2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC10
Submitter : Dr. Robert Scheinberg Date & Time: 08/01/2005 07:08:03
Organization : UCSD Medical Center
Category : Health Professional
Issue Areas/Comments
31 July, 2005

Food and Drug Administration, HHS
Docket No. 2005N-0279

Dear sirs:

I am writing these comments as per your request for comments in the notice for the August 19 meeting on Food Labeling; Gluten-Free Labeling of Foods.

1. To be labeled Gluten-Free each batch of food must be tested by an approved kit
2. Ingredients sold to manufacturers who have indicated that they are producing a line of gluten free products must be tested on a batch by batch basis if there is any possibility of gluten in the ingredient. This will allow the manufacturers to purchase only supplies that are gluten free using the power of the market place.
3. As the FDA also has jurisdiction over drug labeling I respectfully suggest that these suggestions be expanded to include labeling all drugs used both by prescription and over the counter. As a physician who has identified many celiac patients, and as the father of a daughter with celiac disease, I have first hand experience that the effort involved to find out whether a medication is gluten free can be enormous. This has even included searching whether products needed by many with celiac disease such as vitamins, Lactaid, migraine headache medications (tryptans) or medication for acid reflux contained gluten. This can be remedied by having every medication tested and labeled. Again, the marketplace will make it cost effective for drug manufacturers to test their products and to have their suppliers test their materials so the gluten free raw materials will be chosen as inactive ingredients in the medications they produce.

Thank you for the efforts you are making in safeguarding the nations food and drug supply from contamination.


Robert Scheinberg, MD

Clinical Professor
Division of Dermatology
Department of Medicine
University of California San Diego
Medical Center