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FDA Provides Drug Manufacturers With Gluten Guidance

The FDA issued draft guidance yesterday, "Gluten in Drug Products and Associated Labeling Recommendations," that provides drug manufacturers with the agency's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease or other gluten sensitivities. As part of this effort, the FDA is providing drug manufacturers with a recommended labeling statement to indicate that their products do not contain ingredients derived from gluten-containing grains (wheat, barley, or rye). In addition, the guidance describes where to place that statement in the product labeling and informs manufacturers about the supporting product information that the FDA would expect them to include in the submission or have available for agency examination to support the statement. This guidance doesn't apply to food (including dietary supplements), which under a 2013 FDA regulation cannot use "gluten-free" labeling claims unless the product meets federally defined criteria.

"Transparency about what we're putting into our bodies matters to all of us, but for the millions of Americans with celiac disease or gluten sensitivities, who have the potential for serious immune responses when gluten is ingested, it's absolutely essential. We have made great strides in enhancing transparency about gluten in food labeling, but because there has been uncertainty about gluten in certain drug products, some patients may be avoiding medications that would otherwise offer a health benefit," says FDA Commissioner Scott Gottlieb, MD. "The bottom line is that we're not currently aware of any oral drug product marketed in the US that contains more gluten in a single dose than the amount that could be in a single serving of food that can be labeled gluten-free. Today we're encouraging drug companies to be transparent in the labeling of their oral drug products when it is accurate that those products do not contain ingredients made from gluten-containing grains, to better inform consumers and health care professionals about this important topic."

The FDA isn't aware of any oral drug product currently marketed in the United States that is expected to contain more gluten in a unit dose than the amounts that may be present in a single serving of food that can be labeled "gluten-free" under the FDA's regulation. Additionally, the FDA isn't aware of any oral drug products currently marketed in the United States that contain wheat gluten or wheat flour as an intentionally added ingredient. Labeling statements regarding gluten recommended in the draft guidance can provide consumers with information that can help reduce uncertainty. This guidance also 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.