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Celiac.com 02/06/2009 - Have you, as a Celiac, ever suspected that the medicine you were taking was making you sick? It could be because that pill or capsule was made with gluten. That’s because the U.S. Food and Drug Administration (FDA) allows pharmaceutical companies to use wheat gluten, a large protein that celiacs can’t eat, to be used as a mixing agent in drugs. Drug companies use chemical agents called excipients as inert additives to mix and bind the actual active ingredient of a drug so that you can take it in the form of a conveniently sized pill. Currently gluten is on the list of permitted excipients that you might be taking without even knowing it. That’s why I have petitioned the FDA to get gluten out of medicine. In a constitutionally protected act, I have submitted a Citizen’s Petition to the FDA requesting that they take gluten off of their list of permitted excipients. As I write, the National Foundation for Celiac Awareness has asked the FDA only to label medicines that contain gluten, but this approach will continue to allow gluten to be used at the decision of the manufacturer. The FDA has a decision to make. I believe that they should follow existing law and recognize that gluten is toxic to a significant segment of the population. If the FDA got gluten out of medicine it would mean that you could confidently take aspirin, any generic, or any othe drug whether prescribed or over the counter, and not have to worry about gluten—and that would be true for all drugs. It would not, however, mean that the supplements you were taking would be gluten-free, because supplements aren’t regulated like drugs, but are regulared like food. As you probably know, foods will soon be labeled according to a federal gluten-free standard. But only some food makers will decide to make the products that will be labeled gluten-free. And the same thing might happen to drugs, if the FDA decides it is sufficient only to extend the labeling standard to drugs. As a Celiac, you won’t be able to take a drug unless it says gluten-free, because if doesn’t say gluten-free, who knows what’s inside? Is that Tylenol OK for you? Or how about that generic heart medication you get in the mail? The reality is that some day soon, the FDA might allow pharmaceutical companies to make business decisions on whether or not you can take a necessary medication. Taking medicine isn’t a matter of personal choice like foods. Rather, a doctor might not be able to give you a prescription because it might contain gluten. Maybe there won't be an equivalent drug that is also gluten-free. Time to Take Action! There is, however, something you can do. I petitioned the FDA to get gluten gone for good. I asked my congresswoman to write a letter to the FDA highlighting her concern about my petition. And any citizen can comment to the FDA about my petition, for or against. You can ask your congressman to pay attention to the decision, which the FDA is about to make. Now that I’ve wound you all up, here is how to contact the FDA. Go on the internet and surf to www.regulations.gov and enter the Docket number of my petition, 2008-P-0333, which you might enjoy reading. My petition is called Michael Weber of New York State. Highlight the line for comments of submissions, and then tell them what you think and who you are. Tell the FDA why you think there shouldn’t be any gluten in your medicine—please do it now!

Celiac.com 03/07/2007 - The Food and Drug Administration (FDA) recently proposed the following rule regarding the labeling of foods as "Gluten-Free (gluten-free). The rule appears in the Federal Register, Docket No. 2005N-0279, titled Food-Labeling: Gluten Free Labeling of Foods," and includes a definition of the term "gluten-free." There is no current Federal regulation to define the term "gluten-free" for labeling food. By clearly defining the term the FDA seeks to help those with celiac disease, along with their caregivers, to better identify packaged foods that are safe for consumption. The FDA proposes to set the standard acceptable gluten level for products labeled "gluten-free" at no greater than 20 parts of gluten per million. More specifically, the FDA proposes that the term "gluten-free" on food labels will apply to food that is free of any or all of the following: "Prohibited grains," meaning any species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley or their hybrids; Ingredients derived from "prohibited grains," (e.g., wheat flour), that have not been treated to remove gluten. Ingredients derived from "prohibited grains," (e.g., wheat flour), that HAVE been treated to remove gluten, but which results in 20 ppm (parts per million) or more of gluten per gram of food. 20 ppm or more of gluten per gram of food. Foods that are labeled "gluten-free," or claim to be "free of gluten," without gluten, or to contain no gluten," and which fail to meet the terms of the proposed definition of "gluten-free" would be designated as "misbranded." One aspect of the FDA rules that seems to have caused some confusion concerns the status of oats. One recent posting making the rounds among celiac support groups claims that page 2798 of the Federal Register states: that None of the four U.S. celiac associations that responded to the survey considered oats to be an acceptable food for individuals with celiac disease. This quotation is from an April 2000 article by Tricia Thompson, titled: Questionable food and the gluten-free diet: Survey of Current Recommendations. However, page 2798 of the Federal Register actually states the CURRENT positions held by the organizations: According to more recent position statements of 3 of the 4 major celiac associations in the United States that responded to the earlier survey conducted by Thompson (Ref. 57), one of these associations continues to take the position that oats are not an acceptable food for individuals with celiac disease; but, the other two of these associations are not opposed to the inclusion of oats in the diets of individuals with celiac disease, provided that the oats do not contain gluten from other grains and that the daily amount of oats consumed is limited to 1 cup cooked (Ref. 56)." The FDA held an initial public comment meeting for "gluten-free" food labeling in August 2005. Comments received during this meeting, coupled with other information compiled by the FDA, indicate that there is no consensus among either consumers or U.S. food manufacturers as to the nature of foods labeled "gluten-free." The FDA feels strongly that the establishment of clear definitions of "gluten-free," and of uniform guidelines for applying the term in labeling foods, will enable persons with celiac to obtain accurate and truthful information about the foods they purchase, and help to make sure they avoid the adverse health affects that can come consuming food that is mislabeled. For more information the FDA has prepared a document titled: Questions and Answers on the Gluten-Free Labeling Proposed Rule" The document is available for review through the following web-link: http://www.cfsan.fda.gov/~dms/glutqa.html. Act Now! There is a 90-day public comment period for the proposed rule. Submit your comments by April 23, 2007 by clicking here, or comments can also be submit it in writing to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305) Rockville, MD 20852. Celiac.com supports the FDA proposals, and encourages those with celiac disease and their supporters, to review the FDA document and to share your comments in support of these standards.

Celiac.com 09/01/2005 - The Food and Drug Administration (FDA) will hold a public meeting to obtain expert comment and consultation from the public to help them define and permit the voluntary use on food labeling of the term ``gluten-free. The meeting will focus on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Celiac.com needs your help to speak out to make sure that this regulation will be written in such a way as to provide the greatest benefit to the gluten-free community, and to make sure that the new regulation will not create an undue burden on any exiting and future gluten-free food manufacturers. To have an influence on this process please Click Here and send your comments no later than September 19, 2005. If you feel the same way as us feel free to cut and paste the following letter into the comments area of this form: Dear FDA: We encourage you to adopt a regulation on the use of gluten-free on product labels that is in line with that which has been used in Europe and other countries (including the USA via the Codex Alimentarius) for many years--20 PPM for products that contain naturally gluten-free ingredients, and 200 PPM for products that have been rendered gluten-free such as those that may contain Codex Alimentarius quality wheat starch. The formal adoption of these existing regulations will allow for the continued importation of excellent, safe European products that are labeled gluten-free. It is very important that you do not adopt a zero tolerance regulation in this matter because doing so will cause many gluten-free food companies to discontinue their use of the term gluten-free on their labels out of fear of litigation--which is counterproductive for all people with this disease (most, if not all, gluten-free food companies do not grow, transport or mill the gluten-free grains that they use as ingredients--a fact that will make them vulnerable to litigation if a zero tolerance level is adopted). Last, the inclusion of trace levels of gluten in the diets of those with celiac disease have been shown to be safe in many scientific studies, for more details please see: https://www.celiac.com Thank you, Your Name

(Celiac.com 03/17/2000) Under the new FDA rules (effective in 2000), consumers will get more information about the sources of protein hydrolysates in their food. Hydrolyzed proteins are added to foods to serve various functions, including thickeners, flavorings and flavor enhancers, and they pose a major problem for people on special diets. From now on food makers will have to declare the source of added hydrolyzed proteins. The new laws state that the source of all protein hydrolysates--regardless of use--will now have to be identified. Further, caseinate will have to be identified as a milk derivative in the ingredient statement when its used in foods that claim to be non-dairy. According to the FDA these new requirements will help people who have special diet restrictions.