2012 FDA Update
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 is 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."
For more information on the FDA request, click here. Also for informational reading - the Citizen Petition submitted by Michael Weber, June 2008.
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 exipients in drug product on the official label. *Derivative source means the botanical, animal or other source of origin.
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.
2011/2012 Labeling
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 FDA's comment period closed as of October 3rd. Docket FDA-2005-N-0404 comments are posted on the www.regulations.gov site or view here. Check the comment date for newest entries.
CSA 2011 Gluten-Free Labeling Member Survey Results
Notable Comments on Labeling:
- Read CSA's Letter to the FDA on gluten-free labeling.
- Read the Joint Submission to the Docket - a collaborative effort on behalf of North America's non-profit celiac organizations.
- Richard Turner's Letter to the FDA
- Proposed FDA Standard for Gluten-Free Foods (20 ppm) May Not Adequately Protect the Food Supply for Celiacs By: Peter Olins, PhD and Gillian Olins, PhD on August 18, 2011
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.