Don’t be a Glutton When It Comes to Gluten

In response to a petition denial, Docket No. FDA-2015-P-5081, asking the Agency to have products labeled with gluten content (here), the FDA has nonetheless issued a guidance document entitled “Gluten in Drug Products and Associated Labeling Recommendations”, wherein the Agency is permitting firms to add a statement to labeling regarding gluten, based on certain criteria.

The Agency notes and will permit (but, at this time, not require) the following voluntary statement about gluten in drug products:

We [FDA] recommend that drug manufacturers that wish to make statements about gluten anywhere on oral drug product labels or in required labeling use the following statement, when it is truthful and substantiated:

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

FDA denied mandating the statement because only very rarely does a product utilize a gluten-based inactive ingredient in their drug products, but felt that this might be useful information for patients that are sensitive to gluten and/or who may have celiac disease.   According to the guidance, the addition of the statement may be made in the original application, or, if the product is already approved, the change can be made in the next Annual Report.  The full guidance document can be found either at the end of the petition document cited above or here.