Saturday 3 March 2018

FDA: Gluten and drug products

A new document from the U.S. Food and Drug Administration (FDA): This guidance is intended to convey to drug manufacturers FDA’s recommendations on how certain drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. Confronted by uncertainty, some patients may forego important medication rather than risk an adverse reaction to gluten. Thus, even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information. 

Celiac disease (also known as celiac sprue) is an immune-based reaction to dietary gluten that
primarily affects the small intestine in susceptible individuals; unmanaged celiac disease can lead to serious health complications. Approximately 1 percent of the U.S. population has celiac disease. It is characterized by ongoing inflammation of part of the lining of the small intestine that generally heals if foods containing gluten are excluded from the diet and returns if they are reintroduced. At this time, the treatment for celiac disease is adherence to a gluten-free diet. 

FDA’s food labeling regulations define gluten as “proteins that naturally occur in [wheat, barley,and rye or their crossbred hybrids] and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins)” (21 CFR 101.91(a)). Consistent with this definition, the term gluten in this document refers to certain proteins found in wheat, barley, and rye or their crossbred hybrids that lead to symptoms associated with celiac disease. This guidance pertains to human drug products that pass through the small intestine.


Posted by Dr. Tim Sandle

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