FDA Issues Recommendations On Gluten Labeling for Drugs

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in Celiac, News
Published: December 19, 2017

Celiac disease advocates are pleased that the U.S. Food and Drug Administration has issued draft guidance for drug manufacturers on the labeling of medications for gluten content.

The agency is recommending that manufacturers voluntarily include the following statement in the medication’s description section when it is “truthful and substantiated” – that the drug in question “contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).”

“Though the labeling is voluntary, it is definitely a step in the right direction,” said Alice Bast, CEO of Beyond Celiac. The organization has been working on the issue of gluten in medication for over a decade. Beyond Celiac released a national online survey in 2014 that stated almost 25 percent of the 5,623 individuals with celiac disease and gluten sensitivity reported having gluten-related symptoms to prescription medication.

Both patients and health-care providers says this has led to anxiety and non-compliance in taking drugs.

The FDA brought in the national standard of less than 20 parts per million of gluten for a food to qualify as gluten-free in 2014, but the standard did not apply to prescription or over-the-counter drugs. The agency notes that wheat gluten is seldom added as an inactive ingredient to oral drug products. However, the issue has been one of transparency; celiac consumers commonly have often been unable to find out whether gluten was present  in drugs they were prescribed.

“We will continue to fight for accurate labeling and advocate for funding for further research and if appropriate, the elimination of gluten in medications all together,” Bast said in an article on the Beyond Celiac website. “Our community’s health and well-being is at stake.”

See the FDA’s document here.
For an investigation of the gluten and medication issue, see Allergic Living’s feature article.