FDA Proposal Would Make Clear There's No Gluten in Those Pills

(Bloomberg) -- Avoiding gluten? Patients won’t have to worry about whether it’s in their prescription drugs, under a proposal from the U.S. Food and Drug Administration.

In draft guidance issued on Tuesday, the agency is pushing drugmakers to clearly label that medications taken orally don’t have ingredients from grains that include gluten like wheat, barley or rye.

Currently there are no drugs marketed in the U.S. that contain gluten in a quantity that would exceed the amount in a gluten-free food product, the FDA said. The new rules are an attempt to reduce uncertainty for people with gluten sensitivities or diseases aggravated by ingesting gluten.

“Transparency about what we’re putting into our bodies matters to all of us,” FDA Commissioner Scott Gottlieb said in a statement. “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.”

Roughly one in 100 people globally are estimated to have celiac disease, according to the Celiac Disease Foundation, an autoimmune disorder where the consumption of gluten can lead to damage of the small intestine.

--With assistance from Anna Edney

To contact the reporter on this story: Cynthia Koons in New York at ckoons@bloomberg.net.

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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