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    Citizen's Petition to the Food and Drug Administration (FDA) to Make Drugs Gluten-Free


    Michael Weber

    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.


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    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!


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    Guest Michael Shepard

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    Thank you for publicizing this. I was not aware of this significant opportunity to affect change on this important issue.

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    Great idea! This situation is absurd. What is the update for early 2012? Please let us know, thanks!

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