The majority of orally administered drug products either contain no gluten or virtually no gluten. FDA has issued a draft guidance on Gluten in Drug Products and Associated Labeling Recommendations. The draft guidance provides recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease.
The draft guidance gives drug manufacturers a recommended statement to include in their labeling when truthful and properly supported: “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” The draft guidance also describes where to place that statement in the product labeling.
The draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. The recommendations contained in FDA’s draft guidance are intended to reduce this uncertainty and to provide information to consumers and healthcare professionals regarding gluten in drug products.
This draft guidance was developed with individuals with celiac disease in mind. However, the recommendations in this draft guidance may be of interest to individuals with other with other conditions that are treated with a gluten-free diet.
The following Questions & Answers provide additional information for consumers with questions about gluten in drug products:
Questions and Answers about Gluten and Oral Drug Products
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.
- Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry
- Report a problem to MedWatch, the FDA Safety Information and Adverse Event Reporting Program
- Citizen Petition and Response from FDA, 2017
- Citizen Petition and Response from FDA, 2015
- Gluten in Drug Products, Request for Information (RFI), Docket No. FDA-2011-N-0842-0001) issued 12-21-11, closed for comments 3-20-12
- Celiac Disease Awareness Campaign of the National Institutes of Health (NIH)