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Celiac.com 06/10/2024 - The European Union's ban on certain single-use plastics in July 2021 has led to an increase in the use of biobased and biodegradable polymers for food contact materials (FCM). These materials, often made from renewable resources, include proteins from wheat and rye, which contain gluten, a known allergen and trigger for celiac disease. Currently, there is no legislation requiring allergen labeling on FCM, raising concerns about the potential for gluten migration into gluten-free foods and subsequent health risks for individuals with celiac disease or wheat allergies. Study Objective The study aimed to determine the extent of possible gluten migration between six different FCM into various liquid and solid foods to determine the overall risk of exposure for those with wheat allergy and/or celiac disease. The research focused on understanding how material properties, food types, and contact time influence gluten migration, with the ultimate goal of raising awareness and informing future legislation. Materials and Methods - Food Contact Materials and Food Samples Six types of biodegradable FCM were tested, including plates, forks, knives, straws, and a wafer cup. These materials were chosen based on their common availability in Germany. The study utilized various food simulants, including deionized water, acetic acid, ethanol, and olive oil, along with real-life beverages like coffee, Coca-Cola, pineapple juice, and sparkling water. Solid foods tested included gluten-free bread, fish sticks, ravioli, lasagna, and pizza base. Gluten Migration Testing Gluten migration was tested by exposing the FCM to the food simulants and real foods under conditions mimicking normal usage. Contact times varied depending on the material's stability, ranging from 10 to 60 minutes. Gluten concentration was measured using ELISA tests, specifically the RIDASCREEN Gliadin test kits, with a detection limit of 5 mg/kg. Results and Discussion - Gluten Content in FCM The study found significant amounts of gluten in the tested FCM, with levels ranging from 12.8 g/kg in some straws to 91.4 g/kg in wheat bran-based plates. These findings align with earlier studies from Spanish and Dutch researchers. Cutlery No detectable gluten migration was observed from the forks and knives into either the simulants or gluten-free bread, indicating that these specific cutlery items are likely safe for celiac disease patients. The lack of gluten migration is attributed to the cutlery's hardness, small contact area, and short contact times. Straws Gluten migration varied among the tested straws. Straws made from durum wheat semolina showed significant gluten migration into acidic and alcoholic simulants but not into water, coffee, Coca-Cola, or pineapple juice. In contrast, a straw made from rye stalks showed no detectable gluten migration, suggesting that stalk-based straws are safer alternatives for those with gluten sensitivities. Plates Wheat bran-based plates exhibited the highest potential for gluten migration, with substantial gluten levels detected in water, acetic acid, and ethanol, but not in oil. Solid foods placed on these plates also showed gluten contamination, especially with extended contact times. This variability underscores the inhomogeneous nature of the plates and their inconsistent stability. Wafer Cups Gluten migration from wafer cups into liquids was detected, particularly in deionized water, acetic acid, and ethanol. The study also noted the presence of partially hydrolyzed gluten, which can escape detection in some tests but was confirmed using a competitive ELISA. These findings suggest that wafer cups made from oat bran and wheat flour can pose risks to celiac patients, despite not being labeled as containing allergens. Conclusion This study demonstrates that gluten can migrate from certain biobased FCM into foods and liquids, posing a significant risk to individuals with celiac disease and wheat allergies. The extent of migration depends on the FCM's material properties, the type of food or liquid, and contact duration. The lack of mandatory allergen labeling on these materials creates a gap in consumer protection. Implications for Celiac Disease Patients For individuals with celiac disease, the study highlights the need for increased vigilance regarding the use of biodegradable FCM. Given the potential for gluten contamination, patients should avoid using unlabeled biobased FCM, especially those with visible grain components like wheat bran. The study calls for urgent regulatory changes to include allergen labeling on FCM, ensuring that consumers can make informed choices and avoid gluten exposure. This research underscores the importance of comprehensive testing and clear labeling to protect the health and safety of those with celiac disease as the use of biobased and biodegradable FCM continues to grow. Read more at: springer.com

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 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.

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

Celiac.com 01/12/2011 - When Americans shop for caffeine-free tea or soda, the process is a simple one. First, they find their brand of choice, scan the labels for “decaffeinated,” then toss the product into their shopping baskets. Unfortunately, it’s not that simple to find gluten-free versions of foods. Although proposals for gluten-free labeling laws are in the works, currently there is no official definition in this country for “gluten-free,” meaning that gluten-free shoppers can’t rely on a gluten-free label to tell them whether a food product is gluten-free. According to Living Without, neither of the two major food government agencies, the U.S. Department of Agriculture, which regulates egg, meat, and poultry products, nor the FDA, which regulates packaged and other foods, have a specific definition for “gluten free.” Currently, the FDA’s standard for gluten-free labeling is that the label be “truthful and not misleading,” so if a food product is designated “free” of an ingredient, it shouldn’t have that ingredient in it. Whereas certain products can claim to be “free” of substances such as caffeine, a fact which can be confirmed with testing, the analytic technology for testing for zero gluten doesn’t exist yet. Gluten is tested in parts per million (ppm), and currently the smallest detectable amount is 20 ppm. According to Living Without, while celiac experts seem to agree that this is a safe gluten level, other countries define “gluten-free” as containing below 20 ppm of gluten. This means that the current FDA guideline isn’t very useful when it comes to gluten-free labeling. The American Celiac Disease Alliance has published on its website, AmericanCeliac.org, a question-and-answer series from the FDA on the current gluten-free labeling guideline proposals, which were developed in 2006 in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. Due to the limitations in the current analytic technology, the current proposals require that a product contain less than 20 ppm of gluten. According to Living Without, “With the number of products making unregulated gluten-free claims on the rise, the marketplace can be potentially dangerous for consumers with gluten sensitivity and wheat allergy.” Before a labeling regulation can be put into effect, however, the FDA needs to make another draft of the proposal available to the public, then gather and consider the commentary it generates. Following this, a notice regarding the safety assessment must be published. “The FDA will likely publish the notice on the safety assessment soon,” Celiac.com reports, but there is no indication as to just when they will issue the final rule. With “gluten-free” labeling on the rise, it seems more crucial than ever to get these regulations passed with a clear definition for “gluten free.” With even the tiniest amount of gluten having the capacity to make celiac patients ill, reading labels when shopping for gluten-free foods is a fundamental skill to be acquired from the very start of a gluten-free diet. Until there is a standard definition for “gluten-free” and a reliable set of FDA guidelines governing voluntary gluten-free labeling, celiacs need to be especially vigilant when hunting for gluten-free foods. This watchfulness begins with the vital understanding that a “gluten-free” label doesn’t guarantee a product is gluten-free. Resources: • American Celiac Disease Alliance: Gluten-Free Labeling Proposed Rule • Celiac.com: FDA Set to Adopt New Gluten-Free Labeling Standards In-Line with New Codex Alimentarius Standards • Diet.com: Contamination of Naturally Gluten-Free Grains • “GF Product CLAIMS: Can You Trust Them?” Living Without: April/May 2010.

Celiac.com 06/13/2017 - Are consumers wrongly assuming gluten-free foods to be nutritionally equivalent to their gluten-containing counterparts? Are they being mislead? That's the subject of a recent talk presented at the 50th Annual Congress of the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). Among the evidence cited was that gluten-free items have a significantly higher energy content and a different nutritional composition to their gluten-containing counterparts. The presentation also notes that many gluten-containing products, especially breads, pastas, pizzas and wheat-based flours, contain up to three times more protein than their gluten-free counterparts. In all, the study assessed 654 gluten-free products, and compared them against 655 gluten-containing products. Among the group's key findings were that gluten-free breads had significantly higher content of lipids and saturated fatty acids; gluten-free pasta had significantly lower content of sugar and protein; and gluten-free biscuits had significantly lower content of protein and significantly higher content of lipids. These differences can have adverse effects on children's growth, and increase the risk of childhood obesity. The gist of the presentation is that gluten-free products cannot be considered as substitutes for their gluten-containing counterparts, and that numerous gluten-free items should reformulated using healthier ingredients to help promote healthy nutrition in children. Not only are gluten-free products generally poorer in their nutritional composition, but consumers may not be unaware of the crucial differences, due to poor nutritional labelling. Dr Sandra Martínez -Barona, fellow lead researcher, states that "labelling needs to clearly indicate this so that patients, parents and carers can make informed decisions. Consumers should also be provided with guidance to enhance their understanding of the nutritional compositions of products, in both gluten-free and gluten-containing products, to allow them to make more informed purchases and ensure a healthier diet is followed." ESPGHAN expert and lead researcher, Dr Joaquim Calvo Lerma, adds that "…it is imperative that foods marketed as substitutes are reformulated to ensure that they truly do have similar nutritional values. This is especially important for children, as a well-balanced diet is essential to healthy growth and development." Stay tuned to see how the gluten-free food industry responds to efforts by ESPGHAN to improve both gluten-free product formulation, and gluten-free labeling to help people make better nutritional choices. Source: European Society for Paediatric Gastroenterology Hepatology and Nutrition