NFCA Represents Celiac Disease Community at FDA Workshop

December 1, 2009

NFCA Represents Celiac Disease Community at FDA Workshop

Advocates Mandatory Gluten Labeling for Prescription Medications.

By Loretta Jay, NFCA Director of Program Development

You are feeling lousy and finally made it to your doctor’s office. The doctor knows what is ailing you, and assures you that you’ll be feeling better soon. Just take these antibiotics, she says. But wait! Is there gluten in that medicine? It is a question that those with celiac and gluten sensitivity grapple with. Physicians and pharmacists struggle too. According to current US Food and Drug Administration (FDA) guidelines, gluten does not need to be labeled in medications. But hopefully that will all change soon!

On September 24-25 2009, the FDA held a public workshop entitled, “Providing Effective Information to Consumers About Prescription Drug Risks and Benefits” and NFCA was there. There were round-table discussions and debates about what information consumers need to know, and when and how to communicate that information. NFCA presented its position: to make a safe decision about one’s health, consumers, their pharmacists and healthcare providers must know the ingredients of prescribed medications.

Most medication does not contain gluten. It is the few drugs that do, that create the problem. Wheat can be an excipient, used to bind the other ingredients together. It is often labeled as “starch.” Since no current regulations require drug manufacturers to identify the source of inactive ingredients, wheat does not need to be labeled. As a result, it is not easy to determine its presence. When the medication’s gluten-free status is unknown, the pharmacist or consumer must call the manufacturer – every time.

Attending the FDA workshop were drug manufacturers and pharmacists, and also people from organizations that represented pharmacists, manufacturers and consumers. Attendees, all vying for the FDA’s ear, conveyed their differing viewpoints and various needs. On the second day of the workshop, expert panelists presented their opinions about what type of information should be included, in what format, and how much is needed.

NFCA submitted comments to the FDA in which we advocated that gluten must be labeled when in medication so consumers and healthcare providers can make safe decisions regarding its usage.

Please follow this link to read NFCA’s submitted comments.