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

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

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.

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.

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.

I e-mailed Breyers Ice Cream Consumer Service Department last week to ask if their very decadent and delicious Italian Gelato (ice cream) was gluten free. It is more expensive, definitely creamier, contains more calories which I need, but Oh so good! I received a very nice e-mail from them two days later:

"New Productions of Breyers Ice Cream will have a gluten-free symbol on the box. Breyers also has a gluten-free program which includes the segregation of gluten containing ingredients, specific production schedules with gluten-free products made on different days than regular products, superior cleaning procedures, and regular verifications and audits."

Some of the containers of ice cream at your local store may not yet state "gluten-free" as the new boxes are still rolling onto store shelves and any packaging produced prior to this new update will still be available through this year. BUT, at this time if a product does not have the "gluten-free" label on the packaging, but it is listed on their website: (www.breyers.ca/product/category/757004/glutenfree) as gluten free and the ingredient panel does not list any gluten containing ingredients, (for example: wheat, barley, etc.), you can be confident that it is gluten free.

"Always read the ingredient labels for the most up to date information, as recipes may change from time to time and gluten will ALWAYS be called out on the label."

From this information we are assured that Breyers will be segregating their gluten containing ingredients, and having specific production schedules with gluten-free products made on different days than regular products, and they will have a superior cleaning procedure and regular verifications and audits to check By that I believe they mean they will have regular checks of the products coming off the gluten-free line of ice creams to ensure no gluten is present.

They show pictures of their ice creams with the notation at the bottom:

**Carefully read the ingredients statements on all food labels each time you make food choices and to ensure you are choosing Gluten Free Breyers

BASICALLY THEY ARE ENSURING US THAT GLUTEN FREE PRODUCTS ARE MADE ON DIFFERENT DAYS THAN REGULAR PRODUCTS AND SUPERIOR CLEANING PROCEDURES AND REGULAR VERIFICATIONS AND AUDITS ARE DONE REGULARLY.

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.

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

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.

How to Stop the Hidden Autoimmune Damage That Keeps You Sick, Fat, and Tired Before It Turns Into Disease.

On September 20th, with the launch of Dr. Tom O’Bryan’s first book, an entirely new conversation will begin around Autoimmune Disease. THE AUTOIMMUNE FIX: How to Stop the Hidden Autoimmune Damage That Keeps You Sick, Fat, and Tired Before It Turns Into Disease (Rodale Books; ISBN: 978-1-62336-700-8; September 2016; $26.99; 352 pages) highlights the new world of predictive autoimmunity and shines a light on the present medical approach: to wait until millions are suffering from full-blown autoimmune disorders and put them on a lifetime of immune suppressants.

In THE AUTOIMMUNE FIX, esteemed expert Dr. Tom O’Bryan provides a powerful and cogent examination of the mechanisms underlying this modern-day epidemic, with over 80 million people affected by autoimmunity in the US alone, including top celebrities like Selena Gomez who suffers from Lupus and Michael J. Fox, the well known face of Parkinson’s Disease.

A broad spectrum of life altering disorders, Autoimmune Disease includes diseases such as Hashimotos Disease, Rheumatoid Arthritis, Ulcerative Colitis, Irritated Bowel Disease, Crohn’s Disease, Multiple Sclerosis, Lupus, and conditions such as chronic fatigue, muscle and joint pain, and memory and cognitive dysfunction. The list is alarmingly long, and all tolled, adds up to the 3rd leading cause of death in the nation.

Already on it’s way to many bestseller lists, and hitting Amazon #1 New Release in four categories, THE AUTOIMMUNE FIX takes a cold hard look at the failure of the medical community to adequately identify, diagnose and treat the numerous degenerative diseases whose roots lie squarely in autoimmunity. It is Dr. O’Bryan’s belief (backed up with more scientific data than most could absorb without a medical team at our side) that, with the right tools, we could identify diseases years before their symptoms are obvious.

Dr. Tom O’Bryan is seen as a hero to many and contributed much to the field of non-celiac gluten sensitivity and celiac disease. THE AUTOIMMUNE FIX is cutting edge, creating a comprehensive, evidence-based overview that is a veritable reference manual for health practitioners and a roadmap for patients.

I am proud to be part of this video:

'What's With Wheat' documentary, the silent global growing epidemic of gluten intolerance!

There is a free Online Screening available tomorrow –

More and more people are diagnosed with coeliac and non-coeliac gluten sensitivity than every before! You have to ask the question, WHY!

Cyndi O'Meara, nutritionist and founder of Changing Habits, went on a global quest to find out the reason why! She could not understand why after millions of years of eating wheat, that we now have this growing epidemic of wheat and gluten intolerance.

The14 experts, including Dr Perlmutter, Sarah Ballantyne, Dr Terry Wahls, Dr Natasha Campbell McBride, Pete Evans, Dr Rodney Ford, Sayer Ji, Sally Fallon and others, weigh in on the subject and provide chilling answers.

REGISTER FOR THE FREE SCREENING BY FOLLOWING THE LINK BELOW

https://www.changinghabitsaffiliates.com/117-1-5-3.html

FREE 7 DAY ONLINE SCREENING. Commencing June 24 - July 1, 2016.

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.

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

According to Hannaford's Web site:

"This product contains undeclared wheat flour as an ingredient. The presence of an undeclared wheat ingredient poses a potential health hazard."

• Maggi Chicken Bouillon Tablets, 5.08 oz., UPC # 28000-11567
• Maggi Chicken Bouillon Tablets, 2.43 oz., UPC # 28000-24795

Obviously since the product contains wheat flour it would not be gluten-free and anyone with celiac disease or gluten sensitivity should heed this warning.

Hain Celestial Seasoning is recalling Celestial Seasonings Roastaroma Herbal Tea due to gluten containing ingredients. The labeling conflict was due to the fact that it contains barley as an ingredient, but is labeled "Gluten-Free".

The affected products include:

• Celestial Seasonings Roastaroma Herbal Tea Lot code - Best Before 20DEC17 Pack size - 6 retail units (20 count) per case. Best Before 02DEC17 Retail UPC 070734-050138.

Source:

• fda.gov

Ground cumin manufactured by ARZ Group Ltd. has been recalled in Canada by the Canadian Food Inspection Agency because it contains wheat.

Recall date:
December 31, 2015
Reason for recall:
Allergen - Gluten, Allergen - Wheat
Hazard classification:
Class 3
Company / Firm:
ARZ Group Ltd.
Distribution:
Ontario, Quebec
Extent of the distribution:
Retail
Reference number:
10275

• Brand Name: ARZ Fine Foods
• Common Name: Ground Cumin
• Size: 55 g
• Code(s) on Product: 171151525
• UPC: 8 28696 06128 6

Source:

• http://www.inspection.gc.ca 

Joseph Epstein Food Enterprises, Inc., an East Rutherford, N.J. establishment, is recalling approximately 190 pounds of turkey meatball products due to misbranding, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The label declares the product as "gluten-free," a false negative claim.

The Mama Mancini's gluten-free turkey meatball items were produced on Oct. 19, 2015. The following products are subject to recall: [View Labels]

22-oz. cartons of "Mama Mancini's Slow Cooked Italian Style Sauce and Turkey Meatballs – Gluten Free."
The products subject to recall bear establishment number "P-21734" inside the USDA mark of inspection, product code 4740 and expiration date "Use by 12/10/15." These items were shipped to retail locations in New Jersey.

The problem was discovered during the establishment's third party laboratory testing; the product was found to contain an excess of the maximum allowable 20 ppm of gluten. The establishment notified FSIS of the problem.

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. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact Mr. Matt Brown, President, at (917) 705-7514. Media with questions about the recall can contact Mr. Carl Wolf at (973) 985-0280.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: http://www.fsis.usda.gov/reportproblem.

Herr Foods Inc. has initiated a voluntary recall of certain bags of its 1.875 oz. Sour Cream & Onion Potato Chip due to a packaging error that incorrectly states that the product is gluten free.

While the back panel of the package complies with U.S. Food & Drug Administration (FDA) label regulations by listing "Wheat" in the ingredient statement as well as "Contains Wheat" in its related allergen statement, the front panel of the package erroneously features the words "Gluten Free." Gluten is the protein that naturally occurs in wheat, rye, barley, and crossbreeds of these grains. Most people can eat gluten, but in people with celiac disease, gluten intake gradually damages the intestines, prevents the absorption of vitamins and minerals, and can lead to other health problems. Symptoms can include diarrhea, fatigue, headaches, abdominal pain, brain fog, rashes, nausea, vomiting, and other reactions. Herr's has not received any reported illnesses to date.

Herr's Sour Cream & Onion Potato Chips, 1.875 oz. bags only, were distributed nationwide through retail stores, distributors, and internet sales. These products were sold as individual bags. No other bag sizes of Herr's Sour Cream & Onion Chips are involved with this recall. No other Herr's products are involved with this recall.

RECALLED PRODUCT

• 1.875 oz. Herr's Sour Cream
  & Onion Potato Chips
  • Date code: January 02, 2016, up to and
    including January 30, 2016
  • UPC: 72600 00061

The packages are a green metallic color bag with a red Herr's logo at the top center of the package. The lot number is located at the upper right hand corner on the front of the package below the statement "Guaranteed Fresh Until". The UPC number is located at the lower right hand corner of the back panel of the package.

Herr Foods announced the recall to prevent consumers who are allergic or sensitive to gluten from consuming this product. Consumers with wheat allergies, celiac disease or gluten intolerance should not consume them and should return them to the retailer where they were purchased for a full refund. Herr Foods and other retailers are removing recalled product from the retailers' shelves. As a result, consumers can be assured that all other Herr's products that remain on-shelf are safe and not subject to this recall. Consumers with questions may call 1-800-523-5030. Live assistance is available 9am-5pm EST, Monday thru Friday.

General Mills is voluntarily recalling several days of production of Cheerios and Honey Nut Cheerios cereal produced at its Lodi, California facility on certain dates in July of this year because of an undeclared allergen – wheat – with potential adverse health effects. Because this recall relates to an undeclared allergen, this is a Class I product recall.

Cheerios and Honey Nut Cheerios produced on these dates at the company’s Lodi, California facility are being recalled because an isolated incident resulted in wheat flour being inadvertently introduced into the gluten free oat flour system at its Lodi facility. As a result, the products may contain an undeclared allergen – wheat – in products labeled as gluten-free.

General Mills will recall and retrieve affected cereals produced on those dates from customer warehouses and store shelves. Consumers with wheat allergies, celiac disease or gluten intolerance should not consume products bearing the affected code dates and should contact General Mills for a replacement or full refund. 

This voluntary recall includes four days production of original (yellow box) Cheerios, and thirteen days of production ofHoney Nut Cheerios at its Lodi, California facility with the following “BETTER IF USED BY” code dates and the plant code LD which indicates the product was produced at Lodi, California:

Products containing wheat can cause illness or severe reactions for individuals with wheat allergies or celiac disease.  Products containing wheat can also cause illness or discomfort for individuals with gluten intolerance.

General Mills is transitioning five varieties of Cheerios to gluten free. Cheerios and Honey Nut Cheerios cereals produced at General Mills’ other facilities, or on dates other than those noted at the Lodi, California facility, are not impacted. General Mills’ other gluten-free Cheerios varieties – including Apple Cinnamon Cheerios, Frosted Cheerios and MultiGrain Cheerios – are not impacted and are not being recalled. No other General Mills cereals are affected. 

Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-775-8370. 

Source:

• General Mills

GOOD FOR THEM! The Gluten Free Watchdog is really working for the Celiac Community. Gluten-Free Oat Production is into the stage of "Purity Protocol vs Mechanical or Optical Sorting". They ask us if it is important to us, and of course it is. I love oats and have been severely restricted from eating them. My specialist said not to have the OAT CHALLENGE until I had been totally free from a celiac outbreak or dermatitis herpetiformis for at least one year, and I never reached that golden year. There is an article that includes an interview with Michael Marshall of Marshall Gluten Free Milling. His company will be making available gluten-free oats grown on third-party certified gluten-free farms. The article is available at:
https://www.glutenfreewatchdog.org/blog/Gluten-free-oat-production-purity-protocol-versus-mechanical-or-optical-sorting-Does-it-matter-to-you-/54/

Now, I do not know if you have to be a paid up subscriber to the Gluten Free Watchdog in order to avail yourself of this interview, but it is good to know that we are moving ahead with certified gluten free oat production.

The arsenic testing: Rice-based breads are currently at Dartmouth for testing. They have two more product categories left to test as of the middle of June. They were rice grain and rice-based snacks. Choosing five snack foods will be difficult they say as there have been so many product requests. Currently they are thinking of focussing on savory snacks (rice chips, rice crackers, rice cakes, etc.)

Tricia Thompson, MS, RD, Owner/ Founder of Gluten Free Watchdog, LLC agreed to meet with General Mills in July to discuss gluten-free Cheerios. The meeting is/ or was to take place at their new mill facility. It was not another "Cheerios Forum", and those involved with testing Cheerios at Medallion labs also were to be present. General Mills told Tricia Thompson that it was important to provide her with detailed information about their testing protocols as well as allowing her to view the test results. That was necessary so that years of testing data on oats produced under a purity protocol can be compared to testing data on oats "cleaned" at the backend of production using mechanical sorting.

The GLUTEN FREE WATCHDOG has issued a statement on its "Position On Oats as of June 11, 2015, and we have no idea how hard it must have been for the group to reach a consensus on the wording of their position! I have been on a TEAM working on a Positional Statement and it took us two full days to agree on the wording, so a big thank you to all of you!

"Gluten Free Watchdog supports the use of gluten-free oats by the celiac disease community that are produced under a purity protocol. At this time we do not support the use of regular oats that are cleaned at the back-end of production via mechanical and/or optical sorting to be "gluten-free". Before we can support the use of oats "cleaned" in this manner to be gluten-free we must be provided with thorough testing data. We can then compare this data to the thorough testing data provided to us for oats grown under a purity protocol."

I will share, with their permission again, the interview Tricia Thompson had with Michael Marshall, President and CEO of Marshall Gluten Free Milling (www.glutenfreemilling.com), a company that has been working for fifteen years in the natural and organic grain and food ingredient business, Other companies are bound to get on the band wagon, some of them selling cheaper products in order to attract the celiac public. We are a market remember and they all want a "bite" out of us. The bottom line is $$$ and cents. And, as goes the United States, so goes Canada, and according to Health Canada "every effort is being made to harmonize with other countries which have developed similar food labelling laws, i.e.: The European Union, Australia, New Zealand, and the United States. For example, Canada and the United States require food allergens to be declared either in the list of ingredients or in a "Contains" statement. Canada requires food allergens to be declared either in the list of ingredients or in a "Contains" statement to clearly indicate that the information in the statement is in addition to the information in the list of ingredients and that this information has to be exhaustive. (I.e. - all allergens present as ingredients are declared). What is important, says the positional statement and Andre Gagnon, Media Relations Officer Serving Health Canada and the Public Health Agency of Canada, is that all imported foods sold in Canada must meet the same safety requirements including health based labelling requirements as domestic foods sold in Canada. (Andre Gagnon also speaks very highly about The Gluten Free Watchdog which, though American based, serves the celiac community world wide.

You see, most of us are unaware of how production machines work, how they clean them, and how they just add gluten free sorting at the end of a production of regular foods.

AN ASIDE: Picture if you can, a flour mill, with the air floating with flour dust, so much so, that the people working there wear hair nets and masks. Then picture the machines milling flours for hours and hours. And finally being cleaned and allowing them to flow through with gluten free flours. I have watched a machine making "regular" pasta every day except Thursday, when they make gluten free pasta - pasta for ravioli, lasagne, linguini, etc. They are then hung and dried on long wooden poles. Tell me the machines are cleaned and sanitized and the wooden poles are cleaned and sanitized ready for Thursday's production. We are bound to get a certain amount of infiltration. When a Chinese Food Restaurant tells you they have a gluten free menu, do they have a set aside gluten free large deep fryer and large wok specifically set aside ONLY for their gluten free clientele. I experienced ordering from a gluten free menu in a large Chinese Food Restaurant and came away seriously glutened. Because the Chef was busy, and obviously no-one had told him he could not liberally pour Soya Sauce containing MSG and flour over the entire meal!

Watch for the Fall Issue of the Celiac Journal of Gluten Sensitivity for more about food labelling, more "strange, mysterious names that can be our downfall".