1. Celiac Sprue Association Position on FDA-2011-N-0842
CSA supports eliminating ALL ingredients derived from gluten sources, from ALL forms
of human medications.
● When in doubt, celiacs must seek a compounding pharmacy to assure a gluten-free
formulation for drugs others commonly buy at the drug store.
● CSA 2007 member survey indicates celiacs consume an average of eight oral
medications a day.
● A gluten-free lifestyle is the only prescription for all celiacs.
Gluten, in the celiac world, is the inclusive term used to describe the amino acid
sequences that evoke the immune mediated T and B cell responses in those with
celiac disease. These amino acid sequences are ubiquitous in the grasses of the genus
triticum, hordeum, secale, and to a lesser amount in avena plants.[i] [ii] [iii] Oats should also be
eliminated from medications to fully protect all people with celiac disease because the toxicity
depends upon the variety of the oats.[iv] The toxic amount of gluten for any one person is truly
not known.
The only accepted treatment for celiac disease is lifelong adherence to a gluten-free
lifestyle defined as strict elimination of foods, beverages, medications, supplements
and toiletries containing gluten from wheat, barley or rye and to a lesser extent oats..
The FDA Hazard Report reviewed the limited non-confirming data and noted on page 45, “the
tolerable daily intake level for gluten in individuals with celiac disease was determined in a
safety assessment to be 0.4 mg gluten/day for adverse morphological effects and 0.015 mg
gluten/day for adverse clinical effects.” [v] The toxic amount of gluten for any one person is
truly not known.
CSA supports the Citizen Petition submitted by Michael Weber, June 2008 in docket
references.
The use of the term gluten-free in drugs and supplements is not standardized. The “celiac
safe” communication system with drug companies related to active, inactive ingredients and
processing agents has deteriorated. The ability for company representatives to confirm the
presence or lack of presence of derivatives from wheat, barley, rye or oats has worsened since
2008.
There is no down side to eliminating gluten from human medications. Elimination of the
ingredients with the toxic amino acid sequences that evoke the systemic immune mediated
responses is the only method to assure the wellbeing of those diagnosed with celiac disease.
● Such action to eliminate all ingredients derived from gluten sources will remove the
consumer fear of not having the information needed to safely choose one brand over
another.
● Such action will remove the risk of inadvertent ingestion of “gluten” from fillers, carriers
and coatings that delay complete healing or exacerbate the situation.
● Such action provides physicians a choice of the most appropriate drug based upon the
active ingredients.
● Such action provides assurance to the pharmacist who can counsel and dispense the
medications without concern of cross contamination.
● For those with celiac disease and others living the medically required gluten-free lifestyle
a major daily health risk is eliminated.
● Time and health costs are reduced at all levels. (Including the Celiac Sprue Association
office and staff time in counseling and perusing accurate information about drugs.)
For the health and well being of the increasingly diagnosed celiac population and others with
gluten induced health conditions, the Celiac Sprue Association strongly endorses the elimination
of ingredients derived from wheat, barley, rye and common oats in all human medications.
Submitted by Mary Schluckebier, Executive Directo