Celiac.com 01/05/2016 - Did you know that an important step for the celiac and gluten sensitive person occurred on September 30, 2014? Jennifer North, Vice-President of the National Foundation for Celiac Awareness (NFCA) delivered the following comments to the U.S. Food & Drug Administration (FDA), Food Advisory Committee on behalf of those living with gluten disorders:

Photo: CC--Ian Parkes"My name is Jennifer North. I am the Vice President of the National Foundation for Celiac Awareness. I represent approximately 21 million people who require the gluten-free diet for health reasons including those with celiac disease, a genetic autoimmune disease that could lead to cancer, infertility and recurrent miscarriage and the onset of other autoimmune diseases if left undiagnosed or untreated.

The NFCA is an evidence-based organization with an international, medical, and scientific advisory council. We just completed a FDA grant to research the impact of gluten in medication. We provide accredited gluten-free training to over 1000 learners from over 180 restaurants and colleges each year.

Our media campaigns introduced the idea that the gluten-free diet is not a fad, but in fact a medical necessity for those with celiac disease and other gluten-related disorders to nearly a quarter of a billion people thus far in 2014.

We secured the Associated Press' big story of the day on August 5, the compliance date of the gluten-free labeling rule. We also hosted two free webinars on the topic, one including Suzanne Walker, a representative of the FDA as a presenter. As a passive observer it may seem that life has never been better for people looking for gluten-free options. Despite the growth of the marketplace to over $20 billion dollars annually and the availability of gluten-free food in gas stations and convenience stores, the gluten-free diet is proving to be emotionally and logistically difficult to navigate.

The gluten-free community lives in fear of food every day. Their concerns have a basis. Research from the Mayo Clinic shows that nearly 70 percent of people with celiac disease, who maintain a gluten-free diet, continue to have intestinal damage from inadvertent gluten exposure. Last week, the NFCA engaged 350,000 people in a social media dialogue about getting gluten in restaurants. Eating remains the most critical quality of life issue affecting the gluten-free community today. A recent study of disease treatment burden found that the gluten-free diet has an equivalent burden as those with end-stage renal failure rate dialysis. I hope you find that as shocking as we do and we find it unacceptable.

We salute the FDA for finalizing the gluten-free labeling rule which was mandated as part of FALCA and protects consumers whose health is dependent on access to safe gluten-free food. I am here today to ask for your support in seeking clarity from the FDA about references to the obligations of restaurants and food service operators in meeting the requirements of the ruling in order to make a gluten-free menu claim.

The health of those with celiac disease and nonceliac gluten sensitivity depends on food service operators being educated and transparent. We welcome the efforts of the FDA in acting to protect our interests.

However, FALCA is designed for packed foods and was vetted by the packaged foods industry. The regulation not only centers around the prohibition of gluten-containing ingredients but also requires the validation that contamination of gluten-free products does not exceed 20 parts per million of gluten residue.

The FDA's statements in its Q&A and its guidance documents state that while the ruling applies to packaged products, it does expect restaurants to comply. It also states that it may engage state and local bodies and enforcing the ruling in the food service setting. This is problematic because the restaurant setting is not typically closed and well-controlled and predictable system where testing of samples is representative of the overall risk. It is not cost effective for restaurants to test every dish between the kitchen and the table and effective testing for gluten residue requires advanced technical knowledge. With ambiguous language and lack of specific guidance for the food service sector many restaurant operators are holding back on labeling gluten-free items or are using terminology that confuses consumers like low gluten, gluten friendly or gluten-free ingredients.

To back up what we are hearing anecdotally we launched a survey in which nearly 150 responses were received from a wide variety of operators representing all geographies in the US. The majority of respondents were individual owner/operators, but multi-unit regional chains, colleges and universities and K-12 school districts also responded.

Our findings show that 89 percent of respondents either believe the ruling applies to them or are unsure whether or not it applies to them, 12 percent report that the gluten-free label rule will change their menu claims and more than a third are unsure what to do with their menu claims.

While we certainly want to discourage restaurants who are unable to safely and consistently offer gluten-free dishes from doing so, our survey shows that even restaurants who have in-depth knowledge and training and strict controls in place are unclear about whether or not they are able to continue to identify gluten-free dishes to their own customers. We are concerned that this will limit
accessibility of gluten-free friend and quash the great strides we have made in bringing gluten-free food safety to the forefront of the food service industry by working with the largest manufacturers and distributors in the space, a group of loyal chef ambassadors and partner organizations like the National Restaurant Association.

Please stand with us as we seek formal guidance from the FDA that will provide a basis of understanding for how to expect food service operators to legally and responsibly serve those who must adhere to the gluten-free diet for medical reasons. "

Exciting News! The NFCA also has a concise small "Dining Out Tips" card for the celiac that you can get on their web site NFCA Celiac Central. On the right side of the card there is a tear-off section to leave with the restaurant to recommend that they get gluten-free training for the management and staff. Or try their "10 Tips for Resilient Solutions". And while I am on a role regarding information cards, visit glutenfreeandmore.com to purchase Casein-Free Dining Cards, but remember casein-free diets may remove adequate calcium and vitamin D from your diet, and if you have not been diagnosed with autism spectrum disorders, have no further issues as long as you strictly follow your gluten-free diet the casein free diet may not be for you.

The person who becomes lactose intolerant is the one still eating gluten, where after the villi and microvilli in the small intestine have become so damaged they are no longer capable of catching and breaking down the lactose molecule. The problem usually disappears when a celiac removes gluten totally from their diet thus enabling the damaged villi and microvilli to grow back. Remember that lactose intolerance symptoms can continue for a long time after a celiac has gone on a 100% gluten-free diet. (In some cases the villi and microvilli damage can take up to two years to heal completely—Scott Adams, founder and publisher of this Journal of Gluten Sensitivity.)

The NFCA is a major advocate for the consumer with regards to better labeling, and regarding medications, "Legislation and regulation can provide the path for ensuring that consumers have the information they need to make healthy choices". Under the Federal Food, Drug, and Cosmetic Act (FFDCA), OTC medications must list inactive ingredients on the container, and prescription drugs must include a description of the medication, which includes inactive ingredients, in the package insert, but although the inactive ingredients must be disclosed, the source of the ingredients and the potential allergens in them do not need to be clearly named. Common food allergens (like peanuts, milk, eggs, soy, gelatin, and fish) can hide in a medication's excipients, which are inactive or filler ingredients used to provide shape or bulk and sometimes to aid in absorption. These allergens do not need to be specifically identified. For example, "starch" can be corn, potato, tapioca or wheat starch, according to Alice Bast, president of the National Foundation fort Celiac Awareness We are advised to stay with the same Pharmacy and work closely with your doctor and pharmacist. If your medication does not have a package insert ask for one, or an information sheet, and read it watching out for the word "starch".

There are some free websites that can help you or your pharmacist track down details on your drugs. DailyMed (dailymed.nim.nih.gov) allows you access to manufacturers to see full prescribing information, Orange Book helps determine if two products, (a generically named drug vs. the officially prescribed drug name) are therapeutically equivalent (www.accessdata.fda.gov/scripts/cder/ob). GlutenFreeDrugs.com, a website maintained by pharmacist Steve Plogsted of Nationwide Children's Hospital in Columbus, Ohio, identifies which drugs should be safe for those avoiding gluten.
I also contacted Health Canada, Media Relations Unit (613) 957-2983 with regard to food labeling, not only for pre-packaged foods but also to enquire if we are intending to follow the United States Gluten-free Labeling Rule Clarification. In Canada the Federal Government and Provincial Governments share the responsibility of consumer protection regarding food allergies (www.inspection.gc.ca/food-labelling/eng/1299879892810 - 613-957-2983). The drug safety e-mail and toll-free number is info@hc-sc.gc.ca and 1-866-225-0709. It is Eastern Standard Time so calling from the West Coast needs to be before 3:00 p.m. There is a Canadian Food Inspection Agency for B.C. at (604) 292-5700. They are responsible for enforcing regulations with regards to inspection and labeling of foods in the industry (gluten-free claims, allergen free claims, and policy updates: www.inspection.gc.ca/foodlabelling/cooflabelllingforindustry). The person I am dealing with to try to make sense out of our resolutions is andre.gagnon@hc.sc.ca, and he has promised to get back to me with regards to my numerous questions.

It was December 2002 when Food & Drug Regulations were amended to make nutrition labeling mandatory on 'most' food labels. It became mandatory in December 2007 to comply with new regulations regarding pre-packaged foods, and that was for small businesses, who now NOTED the fact that Canada's list of priority food allergens differs from that of the U.S.A., Canada's largest trading partner. If you are planning to shop in Canada it is important to familiarize yourself with the differences regarding per-packaged gluten-free food, including wholesale foods.

Restaurant regulations are provincially mandated in Canada,. That means if you are planning on stopping at an "eat and run" fast food restaurant in B.C. (chains or franchises) its regulations with regards to floured french fries vs. pure gluten-free fries, should be the same as Ontario regulations, as will the oil in which they are fried. You may not be able to find a gluten-free cookie or bar in every franchised store; that is their prerogative. I do not know if every Woods Coffee & Sandwich Shop in the U.S.A. carries gluten-free sandwiches, buns and cookies but they do in the Washington area. The old rule of "asking" and "Caveat emptor" applies. If you don't ask how the sandwiches are made you run the risk of being "glutened" at a health cost to you.

The U.S. may also have concerns about packaged foods coming into the United States from other countries such as Mexico, India and China having their ingredients listed in the language of their native country, and your food choice "gets lost in translation". I did address that inquiry to our local bodies here in Canada and also to Claude Gagnon at the Ministry of food and agriculture in Ottawa, also listing training for restaurant staff, separate sites for preparation, precautions regarding cross-contamination and depending on how long their "leave a message" line was available to me I kept going.

In 2012 detailed regulations officially mandated and greatly clarified the disclosure of priority food allergens in foods offered for sale in Canada. Any food ingredient sourced from a 'priority food allergen' must declare the allergen by its official name, either within the list of ingredients or in a "Contains" disclosure at the end of the ingredients list on the product label. This necessitates reading the list of ingredients with its declaration of the allergies and reading down to, or searching for, the disclosure at the end of the ingredient list on the product label. I have not found that all products list the "contains" disclosure at the end of the ingredients list, but do place it somewhere on the product label, which can, when speed shopping, cause errors.

This is why you have to watch thickening agents, sauces, soy sauce (switch to Tamari) nearly everything needs to be carefully checked out. Corn starch is a great thickener for gravies or sauces. There is a product here in Canada called Veloutine, a sauce thickener, which comes in brown or white and is gluten-free. You are better off switching from sugar to honey whenever you can as sugar depresses the immune system and encourages the growth of candida and the unhealthy bacteria. Honey supports the immune system and the good bacteria but does not support the unhealthy bacteria and candida very well.

Did you know that some anti-caking agents may contain wheat? Check your herbs and spices, especially if they come in a counter friendly rack. Watch the ground spices in particular and avoid the ones which state "Contain wheat products" warning. The Gluten-free Watchdog founded by Tricia Thompson (https://www.glutenfreewatchdog.org) has a new report on spices; it will also tell you the difference between the words 'spices' and 'seasonings' and how it might affect a celiac. Agriculture & Agri-Food Canada actually has a "Gluten-Free Claims in the Market Place" brochure which is free of charge (www.agr.gc.ca/food/glutenfree). Different statistics are as confusing to us as they are to you. Mother Earth News (www.motherearthnews.com) say as of September 2013 the gluten-free products in Canada were a $90 million dollar enterprise, and in the U.S.A. the market was valued at $4.2 billion and climbing. That is not very far from the Rockville, MD based Research Firm which projected $5.5 billion by 2015.

Did you know that with regards to foods that contain casein not all celiac people need to go out and buy coconut milk or soy milk? Scott Adams, the founder of "Celiac.com," says "the fact that lactose intolerance is frequently a side effect of celiac disease. Celiac's who eat gluten become lactose intolerant after the villi and microvilli in their small intestine have become damaged, and are no longer capable of catching and breaking down the lactose molecule. He states that the problem usually disappears when celiacs remove gluten from their diet. Which allows the damaged villi and microvilli to grow back. Lactose intolerance however, can continue for a long time after a celiac has gone on a 100% gluten-free. It "can" in some cases up to two years to heal completely. In most cases it takes between six months and a year.

Another site for people who are gluten-free and dairy free, other than our own web site, is About.com. Nancy Lapid explains the connection in language that you can understand. These two references contained the best descriptions of the celiac disease/lactose intolerance link. It is not something that you can diagnose and handle alone. Those of you who have been taking OTC "Lactaid" long before you were diagnosed with celiac disease need to be evaluated soon! Guidance from a qualified physician or nutritionist is strongly advised. You will either hear or read that casein is like a drug and can cause withdrawal symptoms and a list of complaints that will elevate your blood pressure! Get your facts straight before going on an elimination diet or adding dairy-free to your already difficult diet.

Children with autism frequently seem addicted to wheat (gluten) and dairy (casein) products. Some people with autism and schizophrenia may be incompletely digesting wheat and dairy proteins. These incompletely digested peptides are then absorbed into the body and bind to opiate receptors altering behavior and other physiological reactions. Common symptoms of withdrawal toxification from gluten-derived opioid and brain neurochemical imbalances. The evidence suggests that about 70% of celiac patients will experience these symptoms when starting a strict gluten-free diet. There is the addictive nature of gluten which is often overlooked. There are common symptoms of withdrawal or detoxification from gluten-derived opiates and a brain neurochemical imbalance.

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