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    Scott Adams
    Scott Adams

    FDA Supports Food Allergen Labeling Bill

    Reviewed and edited by a celiac disease expert.

    Celiac.com 12/19/2003 - In a press release dated November 24, 2003, FDA Commissioner, Mark B. McClellan, M.D., Ph.D., applauded the Senate Health, Education, Labor and Pensions Committee reporting out several health-related bills. Among the bills unanimously approved by the Committee was S. 741, a bill that includes the proposed Food Allergen Labeling and Consumer Protection Act of 2003. Action by the Committee took place on November 21.

    I wish to thank the Committee Chairman Senator Judd Gregg, Ranking Member Senator Edward Kennedy and the rest of the Committee members for taking these actions, Dr. McClellan said, and I look forward to continuing to work with the members of both houses of Congress toward the enactment of these bills.



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    The Food Allergen Labeling and Consumer Protection Act will provide improved food labeling to better inform consumers who suffer from food allergies.

    Having the endorsement of the FDA will be key as we look ahead to floor action by the full Senate in early 2004.

    Andrea Levario
    Co-Chair, American Celiac Task Force



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  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994, and, due to the nearly total lack of information available at that time, was forced to become an expert on the disease in order to recover. In 1995 he launched the site that later became Celiac.com to help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives.  He is co-author of the book Cereal Killers, and founder and publisher of the (formerly paper) newsletter Journal of Gluten Sensitivity. In 1998 he founded The Gluten-Free Mall which he sold in 2014. Celiac.com does not sell any products, and is 100% advertiser supported.


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  • Related Articles

    Scott Adams
    The House of Representatives has, once again, acknowledged celiac disease. It has passed the funding bill for the Department of Health and Human Services (HHS), which includes the NIH. The report language detailed below was included in that legislation. This language serves as guidance from Congress to the NIH to focus on certain issues (in this case celiac disease). A special round of thanks is due Representative Nita Lowey (D-NY) for her tireless efforts on behalf of the celiac community. Further thanks go out to Representative Ralph Regula (R-OH), Chairman, House Appropriations Subcommittee on Labor-HHS-Education, for his leadership on this important bill.
    We now wait to see what happens with the Senate version of the funding bill, and whether it is passed before the Congress adjourns later this month.
    HR 5006; Passed House on Sept. 9, 2004
    House Report. 108-636
    "Celiac disease.--The Committee commends NIDDK for recognizing the lack of understanding, and under-diagnosis of the genetic, autoimmune disorder, Celiac disease (celiac disease), and for including celiac disease in the NIH Consensus Development Program for 2004. Although readily diagnosed in European countries, it takes on average eleven years for Americans to be properly diagnosed. Delays in diagnosis place individuals at risk for osteoporosis, anemia, miscarriages, and small bowel cancer. Current evidence demonstrates that celiac disease is the most common genetic disorder in the world, with a treatment-- strict, gluten-free diet--that can be managed almost exclusively by the individual, or family. Education about celiac disease is needed for health care professionals and patients. The Committee encourages NIDDK to coordinate informational and educational programs directed at health professionals, patients and the public to raise awareness and understanding about celiac disease, and the need for early diagnosis."
    A copy of the report is available at: http://thomas.loc.gov/cgi-bin/cpquery/R?cp108:FLD010:@1(hr636):
    Allison Herwitt
    Co-Chair, Legislative Project
    American Celiac Task Force


    Scott Adams
    Celiac.com 01/25/2007 - Under an FDA proposal published yesterday, food companies will have to meet new standards before labeling their products as gluten-free. It also provided a new definition for gluten-free which will give individuals with celiac disease greater confidence that specially labeled foods are in fact, safe for them to eat, according to the American Celiac Disease Alliance (ACDA).
    The Food Allergen Labeling and Consumer Protection Act (FALCPA) passed by Congress in 2004, requires food manufacturers to clearly state if a product contains any of the eight major food allergens: milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, and soy. It also required the FDA to develop and implement rules for using the term ‘gluten-free’ on food packaging.
    Adhering to the gluten-free diet is the only course of treatment for celiac disease, a genetic digestive disorder. The condition, triggered by eating the protein gluten which is found in the grains wheat, rye, and barley, and hybrids of these grains affects an estimated 2 to 3 million Americans.
    There is no single, world-wide accepted definition of gluten-free labeling. The levels of acceptable gluten vary from country to country, as do the symbols and terminology, permissible in the labeling. Research establishing a safe threshold of gluten consumption for those with celiac disease was recently published in the American Journal of Clinical Nutrition. The study, conducted by members of the ACDA at the University of Maryland and referenced by the FDA, concludes that celiacs can safely tolerate up to 20 parts per million (ppm) of gluten a day.
    “The FDA listened to patients, food manufacturers, and members of the scientific community and came up with a well thought out proposal,” said Andrea Levario, Executive Director of the ACDA.
    There is so little research about the gluten-free diet and safe consumption levels that the agency is seeking comments on a number of related issues including: The appropriateness of 20 ppm gluten as the proposed threshold level as determined using an ELISA based testing method; The effect that adoption of a lower threshold level would have on individuals with celiac disease and on industry; Whether a lower threshold level might effect (limit availability of) commercially available foods labeled gluten-free in the United States; Whether a reduced availability would have a negative impact individuals with celiac disease; and Whether oats should be included in the definition of prohibited grains. In the absence of federal rules, food companies have been using a variety of standards in manufacturing gluten-free products. This creates confusion and skepticism among individuals whose health depends on clear, accurate labeling. With only 90,000 out of an estimated 2 million celiacs diagnosed, manufacturers know that uniformity and consistency will benefit them as well consumers, said Levario.
    The FDA has prepared a series of questions and answers to help consumers understand the provisions of the proposal. For a copy go to: http://www.cfsan.fda.gov/~dms/glutqa.html ; and for a copy of the gluten-free labeling guidelines go to: http://www.cfsan.fda.gov/~lrd/fr070123.html .
    About the ACDA
    The American Celiac Disease Alliance (ACDA) was established in March 2003 to provide leadership on public policy issues affecting those with celiac disease, an inherited autoimmune disorder affecting children and adults. The non-profit serves as a national umbrella organization representing all segments of the celiac community -- research centers, physicians, patients, food manufacturers, print media, and the service industry.


    Jefferson Adams
    Celiac.com 07/23/2008 - Folks who follow a gluten-free diet can take comfort that the Codex Alimantarius, the international body responsible for setting food safety standards, has moved a step closer to adopting the gluten-free standards they drafted in November 2007, and their new standards are, for the most part, in-line with the proposed FDA regulations. However, those hoping for speedy adoption of similar standards by the FDA will just have to wait until the FDA takes one last round of public comment and evaluates safety standards used in developing the standards. Certainly, anticipation has been running high, as several blogs and otheronline sources have wrongly claimed that the new FDA standards will go intoeffect in August 2008.
    From June 30 to July 5, 2008, the Codex Alimentarius Commissionrecently held their 31st session, where they accepted without changethe 2007 Draft Revised Codex Standard for Foods for Special Dietary Usefor Persons Intolerant to Gluten. According to the latest CodexAlimentarius standard, any product labeled “gluten-free,” includingthose made from de-glutened wheat starch will contain no more than 20parts gluten per million. This last part is especially important, astheir earlier standards for the use of “gluten-free” on labels allowedup to 200 parts gluten per million if the product contained ingredients that normally contained gluten. The 2007 standard still includes a special category for foods that are not naturallygluten-free, but have been rendered gluten-free through processing, such as wheat starch that has had its gluten removed. Thiscategory is called “foods specially processed to reduce gluten to alevel above 20 up to 100 milligrams per kilogram.” The Codex Alimentarius Committee has yet to post the new standard on the their website.
    The adoption of a less than 20 ppm standard on foods labeled "gluten-free" by both the Codex Alimentarius and the FDA would mean that consumers across Europe and North America could count on a single, uniform standard for food that is labeled "gluten-free." This new standard has been driven primarily by the efforts of celiac disease support groups, people diagnosed with celiac disease, and gluten-free diet followers, whose influence also led to the creation and passage of the Food Allergen Labeling and Consumer Protection Act in 2004.
    The FDA will not issue their final ruling until they make the draft available for public review and consider one more round of commentary, along with previous public comments, as well as publishing a notice on the safety assessment made in developing the final rule. The FDA will likely publish the notice on the safety assessment soon, but there is no indication as to just when they will issue the final rule.
    A large part of the celiac community has been eagerly anticipating the announcement of the final rule. Until that great day, all of you gluten-free folks will just have to be content knowing that solid, reliable standards for the use of the term "gluten-free" on food labels are just around the corner.
    The next session of the Codex Alimentarius Commission will be held from 29 June to 4 July 2009 in Rome.
    Here are the new Codex Alimentarious Standards for Gluten-Free foods, which will appear on their Web site soon:

    2.1.1 Gluten-free foods
    Gluten-free foods are dietary foods
    a) consisting of or made only from one or more ingredients which do not contain wheat (i.e., all Triticum species, such as durum wheat, spelt, and kamut), rye, barley, oats1 or their crossbred varieties, and the gluten level does not exceed 20 mg/kg in total, based on the food as sold or distributed to the consumer,and/or
    consisting of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat, spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed to remove gluten, and the gluten level does not exceed 20 mg/kg in total, based on the food as sold or distributed to the consumer.
    2.1.2 Foods specially processed to reduce gluten content to a level above 20 up to 100 mg/kg
    These foods consist of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat,spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed to reduce the gluten content to a level above 20 up to 100 mg/kg in total, based on the food as sold or distributed to the consumer.
    Decisions on the marketing of products described in this section may be determined at the national level.


    Jefferson Adams
    Celiac.com 02/03/2011 - Okay, so Canadians take their beer seriously. Beer being one of the few things that might stoke the passions of some Canadians almost as much as, say, hockey.
    So, proposed health regulations that would require beer labels to include a warning that beer is made with barley or wheat have the Canadian beer industry in a froth.
    Major players in the Canadian brewing industry are gearing up opposition over the proposed health regulations that would require just such labels, warning consumers that beer contains barley or wheat; something Canadian brewers liken to warning that ketchup contains tomatoes.
    The proposed rules are part of a larger set of regulatory changes Health Canada is seeking to make it easier for people with allergies to identify potential allergens in food ingredients.
    Health Canada statistics indicate that up to six per cent of children and up to four per cent of adults in Canada are believed to be affected by food allergies.
    People with serious allergies can go into shock or even die if they consume certain ingredients. Beer-label warnings are aimed especially at people with celiac disease.
    The proposed rules would require beer labels to "clearly and prominently" display a warning that says, "Allergy and intolerance information: Contains wheat."
    Barley-based beer labels would be required to include a warning that says, "Allergy and intolerance information: Contains barley."
    Canadian beer companies say the measure is not necessary, pointing out that people with celiac disease represent only about one per cent of the Canadian population, and tend to be well informed about the foods they should avoid.
    "These people are very well educated," said Andre Fortin, a spokesman for the Brewers Association of Canada, whose members produce 97 per cent of the beer brewed in Canada. "If a Canadian doctor diagnoses you with celiac disease, you're going to know that beer is not ideal for your system."
    The companies also point out small breweries might be hit especially hard by the labeling regulations. A number of breweries such as Steam Whistle Brewery and Mill St. Brewery sell their beer in vintage-style glass bottles with ceramic paint, which beer stores return to the companies, to clean and refill for reuse. Such companies might have to order new bottles to accommodate such regulations. The move could cost them millions of dollars, they say.
    However, for people who support allergy labeling requirements, the matter is serious. "This isn't just a bunch of fusspots," said Gwen Smith, editor of Allergic Living, a magazine and website that has long lobbied for the regulations. "This is about, 'How do I feed my children at dinner safely?' 'How do I feed myself?'"
    In addition to beer, new rules will apply to allergens derived from a wide range of foods, including almonds, cashews, hazelnuts, pecans, pistachios, sesame seeds, eggs, milk, soybeans, crustaceans, shellfish and fish.
    A review conducted nearly a decade ago for Health Canada estimated that implementing the proposed regulations would cost the Canadian food industry $102 million over two years, with annual costs of $13 million. The department expects the changes will cost the Canadian Food Inspection Agency $3 million annually, and Health Canada about $1 million per year.
    Health officials say that the cost of the implementing the proposed rules could be offset by some cost savings for the health-care system, since people with allergies would require less treatment. The department says the regulations are similar to those already in place in the United States, Europe, Australia and New Zealand.
    A spokesman said that after publication of the final version of the regulations, the food industry will have 18 months to comply.
    "The new labeling regulations are designed to ensure that consumers have the information they need to make appropriate choices and that this information is provided in a clear and consistent manner," the department said in a statement.
    Read more: Canada.com



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