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Frequently Asked Questions About Celiac Disease

Gluten Busters: Gluten-Free Product Alerts by Celiac.com

A blog by Scott Adams

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Keep up to date on any product recalls due to mislabeled products.

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Food Recall Warning (Allergen) - Kim Châu brand Spring Roll recalled due to undeclared egg and wheat

Kim Châu Vietnamese Deli Ltd. is recalling Kim Châu brand Spring Roll from the marketplace because it contains egg and may contain wheat which are not declared on the label. People who have an allergy to egg or wheat, celiac disease or other gluten-related disorders should not consume the recalled product described below. Recalled products Brand Name Common Name Size Code(s) on Product UPC Kim Châu Spring Roll None All packages where egg and wheat are not declared on the label 6 22384 00010 2

September 13

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Gluten-Free Beer Maker Glutenberg Recalls Non-alcoholic Beer Because it Contains Alcohol

The Glutenberg Microbrewery announces that it is voluntarily recalling certain "Glutenberg non-alcoholic" brand beer beverages because of a higher alcohol content than indicated on the package. Only packaging with cans bearing lot code 24606298 and the expiry date of March 29, 2019 are affected by this recall. Tests on previous batches of "Glutenberg without alcohol" had confirmed that they all contained an alcohol level corresponding to that indicated on the packaging, ie 0.1%. The analyzes of lot 24606298, however, revealed that the latter contained an alcohol content of 3.4%. "We do not compromise on the products we offer to consumers. We decided to proceed with this voluntary recall because it is important for us that consumers have the right time when they buy our products and can always trust that they are getting exactly the product they have chosen. Corrective measures have already been put in place to validate the alcohol content of this product even more accurately and to prevent this from happening again, "said David Cayer , Chief Executive Officer . Most of this lot has already been recovered before being sold. All retailers were also contacted to have the product removed from the shelves. Consumers who have purchased these products can take them back to their retailer for a refund or contact the company at info@glutenberg.ca. About the Glutenberg Microbrewery Glutenberg Microbrewery is a leader in the gluten-free beer segment. Winner of 5 World Beer Cup awards and 21 awards at the Canadian Brewing Awards, she is recognized as the world's best gluten-free microbrewery. Glutenberg Microbrewery's sales reach more than 2,000,000 L per year in 10 Canadian provinces, 26 US states and 8 countries. Source: newswire.ca

July 31

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Quorn recalls a batch of its 2 Gluten Free Burgers packs because of undeclared gluten

Quorn is recalling packs of 2 Gluten Free Burgers because they contain undeclared gluten
which is not mentioned on the label. This means the product is a possible health risk for
anyone with an allergy or intolerance to gluten. Product details: Product: Quorn 2 Gluten Free Burgers Pack size: 2 pack (227g) Batch code: 708049 Best Before: 30-Nov-19 No other Quorn products are known to be affected
Risk: Gluten This product contains gluten making it a possible health risk for anyone with an allergy or intolerance to gluten. Our advice to consumers:
If you have bought the above product and have an allergy or intolerance to gluten do not eat it. Instead return it to the store from where it was bought for a full refund. Action taken by the company:
Quorn is recalling the above product from customers and has contacted the relevant allergy support organisations, who will tell their members about the recall. The company has also issued a point-of-sale notice to its customers. These notices explain to customers why the product is being recalled and tell them what to do if they have bought the product. Please see the attached notice. Source: food.gov.uk

July 30

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Van's Foods Voluntarily Recalls Gluten Free Waffles in Eleven States

Van's Foods is voluntarily recalling approximately 1,584 cases of Van's Gluten Free Waffles with a lot code date of #A640234710–WL2, BEST BY AUG 22, 2018 and UPC CODE 8994730206. The products were distributed solely to food retailers in Arkansas, California, Colorado, Georgia, Illinois, Michigan, New Jersey, New York, Pennsylvania, Texas and Wisconsin. The products are being recalled because a limited number of the wrong packaging were used during the production of Van's Belgian Waffles. The product inadvertently packaged in the Van's Gluten Free Waffle box contains gluten and undeclared milk. People who have an allergy or severe sensitivity to milk or gluten run the risk of serious or life-threatening allergic reaction if they consume these products. To date, Van's Foods has received no reports of illnesses or adverse reactions associated with the effected products, which was ordered and shipped to retail customers as Van's Belgian HS WF, Item number 30201, Product Lot #A640234710–WL2, BEST BY AUG 22, 2018. The effected retail packages are labeled as Van's Gluten Free Original, Item number 30206, Product Lot #A640234710–WL2, BEST BY AUG 22, 2018. No other Van's branded products are affected by this voluntary recall. Pkg SKU Brand Product Description Code Date 30206 Van's Van's Gluten Free Original BEST BY : AUG 22 2018
A640234710-WL2* Case SKU Brand Product Description Code Date 30201 Van's Van's Belgian HS WF 12/8 BEST BY : AUG 22 2018
A640234710-WL2 *Van's Gluten Free retail packages with a code containing WL1 are NOT subject to this recall. Consumers who have purchased these products or have questions are requested to contact Van's Consumer Relations department at 1-866-886-8456 for additional information and/or reimbursement. News media and health department officials who have questions should contact Caroline Ahn at 312-614-6047. Source: fda.gov

April 30

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Kamy brand Salad Dressing recalled due to undeclared milk and wheat

Trust Express Inc. is recalling Kamy brand Salad Dressing from the marketplace because they contain milk and wheat which are not declared on the label. People with an allergy to milk or wheat, celiac disease or other gluten-related disorders should not consume the recalled products described below. The following products have been sold in British Columbia and Ontarioand may have been sold in other provinces or territories. Recalled products: Brand Name Common Name Size Code(s) on Product UPC Kamy Salad Dressing 230 mL BAT NO: 230-11-07-79
Pro: 02.2017
Best before: 02.2019 6 260129 410010 Kamy Salad Dressing 680 mL BAT NO: 210-11-07-67
Pro: 02.2017
Best before: 02.2019 6 260129 410034 Source: inspection.gc.ca

April 13

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Durra brand seasoning products recalled due to undeclared sesame and wheat

The food recall warning issued on March 28, 2018 has been updated to include additional product and allergen information. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. Phoenicia Group Inc. is recalling Durra brand seasoning products from the marketplace because they may contain sesame and wheat which are not declared on the label. People with an allergy to sesame or wheat, celiac disease or other gluten-related disorders should not consume the recalled products described below. Recalled products Brand Name Common Name Size Code(s) on Product UPC Durra Mansaf Seasoning 70 g PD: 10/05/2017
BB: 09/04/2019
Lot: 03 6 251136 007096 Durra Dukka Madiny 350 g PD: 11/05/2017
BB: 10/04/2019
Lot: 02 6 251136 001124 Durra Kabsa Mix 75 g PD: 23/12/2017
BB: 22/12/2019
Lot: 16 6 251136 007133 Durra Kabsa Mix 75 g PD: 10/04/2017
BB: 09/04/2019
Lot: 03 6 251136 007133 Durra Biryani Mix 75 g PD: 23/12/2017
BB: 22/12/2019
Lot: 14 6 251136 014896 Durra Biryani Mix 75 g PD: 10/04/2017
BB: 09/04/2019
Lot: 03 6 251136 014896 Source: inspection.gc.ca

April 13

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La Cocina Dyck brand Tamales recalled due to undeclared wheat

La Cocina Dyck is recalling La Cocina Dyck brand Tamales from the marketplace because they contain wheat which is not declared on the label. People who have an allergy to wheat, celiac disease or other gluten-related disorders should not consume the recalled products described below. Recalled products Brand Name Common Name Size Code(s) on Product UPC La CocinaDyck Turkey Tamales 12 pieces All lot codes where wheat is not declared on the label 7 36211 18527 3 La CocinaDyck Pork Tamales 12 pieces All lot codes where wheat is not declared on the label 7 36211 18517 4 What you should do
Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased. If you have an allergy to wheat, celiac disease or other gluten-related disorders, do not consume the recalled products as they may cause a serious or life-threatening reaction. Source: inspection.gc.ca

April 9

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Food Recall Warning (Allergen) - Durra brand Mansaf Seasoning recalled due to undeclared sesame and gluten

Phoenicia Group Inc. is recalling Durra brand Mansaf Seasoning from the marketplace because it may contain sesame and gluten which are not declared on the label. People with an allergy to sesame or who have celiac disease or other gluten-related disorders should not consume the recalled product described below. Recalled products Brand Name Common Name Size Code(s) on Product UPC Durra Mansaf Seasoning 70 g PD: 10/05/2017
BB: 09/04/2019
Lot: 03 6 251136 007096 What you should do
Check to see if you have recalled product in your home. Recalled product should be thrown out or returned to the store where it was purchased. Background
This recall was triggered by Canadian Food Inspection Agency (CFIA) test results. The CFIA is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings. The CFIA is verifying that industry is removing recalled product from the marketplace. Source: inspection.gc.ca

March 30

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Piggie Park Enterprises Inc. Issues Allergy Alert on Undeclared Wheat And Soy in Maurices Southern Gold BBQ Sauce Honey

Piggie Park Enterprises Inc. is recalling Maurice’s Southern Gold BBQ Sauce Honey manufactured in the past two years (March 11, 2016 thru March 11, 2018), because it contains undeclared wheat and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products. Maurice’s Southern Gold BBQ Sauce Honey was distributed Nationwide through our Flying Pig shipping service; in GA, NC, and SC through our retail partners; and also at our retail stores in SC. The product comes in an 18oz, clear plastic bottle with an expiration date before 3/12/20. The expiration date is located on the bottom of the bottle. If the bottle doesn’t contain an expiration date, then the bottle is included in this recall. The bottles have a UPC of 0 75616 54332 6. No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the powdered honey used in making the Maurice’s Southern Gold BBQ Sauce Honey contains wheat and soy, and it was not properly disclosed on the ingredients labels. Consumers who have purchased the 18oz bottles of Maurice’s Southern Gold BBQ Sauce Honey are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-628-7423 M-F 9:00 AM - 5:00 PM Eastern Standard Time. Source: https://www.fda.gov/Safety/Recalls/ucm601980.htm

March 26

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Gluten Free Foods Ltd recalls Barkat Organic Gluten Free Porridge Flakes

Gluten Free Foods Ltd recalls one batch of Barkat Organic Gluten Free Porridge Flakes because the product may contain moths and moth larvae. Product: Barkat Organic Gluten Free Porridge Flakes
Pack size: 500g
Best before date: 06 October 2018 No other Barkat products are known to be affected. Risk
Barkat Organic Gluten Free Porridge is being recalled because of contamination by moths and moth larvae. Our advice to consumers
If you have bought any of the above product do not eat it. Instead, return it to where it was bought for a full refund. Action taken by the company
Gluten Free Foods Ltd is recalling the above product and have written to their affected customers providing a Product Recall Notice to advise of this issue, as well as publishing the details of the recall on their website. These notices explain to customers why the products are being recalled and tell them what to do if they have bought the product. Please see the attached notice. food.gov.uk

February 12

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Gel Spice Company, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Beef Flavored Bouillon Cube Products

Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reaction(s) if they consume these products. The recall covers the following products: Brand/Description and Net Weight Product Labels Best By Date Code(s)* UPC NUMBER Spice Time Beef Flavored
Bouillon Cubes
NET WT. 1.7 OZ (48 g) "See below for the product label" 11/06/20 079679000543 Spice Supreme
Beef Flavored Bouillon Cubes 25 Count
NET WT. 3-1/2 OZ (98 g) "See below for the product label" 11/20/20 076114304419 Spice Supreme
Beef Flavored Bouillon Cubes
NET WT. 1.7 OZ (48 g) "See below for the product label" 09/26/20 11/06/20 12/05/20 076114304426 * “Best By Date” coding can be found on the back of the product bottle, below the product cap and above the product label. The beef flavored bouillon cube products identified above were distributed by Gel Spice throughout the United States to retail locations and distribution centers located in: Alabama; California; Connecticut; Florida; Georgia; Illinois; Indiana; Iowa; Maryland; Michigan; Minnesota; Montana; New Hampshire; New Jersey; New York; North Carolina; Ohio; Pennsylvania; South Carolina; South Dakota; Texas; Virginia; and Washington. Out of an abundance of caution and with an emphasis on consumer safety, Gel Spice is issuing this voluntary recall to ensure that consumers are made aware of the potential hazard. No reports have been received to date of any consumer injuries or complaints. The recall was initiated after it was discovered that the beef bouillon flavored cube products containing soy and wheat were distributed in packaging that did not reveal the presence of such soy and wheat. Subsequent investigation indicates the problem was caused by a temporary packaging error that has now been rectified. Consumers who have purchased the Spice Time and Spice Supreme products identified above are urged to return them to the place of purchase for a full refund. Customers are encouraged to visit Gel Spice’s website (http://recall.gelspice.com) to register to receive a replacement product at no charge. Customers with questions about the recalled product may also call Gel Spice at 201-354-2203 between 9:00 a.m. and 5:00 p.m. EST, Monday through Friday, or may e-mail the company at recall@gelspice.com.

December 20, 2017

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ImmunoMolecular Therapeutics Announces Two Issued Patents for Small Molecule Therapies in Type 1 Diabetes and Celiac Disease

ImmunoMolecular Therapeutics (IM Therapeutics), a company developing personalized small molecule therapies for the treatment of genetically defined autoimmune diseases, today announced the issuance of US Patent 9,629,848 covering the use of methyldopa (MDOPA) and other small molecular entities in immunotherapy for type 1 diabetes (T1D) and US Patent 9,820,957 covering the use of the D enantiomer of methyldopa (D-MDOPA) for T1D and celiac disease. Proprietary molecule, D-MDOPA, is being developed as lead candidate, IMT-002, to inhibit the autoimmune cascade in recent onset T1D patients with the human leukocyte antigen (HLA)-DQ8 gene. "The issuance of these patents ensures that IM Therapeutics has exclusive rights to use methyldopa and D-methyldopa in immunotherapy for T1D and will be essential in solidifying the intellectual property protection of IMT-002 as it advances through the clinic and eventually to commercialization as a potential treatment for the underlying autoimmunity of T1D," said Steve Orndorff, Ph.D., Chief Executive Officer, IM Therapeutics. These patents provide further support for IM Therapeutics' celiac disease program that is currently using in silico discovery and proprietary screening assays to identify and validate new small molecule inhibitors of DQ2, the major genetic risk factor for celiac disease and part of the HLA-MHC Class II target platform for autoimmune diseases being explored by IM Therapeutics. The patents have claims to composition of matter, dosing, formulation, and use, and enhance the protection offered by IM Therapeutics' exclusive, worldwide license from the University of Colorado. IM Therapeutics was previously granted Orphan Drug status for MDOPA, also applicable to D-MDOPA, from the United States Food and Drug Administration, further strengthening marketplace protection for IMT-002. About IMT-002 IMT-002 (D-methyldopa) is an oral small molecule drug being developed to treat type 1 diabetes (T1D) in patients with the HLA-DQ8 gene. IMT-002 occupies the peptide binding groove of DQ8 present on the surface of antigen presenting cells where diabetogenic peptides such as insulin are presented to CD4 T-lymphocytes to initiate the autoimmune cascade. When HLA-DQ8 function is inhibited, the immune system will no longer attack insulin producing beta-cells, thus creating the potential for at risk or early stage patients to maintain normal insulin production. About IM Therapeutics IM Therapeutics is developing personalized immuno-therapeutic drugs for autoimmune diseases based on the genetic risk attributed by human leukocyte antigen genes. The lead candidate drug is an oral small molecule that starves the autoimmune process in type 1 diabetes by blocking DQ8 on specific immune cells. Our goal is to preserve pancreatic beta cell function and maintain normal insulin production in at-risk and early-stage patients with type 1 diabetes.
http://imtherapeutics.com/ View source version on businesswire.com: http://www.businesswire.com/news/home/20171206005289/en/ Read more: http://www.digitaljournal.com/pr/3586192#ixzz50biBt6IB

December 7, 2017

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Energy Balls Are Going to Be the Only Snack You Need This Fall

If you're looking for a simple snack solution as your schedule heats up into fall, energy balls are your answer. They're not only portable and customizable: Most offer a combination of protein and healthy fats and carbs that'll give you and the fam plenty of energy and keep you satisfied. They're the perfect replacement for store-bought protein and granola bars — you're able to choose the ingredients to ensure you're eating something that's actually healthy! Plus, if you're on a budget, they're often less expensive. Make a big batch over the weekend and you'll be snacking happy all week. Check out the recipes below for a variety of energy ball ideas and pick a few to try based on your favorite flavors and snacking needs. For more info visit: https://www.healthline.com/health/energy-ball-snack-recipes#1

December 7, 2017

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Celiac.com and the Santa Rosa Fires: An Update For Gluten-Free Evacuees

Celiac.com 10/16/2017 - As you may know, Celiac.com is based in Santa Rosa, CA. So far, all staff is fine, and the founder, Scott Adams, has had to evacuate his home (which is currently fine, but close to the Oakmont fire). We'll do our best to keep our articles and information on celiac disease flowing. Luckily our servers are not located in California. We'd like to pass on this information from the Celiac Community Foundation of Northern California to other celiacs who may be affected by the evacuations:

October 16, 2017

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H-E-B Meat Plant Recalls Poultry Products Due To Undeclared Wheat

H-E-B Meat Plant, a San Antonio, Tex. establishment, is recalling approximately 1,150 pounds of diced chicken thighs due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen which is not declared on the product label. The raw, diced chicken thighs were produced on Sept. 22, 2017. The following products are subject to recall: 1.75-lb. (approximate catch weight per package) plastic shrink wrapped packages of “MI TIENDA PARA TACOS DE POLLO CASERO SEASONED DICED SKINLESS CHICKEN THIGHS” with a freeze by -/- sell by date of Oct. 12, 2017. The products subject to recall bear establishment number “P-7231” inside the USDA mark of inspection. These items were shipped to retail locations in Texas. The problem was discovered on Oct. 2, 2017 when a consumer noticed an incorrect label and notified the company, which then notified FSIS. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. Consumers and media with questions about the recall can contact Dya Campos, at (210) 938-8075.

October 5, 2017

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Love Child Organics brand Baby's First Buckwheat & Chia Organic Infant Cereal Recalled Due to Undeclared Gluten

Greenspace Brands is recalling Love Child Organics brand Baby's First Buckwheat + Chia Organic Infant Cereal from the marketplace because it may contain gluten which is not declared on the label. People with a sensitivity to gluten should not consume the recalled product: Brand Name:
Love Child Organics Common Name:
Baby's First Buckwheat + Chia Organic Infant Cereal Size:
227 g Code(s) on Product:
2017NO16
2017DE21
2018JA18
2018AL09
2018SE26 UPC:
8 58860 00181 7

September 15, 2017

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Missa Bay, LLC Recalls Chicken Products Due To Misbranding and an Undeclared Wheat Croutons in their Chicken Caesar Salads

Missa Bay, LLC, a Swedesboro, N.J. establishment, is recalling approximately 1,719 pounds of chicken caesar salad products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen, which is not declared on the product label. The chicken caesar salad product was produced on August 1, 2017. The following product is subject to recall: 9.95 oz. plastic salad bowls containing “Cumberland FARMS CHICKEN CAESAR SALAD with ROMAINE LETTUCE, ROASTED CHICKEN, PARMESAN CHEESE, BACON, MULTIGRAIN CROUTONS & CREAMY CAESAR DRESSING and bar code: 042704 034301, with a use by date of August 16, 2017. The products subject to recall bear establishment number “P18502B” on the front of the product label. These items were shipped to Cumberland Farms retail locations in Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island and Vermont. The problem was discovered when the establishment received notification from the sole retailer of the chicken products that the incorrect ingredient label was applied to the chicken caesar salad products. The ingredient label has a statement that the products were made without gluten containing ingredients, however, the Chicken Caesar Salad contains croutons made with wheat, and thus the wheat allergen was not declared on the label. Cumberland Farms, the sole retailer, released a recall statement on August 9, 2017, which informed consumers of the product misbranding. FSIS is issuing its own press release. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. Consumers and Media with questions about the recall can contact Kel Kelly, with Cumberland Farms, at (781) 690-3213 or email kel@kelandpartners.com. Source: fsis.usda.gov

August 17, 2017

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Vibrant Health Products Issues Allergy Alert On Undeclared Egg In LiveGfree Gluten Free Classic Soft White Hamburger Buns

Vibrant Health Products, a family-owned bakery in Abbotsford, B.C., Canada, has voluntarily recalled one lot of liveGfree Gluten Free Classic Soft White Hamburger Buns due to a packaging error. As a result, this product may contain undeclared egg. The precautionary recall was necessitated when it was discovered that liveGfree Gluten Free White Bread was packaged into liveGfree Gluten Free Classic Soft White Hamburger Bun packaging. The liveGfree Gluten Free White Bread contains egg, which is not listed in the ingredients or as an allergen on the liveGfree Gluten Free Classic Soft White Hamburger Buns. People who have an allergy or severe sensitivity to eggs should not consume these products due to the risk of serious allergic reaction. The recalled liveGfree Gluten Free Classic Soft White Hamburger Buns were sold through certain ALDI stores from 4/13/2017 to 7/27/2017 in the following states: Arkansas, Washington D.C., Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Missouri, North Carolina, Nebraska, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin, and West Virginia. The recalled product is in an 11.3-ounce blue package marked “liveGfree Gluten Free Classic Soft White Hamburger Buns” with lot numbers ending in #0897 on the front of the package and the UPC #0 41498 25980 8 on the back of the package. The package has an allergen statement that states, “Made in a facility that also produces products with eggs.” No illnesses have been reported to date in connection with this issue. Consumers who have purchased the 11.3-ounce packages of liveGfree Gluten Free Classic Soft White Hamburger Buns with the above lot number should return them to the ALDI store where they were purchased for a full refund. Consumers with any questions may contact the supplier of the gluten-free buns, Vibrant Health Products, from 8:00 a.m. to 5:00 p.m. Pacific Time, Monday through Friday: Jenene Kilian at 604.743.4455 or jkilian@vibranthealthproducts.com. For media inquiries, contact Radha Marcum at 360.306.7322 or rmarcum@vibranthealthproducts.com.

July 31, 2017

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ImmusanT Reports Data on Novel Celiac Disease Diagnostic Approach

ImmusanT, Inc., a clinical-stage company developing Nexvax2®, a therapeutic vaccine intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease, today announced the presentation of data demonstrating a novel method of identifying patients on a gluten-free diet with celiac disease. The study, conducted in collaboration with researchers from the Walter and Eliza Hall Institute, was presented in an oral presentation at Digestive Disease Week (DDW) 2017 in Chicago, Illinois. Celiac disease (CeD) is an immune-mediated gastrointestinal disease caused by dietary gluten predominantly in individuals who carry the human leukocyte antigen-DQ2.5 (HLA-DQ2.5) immune recognition gene, and shares key pathogenic and genetic features with organ-specific autoimmune diseases. Currently, there is no pharmaceutical treatment for celiac disease and the only method of management is to maintain a gluten-free diet (GFD). GFD is often adopted before evaluation for CeD, which renders current tests for CeD inaccurate and creates diagnostic and management uncertainty. Patients on a GFD who seek a diagnosis of CeD often refuse or cannot tolerate a gluten challenge for the duration typically needed for accurate results of tests for serological and histological markers of CeD. Because of this, a faster and more tolerable diagnostic is needed to identify patients on a gluten-free diet with celiac disease. "In this study, we have identified a distinct cytokine signature present in the serum of subjects with celiac disease 4 hours after the ingestion of gluten, suggesting that the measurement of serum cytokines following a single gluten challenge may allow for the identification of patients on a gluten-free diet with celiac disease," said Dr. Bob Anderson, Chief Scientific Officer of ImmusanT. "We are hopeful that with additional studies, this could ultimately provide an improved alternative to current methods of testing for the diagnosis of celiac disease, which are cumbersome and often not well tolerated by the patient." "Celiac disease is estimated to affect approximately 1% of the United States population, but over 80% of cases remain undiagnosed, as methods of diagnosis are invasive and inconvenient for patients," said Leslie Williams, President and Chief Executive Officer of ImmusanT. "The study presented today provides rationale for continued development of this novel diagnostic method as we aim to provide a more sensitive, rapid and tolerable alternative to current tests for patients suffering from celiac disease." In an oral presentation titled "Serum IL-2 and IL-8 are elevated within 4h after gluten ingestion in celiac disease (CeD) patients on glutenfree diet (GFD) – potential to resolve indeterminate diagnoses for patients on GFD," Dr. Anderson presented data from a randomized, double-blind, placebo-controlled food challenge study that enrolled volunteers with HLA-DQ2.5+ celiac disease who were compliant with a gluten-free diet. In the study, 21 volunteers received either vital wheat gluten flour or a matched gluten-free flour drink over the course of 10 minutes. Serum chemokines and cytokines were measured 30 minutes prior to food challenge, then at four, six, and 24 hours after the challenge. Vital signs and patient-reported outcomes (CeD PRO) were recorded hourly. Results of the study demonstrated that, at 4 hours following food challenge, serum levels of the cytokine IL-8 were significantly higher after exposure to gluten than placebo (median fold change from baseline: gluten: 2.4 vs. placebo: 1.1, p=0.012). Serum levels of IL-2 were also significantly increased at 4 hours, confirming T-cell activation in response to gluten exposure (median fold change from baseline: gluten: 19.5 vs. placebo: 0.7, p=0.0001). About Celiac Disease Celiac disease is a T cell-mediated autoimmune disease triggered by the ingestion of gluten from wheat, rye and barley in genetically susceptible individuals. A gluten-free diet is the only current management for this disease. The community prevalence of celiac disease is approximately 1% in the U.S., but over 80% of cases go unrecognized. When a person with celiac disease consumes gluten, the individual's immune system responds by triggering T cells to fight the offending proteins, damaging the small intestine and inhibiting the absorption of important nutrients into the body. Undiagnosed, celiac disease is a major contributor to poor educational performance and failure to thrive in children. Untreated disease in adults is associated with osteoporosis and increased risk of fractures, anemia, reduced fertility, problems during pregnancy and birth, short stature, dental enamel hypoplasia, dermatitis, recurrent stomatitis and cancer. With no available drug therapy, the only option is a strict and lifelong elimination of gluten from the diet. Compliance is often challenging, and the majority of people continue to have residual damage to their small intestine in spite of adherence to a gluten free diet. About Digestive Disease Week Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. About ImmusanT Inc. ImmusanT is a privately held biotechnology company focused on protecting patients with celiac disease against the effects of gluten. By harnessing new discoveries in immunology, ImmusanT aims to improve diagnosis and medical management of celiac disease by protecting against the effects of gluten exposure while patients maintain a gluten-free diet. The company is developing Nexvax2®, a therapeutic vaccine for celiac disease, and diagnostic and monitoring tools to improve celiac disease management. ImmusanT's targeted immunotherapy discovery platform can be applied to a variety of autoimmune diseases. Founded in 2010, ImmusanT is backed by Vatera Healthcare Partners. More information may be found at www.ImmusanT.com, or follow ImmusanT on Twitter.

May 9, 2017

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Papa John's Pizza Unveils Gluten-Free Crust Made with Ancient Grains

Gluten-Free Crust Pilot Program Launches in Los Angeles, Phoenix, St. Louis, Houston and Nashville

Papa John's International (NASDAQ: PZZA) continues to reinforce its commitment to BETTER INGREDIENTS. BETTER PIZZA. and providing consumers with quality menu options and "clean” ingredients by introducing another new pilot—Gluten-Free Crust made with Ancient Grains.

Papa John's Gluten-Free Crust is made with Ancient Grains, specifically sorghum, teff, amaranth and quinoa, and is currently being tested in Papa John's locations across Los Angeles, Phoenix, St. Louis, Houston and Nashville.

The new, never frozen Gluten-Free Crust made with Ancient Grains, showcases the brand's unwavering commitment to have the highest quality ingredients among national pizza brands. The Papa John's R&D team spent more than a year to develop the product with the goal of offering pizza fans a better tasting Gluten-Free pizza crust.

"This is something we've heard from our customers for some time, but we were never satisfied with the flavor profile of the gluten-free crusts options we tasted—that is until now,” said Sean Muldoon, Chief Ingredient Officer at Papa John's. "At Papa John's, we listen to our customers, and not only do they want to know where their food comes from but they are also concerned about what goes into their food. Or in this case, what is not included in their food: gluten.”

Papa John's goal was to create a crust with some added benefits that stood out from the competition including a heartier flavor. Ancient Grains add a more robust texture and flavor to the Gluten-Free crust. In addition to the taste, the Ancient Grains are naturally gluten-free and higher in protein and fiber than other grains.

From an operations standpoint, Papa John's employs procedures to prevent contact with gluten, and while the Ancient Grains gluten-free crust is prepared in a separate, gluten-free facility before being shipped to stores, it is possible that a pizza with gluten-free crust could be exposed to gluten during the in-store, pizza-making process. Therefore, the brand does not recommend its Gluten-Free Crust made with Ancient Grains for customers with Celiac Disease or serious gluten intolerances.

With the introduction of Papa John's Gluten-Free Crust made with Ancient Grains, and the recent announcement of the organic ingredients pilot program, the pizza maker continues to find new and exciting ways to expand and deliver on its BETTER INGREDIENTS. BETTER PIZZA. promise.

Papa John's is the first national pizza delivery chain to announce the removal of the following ingredients across its entire food menu: Preservatives BHA and BHT Flavor enhancer MSG Cellulose and partially hydrogenated oils Artificial flavors and synthetic colors High fructose corn syrup In 2016, the brand announced the elimination of artificial flavors and synthetic colors across its entire food menu. Last summer, the pizza brand also fully transitioned the chicken used in grilled chicken pizza toppings and poppers to be fed on a vegetarian diet and raised without human or animal antibiotics, and went completely cage-free with its eggs.

Pizza lovers in LA, Phoenix, St. Louis, Houston and Nashville can try a small, two-topping pizza on Gluten-Free Crust made with Ancient Grains for just $9.99. For more information regarding Papa John's NEW Gluten-Free Crust made with Ancient Grains, please visit the frequently asked questions page on the Papa John's website.

About Papa John's

Headquartered in Louisville, Kentucky, Papa John's International, Inc. (NASDAQ: PZZA) is the world's third-largest pizza delivery company. For 15 of the past 17 years, consumers have rated Papa John's No. 1 in customer satisfaction among all national pizza chains in the American Customer Satisfaction Index (ACSI). Papa John's is the Official Pizza Sponsor of the National Football League, the Official Pizza of Major League Baseball and the Official Pizza Partner of the National Hot Rod Association (NHRA). For more information about the company or to order pizza online, visit Papa John's at www.papajohns.com.

April 19, 2017

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Gluten-free Diet May Increase Risk of Arsenic, Mercury Exposure

Celiac.com 02/14/2017 - People who eat a gluten-free diet may be at risk for increased exposure to arsenic and mercury - toxic metals that can lead to cardiovascular disease, cancer and neurological effects, according to a report in the journal Epidemiology. Gluten-free diets have become popular in the U.S., although less than 1 percent of Americans have been diagnosed with celiac disease - an out-of-control immune response to gluten, a protein found in wheat, rye and barley. A gluten-free diet is recommended for people with celiac disease, but others often say they prefer eating gluten-free because it reduces inflammation - a claim that has not been scientifically proven. In 2015, one-quarter of Americans reported eating gluten-free, a 67 percent increase from 2013. Gluten-free products often contain rice flour as a substitute for wheat. Rice is known to bioaccumulate certain toxic metals, including arsenic and mercury from fertilizers, soil, or water, but little is known about the health effects of diets high in rice content. Maria Argos, assistant professor of epidemiology in the UIC School of Public Health, and her colleagues looked at data from the National Health and Nutrition Examination Survey searching for a link between gluten-free diet and biomarkers of toxic metals in blood and urine. They found 73 participants who reported eating a gluten-free diet among the 7,471 who completed the survey, between 2009 and 2014. Participants ranged in age from 6 to 80 years old. People who reported eating gluten-free had higher concentrations of arsenic in their urine, and mercury in their blood, than those who did not. The arsenic levels were almost twice as high for people eating a gluten-free diet, and mercury levels were 70 percent higher. "These results indicate that there could be unintended consequences of eating a gluten-free diet," Argos said. "But until we perform the studies to determine if there are corresponding health consequences that could be related to higher levels of exposure to arsenic and mercury by eating gluten-free, more research is needed before we can determine whether this diet poses a significant health risk." "In Europe, there are regulations for food-based arsenic exposure, and perhaps that is something we here in the United States need to consider," Argos said. "We regulate levels of arsenic in water, but if rice flour consumption increases the risk for exposure to arsenic, it would make sense to regulate the metal in foods as well." ### Catherine Bulka of UIC; Matthew Davis of the University of Michigan; Margaret Karagas of Dartmouth University; and Habibul Ahsan of the University of Chicago are co-authors on the paper. This research was supported by National Institutes of Health grants R01 ES024423, R21 ES024834, R01 CA107431, P42 ES010349 and T32 HL125294.

February 14, 2017

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Exercise May Help Manage Celiac Disease

Celiac.com 01/11/2017 - A study aimed at helping more than 110,000 Canadians living with celiac disease has been given a boost thanks to a Seed Grant from the University of Calgary's Faculty of Kinesiology. Justine Dowd, Raylene Reimer, Guillaume Millet and principal investigator Nicole Culos-Reed are studying holistic, evidence-based approaches to help patients with this autoimmune disorder, which can cause bloating, diarrhea, constipation, and increased risk of intestinal cancers and osteoporosis.
"Our focus is on helping people to improve their quality of life," says Dowd, who was diagnosed with celiac disease six years ago. "Often, people are diagnosed and start to eat gluten-free, but still have a variety of negative symptoms." The study, referred to as MOVE-C (Understanding the Relationship Between the MicrobiOme, Vitality and Exercise in Celiac Disease,) received $50,000 to conduct research into the ways in which the chronic condition can be managed beyond just adherence to a gluten-free diet. Relying on 'gluten-free' label doesn't always work
According to Dowd, just looking for the words "gluten-free" on packaging might not be enough to manage the disease in a healthy way. "Lots of gluten-free food is very processed, low in nutrition, and high in calories, which causes this perfect storm. People are often underweight when they are diagnosed with celiac disease, and then if they are eating over processed, high-calorie foods, they can gain too much weight on a gluten-free diet and are at risk of health complications like metabolic syndrome." In addition to promoting a whole foods diet, Dowd's team will be exploring the benefits regular exercise can have on patients. "Exercise is good for everyone, and we want to see how getting people with celiac disease more active can get them to a healthier weight status and healthier in general," says Dowd. Aside from the obvious benefits, exercise may also help to promote a healthy balance of gut bacteria. "There are preliminary studies that show that exercise has led to a healthier microbiome in animals and humans," says Dowd. Study seeks adult participants
Currently, the MOVE-C study is seeking adults (18 years of age and older), who have been diagnosed with celiac disease and do not engage in regular exercise, to participate in a free exercise program at the University of Calgary. Dowd has also developed an app, MyHealthyGut, that helps educate people about which foods are safe to eat, as well as record symptoms. Other key parts of the program will include interviews with experts on everything from acupuncture to sleep. "It's about empowering people to manage their celiac disease," says Dowd. "I am so happy to be able to provide people with a program that is evidence-based. I wish I had had it myself years ago."
For inquiries about the free exercise program, please email move@ucalgary.ca
MyHealthyGut is available for download in the iTunes store. About the University of Calgary
The University of Calgary is making tremendous progress on its journey to become one of Canada's top five research universities, where research and innovative teaching go hand in hand, and where we fully engage the communities we both serve and lead. This strategy is called Eyes High, inspired by the university's Gaelic motto, which translates as 'I will lift up my eyes.' For more information, visit ucalgary.ca. Stay up to date with University of Calgary news headlines on Twitter @UCalgary. For details on faculties and how to reach experts go to our media center at ucalgary.ca/mediacentre

January 11, 2017

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Savory Foods Recalls Pork Rinds Due To Misbranding and Undeclared Wheat

Savory Foods, a Portsmouth, OH establishment, is recalling approximately 32,928 pounds of pork rind products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat, a known allergen which is not declared on the product label. The Hot and Spicy Pork Rind items were produced from August 11, 2015 to August 31, 2016. The following products are subject to recall: [View Labels (PDF Only)] 3.5-oz. PLASTIC BAGS containing pieces of “UTZ HOT AND SPICY PORK RINDS CHICHARRONES” with use by codes of 2475 NOV 28/15 to 2475 DEC 9/16: The products subject to recall bear establishment number “EST. 1001” printed by the USE BY DATE in the upper right hand side of the bag. These items were shipped to a distribution center in Pennsylvania. The problem was discovered by FSIS personnel during a routine label review. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

September 14, 2016

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Celimmune Commences First-Ever Dosing with AMG 714 in Celiac Disease

Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases, announced that it has dosed the first patient in its Phase 2 clinical study for AMG 714 in celiac disease. AMG 714 is an investigational anti-IL-15 monoclonal antibody being studied for the treatment of gluten-free diet non-responsive celiac disease (NRCD) and refractory celiac disease Type II (RCD-II). The celiac disease study is being conducted by several expert academic medical centers in Tampere, Oulu, and Turku, Finland, a country where the incidence and understanding of celiac disease ranks among the highest in the world. The randomized, double-blind, placebo-controlled, parallel-group study is expected to enroll 63 patients with a diagnosis of celiac disease confirmed by intestinal biopsy at least 12 months prior to screening. The study will evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge. Study duration is 20 weeks and visits to the site take place every two weeks. Francisco Leon, M.D., Ph.D., CEO and Chief Medical Officer of Celimmune, commented, "Dosing the first celiac disease patient with AMG 714 is an important milestone for our company and an exciting step forward in the endeavor to find much-needed therapeutic treatment options for celiac disease when the gluten-free diet is not effective and for refractory celiac disease type II (RCD-II). We have chosen Finland for the excellence of its celiac research, its efficient clinical research community and its generous celiac patients, at the forefront of advancing the field." Markku Maki, professor and celiac disease researcher at Tampere University and University Hospital of Tampere, and an eminent figure in the field of celiac disease, commented, "AMG 714 is the first experimental therapeutic for celiac disease designed to block IL-15. We believe this approach to treating celiac disease has strong potential and look forward to continuing the enrollment of this study and evaluating the results to further our understanding of celiac disease." AMG 714 is a human immunoglobulin monoclonal antibody that binds to IL-15 and neutralizes its effects. IL-15 is considered to have a central role in celiac disease and to be a key driver of the generation of aberrant and malignant intraepithelial lymphocytes (IELs) in RCD-II. In four previous clinical studies, AMG 714 has been well tolerated by healthy volunteers, as well as by patients diagnosed with rheumatoid arthritis or psoriasis. NRCD is defined as persistent symptoms, elevated celiac antibodies, or small intestinal damage following 6-12 months on a strict gluten-free diet. In most cases, NRCD is caused by unintentional gluten exposure from unrecognized gluten-containing products, such as foods believed to be, or labeled, gluten-free, or non-food products such as medications or household items (e.g. toothpaste, lipstick). To learn more about Celimmune, AMG 714 or our Phase 2 clinical studies, visit www.celimmune.com or www.clinicaltrials.gov: Celiac Disease:
ClinicalTrials.gov Identifier: NCT02637141
https://clinicaltrials.gov/ct2/show/NCT02637141?term=NCT02637141&rank=1
Refractory Celiac Disease Type II:
ClinicalTrials.gov Identifier: NCT02633020
https://clinicaltrials.gov/ct2/show/NCT02633020?term=NCT02633020&rank=1 About Celimmune
Celimmune, LLC is a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases and is headquartered in in Lebanon, New Jersey, and Bethesda, Maryland. Celimmune will initially focus its distinctive core competence in translational medicine, immunotherapy clinical development and commercialization on combating celiac disease and other serious immune-mediated diseases. Celimmune has an exclusive licensing agreement with Amgen to develop, manufacture and commercialize AMG 714, a Phase 2-stage anti-IL-15 monoclonal antibody.

May 8, 2016

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ImmunogenX Acquires the Assets of Alvine Pharmaceuticals

Celiac.com 03/16/2016 - ImmunogenX, a biopharmaceutical company focused on the diagnosis and treatment of autoimmune and gastrointestinal diseases, today announced that it has completed the acquisition of the non-cash assets of Alvine Pharmaceuticals. This includes the Latiglutenase (formerly known as ALV003 and renamed IMGX-003), an orally administered mixture of two recombinant gluten-specific proteases that degrades gluten proteins into small physiologically irrelevant fragments. The technology is backed by over 50 issued or pending patents, has been extensively studied in Phase I and Phase 2 clinical trials, and is the only CD treatment that has demonstrated histologic success as well as symptomatic improvements in clinical trials. "We are exceptionally fortunate to have had the opportunity to acquire what is arguably the leading therapeutic advance for celiac disease," said Dr. Jack A. Syage, CEO of ImmunogenX. "Alvine has established itself as one of the most professional and accomplished emerging biopharmaceutical companies and has made tremendous progress in advancing its recombinant protease drug product through clinical trials. We are privileged to be entrusted to take this much needed therapy through development and to market to help improve the quality of life of celiac disease patients who suffer from the inevitable intrusions of gluten that occur even under the most diligent of gluten-free diets." David Southern, Alvine’s CFO and Acting CEO commented, "We are gratified that ALV003, which in randomized clinical trials appeared to be well tolerated and attenuated gluten-induced intestinal mucosal injury in well-controlled celiac patients, will be further developed by a company that is deeply knowledgeable about celiac disease and plans to take it through late-stage clinical trials. ImmungenX has impressed us with their exceptional team, their drive, and most of all their dedication to helping the celiac community." "I have had the privilege of participating in ALV003 trials and am aware of the tremendous potential benefits it may offer celiac disease sufferers," remarked Dr. Peter H. R. Green, MD, head of the Celiac Center at Columbia University. "As a member of both the Alvine and ImmunogenX scientific advisory boards, I cannot be more happy to see ALV003 transition smoothly into such capable hands." About ImmunogenX "ImmunogenX" (a subsidiary of Immunogenics LLC) is a clinical-stage company founded in 2013 and is supported by a team of world-renowned clinicians, scientists and advisors in celiac disease research. In addition to the newly-acquired IMGX-003, ImmunogenX is developing an advanced diagnostic tool. For disease management, ImmunogenX is extending and commercializing a successful clinical study for a metabolic marker compound that can measure the state of recovery of a celiac patient undergoing gluten-free diet treatment. This is a unique capability for which there is no other effective diagnostic. For food safety, ImmunogenX is pioneering advanced mass spectrometry methods to identify new physiologically relevant gluten peptide sequences in wheat, barley, and rye and has developed a multiplexed quantitation method to screen for the full range of gluten proteins in food and consumer products.
www.Immunogenx.com

March 16, 2016

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