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The Dermatitis Herpetiformis Online Community Blog
| This weblog (blog) is a place for me to post articles of interest for people with DH and coeliac disease and enables me to communicate notices to site visitors. If you'd like to be advised when new posts are added, please either subscribe to the web feed or sign up for email notifications.
Annie Barnes (Site Admin)
US FDA Proposes to Define the Term "Gluten-Free" for Voluntary Use in Food LabelingFDA Proposes to Define the Term "Gluten-Free" for Voluntary Use in Food LabelingThe Food and Drug Administration (FDA) has published a proposed rule in the Federal Register, Docket No. 2005N-0279, titled "Food-Labeling: Gluten Free Labeling of Foods" (72 FR 2795). Included in the proposed rule is a definition established by the FDA for the term "gluten-free" for voluntary use in the labeling of foods. A definition for the term "gluten-free" would assist those who have celiac disease (also know as celiac spue or gluten-sensitive enteropathy) and their caregivers to more easily identify packaged foods that are safe for persons with celiac disease to eat. Celiac disease occurs in genetically susceptible individuals and causes damage to their small intestine when they consume gluten found in "prohibited grains". Celiac disease has no cure, but avoiding the consumption of gluten can resolve its symptoms, mitigate and possibly reverse damage, and reduce associated health risks. This proposed rule has been prepared in response to the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directs the Secretary of the Department of Health and Human Services to propose, and later make final, a rule that defines and permits the use of the food labeling term "gluten-free". FDA is proposing to define the food labeling term "gluten-free" to mean that a food bearing this claim does not contain any of the following:
A food that bears the claim "gluten-free" or a similar claim (e.g. "free of gluten", "without gluten", "no gluten") in its labeling and fails to meet the conditions specified in the proposed definition of "gluten-free" would be deemed misbranded. Currently, there is no Federal regulation that defines the term "gluten-free" used in the labeling of foods. Based upon comments FDA received during its public meeting on "gluten-free" food labeling held in August 2005 and other information available to the Agency, there is no universal understanding among U.S. food manufacturers or consumers about the meaning of a food labeled as "gluten-free". FDA believes that establishing a definition for the term "gluten-free" and uniform conditions for its use in the labeling of foods will ensure that persons with celiac disease are not misled and are provided with truthful and accurate information. The proposed rule has a 90-day public comment period. A document titled "Questions and Answers on the Gluten-Free Labeling Proposed Rule" has been prepared by FDA and is available online.
In patients with positive endomysial antibody (EmA) tests, over what period...In patients with positive endomysial antibody (EmA) tests, over what period do EmA sera levels revert from positive to negative in patients on gluten free diets?Source - National Library for Health Primary Care Question Answering Service Interpretation: Is the presence of endomysial antibody affected by a period of time on a gluten free diet? Answer: A CREST guideline on coeliac disease in adults, issued in 2006, states: "TGA and EmA can be used not only for diagnosis but also for monitoring of dietary compliance: seroconversion occurs rapidly with strict gluten exclusion."[1] Midhagen et al measured the speed at which serum titres decreased following the introduction of a gluten free diet (GFD) in 20 patients. The authors report: "The patients were followed for 1 year and sera were taken after 1, 3, 6 and 12 months after start of a GFD. Sera were stored at -20 °C and analysed for IgA antibodies against gliadin, endomysium and two different commercial tTG assays based on recombinant human tTG (tTGrh) and guinea-pig liver (tTGgp). Twenty patients could be followed during GFD and all antibody titres fell sharply within 1 month after introduction of a GFD and continued to decline during the survey interval. Thirty days after beginning the diet only 58, 84, 74 and 53% of all patients had positive antibody levels of tTGrh, tTGgp, EmA and AGA respectively...[2] Fotoulaki et al assessed the effectiveness of immunological markers as monitoring tests in coeliac disease in 30 patients, aged between 1 and 24 years old, and found: "One month following the exclusion of gluten from the diet, most antibodies are still positive. Twenty-three to 43% of antibodies remained positive by the end of the third month. At 6 and 9 months, 17% and 10% were positive, respectively. At 12 months no positive antibodies were detected. After gluten challenge, positive IgA-AGA and IgA-EmA titers were already demonstrated at 3 months (90% and 86%, respectively), while Ig-ARA titers showed a slow increase." [3] Kapuscinska et al recruited 84 patients (33 children aged less than five years old and 51 adults) to evaluate changes in EmA levels in patients on gluten free diets: "Of the 33 children, 11 were untreated and symptomatic and were IgA-EmA positive at initial presentation. Twenty-two children previously controlled on a gluten-free diet (GFD) exhibited IgA-EmA titers during gluten challenge. Furthermore, the antibody levels declined in all cases (usually to negative) when the patients were again placed on a GFD for 6-12 months. Changes in intestinal histopathology paralleled the changes in antibody titers in six cases undergoing serial biopsies. Of the 51 adult patients with proven CD who were prescribed a GFD for at least 12 months, IgA-EmA were detected in 10 cases who were noncompliant to their GFD, whereas the antibodies was found in only 1 of the remaining 41 patients strictly adhering to their diet." [4] Finally, an e-Medicine article on coeliac sprue adds: "The presence of serum IgA antibody to endomysium in untreated celiac sprue has higher sensitivity and higher specificity than antigliadin antibodies. However, serum IgA antiendomysial antibody often becomes undetectable after 6-12 months of gluten withdrawal." [5] References 1. CREST. Guidelines for the diagnosis and management of coeliac disease in adults. May 2006. (http://www.crestni.org.uk/publications/coeliac-disease-adult-diagnosis.pdf). 2. Midhagen G.,Aberg A. and Olcen P et al. Antibody levels in adult patients with coeliac disease during gluten-free diet: a rapid initial decrease of clinical importance. J Intern Med 2004; 256(6): 519-524. (http://www.blackwell-synergy.com/links/doi/10.1111/j.1365-2796.2004.01406.x/abs/). 3. Fotoulaki M, Nousia-Arvanitakis S, Augoustidou-Savvopoulou P, Clinical application of immunological markers as monitoring tests in celiac disease. Dig Dis Sci. 1999 Oct;44(10):2133-8. (http://www.hubmed.org/display.cgi?uids=10548368). 4. Kapuscinska A, Zalewski T, Chorzelski TP et al. Disease specificity and dynamics of changes in IgA class anti-endomysial antibodies in celiac disease. J Pediatr Gastroenterol Nutr. 1987 Jul-Aug;6(4):529-34. (http://www.hubmed.org/display.cgi?uids=3323442). 5. Klapproth J and Yang V. Celiac sprue. e-Medicine. January 2007. (http://www.emedicine.com/med/topic308.htm#section~workup).
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