Celiac Awareness Month: Ten Things Everyone Should Know

May is Celiac Awareness Month.

As you may have read, I have celiac disease and I talk (and write) about it a lot. It is a huge part of my life – it controls everything I eat, where I eat it, the medication I can take, and even what sunscreen I can wear. In my many discussions about celiac disease with friends, family, servers, colleagues, grocery store clerks, doctors, nurses, and others, I find that people are usually very interested in knowing more about celiac disease.

So, in the spirit of increasing awareness, I offer my list of ten things everyone should know about celiac disease.

1. Celiac disease is an autoimmune disease. When people with celiac disease eat gluten it causes an immune response and their immune system attacks and damages their intestines. This damage stops the body from absorbing nutrients properly. Celiac disease is not an allergy or an intolerance to gluten.
2. Celiac disease is genetic. In order to develop the disease you must have the HLA-DQA1 and HLA-DQB1 genes.
3. One in every 133 people has celiac disease. Many have the disease and do not know it.
4. Celiac disease has more than 300 symptoms, affecting many different parts of the body, these can include chronic diarrhea, skin disorders, and infertility. These symptoms often subside after a gluten-free diet is instituted.
5. Celiac disease diagnoses requires a blood test and biopsy. In order to properly diagnose a person with celiac disease the person should be eating gluten, have a blood test, and a biopsy of the upper intestine. If the blood test and the biopsy are positive the person has celiac disease.
6. The only treatment for celiac disease is a gluten-free diet. Gluten is a protein found in wheat, rye, and barley.
7. The intestinal damage caused by celiac disease can heal over time if gluten is eliminated from the person’s life. A person with celiac disease can never safely reintroduce gluten into his or her diet.
8. Gluten is found in many products other than breads, crackers, and cereal. It can also be found in soy sauce, condiments, juices/smoothies, candy bars, processed foods, ice cream, beauty products, and alcoholic beverages, to name a few.
9. Food is not gluten-free if it has come in contact with a surface, utensil, or other ingredient that contains gluten. That is called cross contamination and it can make a person with celiac disease sick.
10. Not everyone on a gluten-free diet has celiac disease. There are many reasons why people may be on a gluten-free diet.

 

Celiac Disease and Drug Labeling

It has been nine months since I was diagnosed with celiac disease (CD). The only treatment for CD is strict avoidance of gluten. The transition to a gluten-free lifestyle has been a challenge. Leaving behind the food, and sometimes the beauty products, that you love is unpleasant at best. Another significant challenge is mastering the art of label reading.

Food labels can be difficult to understand, and cosmetics and cleaning supplies are more even more challenging – but the most challenging and complicated, by far, are drug labels. Ingestion of gluten from any of these sources can cause some patients with CD to have reactions and become symptomatic.

Last month I came down with my biannual upper respiratory infection. It happens the same way every time. Usually, all I need is a course of antibiotics (or at least I think I need them) and some Mucinex. The old days, before celiac, I would run to the doctor for a Z-Pak or Cipro and then to the pharmacy for some Mucinex. In a few days I would be healthy. Not anymore. Now, I have to figure out if the drugs I am prescribed and buy are safe for me to take – are they gluten-free.

Many over-the-counter (OTC) and prescription medications contain gluten. Gluten is used as an excipient in medications. Excipients are inactive ingredients that form the vehicle for delivery of the active ingredient. The most common gluten-containing excipient or inactive ingredient used is starch. Starch can be derived from corn, wheat, potato, or tapioca. Additional ingredients that may be derived from gluten include, but are not limited to, wheat, modified starch, pregelatinized starch, dextrates, dextrimaltose, caramel coloring, and dextrin. In patients with CD a medication using a wheat-derived excipient can trigger an autoimmune response and the symptoms that accompany it, such as diarrhea, abdominal pain, depression, joint pain, or skin rashes.

How do you tell if a medication is gluten-free?

The Food Allergen Labeling Consumer Protection Act of 2004, which requires that a product containing wheat must list the word “wheat” on the label, does not require that over-the-counter and prescription medications identify wheat or gluten containing ingredients in medications. 21 U.S.C. § 321(qq) (2012).

Under the Food, Drug and Cosmetic Act, OTC medications must list the inactive ingredients in the drug on the “Drug Facts” panel on the medication’s container. 21 C.F.R. §§ 201.66(c)(8) (2012).

Prescription drugs must include a description of the drug, including the inactive ingredients, in the drug’s package insert. Package inserts are part of the labeling for prescription drugs written for the benefit of practitioners.  21 C.F.R. §§ 201.56, 201.57, 201.100 (2012).

Since inactive ingredients must be included on labeling for both OTC and prescription drugs then patients should be able to determine from the label whether the drug contains gluten. Not true.

The inactive ingredients on both OTC and prescription drugs are often listed in a way that makes it impossible to tell if the product contains gluten. In the case of starch the label or package insert may only say “starch” or “pregelatinized starch.” If this is the case then the patient has to take additional precautions for taking the drug.

In the case of prescription drugs the patients’ sources of information is the package insert, the pharmacist, or a call to the manufacturer. Patients are given package inserts under limited circumstances, so a patient cannot count on receiving that information automatically. To access a package insert the patient can conduct a search for it at DailyMed using the drug name. The patient can also ask the pharmacist to provide the package insert or read it for him or her. If the ingredients listed show an excipient that can is or can be derived from a gluten source then the patient must call the manufacturer to confirm the source of the ingredient. Of course, this needs to be done before the pharmacist fills your prescription so you don’t pay for medication you can’t ultimately use. So, practically, this requires an additional visit to the pharmacy and a delay in filling the prescription.

It is important to know that manufacturers change excipients often and excipients vary between brand and generic drugs. Further, pharmacies do not stock the same generic medications from the same manufacturer. A pharmacy may change manufacturers regularly to get the best prices. Therefore, it is not enough to check on a drug’s status just once; you have to check and recheck to ensure you are safe.

As I prepared to tackle my upper respiratory infection I went to my usual OTC weapon, Mucinex. I read the label. The ingredient list for Mucinex includes the word “starch” with no qualifier (“starch(corn)”) Many will say that Mucinex is okay for people with CD because it is on the list of safe drugs on www.glutenfreedrugs.com. This is a handy website and I use as a place to start. However, despite the good intentions of the unnamed pharmacist author of the website, the site neither describes the methods used for compiling its gluten-free list nor the process for maintaining the list. For these reasons, I do my own research.

I went to the Mucinex website to investigate. There is no frequently asked questions list addressing gluten or offering a gluten-free statement. I then followed the site’s instructions and completed the online form for questions where I asked whether Mucinex contains gluten. Notice I did not limit my inquiry to just the starch – gluten can hide elsewhere and it’s good to be general because the response will be technical. Count on it.

A day or so later I received the following:

Dear Ms. Caudill,

Thank you for your email regarding Mucinex®.

In response to your inquiry, while Mucinex® products are not formulated with any ingredients that contain gluten, we have not certified that these products are gluten-free.  The starch ingredient is derived from potatoes.

We appreciate your interest in our product and we regret that we could not be more helpful.

Sincerely, Consumer Relations

This email was friendly, but it does not leave me feeling 100% confident that this medication is gluten-free. Did it even answer my question? The product is “not formulated with any ingredients that contain gluten” and “[t]he starch ingredient is derived from potatoes.” – okay, but does the drug contain gluten? They really won’t say for certain. Is the facility gluten-free? Should I worry about cross contamination? There is no way to know those things from this response.

In most cases, the response from Mucinex is representative of the type of answer you will get from a manufacturer, whether asking about an OTC or prescription drug. If a company does not specifically test for gluten it is highly unlikely that they will state without qualification that a product is gluten-free. They will often remind you that they cannot guarantee that the raw materials that they purchased to make the drug have not suffered cross-contamination. I don’t blame them – saying those things increases their liability.

Mucinex is not the problem. It is a good product. The problem is a lack of laws and regulations requiring prescription and OTC drug labeling to clearly disclose the presence of gluten contained in the drug’s inactive ingredients.

If regulations existed to require manufacturers to clearly list the inactive ingredients on product labels then patients would be better equipped to make choices in the drug store aisle without a day or more delay. Currently, making decisions in the drug store aisle is impossible. To be certain a drug does not contain gluten patients with CD, non-celiac gluten sensitivities (NCGS), or wheat allergies must make multiple phone calls, perform internet searches, and/or have the pharmacist review the package insert with them. At least most of us are able to do those things.

What about the patients with limited education or resources? We wrongly assume that all patients have internet access and are literate. Can everyone access DailyMed and read a package insert (which is written for practitioners), find manufacturer’s contact information, or be confident enough to ask a very busy pharmacist to stop what she is doing and help? Where a patient may not be able or empowered to do those things, most would be able to identify the words “gluten-free” on a drug label.

Assuming that the patient can access the manufacturer or pharmacist, even then, the patient can’t be 100% certain that the drug has not come in contact with gluten in the manufacturing process. There are no regulations that establish what it means for a drug to be gluten-free or to address gluten cross-contamination issues in drug manufacturing.

Part of this problem would be solved if drug labeling laws required that drug labels clearly identify the presence of gluten in a product. The second problem of what it means for a drug to be gluten-free would be solved if the FDA established a gluten threshold for drugs in the United States much like the regulations establishing gluten-free standards for food in the U.S., which are currently awaiting approval by the White House. Establishing such regulations not only benefits patients directly, but it ensures that physicians, pharmacists and other providers are better prepared to treat patients with CD, NCGS, and wheat allergies.

The Food and Drug Administration can make this happen. Let’s ask them to make drugs safe for those with CD, NCGS, and wheat allergies.

Gluten-Free Labeling in the United States

Grocery shopping has become challenging for me, because large sections of the grocery are off-limits. I have celiac disease (CD). CD is a systemic autoimmune disorder caused by exposure to gluten in genetically-susceptible people. Gluten is a protein found in wheat, rye, and barley. The immune response activated in celiac disease causes the body to attack gluten as if it is an antigen. Symptoms and other health problems associated with CD include including abdominal pain, bloating, diarrhea, psychiatric disorders, infertility, birth defects, osteoporosis, and life-threatening conditions such as intestinal cancer. According to the University of Chicago Celiac Disease Center, there are approximately 300 recognized symptoms of Celiac Disease. CD affects 1 in 133 people in the U.S. — the number of people in the U.S. with CD could fill 4,400 Boeing 747 jets.

The only treatment for CD is adherence to a gluten-free diet. This means that I must avoid anything that contains or has come in contact with gluten (wheat, barley, or rye). The list of gluten-containing substances I must avoid is not limited to food. People with CD must find cosmetics, beauty products, cleaning supplies, and medications that are gluten-free. Exposure to gluten from these sources can also result in a CD immune response and its accompanying symptoms.

I learned quickly after my diagnosis that the easiest way to eat is to buy fresh food. You know, the food found on the perimeter of the grocery store. I have little use for the guts of the grocery store where all the tasty bagged, boxed, and canned foods live.

When I pick up an organic bunch of kale, I know what is in it. That is not true of food that comes in boxes, bags, and cans. Decoding the ingredients of processed products is tricky. In foods not labeled “gluten-free,” I avoid anything that includes the ingredients “natural flavors,” “artificial flavoring,” or anything else that is vague. Then, I have to spend time Googling or using my gluten-free phone app to see if I can determine the gluten-free status of any other ingredients.

I am that lady standing in the aisle, probably in your way, basket on the floor, can in one hand, and an iphone in the other. Even if the product I am looking at has the words “gluten-free” on the label, I still have to wonder if it is gluten-free. I cannot just sigh with relief and toss it in my basket.

Why?

In the United States, there is no legal definition for the phrase “gluten-free.” That is right; manufacturers can use that phrase as they choose without meeting any established, regulated standards. “Gluten-free” means whatever they say it means as long as, according to the U.S. Food and Drug Administration (FDA), it is not “misleading.” There are instances of food products being sold with “gluten-free” labeling, and some products contain varying amounts of gluten, include “wheat” in the ingredients, and are exposed to gluten in the manufacturing process.

How can this be?

The FDA has failed to accurately define the term “major food allergen,” establish safe gluten thresholds for food products, and meet its legal obligation under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP) to create and implement final rules for gluten-free food labeling.

The phrase “major food allergen” under FALCP means “(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g. crab, lobster, or shrimp), tree nuts (e.g. almonds, pecans, or walnuts), wheat, peanuts and soybeans. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived form such highly refined oil. . . . .” 21 USC 321(qq) (2012). The FALCP requires that manufacturers identify these allergens by their common names (i.e. wheat, milk, or soy) on labeling for easy identification by consumers.

In order for a product to be gluten-free, it must be free of all gluten: wheat, barley, and rye. Unfortunately, the current law does not meet that standard. The definition of major food allergen includes only wheat. It does not include rye and barley, both of which contain gluten. The FDA’s definition of major food allergen must include the term “gluten” or the words “wheat, barley, and rye” to safely protect citizens with CD or other non-celiac gluten sensitivities.

Additionally, the FALCP charged the FDA to have final standards for gluten-free labeling in place by 2008, no later than four years after the enactment of FALCP. In 2007, following up on the mandate from FALCP, the FDA issued a proposed rule “Food Labeling: Gluten-Free Labeling of Foods.” The proposed rule states that a food is gluten-free if the food does not contain any of the following:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
2. an ingredient derived from these grains and that has not been processed to remove gluten;
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten; or
4. 20 ppm or more gluten.

Food Labeling; Gluten-Free Labeling of Foods, 72 Fed. Reg. 2795 (proposed January 23, 2007) (to be codified at 21 CFR Part 101).

The FDA’s notice described the currently-adopted analytical methods for gluten detection as being able to reliably and consistently detect gluten at levels of 20 parts per million or more in a variety of foods. Participation by food manufacturers would be voluntary if they wish to market products as gluten-free. The comment period for these rules passed with no action. No final rules were issued by the FDA.

In 2011, the FDA reopened the comment period on the same proposed regulations for “Food Labeling; Gluten-Free Labeling of Foods.” That comment period closed and, again, no action was taken. No final rules were issued by the FDA regarding the labeling of gluten-free foods.

Over a year later, on Dec. 14, 2012, the FDA issued a notice titled “Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket.” The comment period on the notice will close on Feb. 12, 2013, and an advisory committee meeting of the FDA is scheduled for March 7, 2013 from 8 a.m. to 5 p.m.

Have you ever shopped for a gluten-free cookbook for yourself or a friend? Do you know anyone with CD? It is likely that you do. Please consider supporting them by taking time to help prompt the FDA to do something with the power provided to it by Congress. Commenting on proposed government rules is a way for us to directly impact policy making. Your comments can directly impact and in some cases be included in the FDA’s final rules. Let your voice be heard.

It has been five years since the statutory deadline for final rules on gluten-free labeling, and the FDA has taken no final action. Five years. It is time for the FDA to do something.

This post is featured on The Huffington Post Blog.

Gluten House Arrest

The gluten drama continues.

You may recall that recently I droned on about how great I feel now that I am gluten-free. All that is still true. No bloat, thin is back, along with more energy. Great. So what can mess that up?

One blood test.

I had my first follow-up antibody test after my diagnosis. Not good. Four months later and my levels are still elevated. Now a non-perfectionist, rational person who did not have expectations built around this test would not have been devastated. That person would not be me. I fully expected to see a within normal range result (0-10). Nope, in four months I am still not “normal.”

My gastroenterologist has a kind and super competent nurse, Tina. She gets me. She knows that I will ask a 100 questions, so before she calls me back she always talks to the doctor so she can give me the best information possible. Love her. After this unfortunately blood test she and I had a chat and she suggested that I remove any gluten from my beauty regime and she scheduled an appointment with my doc in about 30 days. So, me being me, I made a complete and comprehensive list of everything that I come in contact with on a daily basis that could end up in my mouth and ultimately my guts. I called manufacturers (thanks a lot Clinique – I’ll never use you again), read labels, did research and in less than a week my bathroom, laundry room, medicine cabinet, and cleaning products were confirmed gluten-free. Fine. Surely this will help.

Thirty days later I went back to the doctor. He gets me too. He never rushes me, he answers all my questions, and always asks if I have more questions (God bless him). He also is not offended when I mock him. Like when I reminded him that when he diagnosed me he said in response to my reaction “no, this doesn’t suck, you can easily manage this with a gluten-free diet.” Oh, really? He has now conceded that for “most people” it is easily managed. Folks, I am not “most people.” When I have a condition I am always the 1% that has it the worst. I go all out. Thank the Lord none are life-threatening. Not shockingly, we seriously suspect that I am one of those celiac patients that is super sensitive to the smallest amount of gluten. An over-achiever once again.

How do we fix this? The doctor suspects I am eating out too often and that is where I am getting glutened. Who knew that eating out two times a week is a lot? The plan: stop taking all supplements and NO eating out for four months (until the next appointment). Seriously? Is this a joke? Yes, I can stop my supplements and work them back in one at a time to see if one of them is causing a problem even though they are allegedly “gluten-free.” But no eating out? That is too much. Not fair.

I am on gluten house arrest.

For those of you who think I am over-reacting here, stop a minute and think about it. I am single, have an intense need for being social, and I love food. Now, when I meet someone out for a visit I have to run home and eat first or have another KIND bar. I have to cook in bulk so I am never left with nothing to eat. I have to go to the grocery at last twice a week because now the food I have to buy is all perishable (when you are really gluten-free it’s basically a whole foods diet. The boxed and bagged gluten-free food is not good for you and real food rots). Oh, and I now always have a banana, apple, or pear in my purse. Next thing you know I’m going to have tissues stuffed up my shirt sleeves.

The doctor, in reaction to me spewing some version of what I just typed at him, calmly reminded me, as he looked at my evenly spaced and spell checked typed list of all my gluten-free products, that I am “doing everything I can do and I have to live.” He then said, if you have to travel and can’t eat at home just be extra careful and take your Imodium with you. Sage advice.

At the end of this appointment he sent me to have another round of blood work resulting in more bad news. After 30 days of no gluten-free product touching my skin Tina reported that all levels are still up and mostly unchanged. Sigh. She sweetly offered to have the doc call me and listened while I declared that this is “hopeless” and I “am giving up on the titres.” God bless her heart.

It took a couple days, but I have calmed down. My non-perfectionist, rational side has woken up and I realize that I am not killing myself and that this is a process. Not a contest. Having normal titres is just going to take time because, well, I am special. I have to stop looking at it like some sort of goal that if I don’t accomplish I am a failure or loser.

It is just a blood test is my new mantra, or something.

Ultimately, my little rule-following and people-pleasing (including my doctor) self will behave and do as told. So, it looks like the only answer for the next four months is to make my kitchen foodie-worthy, carry-in my dinners to restaurants (classy), and become smug about my super healthy food lifestyle (or not). Maybe my next career with be gluten-free chef . . . talk about unrealistic expectations!

Thank the Lord gluten-free house arrest doesn’t involve some sort of tracking bracelet.

Gluten-Free Dining in Fort Wayne

Gluten-free eating can be pretty easy and very tasty at home. Whole foods do not contain gluten, so eating gluten-free at home is a healthy and naturally low-calorie way to eat. Just whip up a meat and three and you are good to go.

Eating gluten-free outside of your own kitchen can be challenging. The challenges can include the type of cuisine (hello, Italian), the knowledge and understanding of the chef and staff about the dietary restrictions, or your (my) own fear of cross-contamination (you don’t know what happens to your food before you get it). So far in my gluten-free adventure I have encountered uninterested, cynical, and disbelieving servers and restaurant owners. You know, the ones that think you are asking for a gluten-free meal because you are a low-carb weight loss diet (which is fine if you are – just say it and stop claiming you have a disease, allergy, or legitimate intolerance). This is why I have started using the word Celiac as much as possible. I hope to bring at least some awareness to a handful of people.

Anyway, for every one of those people, I run into two or three people who are genuinely interested in making sure I have a positive dining experience. They ask questions, offer suggestions, and take recommendations happily. Below is a list of the places in Fort Wayne where I have enjoyed great gluten-free food and service so far. I plan to share as many as I can find that are worth a share. I hope this helps guide you to the happiest gluten-free places in town.

Acme Bar & Grill – I love the hamburgers at the Acme. So, when I went in recently and asked for one, sans the bun and fries, my server never missed a beat. I had a salad instead of fries and it was a great gluten-free meal. Remember if you are not sure the fries are prepared in a dedicated fryer then they may be contaminated. Booo.

BakerStreet Steak, Seafood, & Spirits – This spot is one of my favorites, it has a great gluten-free menu as well as attentive, caring, and knowledgeable servers. I had a perfectly prepared steak with asparagus, a spinach salad, and a to-die-for flourless chocolate cake. Top notch. Also, if you want to participate in their dining events (they do some farm to fork dinners) then let them know when you make the reservation that you are gluten-free and they will make sure you can participate.

Casa – This Italian eatery has a comprehensive gluten-free menu that will satisfy the biggest, baddest pasta craving! Other than the bread, you would never know that you were eating gluten-free.

Firefly Coffee House – You can get a gluten-free Oregon Chai latte (my favorite) amongst other tasty safe drinks. They serve gluten-free cookies and crustless quiche from their kitchen. The staff is also never too busy to answer a question, show you a product label, or listen to any helpful suggestions. The folks get it. They have also started carrying almond milk in addition to soy for those of us who can’t tolerate lactose.

Friends – They do not have a gluten-free menu but they do have an accommodating kitchen and a flexible menu. Enjoy the chicken souvlaki with potatoes and a great Greek salad (it has pineapple and beets on it – I love it).

Grabill Country Store – Call ahead to this lovely Amish store in the burg of Grabill and they will bake you a loaf of your favorite bread – gluten-free. The Grabill Store also has a large selection of gluten-free flour, mixes, and other fixins. The daily breakfast and lunch buffet has naturally gluten-free options also (eggs and bacon are beautiful things).

J.K. O’Donnell’s – JK’s has outstanding salads that are gluten-free. For those that enjoy a snort every now and again, JK’s offers a gluten-free beer as well as a selection of ciders that are naturally gluten-free.

Madeleine’s Bakehouse – During your next shopping trip to Jefferson Pointe stop into Madeleine’s and enjoy one of their many macaroons and a cup of tea. Both are gluten-free and lovely!

The Oyster Bar – There is no gluten-free menu at The Oyster Bar but the chef is knowledgeable about gluten-free cooking and can whip you up some great fish, gluten-free. There are many things on The Oyster Bar’s expansive menu to enjoy gluten-free, including oysters.

Spice & Herb – Asian food can be tricky in regards to gluten, it is hard to know exactly what thickeners are used and there is typically no gluten-free menu. This is not a concern at Spice & Herb, I had a great lunch of noodles made of mung beans, tea, and salad, all gluten-free. The server was attentive, helpful, and knew exactly what I needed.

There are fast-food joints that offer pretty solid gluten-free options . . . Red Robin has a good gluten-free menu, Chik-fil-a offers gluten-free fries and chicken options (no bun), Culver’s custard in a cup (I only eat vanilla) is gluten-free, Chipotle is accommodating and can make a super gluten-free salad, and in a pinch you can get a bun-less cheeseburger at McDonald’s (although I prefer to go inside as I feel it is harder to mess up my food if you have to look directly at my face).

This diagnosis has been very hard for me – my hobby and great pleasure in life is finding and enjoying good food. I love to eat adventurously and being gluten-free has certainly changed how I can do that now. The days of not thinking about food are over – I have to pre-plan all my meals and carry snacks everywhere I go. But there is hope, in fact, after writing this list I feel a renewed hope that not all of my going-out-to-eat options are lost. That sure is a pretty thought.

Be patient, friendly, kind, and smile a lot and more often than not you will find someone who truly wants to meet your food needs!