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  • Jefferson Adams
    Jefferson Adams

    Gluten in Medicine Disclosure Bill Hits the Senate

    Reviewed and edited by a celiac disease expert.

    A bill that requires drug makers to label medications intended for human use with the list of ingredients, their source, and whether gluten is present hits the US Senate.

    Gluten in Medicine Disclosure Bill Hits the Senate - Soon we may finally know what's in our medications. Image: CC BY-SA 2.0--javYliz
    Caption: Soon we may finally know what's in our medications. Image: CC BY-SA 2.0--javYliz

    Celiac.com 01/29/2020 - After a long time in the making, and much effort, a bill that will require drug makers to label gluten in drugs is now officially in the lap the United States Senate. Senator Richard Blumenthal (D-CT) recently introduced S.3021: Gluten in Medicine Disclosure Act of 2019 to the Senate. 

    The proposed law makes it easier to identify gluten in prescription drugs. We've written over the years about gluten in prescription drugs, and how to find out if your drugs or medicines contains gluten.

    Under the Proposed Law

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    Drug manufacturers would be required to label medications intended for human use with the list of ingredients, their source, and whether gluten is present. Sorry, but there is no coverage for pet medicines just yet.

    A gluten-containing drug that does not meet these requirements would be misbranded under Section 502 of the Federal Food, Drug, and Cosmetic Act.

    This new labeling will help consumers to know, for example, if the starch in their prescription drug comes from wheat or corn, a small but important distinction. Currently, it is nearly impossible to know if there's any gluten in prescription medicine.

    Current FDA Law

    Current FDA rules require that packaged foods label wheat and 7 other allergens, but unfortunately rye and barley are not included. More alarmingly, medications are not covered, so there's no good way to figure out if prescriptions might contain gluten.

    Celiac disease is a serious autoimmune condition, and accidental ingestion of gluten triggers an immune response that could interfere with absorption of the medication. In many cases people must take drugs every day. People with gluten sensitivity due to celiac disease or other medical issues need to know that their medicines contain safe ingredients.

    Get Involved

    Celiac Disease Foundation CEO Marilyn G. Geller and the Celiac Disease Foundation have been major supporters of efforts to advance what became House version, HR 2074: Gluten in Medicine Disclosure Act of 2019, which garnered 47 cosponsors. Thanks are due to the CDF, the numerous supporters in the celiac community, and to Senator Blumenthal (D-CT), Congressman Tim Ryan (D-OH), and Congressman Tom Cole (R-OK).

    The foundation will now turn to securing cosponsors for the Senate version of this important legislation that will "make it easier and safer for individuals with celiac disease or gluten sensitivity to make informed purchases of needed medications."

    Get involved by going to celiac.org, and using the link to email your Senators to urge them to become a cosponsor, and to ask that you email your Representatives to continue to rally House support. The Foundation makes it easy. Their software handles everything, including a pre-populated message with the ability for you to personalize it, and email delivery to your Senators and Representatives.

    Edited by Jefferson Adams



    User Feedback

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    Elisabeth Gerritsen
    8 hours ago, Guest Sounds good! said:

    But...

    There is a very big push (and I'm not getting political here) from current Democrat candidates for allowing non-US pharmaceuticals into the US. Since most of the rest of the world, particularly where socialized healthcare is the norm, does not have the same requirements US labelers do, would such legislation be all that effective? Seems this would require US pharmas who import all classes of pharmaceuticals to sample every batch they receive to ensure proper labeling. OR, a simple statement saying something like "This has not been tested to US standards for gluten ingredients or contamination."

    In my case I had to import the gluten- and lactosefree medicine from the US to the Netherlands!  No lactosefree Plaquenil for sale here. But the same problem here: no mention of any gluten or lactose contents. You have to read the ingredients and make a complete study of what is: glucose-fructose syrup, maltodextrin, dextrose and so on. It also differs from where it was made: in the US they make maltodextrin from corn, in Europe from wheat! So even now, when I want to buy a Dutch glutenfree bread, it still contains the bad maltodextrin and I get sick! So I have to buy ther German brand from Schär, which is really glutenfree, but not as tasty as the Dutch brand.

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    CelesteRY

    I hope this helps... I’ve been using this (below) website with much success over the past 7 years. The pharmaceutical companies are required to provide the most up to date ingredient list to the government and I’ve found it to be more helpful than the drug inserts provided to the pharmacies. Here’s how I do it.. when a medication has been called in by my physician, I call the pharmacist to get the NCD number for the prescription. Then I plug in the NCD number into the search bar on the website and it brings up the ingredients that were provided to the government for all pills manufactured under that NCD number. The starches are sourced  99% of the time, will say potato corn wheat etc. If your medication does have gluten in it, you can go back to the search bar and look for your prescription by it’s generic name and find a manufacturer who makes it without gluten. My pharmacy has ordered another manufacturer’s medication at my request. 

    Using this, I’ve only gotten sick once over the past 7 years from my meds and it was a super small shady manufacturer I’ve never heard of with a single phone number and a vague voicemail. 

    I can’t say it’s perfect because the pharmaceutical companies have to play their part in providing up to date ingredients every time one changes in their “recipe”. Contamination is another major hurdle but when you find yourself in need of medication, this is better than having nothing to go on.
     

    That said, I really hope this new bill goes somewhere. Talk about one way to reduce healthcare costs... celiac disease is the only autoimmune disease where we know exactly what causes an attack and how to stop it. But we need basic tools to help ourselves stay healthy and prevent the onset of additional AI diseases, cancers, health issues, etc. 

    For now, here’s the website:


    Open Original Shared Link

     

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    Guest Debz

    I have recently been diagnosed with celiac. I also have ra and fibromyalgia. I have had several complications with meds . Did my first infusion for ra . Told them I would refuse if any chance of gluten. So far so good. But the thought of it going into my blood makes me really nervous about doing them . My belly is swollen. 

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    cyclinglady
    1 hour ago, Guest Debz said:

    I have recently been diagnosed with celiac. I also have ra and fibromyalgia. I have had several complications with meds . Did my first infusion for ra . Told them I would refuse if any chance of gluten. So far so good. But the thought of it going into my blood makes me really nervous about doing them . My belly is swollen. 

    Gluten is not found in IV drugs.  If gluten is in drugs, it is usually is an inactive ingredient to bind the medication into a pill.   I never worry about injections and IVs triggering my celiac disease.

    Anyone can have an allergic reaction to a drug or experience side effects.  Talk to your doctor about these risks and how they might effect you.  

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    CelesteRY

    I continued to be sick for 14 months post diagnosis (with a swollen belly) and during that time I feared everything so I understand how you feel right now. Just know that you will get better so hang in there. I received IV iron therapy and learned that gluten isn’t to be feared in your IV meds. You won’t find gluten in those medications but in addition to that, gluten must go through your small intestine in order for your immune system to recognize the “invader” and provoke an attack. You may want to ask your doctor to check you for SIBO. It’s pretty common in newly diagnosed and for me the symptoms are identical to gluten ingestion. (I say ‘are’ because it tends to come back.)

    Good luck to you. Just remember that you will get better!! It takes time and a very clean diet free of cross contamination. 

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    RivkaGF

    What is the state of this bill now?

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    Scott Adams

    It hasn't gone anywhere yet, but we'll report on this should anything change.

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    RivkaGF
    5 hours ago, Scott Adams said:

    It hasn't gone anywhere yet, but we'll report on this should anything change.

    Thanks for your response.  So, does it make sense to be sending emails and signing petitions now?  Is it still in the running?  If so, I'd like to help publicize it.

     

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    Scott Adams

    The links in the article still work. When checking the status It says:

    Quote

    LAST ACTION: 12/11/2019 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
    Action By: Senate

    To me it looks dead...most likely killed by the drug industry.

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    TLee

    What is the status of this bill?

     

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    Elisabeth Gerritsen
    On 1/31/2020 at 4:10 AM, Guest Dawn D said:

    Lactose needs to be added to this bill - it’s a very commonMy used filler.

    I totally agree!

     

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  • About Me

    Jefferson Adams

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


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