FDA Releases Draft Guidance on Gluten in Drug Products

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The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

On Dec. 12, 2017, FDA published draft guidance on gluten in drug products. The guidance 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-based sensitivities.

Additionally, the guidance describes where to place that statement in the product labeling and informs manufacturers about the supporting product information that FDA would expect them to include in the submission, or to have available for agency examination to support the statement. This guidance does not 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,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “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.”


Source: FDA