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FDA offers guidance on gluten-labeling for medications

The US Food and Drug Administration has issued draft guidance for drug manufacturers to clarify when a gluten-containing ingredient has been used to make prescription and over-the-counter drugs.

Gluten is a protein found in wheat, barley and rye. 

This comes three years after the FDA set voluntary guidelines for labeling foods gluten free.

The guidance encourages drug makers to voluntarily include a statement that their drug "contains no ingredient made from a gluten-containing grain (wheat, barley or rye)" when such a statement is "truthful and substantiated" in the description section of the drug's prescribing information.

“We at Beyond Celiac – formerly the National Foundation for Celiac Awareness – have been working on addressing the issue of gluten in medications for a decade.” said Alice Bast, Beyond Celiac CEO. “Though the labeling is voluntary, it is definitely a step in the right direction.”

Beyond Celiac has heard repeatedly from its constituents that undisclosed gluten in medications was making them sick. With the goal of turning anecdotes into documented, quantifiable research, the organization received a $50,000 grant in 2011 from the FDA to study the prevalence of hidden gluten in medications, the first study of its kind.

 The Food Allergen Labeling Consumer Protection Act (FALCPA) of 2004, which requires packaged food labels to identify all ingredients containing wheat and other common allergens, was a major landmark for people with celiac disease and food allergies. Medication labels were not included in FALCPA.

In 2011, 5,623 people with celiac disease and gluten sensitivity responded to an online survey. 1,399 of these respondents – 25% – reported that they suspected an adverse reaction caused by gluten in their medication.

Patients and healthcare providers find it difficult to ascertain whether a medication is gluten-free, causing anxiety, lack of confidence, medication substitutions and noncompliance. Patients reported a wide range of symptoms associated with their suspected gluten exposure, including: constipation, nausea, diarrhea, abdominal pain, bloating, headache, fatigue, irritability, muscle tremors/cramps, failure to thrive and skin rash. Some of the reactions reported by survey respondents are also known side effects of these mediations, others are not.

“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 stated. “Our community’s health and well-being is at stake.”

For a person with celiac disease, undigested gluten fragments trigger a reaction by the immune system in the small intestine, which can lead to systemic inflammation. The relationship to the gut and the microbiome, which is evolving as central to overall health in general, is well-documented. Systemic damage caused by gluten can be catastrophic, affecting not only the GI system, but also the brain and nervous system. Attending to the gut-brain connection is an important part of overall healthcare for the celiac disease community.