that individual herbs and spices are naturally gluten-free, but premade spice blends and seasoning mixes can be a surprising source of gluten. Some manufacturers add flour or wheat starch as an anti-caking agent to keep spices from clumping. When shopping for spices, opt for single-ingredient options or gluten-free labeled spice blends. 4. Soups and Broths Packaged soups and bouillon cubes are another area where gluten can sneak in. Flour is often used to thicken soups, and barley is sometimes added as a flavoring agent. Even broths, which seem like a safe choice, can sometimes include gluten-based additives. When in doubt, choose brands that are certified gluten-free or make your own soups at home. 5. Candy and Sweets Surprisingly, some candies contain gluten, particularly those with malt flavoring, which is derived from barley. Chewy candies, licorice, and even chocolate bars can contain gluten, making it essential to check the ingredient list before indulging in your favorite treats. Check out our list of gluten-free candy. Gluten in Non-Food Products While most people are vigilant about avoiding gluten in their food, they may not realize that gluten can also be found in personal care and household products. While it may not cause an internal reaction unless ingested, using products containing gluten can still pose risks, especially for those with severe celiac disease or gluten sensitivity. 1. Beauty Products Gluten is sometimes used as a binding agent or filler in cosmetics and skincare products, including makeup, lotions, and shampoos. Lipsticks and lip balms, in particular, can be risky because they are applied to the mouth and could be accidentally ingested. Always choose beauty products that are labeled gluten-free, and be especially cautious with anything that could come into direct contact with your mouth. 2. Hair Care Products Shampoos, conditioners, and hair styling products can also contain gluten, which might surprise many. While gluten in these products may not be absorbed through the skin, the risk arises from accidentally ingesting small amounts of product while washing your hair. For people with gluten sensitivity, using gluten-free hair care products is a safer choice. 3. Medications and Supplements Some over-the-counter medications, vitamins, and supplements use gluten as a filler or binder. This can be particularly concerning because gluten content in these products may not always be clearly listed on the label. Speak to your doctor or pharmacist about gluten-free alternatives, and always check with manufacturers to verify whether their products contain gluten. You can search this site for prescriptions medications, but will need to know the manufacturer/maker if there is more than one, especially if you use a generic version of the medication: dailymed.nlm.nih.gov. To see the ingredients you will need to click on the correct version of the medication and maker in the results, then scroll down to "Ingredients and Appearance" and click it, and then look at "Inactive Ingredients," as any gluten ingredients would likely appear there, rather than in the Active Ingredients area. 4. Toothpaste and Mouthwash Although most toothpastes and mouthwashes are naturally gluten-free, in rare cases they can also contain gluten, especially those that include flavorings or thickeners. Since these products come into direct contact with your mouth, choosing gluten-free options is crucial to avoid accidental ingestion. 5. Household Products Though less common, certain household items, such as dishwashing detergents and cleaning products, may also contain gluten-derived ingredients. While the chances of ingesting gluten from these products are low, people with severe gluten sensitivities may prefer to use gluten-free cleaning products to eliminate any risk. Tips for Avoiding Hidden Gluten Navigating the hidden sources of gluten can be challenging, but with a few smart strategies, you can protect yourself from accidental exposure. 1. Read Labels Carefully One of the most important steps is to always read labels, even on products you wouldn't expect to contain gluten. Gluten can be hidden in ingredients like "malt," "wheat starch," or "hydrolyzed wheat protein." However, labels are not always complete or clear, especially when it comes to processed foods and non-food items. This is where visiting the company's website can be incredibly helpful. Many companies provide detailed ingredient lists, frequently asked questions, and information on whether their products are gluten-free. In fact, some manufacturers will even provide documentation or certification on their websites that guarantees their products have been tested and meet the standards for being labeled gluten-free. If the information online is still unclear, don’t hesitate to contact the company directly. Most companies have customer service hotlines or email support where you can ask specific questions about the gluten-free status of a product. When contacting the company, ask about their manufacturing processes and whether their products are made in facilities that handle gluten, as cross-contamination can sometimes occur. You can also inquire if they perform regular gluten testing on their products to ensure they meet safety standards. By taking this extra step, you can get accurate, up-to-date information and have peace of mind knowing exactly what you’re consuming or using. Taking a proactive approach and engaging with manufacturers ensures you are fully informed about the products you use, which is crucial for maintaining a gluten-free lifestyle. 2. Choose Certified Gluten-Free Products Many companies now offer certified gluten-free options across a wide range of categories, from food to beauty products. Products with a certified gluten-free label have undergone rigorous testing and must meet strict standards, such as containing less than 10 parts per million (ppm) of gluten, 50% less than that required by regulatory agencies like the FDA. This certification process is typically conducted by third-party organizations to ensure the product is safe for those with celiac disease or gluten sensitivities. On the other hand, items simply labeled "gluten-free" may not always meet these stringent testing requirements. While the "gluten-free" label indicates the product doesn’t contain gluten ingredients, it may still carry a higher risk of cross-contamination if it's not certified. Whenever possible, opt for certified products to have an extra layer of assurance, but at the very least, choose items clearly marked "gluten-free" to reduce the risk of gluten exposure. 3. Ask Questions When dining out or trying new products, asking the right questions is essential to protecting yourself from hidden gluten. Restaurants, in particular, can be a major source of gluten exposure, even when offering gluten-free options. Cross-contamination often occurs in kitchens where gluten-containing ingredients are used alongside gluten-free ones. For example, a restaurant might prepare gluten-free pasta but cook it in the same pot or water used for regular pasta, or gluten-free pizza may be made on the same surface used for dough containing wheat. This can result in trace amounts of gluten making their way into your meal, enough to trigger symptoms in those with celiac disease or gluten intolerance. To avoid this, don’t hesitate to ask the restaurant staff how they prepare gluten-free meals. Some important questions to ask include whether they use separate utensils, cookware, or prep areas for gluten-free foods, and if they train their staff on gluten safety. You can also inquire about specific ingredients and how they ensure their gluten-free options remain safe from cross-contact. Many restaurants are happy to accommodate special dietary needs, but it’s always a good idea to have a thorough conversation before ordering to ensure your meal is safe. 4. Stay Vigilant with Cross-Contamination Even products that are naturally gluten-free can become contaminated with gluten during manufacturing or preparation. For example, oats are often processed in facilities that also handle wheat, which can lead to cross-contamination. Make sure to choose products that are labeled as gluten-free and produced in dedicated gluten-free facilities. When trying new products, it’s equally important to verify the gluten content. Some products may claim to be gluten-free but are processed in facilities that handle gluten-containing grains, leading to potential cross-contamination. If you’re unsure about the gluten status of a product, it’s worth reaching out to the manufacturer for clarification. As mentioned earlier, many companies offer detailed information online, but if anything is unclear, don’t hesitate to contact them directly. Ask about their gluten-free certification process, whether the product is tested for gluten, and if the manufacturing facility handles other gluten-containing products. By staying informed and asking the right questions—whether at a restaurant or with a product manufacturer—you can better protect yourself from accidental gluten exposure. This proactive approach is essential for maintaining your health and continuing your gluten-free journey safely. Conclusion: The Importance of Staying Gluten-Free For individuals with celiac disease or gluten sensitivity, avoiding gluten is critical to maintaining good health. Hidden gluten in everyday products, from sauces to beauty items, can be tricky to spot but can still cause harm. By becoming more aware of where gluten might be hiding and making conscious choices about the products you use and consume, you can significantly reduce the risk of accidental gluten exposure. Staying vigilant, reading labels, and choosing gluten-free certified products can help ensure that you live a safe and healthy gluten-free lifestyle. 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 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 11/12/2022 - It is the issue that unites every family affected by celiac disease: The need for clear and understandable food labeling in the United States. At a time when so few celiacs receive a diagnosis, those that do often fend for themselves when learning the gluten-free diet. Mistakes are made, and the person with celiac disease can face debilitating symptoms and health problems later in life. After years of working to raise awareness, the celiac disease community felt the floodgates open when the U.S. celiac disease prevalence study was published in the Archives of Internal Medicine. Since February, there has been a significant amount of news coverage on celiac disease, including a segment on the Today Show, articles in the nation’s most prominent newspapers and news segments on local television stations across the country. A key group of advocates has come together to build on this momentum, specifically by calling on Congress to enact legislation that would significantly improve food labeling for consumers affected by celiac disease and food allergies. The American Celiac Task Force is comprised of research institutions, support organizations and industry representatives (14 organizations in all) that have been working since March to develop and implement a comprehensive strategy on food labeling. The Task Force is lead by highly experienced advocates who have a track record of success on Capitol Hill and are personally affected by celiac disease. The primary objective of the Task Force is to influence the development of legislation that addresses the most important issues of the celiac community in a manner that is likely to be approved at the committee level and in both houses of Congress, and then signed into law. While many celiacs have noticed that companies such as Kraft have voluntarily begun to identify the eight major food allergens in their foods (dozens of companies have voluntarily done the same), this arrangement has been at the initiative of the manufacturer, and many food companies are not doing so. The American Celiac Task Force has decided to join forces with the food allergy community to work towards a comprehensive bill that will require companies to label the eight major food allergens in their foods. Wheat is one of those allergens, and it is the ingredient that causes the most headaches and heartaches for the celiac community (rye is almost never labeled as anything but, and barley, when not labeled barley is most often listed as malt). This approach is most ideal because it has already received some industry support (evidenced by voluntary labeling) and it is not a piecemeal approach to labeling, unlike legislation that calls for labeling only the sources of spices and natural flavors. The American Celiac Task Force strategy would effectively encompass that and far more. The reality of enacting food labeling legislation for celiacs is that a label stating "gluten-free" will not be acceptable to lawmakers and the industry (think of the last time you called a company and they said "we cannot guarantee that this product is gluten-free"). Eliminating the fear of lawsuits is the key to developing—and passing—food labeling laws. While we would all wish it to be the case, it is not possible to legislate away all of the work that a celiac has to do in order to go grocery shopping. You can imagine, however, what a tremendous burden would be lifted if you could read a statement that says “this product contains wheat.” Many celiacs and their families are experiencing this now when they purchase a Kraft product, for instance. What you imagine today could become real in the near future, but not without your help. Join the efforts of the American Celiac Task Force and speak with one voice to educate and influence members of Congress. You can find out how by going to www.celiaccenter.org/taskforce.asp and registering to receive regular updates. You can go to www.capwiz.com/celiac to send your member of Congress a letter urging them to support better food labeling laws. Most importantly, if you receive publications, mailings or are a member of an organization on the American Celiac Task Force (such as the University of Chicago Celiac Disease Program) you can be assured that you will be hearing more about the American Celiac Task Force and what you can do to help this tremendous effort. Each organization is working to educate its own constituency directly, in addition to a public effort to urge families to join this effort. Make sure you do your part.

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 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 03/15/2022 - A lawsuit filed in Missouri accuses food retailer Frickenschmidt Foods of mislabeling products as gluten-free, when they actually contain gluten. The suit accuses Frickenschmidt of labeling its Wicked Cutz Teriyaki Beef Stick as gluten-free, despite the fact that, according to plaintiff Oluwakemi Adewol, the product does contain gluten. The plaintiff seeks declaratory, injunctive and monetary relief, including punitive damages and “restitution and disgorgement,” herself and “all others similarly situated," on behalf of three separate classes of product purchasers: a “Multi-State Consumer Class” that includes California, Florida, Illinois, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, New York, Pennsylvania, Oregon, and Washington; a specific Maryland Class; and a Nationwide Class. The suit comes in the wake of a finding by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), on February 22, 2022, which determined that Frickenschmidt's Wicked Cutz Teriyaki Beef Stick contains wheat and thus is not ‘gluten free,’” and accordingly, that the FSIS “ordered a recall for approximately 6,000 pounds of the Product that remained in the marketplace.” In the complaint, the plaintiffs claim that consumers would not have purchased the product, or have paid a premium for the product, had they known the product contained gluten. The complaint alleges five causes of action: Violation of State Consumer Protection Statutes (On Behalf of the Multi-State Consumer Class); Violation of the Maryland Consumer Protection Act; and Breach of Express Warranty, Breach of the Implied Warranty of Merchantability and Unjust Enrichment, all on behalf of the Nationwide Class. We'll keep you posted if this suit moves forward. Stay tuned for more on this and related stories. Read more at LawStreetMedia.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 06/21/2021 - In a move that could help to protect people with celiac disease who purchase oral drugs, a senator in the Illinois State Legislature has sponsored a measure to require oral drugs to carry proper warning labels to alert users to the presence of gluten or other allergens. “Restaurants and grocery stores have increased their gluten-free offerings and have become far better equipped to properly label and handle items for people with dietary restrictions,” Morrison said. “People with Celiac and other gluten intolerances should feel just as protected when visiting a pharmacy.” Under the recently passed legislation, any prescription or over-the-counter drug that contains gluten that is not labeled would be considered misbranded. The fact is that most oral drugs do not contain gluten, so many consumers assume that all are gluten-free, unless otherwise specified. However, that is not true. Currently, many oral drugs do contain gluten ingredients that are not labeled and not required to be labeled by law. Inadvertently consuming gluten can be harmful to with celiac disease or other gluten intolerance, and may interfere with the action of some medications. “The measure will make it easier and safer for people with Celiac disease or gluten sensitivity to make informed purchases of necessary medications,” Morrison said. “We expect the food we purchase to be properly labeled, so why shouldn’t we expect the same from the medications we take?” Illinois House Bill 279 has now passed both chambers, and now goes to the Governor for approval. Read more at illinoissenatedemocrats.com.

Celiac.com 10/26/2020 - The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) has announced a new policy that permits any distilled spirits made from gluten-containing grains to be labeled as "gluten-free." The move follows a ruling by the US Food and Drug Administration (FDA) in July that permits any distilled foods made from gluten-containing grains to be labelled "gluten-free." Previously, both rules permitted gluten-free labeling only on distilled spirits made from non-gluten ingredients, such as grapes, corn or potatoes. Following the FDA rule change, the Distilled Spirits Council of the US (Discus), an alcohol industry trade group, urged the TTB to update its policy to match FDA rules. In response, the TTB updated its rule on 13 October. Discus CEO and president, Chris Swonger, welcomed the move, saying that the new rule "...provides additional clarity for consumers and allows for more information to assist them in making informed decisions about what products meet their dietary needs. This policy update also provides greater flexibility for industry members in labeling their products." To match the new policy, the TTB has rewritten the rules for gluten content statements on labels and in advertisements for distilled spirits, wine and malt beverages regulated under the Federal Alcohol Administration Act. Under the revised ruling, TTB permits the use of the term "gluten-free" for labeling if the product meets FDA regulations for gluten-free labeling. However, companies are required to follow manufacturing practices that prevent any gluten-containing material from entering the final product. Additionally, TTB will continue to allow labels and advertisements for products fermented from gluten-containing grains to declare that the product has been processed to remove gluten. The TTB will require documentation to support the claim. It has long been known, and scientifically proven, that distillation removes removes gluten from the final product, and that all distilled spirits are gluten-free. Numerous health professionals and celiac support groups, such as Celiac.com and Coeliac UK, permit the consumption of spirits as part of a gluten-free diet.

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 06/15/2020 - Usually, when a food manufacturer makes an ingredient change, even a minor one, to a food product, they must produce a new label for all the changed products. However, Covid-19 has changed that. Responding to calls from food manufacturers facing supply chain problems in the wake of the Covid-19 pandemic, the Food and Drug Administration (FDA) is relaxing some labeling requirements for certain ingredients in food in the U.S. The move will give food manufacturers the ability make small changes to the ingredients in a product without making label changes. That may mean adding, omitting, or blending ingredients to meet the product needs. The FDA guidance on the matter states that such labeling changes "should not cause any adverse health effect, including those from gluten and food allergens." The guidance states that ingredients used as substitutes should not alter any voluntary nutrient or health claim on the label, such as gluten free, and that ingredients that are the reason for the label should not be changed. Basically, “Manufacturers should avoid substitutions that could result in a safety concern without making a conforming label change or providing other means to inform consumers of the change,” the new guidance says. The FDA wants to avoid any risk of allergic reaction due to any such substitutions, and the temporary rule change reflects that. The safety, claims, and prominence section of the guidance specifically states that no gluten ingredient can be used as a substitute for a gluten-free ingredient. The flexibility in labeling will continue for the duration of the public health emergency declared by the Department of Health and Human Services, including extensions. The FDA notes that it may consider extensions, depending on how quickly supply chains return to normal. For questions, answers, and more information, read the FDA's page on Food Safety and the Coronavirus Disease 2019 (COVID-19)

Celiac.com 03/28/2020 - Were you thinking that there wasn't much gluten in your medicine? Had you read that less than 1% of drugs were made with it? Think again, because while pharmaceutical manufacturers don't actually add gluten to drugs in most instances, they very frequently cannot say that their products are gluten free. That's because before some ingredients get into a manufacturing facility, they are purchased from suppliers that are not controlled by the drug maker. Let me explain. When you take a drug, most of what you are swallowing is filler. This is called an excipient in the trade. Excipients are inert stuff that the actual drug is mixed with, and it influences the rate the drug enters your blood. For people with celiac disease, the problem is that the excipient is often made from starches derived from corn, rice, tapioca, etc. If you're reading this, you probably just recognized how gluten could be getting into your medicine even when a drug maker did not intentionally use gluten as the excipient. Drug companies affirm that even when they have not added gluten to a particular drug, there could be gluten in that drug, and they won't say the drug is gluten free. Here is where Sister Jeanne Patricia Crowe Pharm.D. (no relation to the actor) comes into the picture. About ten years ago Sister Jeanne Patricia did a study which established just how much trouble drug makers had even knowing when there was gluten in their products. Working with her research partner Nancy Patin Falini M.A., R.D., Crowe sent out questionnaires to about 170 drug makers asking each what the gluten content of their medicine was. Their results were published in the American Journal of Health-System Pharmacy in 2001 (1). In their peer reviewed article titled Gluten in Pharmaceutical Products, the two researchers were able to conclude the following: Only 5 of 100 pharmaceutical companies that responded to a survey reported having a policy of producing gluten-free products. Many companies believed their products were gluten-free but could not guarantee it. But what Crowe and Falini's results also showed was that drug makers themselves had a hard time making sure that when they bought an ingredient from an outside supplier, that they were not letting gluten get into their manufacturing facility. Two other studies support the Crowe and Falini findings, so they are pretty convincing. Simply put, gluten can be making its way into your drugs, and you can't find out about it because the drug manufacturer also doesn't know it's there. And if the drug maker doesn't know, then when your pharmacist helps you to read the package insert, it really won't matter much what it says on the label. This chaotic situation is not acceptable for the manufacture of medication. At the least, a company that makes drugs needs to determine whether they are making their product with an excipient like corn starch, and whether that the corn starch is gluten-free. Either the excipient is gluten-free or it isn't. Even when a consumer goes to buy a gluten-free food like Cheese Curls, the manufacturer at least has a letter from its raw ingredient suppliers, stating that the ingredients are gluten-free. Some food makers will even test every batch of raw ingredient before it enters their own facility. It isn't too much to ask that drug makers learn what's in their products. The FDA is currently looking at how to address the issue of gluten in medications. One approach is to require that drug makers disclose when a particular drug is gluten-free. At the other extreme, as a petitioner, I have argued that because gluten is toxic, the law of the United States should be satisfied, and gluten should be taken off the list of allowed excipients. But the work of Sister Crowe and Nancy Falini has demonstrated just why the FDA must take a step back and first require drug makers themselves to know exactly what's inside that pill or capsule. I hope that I've gotten at least a few of you wound up. I'm a bit surprised that drug makers would put themselves in a position where they sometimes don't know what's in any given pill they make. Don't they see the liability issues? Where are their lawyers, anyway? In the first article I wrote for celiac.com, I asked readers to let the FDA know that they wanted to get gluten out of drugs, and many people did exactly that. And those comments do get read. Now I am going to make sure that the FDA takes into account the work of Sister Crowe and Nancy Falini. Tell the FDA what you think. Maybe next time you fill a prescription for whatever ails you, it will be possible for you and your pharmacist to determine whether gluten is present in your medication. Michael Weber lives in New York and can still remember what pizza tastes like. References: 1. Crowe, JP, Falini, NP Gluten in pharmaceutical products Am J Health Syst Pharm 2001 58: 396-401

Celiac.com 06/18/2015 - An Irish distillery has run afoul of regulatory authorities over labels that tout its gin and vodka as "gluten-free." The artisanal, Cork-based, St Patrick's Distillery claims it is a common misconception that all gin and vodkas were gluten-free. The company claims that, since its products are made with gluten-free ingredients, its labels are accurately distinguishing its vodka and gin from other products made with wheat. However, after numerous complaints, the Food Safety Authority of Ireland plans to follow up on the distillery's claims. The FSAI points out that all distilled beverages are gluten-free, calls the claims misleading, and says the company could be in breach of strict Irish food-labeling laws. A spokesperson for th FSAI said: "Under the Food Information for Consumers Regulation, the food information must not mislead the consumer by suggesting that the food possess special characteristics when, in fact, all similar foods (in this case, vodka and gin) possess such characteristics." Niamh O'Connor, who runs Cork Nutrition, said she that she was incredulous about the company's claims. "It is an absolute indisputable fact that distilled spirits are gluten-free, even if gluten-containing grains are used as a raw ingredient," said O'Conner. "Therefore…all gin and vodka products are gluten-free so one cannot label their own product as "gluten-free." Ireland's Coeliac Society, which supports people with the food intolerance, described the claims from St Patrick's Distillery as "unhelpful". "Wine, spirits, and cider are gluten free," said the society's Gráinne Denning. In addition to labeling their gin and vodka as "gluten-free," the company also refers to their new range of spirits as being lactose free. Of course, all distilled spirits are naturally dairy free and lactose free. What do you think? Are such labels helpful, or misleading? Share your thoughts below.

Celiac.com 07/26/2019 - The Food and Drink Federation (FDF) is a support group that advocates for the food and non-alcoholic drink manufacturing industry, and certain food sectors in the UK. Seeking to provide clarity for consumers and consistency for manufacturers over gluten labeling, the FDF recently issued a set of product labeling guidelines called the Gluten Labeling Guidance: Best Practice for Pre-packed Foods which Include or Exclude Cereals Containing Gluten. The FDF guidelines address various labeling scenarios, with special attention to oat and wheat types. The guidelines include information about the differences between celiac disease and cereal allergy, advice on precautionary allergen labeling, and flow charts for making claims about gluten absence in a given product. They also include an overview of the relevant EU and UK laws and policies. Consumers rely on labels in order to make safe, informed choices about packaged foods. For consumers with food allergies or sensitivities, labels become even more important. Did the food originally contain gluten ingredients? Is it naturally gluten-free? Is it produced in a dedicated facility? For these and other reasons, it is crucial for manufacturers to label their products in compliance with law. That's where FDF comes in. FDF is committed to providing best-practice regulatory guidance, and looks for its new, more comprehensive guidelines to help food manufacturers, large and small, to make safe, informed choices for their package labels, says Alex Turtle, food law, labeling and enforcement manager, FDF. The march toward clear, consistent and helpful package labeling for gluten-free and other foods is an ongoing affair, but the FDF's latest guidelines represent a small victory for all sides in the world of gluten-free foods. The new guidelines are supported by Coeliac UK, Anaphylaxis Campaign, the British Retail Consortium and the Gluten Free Industry Association. Read more at IFST.org