FDA Issues Guidance On Labeling Gluten-Free Medications

Steve Plogsted, a pharmacist at Nationwide Children’s Hospital in Columbus, Ohio, is an expert on gluten in medications. His website, glutenfreedrugs.com, is widely recognized as the most reliable source of information on gluten-free prescription and over-the-counter drugs. Have a question about gluten and medications? Send it to [email protected].

 

Q: I get very frustrated when I ask my pharmacist or physician if a medication I am prescribed contains gluten. Nobody seems to know the answer or where to find it. Can’t the federal government help this situation?

A: Our celiac community received some important help from the government. On Dec. 12, 2017, the FDA issued guidance to drug manufacturers on voluntarily labeling medications to state that no known gluten-containing ingredients were used in their product. This effort has been ongoing since 2015, when Rep. Tim Ryan (D-Ohio) introduced legislation to Congress. His persistent efforts, along with those of other experts and stakeholders in the celiac community, paid off.

Although this legislation asks for voluntary compliance for now, it could lead to more mandatory labeling in the future. I am particularly excited because Congressman Ryan’s office has contacted me to provide them with some background information on gluten in medications. This legislation also addresses the sugar alcohol issue. Sugar alcohols, or polyols, are substances used as sugar substitutes in food products. Some manufacturers categorically state that their drug product contains gluten simply due to the presence of one of these sugar alcohols. While sugar alcohols could be derived from a wheat source, the gluten protein is removed during the manufacturing process. The major celiac organizations do not recommend avoiding these sugar alcohols.

Since there is no official definition of gluten free in drug products, this is the best they can do at this time. You can read the legislation at http://bit.ly/2CzPCug.

For more of Steve Plogsted’s advice and information on gluten-free medications, read these past Q&As:

To read resident dietitian Amy Keller’s advice on following and thriving on the gluten-free diet, check out these Q&As:

 

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