FDA 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.
‘FDA says the guidance was developed to address concerns for patients with celiac disease and that its recommendations also apply to patients with other conditions treated with a gluten-free diet.’
"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.
How Does FDA Define 'Gluten-Free'?
In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA now allows manufacturers to label a food "gluten-free" if the food does not contain any of the following:
- an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
- an ingredient derived from these grains and that has not been processed to remove gluten
- an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
Under the final rule, a food label that bears the claim "gluten-free," as well as the claims "free of gluten," "without gluten," and "no gluten," but fails to meet the requirements of the rule is considered misbranded and subject to regulatory action by FDA.