With the growing popularity of gluten-free products at your local grocery store, you may have wondered if you should avoid eating gluten. Sidestepping gluten can be a lifestyle choice for many. But for those with a condition known as celiac disease, it’s a medical necessity.

Gluten is a protein found in wheat, barley, rye, and sometimes oats—ingredients often used in breads, pastas, and desserts. Some people get gas, diarrhea, or bloating after eating gluten. These symptoms could be caused by intolerance to the protein or a wheat allergy, but celiac disease is different.

When a person with celiac disease eats or drinks anything with gluten, the body’s immune system attacks the inside of the small intestine. The damage from this attack keeps the body from absorbing needed nutrients. If left untreated, celiac disease can lead to malnutrition, depression, anxiety, anemia, or weakened bones. It can also delay children’s growth.

Celiac disease can be hard to spot, because its symptoms can be similar to other disorders. The condition affects about 1% of people worldwide; nearly 80% of them haven’t been diagnosed, says Dr. Alessio Fasano, a celiac disease specialist at Massachusetts General Hospital. “Celiac disease is a clinical chameleon. This creates tremendous confusion and challenging situations for both health care professionals and people who are trying to understand what’s wrong with them,” Fasano says.

Your doctor can use a blood test to look for signs of celiac disease. Before the test, continue eating foods with gluten. Otherwise, the results may be negative for celiac disease even if you have it. Eating a regular diet can also help your doctor determine if you have a form of gluten sensitivity that is not celiac disease. Gluten sensitivity is something you may grow out of over time, Fasano explains, whereas celiac disease is a lifelong condition.

If your tests and symptoms suggest celiac disease, your doctor may confirm the diagnosis by removing a small piece of your intestine to inspect it for damage.

Genetic tests may be used to detect the genes that turn on the body’s immune response to gluten. Such tests can help rule out celiac disease, but they can’t be used for diagnoses; many people who have the genes never develop celiac disease.

Fasano’s team is studying why some people with these genes don’t have symptoms. The NIH-funded researchers will follow infants who are at increased risk because a family member has celiac disease. The team hopes its findings will help doctors predict who will get celiac disease and learn how to prevent it.

People with one autoimmune disease are at increased risk for other autoimmune diseases. Because celiac disease and type 1 diabetes share risk genes, a large international study is following newborns at risk for both conditions to identify environmental factors that may trigger or protect from these diseases.

Going on a strict 100% gluten-free diet for life remains the only treatment for now. “We can’t take the genes out, so we remove the environmental trigger,” Fasano says.

Gluten is sometimes found in unexpected sources—such as medications, vitamins, or lip balms—so check ingredient lists carefully. The U.S. Food and Drug Administration has strict regulations for the use of “gluten-free” labels. Talking with a dietitian can also be helpful for learning about your food options.

If you suspect you may have celiac disease, talk with your doctor. Waiting too long for a diagnosis might lead to serious problems.

Symptoms of Celiac Disease

Celiac disease symptoms can be similar to other conditions. Blood tests or biopsies may help confirm a diagnosis. Symptoms include:

• Stomach pain
• Gas
• Diarrhea
• Extreme fatigue
• Change in mood
• Weight loss
• Itchy, blistering skin rash

If you have celiac disease, removing gluten from your diet will control symptoms, heal existing damage to the small intestine, and prevent further damage over time.

A gluten-free diet means not eating foods that contain gluten, a protein found in wheat, barley, and rye. If you have celiac disease, removing gluten from your diet will control symptoms, heal existing damage to the small intestine, and prevent further damage over time.

Your doctor may suggest that you work with a dietitian to create a gluten-free diet plan. The dietitian can help you understand how to read food labels and identify gluten-containing foods at the grocery store or eating out.

The good news is that there are many healthy, gluten-free foods available, and most people recover completely on a gluten-free diet.

Gluten is a protein found in wheat, rye, and barley. It is found mainly in foods but may also be in other products like medicines, vitamins, and supplements. People with gluten sensitivity have problems with gluten. It is different from celiac disease, an immune disease in which people can't eat gluten because it will damage their small intestine.

Some of the symptoms of gluten sensitivity are similar to celiac disease. They include tiredness and stomachaches. It can cause other symptoms too, including muscle cramps and leg numbness. But it does not damage the small intestine like celiac disease.

Researchers are still learning more about gluten sensitivity. If your health care provider thinks you have it, he or she may suggest that you stop eating gluten to see if your symptoms go away. However, you should first be tested to rule out celiac disease.

Celiac disease is a chronic digestive and immune disorder that damages the small intestine. The disease is triggered by eating foods containing gluten. Gluten is a protein found naturally in wheat, barley, and rye, and is common in foods such as bread, pasta, cookies, and cakes. Many products contain gluten, such as prepackaged foods, lip balms and lipsticks, toothpastes, vitamin and nutrient supplements, and, rarely, medicines.

Celiac disease can be serious. The disease can cause long-lasting digestive problems and keep your body from getting all the nutrients it needs. Celiac disease can also affect the body outside the small intestine.

Celiac disease is different from gluten sensitivity or wheat intolerance. If you have gluten sensitivity, you may have symptoms like those of celiac disease, such as abdominal pain and tiredness. Unlike celiac disease, gluten sensitivity does not damage the small intestine.

Celiac disease is also different from a wheat allergy, a type of food allergy. In both cases, your body’s immune system reacts to wheat. However, some symptoms of wheat allergies, such as having itchy eyes or a hard time breathing, are different from celiac disease. Wheat allergies also do not cause long-term damage to the small intestine.

Gluten occurs naturally in certain grains, including

• wheat and types of wheat, such as durum, emmer, semolina, and spelt
• barley, which may be found in malt, malt extract, malt vinegar, and brewer’s yeast
• rye
• triticale, a cross between wheat and rye

Gluten is found in foods that contain ingredients made from these grains, including baked goods, baking mixes, breads, cereals, and pastas. Drinks such as beer, lagers, ale, flavored liquors, and malt beverages may also contain gluten.

Many food ingredients and additives—such as colorings, flavorings, starches, and thickeners—are made from grains that contain gluten. These ingredients are added to many processed foods, including foods that are boxed, canned, frozen, packaged, or prepared. Therefore, gluten may be found in a variety of foods, including candy, condiments, hot dogs and sausages, ice cream, salad dressing, and soups.

Cross-contact

Cross-contact occurs when foods or products that contain gluten come into contact with gluten-free foods. Cross-contact can spread gluten to gluten-free foods, making the gluten-free foods unsafe for people with celiac disease to consume. Cross-contact can occur at any time, including when foods are grown, processed, stored, prepared, or served.

A registered dietitian can help you learn to identify and avoid foods and drinks that contain gluten when you shop, prepare foods at home, or eat out.

For example, when you shop and eat at home

• carefully read food labels to check for grains that contain gluten—such as wheat, barley, and rye—and ingredients or additives made from those grains.
• check for gluten-free food labeling.
• don't eat foods if you aren’t sure whether they contain gluten. If possible, contact the company that makes the food or visit the company’s website for more information.
• store and prepare your gluten-free foods separately from other family members’ foods that contain gluten to prevent cross-contact.

When you eat out at restaurants or social gatherings

• before you go out to eat, search online for restaurants that offer a gluten-free menu.
• review restaurant menus online or call ahead to make sure a restaurant can accommodate you safely.
• at the restaurant, let the server know that you have celiac disease. Ask about food ingredients, how food is prepared, and whether a gluten-free menu is available. Ask to talk with the chef if you would like more details about the menu.
• when attending social gatherings, let the host know you have celiac disease and find out if gluten-free foods will be available. If not, or if you are unsure, bring gluten-free foods that are safe for you to eat.

No. If you think you might have celiac disease, you should talk with your doctor about testing to diagnose celiac disease before you begin a gluten-free diet. If you avoid gluten before you have testing, the test results may not be accurate.

Also, if you start avoiding gluten without advice from a doctor or a registered dietitian, your diet may not provide enough of the nutrients you need, such as fiber, iron, and calcium. Some packaged gluten-free foods may be higher in fat and sugar than the same foods that contain gluten. If you are diagnosed with celiac disease, your doctor and dietitian can help you plan a healthy gluten-free diet.

If you don’t have celiac disease or another health problem related to gluten, your doctor may not recommend a gluten-free diet. In recent years, more people without celiac disease have begun avoiding gluten, believing that a gluten-free diet is healthier or could help them lose weight. However, researchers have found no evidence that a gluten-free diet promotes better health or weight loss for the general population.

Since 2014, the U.S. Food and Drug Administration (FDA) has required that claims on food labels that a food contains no gluten meet a clear standard that assures consumers that “gluten-free” claims on food products will be truthful and consistent. The gluten-free labeling regulation gives consumers a standardized tool for managing their health and dietary intake — especially those with celiac disease, an auto-immune reaction to eating gluten, a protein found in wheat, barley and rye.

What is Gluten?

Gluten occurs naturally in wheat, rye, barley, and crossbreeds of these grains. Foods that typically contain gluten include breads, cakes, cereals, pastas, and many other grain-based foods.

Gluten is the substance that gives breads and other grain products their shape, strength, and texture. But, for the estimated 3 million Americans suffering from celiac disease, consuming gluten causes damage to the lining of the small intestine which prevents absorption of vital nutrients causing deficiencies that can lead to serious conditions, including anemia, osteoporosis, diabetes, thyroid disease, and intestinal cancers.

FDA’s Regulation of “Gluten-Free” Claims

While “gluten-free” is a voluntary claim that manufacturers may choose to use in the labeling of their foods, FDA’s gluten-free food labeling rule specifies what the claim actually means on a food label. Accordingly, manufacturers that label their foods as free of gluten are responsible for using the claim in an accurate and not misleading manner, and for complying with all requirements established by the regulation and enforced by FDA.

Inside the Regulation

The rule specifies, among other criteria, that any foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. This level is the lowest that can be reliably detected in foods using scientifically validated analytical methods. Other countries and international bodies use these same criteria, as most people with celiac disease can tolerate foods with very small amounts of gluten.

Before the regulation was issued in 2013, there were no U.S. standards or definitions for the food industry to use in labeling products as “gluten-free.” This left many consumers, especially those with a health concern, unsure of whether a food was free of gluten. .

Besides the limit of gluten to 20 ppm, the rule permits labeling a food “gluten-free, if the food does not contain:

• An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains,
• An ingredient derived from these grains that has not been processed to remove gluten, or,
• an ingredient derived from these grains that has been processed to remove gluten, but results in the food containing more than 20 ppm of gluten

Compliance with the Regulation

Manufacturers had until August of 2014 to bring their labels into compliance, allowing them sufficient time to make whatever changes were needed in the formulation or labeling of their foods bearing a “gluten-free” claim. Today, a food that is labeled as “gluten-free” but fails to meet the requirements of the regulation is subject to regulatory action by FDA. In 2017, FDA released the results of an analysis of 702 samples from more than 250 products labeled “gluten-free.” Only one of the products did not comply with the labeling requirements. That product was recalled and subsequent testing did not find any products that violated the regulation.

Grains: A Closer Look

Certain grains are especially likely to contain naturally occurring gluten. However, these grains can be processed to remove gluten, including:

• Wheat
• Barley
• Rye
• Crossbred hybrids like triticale

Foods That Can Be Labeled As “Gluten-Free”

Whether a food is manufactured to be free of gluten or by nature is free of gluten, it may bear a “gluten-free” labeling claim if it meets all FDA requirements for a gluten-free food. Some foods and beverages, such as bottled spring water, fruits, vegetables, and eggs, are naturally gluten-free. However, because a “gluten-free” claim isn’t required to be on a food package, it may not appear even if the food is, in fact, gluten-free.

What About Restaurants?

FDA recognizes that compliance with the gluten-free regulation in processed foods and food served in restaurants is important for the health of people with celiac disease.

FDA’s regulation established a federal definition of the term “gluten-free” for food manufacturers that voluntarily label FDA-regulated foods as “gluten-free.” The definition was intended to provide a reliable way for people with celiac disease to avoid gluten, and, given the public health significance of gluten, restaurants’ use of gluten-free labeling should be consistent with the federal definition.

State and local governments play an important role in oversight of restaurants. FDA continues to work with state and local government partners with respect to gluten-free labeling in restaurants.

Gluten-Free Labeling: What It Looks Like

The regulation doesn’t require manufacturers to place a food’s “gluten-free” claim in any specific location on the food label. So, manufacturers may choose where they place a “gluten-free” claim, providing that it doesn’t interfere with mandatory labeling information and meets the regulatory requirements.

• Some manufacturers may choose to include the logo of a gluten-free certification program on their food labels; however, FDA does not endorse, accredit, or recommend any particular third-party gluten-free certification program.
• Packaging of some foods that were labeled as “gluten-free” prior to the regulation may look the same as they did before because the foods already met the definition and did not need revised packaging.

Products Covered by the Gluten-Free Regulation

FDA’s regulation applies to all foods and beverages (including packaged foods, dietary supplements, fruits and vegetables, shell eggs, and fish) exceptfor :

• Meat, poultry, and certain egg products, which are regulated by the U.S. Department of Agriculture (USDA), and,
• Most alcoholic beverages (all distilled spirits, wines with 7 percent or more alcohol by volume, and beverages made with malted barley and hops), which are regulated by Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Department of the Treasury.

What is gluten?

FDA uses the term “gluten” in its guidance on oral drug products as meaning certain proteins found in wheat, barley, and rye or their crossbred hybrids that lead to symptoms associated with celiac disease.

What is celiac disease?

Celiac disease (also known as celiac sprue) is an immune-based reaction to dietary gluten that primarily affects the small intestine in susceptible individuals; unmanaged celiac disease can lead to serious health complications. Approximately 1 percent of the U.S. population has celiac disease. It is characterized by ongoing inflammation of part of the lining of the small intestine that generally heals if foods containing gluten are excluded from the diet and returns if they are reintroduced. At this time, the treatment for celiac disease is adherence to a gluten-free diet. Information is available on FDA’s food-labeling regulations and gluten-free diets web page.

What types of ingredients that may contain gluten are in oral drug products?

The majority of oral drug products either contain no gluten or virtually no gluten.

Based on information available to the Agency, we are aware of no oral drug products currently marketed in the United States that contain wheat gluten or wheat flour intentionally added as an inactive ingredient. We would expect any such product, if it existed, to include wheat gluten or wheat flour in the list of ingredients in its labeling.

FDA has identified very few oral drugs that contain wheat starch as an ingredient. Starch can also be used as a starting material for manufacturing various ingredients found in oral drugs. Starch used for this purpose is often corn starch or potato starch, not wheat starch. Even if wheat starch were used, either as an ingredient or as a starting material, there would be very little gluten, if any, expected to be present in the ingredient or the drug product. Very few, if any, oral drug products contain ingredients derived from barley or rye.

Typically, how much gluten is in a drug product?

The vast majority of oral drug products either contain no gluten or virtually no gluten. In the very rare cases where gluten may be present, we estimate based on drug formulation information that wheat starch and other ingredients derived from wheat would contribute no more than 0.5 mg gluten to a unit dose of an oral drug product. This amount is less than may be found in a single 30-gram serving of food labeled gluten-free according to FDA’s regulations.

How do I find out what ingredients my drug product contains?

For nonprescription drug products, ingredients are listed on the “Drug Facts” label in the “inactive ingredients” section. For prescription drug products, ingredients will generally be listed on the labeling in the “Description” section.

You can also look up the labeling for more than 90,000 prescription and nonprescription drug products on the internet at DailyMed. Here are a couple of points to keep in mind when looking up information about a drug product:

• Be sure that the product label you are looking at matches the product you are interested in getting more information about. For example, the product name and product manufacturer or distributor listed on the label should match the product you are interested in.
• If the list of ingredients does not mention wheat gluten or wheat flour, then the product should not contain gluten in an amount that would harm a typical (non-refractory) individual with celiac disease.

FDA encourages drug manufacturers to have accurate information on the sources of their ingredients available so they can respond to questions from the public and health care providers.

Partners Rose and Jack approach celiac disease together

Rose's story

When Rose Perry was in high school, she developed a skin rash and didn't know why. It was a complete mystery to her and her family.

After six months, she finally knew what was wrong. A skin biopsy revealed she had dermatitis herpetiformis, which then led to the diagnosis of celiac disease.

She and her mom had to make a number of changes. Their work started in the kitchen. They got rid of all foods containing gluten in their house. They also threw away food that had come into contact with gluten-containing foods.

Then Rose had to go through her beauty products and toss any soap, shampoo, or other products that contained gluten. Since those products could come in contact with her mouth, they could cause accidental gluten exposure.

"The idea was to eliminate everything that you could from things that you could touch, so that you wouldn't have to worry about it," she said.

Living at home, she had control. College was going to be different. As a student at Iowa State University, Rose had to learn about the school's resources for students living gluten-free. She adapted to her new lifestyle.

Jack's story

For some people, college is the best time of life. It wasn't for Jack Gottschalk. He felt too sick to enjoy himself.

"I felt sick all the time. I couldn't eat anything and feel good afterwards," said Jack.

As a swimmer at York College in Pennsylvania, Jack often had pasta parties with his teammates. He never guessed that the delicious pasta was causing him trouble.

The summer before his senior year, Jack was diagnosed with celiac disease. It turns out that most pasta is primarily made with gluten.

He was surprised to learn that there was only one treatment: Jack had to follow a strict gluten-free diet. "There isn't really anything you can do for this," he said. "You're going to have to live differently and that's kind of a shock."

Rose and Jack's story

Rose and Jack met in 2015. She was attending grad school in Maryland, where he lived.

In addition to their Maryland residency, it turns out they had one more thing in common. They both have celiac disease.

"It's a huge advantage to have a partner with the same dietary restrictions," Rose said. "Knowing that you have somebody who is going through something similar and understands how serious it is, you're not going to get questions all the time like, 'Is that really necessary? Do you have to do that?'"

Jack says it makes things easy to have an entirely gluten-free home. Both he and Rose say they never have to worry about grabbing something out of the pantry to snack on.

"I can live a totally normal life within the confines of our home," Jack said. "It fades into the background and you don't even remember it half the time when you're at home because it's not something you have to worry about actively."

The two have found, as so many with celiac disease have, both benefits and frustrations with the rise in people choosing a gluten-free lifestyle. "The awareness of celiac disease and gluten-free diets has been both a blessing and a curse," Rose said.

Since they were diagnosed, there are many more foods they can eat. They are both happy with the expanded gluten-free offerings and accommodations they've found, but food labels can still be challenging.

Rose explained that often they will find a product labeled gluten-free, only to turn the package over and read that it was made in a facility that processes wheat.

"It does lead to a lot more accidental exposures," Rose said. "People will try something new thinking that it will be okay and it isn't."

Over time, Rose and Jack have become used to their gluten-free lives. They hope others faced with the same diagnosis will not be too worried about the adjustment. "It's not as bad as you think it is," Rose said.

Jack recommends that those who are newly diagnosed take time to explore new food options and be prepared for things like social gatherings. He says you should still go to parties and get togethers—just bring your own food.

"It's really not a big deal, especially compared to the peace of mind you'll have knowing your food is safe," Jack said.

Rose and Jack enjoy busy lives. Rose is a medical and scientific illustrator and Jack is a retail professional.

Dealing with celiac disease is just one aspect of their lives.