Medication and Supplement Use in Celiac Disease

Ashley N. Johnson, PharmD, BCPS; Angela N. Skaff, BS, PharmD Candidate; Lauren Senesac, PharmD Candidate


US Pharmacist. 2014;39(12):44-48. 

In This Article


Increased awareness of CD in recent years not only has identified more cases of CD, but also has sparked legislation on gluten-free labeling. In May 2013, H.R. 2003, the Gluten in Medicine Disclosure Act of 2013, was introduced and referred to the Committee on Energy and Commerce to amend the Federal Food, Drug, and Cosmetic Act. Enactment of this bill would have amended the law to require the labeling of drugs intended for human use to contain a statement identifying the source of any ingredient made of or derived from a grain or starch-containing ingredient.[14] This bill did not move forward, however. Neither did a similar bill that preceded it in April 2012, H.R. 4972, Gluten in Medicine Identification Act of 2012.[15]

Previously, the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which identified eight food groups as major allergens, was passed by Congress.[15] FALCPA required food manufacturers to include the word "Contains" followed by the name of the food source from which the major allergen (e.g., wheat) was derived or to give the common name of the major allergen in the list of ingredients, including the name of the food source.[16]

Although the FALCPA regulations safeguarded consumers seeking to identify wheat-containing products, they did not apply to rye and barley, which also contain gluten. FALCPA did, however, require the FDA to issue a proposed rule to define and permit voluntary use of the term "gluten-free" on food labels. In August 2013, the FDA issued a final rule under FALCPA on the use of the term "gluten-free" in food labeling for manufacturers choosing to use the term. Manufacturers who labeled FDA-regulated foods and dietary supplements as "gluten-free," "no gluten," "free of gluten," or "without gluten" were given until August 5, 2014, to comply with the new rules and ensure that the product contained no more than 20 parts per million of gluten-containing ingredients or derivatives (i.e., ≤20 mg gluten/kg of food). Failure to meet the requirements for the claim would be considered misbranding.[17]

At present, no legislation is in place to facilitate the identification of gluten-containing ingredients in prescription and nonprescription medications.