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    New FDA Gluten-Free Label Rules Include Dietary Supplements


    Jefferson Adams
    New FDA Gluten-Free Label Rules Include Dietary Supplements

    Celiac.com 09/12/2013 - Good news for consumers of gluten-free foods and other products: The FDA's new standards for the labeling of gluten-free food and other products apply to all foods and products labeled gluten-free, including dietary supplements and vitamins.

    GIEThe FDA rules state that any product declaring the contents to be "gluten-free," "no gluten," "free of gluten" or "without gluten," must meet all parts of FDA's gluten-free definition, including the requirement that the food contains less than 20 parts per million of gluten.

    People with celiac disease who consume gluten from wheat, rye, or barley risk gradual damage to the intestines, leading to poor absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer," according to Virginia Cox, Associate Commissioner of FDA's Office of External Affairs.

    Creating uniform rules and conditions for the use of the term 'gluten-free' in the labeling of foods and other products is "necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled, " according to the text of the final rule, which was published last week in the Federal Register.

    FDA projects the new requirements will yield annual health benefits of roughly $110 million, compared to estimated annual costs (related to testing and relabeling) of $7 million.

    Manufacturers of gluten-free foods and products will have one year to comply with the FDA's labeling requirements.

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    Guest john j acres

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    I can't even eat buckwheat which is very low in gluten that is how sensitive my coeliac disease is & now you want to put it in gluten free products.

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    I can't even eat buckwheat which is very low in gluten that is how sensitive my coeliac disease is & now you want to put it in gluten free products.

    FYI: Buckwheat is gluten-free, not related to wheat, and is in the rhubarb family of plants.

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided health and medical content for Sharecare.com.

    Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book Dangerous Grains by James Braly, MD and Ron Hoggan, MA.

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    Scott Adams
    The following was a post from Merete Askim regarding the avoidance of the contamination of foods during the manufacturing process. If you have any questions regarding it, direct them to him at: Merete.Askim@INF.HIST.NO.
    My name is Merete Askim, and I am a College Lecturer at the Department of Food Science, Soer-Tronedelag College, Trondheim, Norway. In my teaching in nutrition and food chemistry, I am very interested in food allergy and intolerance. My students get jobs as food technologists, so it is important for them to be aware of food allergy and intolerance.
    I have invented a new concept which I call ALLERGY-HYGIENICS.
    This combines both the aspects of avoiding contamination by:
    Harmful Bacteria Ingredients Not Meant to be Part of the Food in Question A traditional concept in industrial food production is called HACCP (Hazard Analysis Critical Points), which is concerned primarily with bacterial contamination. My new concept ALLERGY-HYGIENIC improves upon HACCP, by adding the concept of consideration of allergic and intolerant ingredients, either directly through insufficient consideration of the impact of an ingredient on the population, or inadvertently through contamination by ingredients not meant to be part of the food in question.
    We teach the students to start the analysis of food production with the least complex product, and end with the most complex, to have knowledge of every ingredient, down to the smallest, including the food-additives.
    For example, some firms use vacuum tubes to deliver ingredients from storage facilities to their production machinery. If a gluten free product is being made, and the tube used to deliver rice flour was previously used to deliver wheat flour, there is likely cross-contamination which cannot be removed by simply cleaning the final production machinery. The tube itself would have to be cleaned out, or the facility would have to be designed so that gluten free flours are never transported in tubes which at other times contain gluten.
    Another example is when a dairy produces both "strawberry-yogurt" and "raspberry -yogurt" on the same day, the ALLERGY-HYGIENIC concept is to avoid any strawberry contamination in the raspberry product, or vice versa.
    Our goal is that all products will eventually have ALLERGY-HYGIENIC qualities!
    But we know this takes time and can be expensive in some occasions. It is a new concept in the traditional way of hygienic thinking. Even with ALLERGY-HYGIENICS, we can not guarantee no contamination, but we are attentive, and take our precautions.
    At our Department of Food Science, Trondheim, Norway, want this new concept ALLERGY-HYGIENIC to catch-on all over the world, and become common knowledge. So please tell others, and if you dont mind, remember that it was created here.
    When you are in contact with the food-industry, you might ask them:
    Is your production in accordance with ALLERGY-HYGIENIC principles? Have you taken ALLERGY-HYGIENIC considerations in your production? If you find this concept useful, please let me know by private email. I would also be interested in your experiences as Celiacs with locating cross-contamination in foods. By cataloging your real-life experiences in the field, I can help my students and their companies determine likely problematic areas in food production.
    Merete Askim: Tel (work): 47 73 91 96 25
    N-7004 Trondheim, Norway

    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.
    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!


    Jefferson Adams
    FDA Clarifies Gluten-Free Rules for Restaurants
    Celiac.com 01/03/2014 - The United State Food and Drug Administration (FDA) has clarified what their recent gluten-free rule means for restaurants. When the FDA announced its gluten-free labeling standard in August, the agency said that, for restaurants, “any use of an FDA-defined food labeling claim (such as “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions.
    The agency noted this same approach would now be followed with respect to “gluten-free” claims made in restaurants and other retail food service establishments.
    The FDA's updated Question & Answer, #9 under ‘Labeling’, now reads:
    FDA recognizes that compliance with the gluten-free rule in processed foods and food served in restaurants is important for the health of people with celiac disease.
    In August 2013, FDA issued final rule that established a federal definition of the term ‘”gluten-free” for food manufacturers that voluntarily label FDA-regulated foods as “gluten-free.”
    This definition is intended to provide a reliable way for people with celiac disease to avoid gluten, and we expect that restaurants’ use of “gluten-free” labeling will be consistent with the federal definition.
    The deadline for compliance with the rule is not until August 2014, although we have encouraged the food industry to bring its labeling into compliance with the new definition as soon as possible.
    Given the public health significance of “gluten-free” labeling, we encourage the restaurant industry to move quickly to ensure that its use of “gluten-free” labeling is consistent with the federal definition and look forward to working with the industry to support their education and outreach to restaurants.
    In addition, state and local governments play an important role in oversight of restaurants. We expect to work with our state and local government partners with respect to gluten-free labeling in restaurants. We will consider enforcement action as needed, alone or with other agencies, to protect consumers.
    For more information:
    ACDA Statement on Gluten-free Regulation Regulation from the Federal Register FDA: Gluten-Free Labeling FDA: Gluten-Free Labeling Final Rule Q&A Consumer Update

    Jefferson Adams
    Celiac.com 05/12/2015 - The current treatment for celiac disease is the avoidance of gluten-containing foods, beverages, and other products by means of a strict gluten-free diet.
    Following such a diet can be challenging, but recent FDA labeling rules go a long way toward helping people with celiac disease know with pretty good certainty whether a food product contains gluten, or is gluten-free.
    However, When it comes to prescription drugs, medicines, OTC products, supplements, and vitamins, people with celiac disease currently have little guidance. The FDA rules that mandate the labeling of gluten and other known allergens on food product labels does not apply beyond food. There are currently no rules mandating the labeling of gluten in drugs and medicines. That means that your average person with celiac disease might have a hard time finding out which medications, OTC products, supplements, and vitamins may contain gluten, and may experience adverse symptoms from continued gluten ingestion.
    A team of researchers set out to assess the role of pharmacists in educating patients and evaluating their medication use to ensure the optimal management of celiac disease. The research team included Ashley N. Johnson, PharmD, BCPS, Angela N. Skaff, BS, PharmD Candidate, and Lauren Senesac, PharmD. They are affiliated with the Pharmacy Practice Drug Information Center, and the Lloyd L. Gregory School of Pharmacy Palm Beach Atlantic University West Palm Beach, Florida.
    The team celiac disease review included Etiology and Risk Factors, Clinical Presentation and Diagnosis, Factors That May Impair Drug Absorption, Legislation, Management, and Resources. They found that pharmacists do indeed have an essential role to play in educating patients and evaluating their medication use to ensure the optimal management of celiac disease. This often can be accomplished by evaluating the ingredient list, contacting the manufacturer, or utilizing a variety of other resources.
    Gluten can potentially be introduced and contaminate otherwise gluten-free products during the manufacturing process, although the likelihood is low. Key points to consider are that even if a brand product is confirmed to be gluten-free, it cannot be assumed that the generic version is also gluten-free, and that if a product has a new formulation, appearance, or manufacturer, it is prudent to reassess it and confirm that it remains gluten-free.
    When evaluating the gluten content of prescription and OTC products, it should be remembered that gluten can be masked in an excipient.
    Starches used as excipients in pharmaceutical products are often derived from rice, potato, or tapioca, which are gluten-free. However, if the source of the starch is not explicitly stated, the excipients may contain gluten. Sources of excipients that contain gluten include barley, farina, kamut, rye, spelt, triticale, and wheat.
    Pharmacists play a pivotal role in educating patients about gluten-containing foods, medications, and supplements in order to help them adhere to a GFD and in ensuring that patients receive additional follow-up care, if needed.
    Source:
    US Pharmacist. 2014;39(12):44-48.

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