Require An Official Testing Protocol for Gluten By The FDA

    The FDA states there is little to no gluten in current medication and is safe for consumption by the gluten free community.
    Yet the FDA does not have a standard testing protocol to test for gluten in fermented and non-fermented food and drinks. This statement is made in bad faith, and is not accurate.

    Independent labs in the US have used testing protocols, the standard ELISA, that have incorrectly labeled food and drinks as being safe for consumption by Celiacs and the gluten intolerant community. Those tests produced faulty results and made trusting people very sick with gluten poisoning. This occurred because the testing method used (ELISA sandwich), can only test for gluten in non-fermented food and drinks. Any fermented ingredient or food product cannot be tested accurately, like kimchi, beer, miso, wine, or kombucha.

    Once food or drink have been fermented, the test is no longer able to detect gluten, and gives a false negative saying gluten is no longer present. Gluten reduced or gluten removed products have been incorrectly labeled and have made Celiac and gluten allergy patients very sick.

    We ask the FDA to establish an official testing protocol for gluten using the LCMS (Liquid Chromatography Mass Spectrometry) method that according to Australian research papers can detect gluten in both fermented and non-fermented food and drinks. To recreate these test results in the US, the University of Rhode Island requires a postdoctoral study with lab materials and a year of exhaustive tests.

    Please support ongoing research at the University of Rhode Island to establish this testing protocol using the LCMS and the control ELISA sandwich method to detect gluten in food and drinks.

    Please tell the FDA to establish an official testing protocol for gluten so we can accurately determine the level of gluten present in our medications, food, and drinks. Instead of being treated like guinea pigs. Often patients are told to try medication to see if we get sick as an indicator if it contains gluten. This is very dangerous and causes immediate painful symptoms when exposed to gluten, but exposing a Celiac patient to small doses of gluten long term, can also cause permanent damage including cancers of the digestive tract, loss of function of the digestive system, tumors, and early death.

    The FDA does not have an official testing protocol to determine if gluten exists in medications. The website that lists gluten free medications has a disclaimer at the bottom of the page, stating they are not responsible for false information, and that they are a volunteer trying providing a service to the community. The website is often not updated properly and encourages patients to contact the drug manufacturer to see if their ingredient list has changed. Relying on faulty information on an outdated website should not be our source of gluten free medications.

    Name brand medications are not allowed to change their ingredients, manufacturing process, or venders due to trademark. Often an insurance will not cover a name brand medication unless the generic has been tried for 4-6 weeks and an extensive medwatch forms have been completed. This policy is considered the "Fail First" step procedure and is very dangerous to at risk patients like Celiacs.

    Generic drug manufacturers cannot change the active ingredients, but can change the inactive ingredients, the manufacturing process, and ingredient venders at any time to stay competitive within the market as often as they want without any requirement to notify the distributor, pharmacist, or patient. Therefor it is not possible to determine if a generic medication is gluten free or has cross contamination of gluten, because they can change their product at any time, and there is not an official testing protocol to detect gluten in their medication. According to drug manufacturers, their equipment is used to make hundreds of unique medications sold worldwide. They cannot determine if a medication is gluten free without testing it for gluten based of exposure within their facility and shared equipment.

    Patients often work hand in hand with pharmacists to contact name brand drug manufacturers to determine if a medication contains gluten and is safe to take. Waiting on ingredient and manufacturing details often delays patient treatment by days or weeks because manufacturers aren't required to provide that information to the public. Internal research within the company is often required.

    Almost 1/4 of all medications are imported into the United States. When contacting countries like India, China, Iran, drug manufacturers do not immediately always know what gluten contamination is when asked and needs to research. This further delays patient treatment. Because the FDA does not have an official testing protocol to test for gluten, there is not a requirement for imported prescriptions to be tested for gluten.

    This song and dance should not be required by a Celiac patient or pharmacist to fill a prescription from their doctor, or buy food at a grocery store, or purchase food at a festival or food event. People should be able to trust the food labels on packages and information provided by the manufacturer. Everyone should have access to safe medications, food, and drinks including the gluten free community.
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