Celiac Support Association

Labeling Gluten-free Background Informaton

Volunteer to serve celiacs in the legislative process. 
Gluten in Medications -- Bill in the House of Representatives

CSA's 2012 position statement on gluten in medications.


The FDA's Center for Drug Evaluation and Research (CDER) has issued a request for comments on gluten in medications. The comment period was open until March 20, 2012. Search for Docket No. FDA-2011-N-0842 and read current comments here.  

"FDA is particularly interested in understanding what impact would result if the use of drug ingredients derived from wheat, barley, or rye were completely discontinued in human drugs."   

Also for informational reading - the Citizen Petition submitted by Michael Weber, June 2008.

CSA supports eliminating ALL ingredients derived from gluten sources, from ALL medications.   

  • The result would be all medications would be completely gluten-free.
  • Cross contamination would be eliminated.
  • Including all drugs dispensed orally or other method.


     Until ingredients from gluten sources are removed  from medications ---- The CSA labeling position statement is in support of Policy Statement 0808 Council on Pharmacy Practice by the American Society of Health-System Pharmacists. Disclosure of Excipients in Drug Products: To advocate that manufacturers declare the name and derivative source of all excipients in drug product on the official label. *Derivative source means the botanical, animal or other source of origin.

Labeling in Canada Regulations begin August 4, 2012

June 2012 - Health Canada releases position statement on gluten-free labeling in Canada 
Labeling regulations begin August 4, 2012   Visit Canadian Celiac Association for consumer information.

2011 Labeling

Label Reading

CSA 2011 Gluten-Free Labeling Member Survey Results

The regulation to define "gluten-free" for volunteer labeling of foods is expected to be published in the third quarter of 2012. The proposed regulation from 2007 can be found here. A copy of the May 2011 FDA's Health Hazard Assessment ("Gluten-Report") can be viewed here.  The Peer Review of the Hazard Assessment can be viewed here.

Read posted comments for Docket FDA-2005-N-0404 on the www.regulations.gov site or view here.  The FDA's comment period closed as of October 3, 2011.

Notable Comments on Labeling:

Thanks for helping to support the needs of those with celiac disease and gluten-induced sensitivity. Now is the time to support meaningful, verifiable and consistent food labeling. Joining CSA or donate today to aid in our education and awareness programs.

 Read more information about prior FDA Labeling action

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