2005N-0231 Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
FDA Comment Number : EC4
Submitter : Dr. Ciaran Kelly Date & Time: 07/28/2005 07:07:48
Organization : Harvard Medical School
Category : Health Professional
Issue Areas/Comments
Below are some minor comments and suggestions regarding the celiac sections of the DRAFT Threshold Report that I did not raise during the committee meeting as they were too minor and would be a misuse of committee time. I hope they are helpful.

Comments on III. Celiac Disease

B. Pathogenesis

Page 30 of 103

Line 2 ?and specifically targets? is inaccurate ? ?and is characterized by damage to? may be preferable

Line 12..The damage is not ?self-perpetuating? in celiac disease as it resolves when gluten is avoided (unlike refractory sprue where the T cell activation is indeed self perpetuating)

C. Adverse Effects

Page 31

Line 2 I suggest adding ?The reasons for this spectrum of clinical presentations are unknown but may result from? the age and immunol??. etc.

Line 23 to 25 Are the quoted relative risks correct? I thought that the relative risk for lymphomas was greater than for small bowel carcinoma.

Page 32

Line 5 ?Silent? celiac disease is characterized by the absence of symptoms or nutritional deficiency states not by the degree of intestinal involvement

Line 9 Silent and latent celiac disease are not characterized by atypical disease manifestations but instead by the absence of symptoms or other disease manifestations (other than the mucosal abnormalities present in silent disease).

D. Prevalence

Page 32

Line 2 I believe the prevalence reported by Talley in 1994 was ~1:5,000

Line 11 Celiac disease is rarely misdiagnosed as Crohn?s disease so I suggest ?The disease is often misdiagnosed as another gastrointestinal disorder (e.g. lactose intolerance, irritable bowel syndrome) due to similarities in ? ??.

IV Discussion and recommendations

D.1.c. Foods of Concern

Page 55

Line 2 The % of individuals with celiac disease that are sensitive to oats has not been determined but is likely to be <1%