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Glutino Share Views on FDA Labeling Proposal
To Whom It May Concern:
I am writing in response to the Food and Drug Administration’s proposed rule on the “gluten-free” labeling of foods required by Section 4302 of the Food Allergen Labeling and Consumer Protection Act (docket # FDA 2005-N-0404). I would first like to applaud the FDA for moving forward on this issue and creating a sense of urgency to finalize the regulations. As a pioneer and leader in the gluten-free space for more than 27 years, Glutino is proud to support the FDA in finalizing standards for the millions of Americans affected by celiac disease and gluten sensitivity.
As you are aware, uniform standards and labeling regulations for gluten-free products are critical across the category to ensure transparency and safety for the three million Americans diagnosed with celiac disease and the additional 40 million with gluten sensitivities. With so much growth in the gluten-free industry, labeling regulations need to be clearly defined and consistent for all manufacturers in the category. This alignment will most importantly ensure safety for consumers, but will also help to create a level playing field for manufacturers in the space who are fully committed to providing safe gluten-free products that meet recognized standards.
As such, Glutino is in alignment with the current FDA recommendation for gluten-free labeling, which states that a product may be labeled “gluten-free” if it does not contain:
- an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
- an ingredient derived from these grains and that has not been processed to remove gluten;
- an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
- 20 ppm or more gluten.
Research has demonstrated that a 20ppm standard is safe for the majority of individuals with celiac disease [1]. Glutino is deeply committed to meeting or exceeding those standards for gluten-free products. All of Glutino’s products adhere to strict gluten-free manufacturing guidelines to ensure delivery on the gluten-free promise for our consumers. In fact, Glutino is already in compliance with the FDA’s proposed standards and tests each production lot using the approved ELISA R5-Mendez method.
Finally, once the final gluten-free standard is in place, I urge the FDA to regularly review the scientific research supporting the standard and revise it as appropriate to ensure the continued safety of celiac consumers.
I appreciate the opportunity to provide comment on the proposed rule and thank you in advance for your consideration.
Sincerely,
Terence Dalton
General Manager for Glutino
[1] Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007;85:160–6.
What the Experts Are Saying About FDA’s Labeling Proposal
FDA Reopens Comment Period on Gluten-Free Labeling Proposal
The agency’s announcement coincides with the anniversary of allergen law mandating standards for products consumed by individuals with celiac disease and others adhering to medically prescribed gluten-free diet.
ALEXANDRIA, VA – August 2, 2011 – Today, the FDA announced it was reopening the public comment period on its gluten-free labeling proposal mandated in a seven-year old allergen labeling law according to the American Celiac Disease Alliance (ACDA), the national advocacy organization representing patients, researchers, food manufacturers and others serving the celiac community.
Along with news about opening up the comment period, the agency released a safety assessment, analyzing the research on the amount of gluten that can safely be consumed by those who have celiac disease. The 60-day comment period for both the overall gluten-free labeling proposal and the safety assessment will run from the date FDA’s notice is published in the Federal Register. The docket number is FDA-2005-N-0404 and comments can be submitted by going to www.regulations.gov.
The FDA is allowing time for additional comments to ensure that it has the best scientific, evidence-based information to establish the country’s first ever standard for gluten-free products. The Food Allergen Labeling and Consumer Protection Act (FALCPA) directed the FDA to come up with a standard and the agency in 2007 proposed that gluten-free food contain less than 20 parts per million (ppm) of gluten. Action was to be completed the following year, instead the regulation then stalled.
Dr. Alessio Fasano of the University of Maryland’s Center for Celiac Research has authored research demonstrating a 20ppm would be safe. “This is a standard that has been in use in Europe for almost two decades, and the science supports the U.S. adopting it as well,” said Fasano.
Advocates, led by the ACDA, have been pressuring FDA for years to complete the gluten-free regulations. In May, hundreds from the celiac and gluten-free community rallied at the Gluten-Free Labeling Summit in Washington, DC. The event garnered nationwide attention as baking expert, and cookbook author, Jules Shepard, assisted by other gluten-free chefs, constructed the world’s largest gluten-free cake. Michael Taylor, FDA’s Deputy Commissioner for Food, attended providing assurance the agency was working hard to complete the gluten-free regulation.
“FDA now appears intent on getting the job done, and doing right by focusing on the science,” said ACDA President Beth Hillson. “This is critically important since individuals with celiac disease and gluten-sensitivity have been left to fend for themselves, while companies place ‘gluten-free’ on products like water that never contained any of the forbidden grains – wheat, rye, or barley,” added Hillson.
An estimated 3 million Americans have celiac disease, and possibly even more are thought to be gluten-sensitive. Both conditions require adherence to the medically prescribed gluten-free diet. In Italy, England, Australia, and elsewhere in the world, labeling standards have existed for decades. In the U.S., food manufacturers can claim “gluten-free” on product labels without taking any steps to ensure the ingredients they use are not cross contaminated with harmful levels of gluten.
Dr. Stefano Guandalini, Medical Director of the University of Chicago Celiac Disease Center notes, “Celiac disease is a serious, life-threatening medical condition. In this country, the food products that patients need to treat the condition are virtually unregulated leaving these individuals at risk of harm each and every day. It is inexcusable.”
The gluten-free market has changed dramatically since 2004, when sales were $560 million. By next year, those sales numbers are expected to exceed $2.6 billion. Many companies are now using the gluten-free label to attract customers, but some do not follow the strict procedures needed to guarantee a product is truly gluten-free. Other manufacturers are reluctant to label their products “gluten-free” because there is no accepted standard.
Scott Mandell, CEO of Enjoy Life Foods states, “The absence of a standard has created substantial anxiety and confusion for those who must adhere to the gluten-free diet for medical reasons. Industry is looking forward to FDA taking the next step and finalizing this standard.”
About the American Celiac Disease Alliance (ACDA)
The non-profit American Celiac Disease Alliance was established in 2003 as the national advocacy organization for celiac disease in the United States. Unifying patient support groups, researchers, food manufacturers and others serving the community, the ACDA advances policy initiatives to improve the lives of those with celiac disease. The organization spearheaded the grassroots campaign that was instrumental to the passage FALCPA.
Senators Wyden & Leahy Press FDA To Finish GF Rules
Our community has been hard at work asking for help in all the right places. This time, our champions are Senator Ron Wyden (OR) and Senator Patrick Leahy (VT). Both senators have a passion for health issues, and seniority to make things happen. After conversations with the ACDA, they sent the letter below to FDA Commission Dr. Margaret Hamburg.
Senator Wyden later tweeted his thanks for our help, “@CeliacAlliance Thanks for your support about @RonWyden’s letter to @US_FDA for gluten-free food standards . . .”
Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002Dear Commissioner Hamburg:We are increasingly concerned about the pace and apparent inaction at the Food and Drug Administration in finalizing standards for gluten-free labels on food. We believe this delay is creating unnecessary confusion for consumers and uncertainty for agricultural producers.
On August 2, 2004, the Food Allergen Labeling and Consumer Protection Act was signed into law with widespread, bipartisan support, passing the Senate by unanimous consent, and the House of Representatives by a voice vote. Section 206 of this bill required the Secretary of Health and Human Services to issue a proposed rule on gluten labeling within two years, and a final rule within four years. In January 2007, FDA issued its proposed rule. Since then, no final rule has been proposed or issued. It has since been seven years since Congress mandated that your agency address this issue, and more than four years since any significant action on this has been taken.
The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of “gluten free” standards and labels provided by 3rd party groups. This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be.
We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.
We look forward to your response and to working with you in the future.
Sincerely,
Ron Wyden
United States Senator
Patrick J. Leahy
United States Senator
Rep. Moran, Democrats Urge FDA to Define GF Labeling
It didn’t take long after our big event before leaders in Congress came to the aid of the celiac community. Rep. Jim Moran (VA), quickly circulated a letter to his colleagues, asking them to join him in urging the FDA to define GF labeling. In his press release on the issue, the Congress said, “The FDA has access to world-class researchers and was given a reasonable timeline to fix the inconsistent labeling,” Moran continued. “They need to take immediate action and determine an appropriate system to protect those individuals affected by food-based sensitivities.” Moran’s push for accurate gluten labeling has received the support of the American Celiac Disease Alliance. (emphasis added) Read the letter below.
Margaret Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993Dear Commissioner Hamburg,
We are writing today to express our concern with the delay in producing a definition for the term “gluten-free” for food manufacturers to use in their labeling processes. With the rate of celiac disease on the rise in the United States, it is time to establish a uniform definition to protect these individuals from inconsistent, and in some cases, fraudulent labeling.
As you know, celiac disease (CD) is an autoimmune condition affecting an estimated 3 million children and adults nationwide. Furthermore, The Washington Post recently reported that new research indicates an additional 17 million Americans are gluten-sensitive. According to the Celiac Disease Foundation, when people with CD ingest foods that contain gluten– whose proteins are found in all forms of wheat – it creates a toxic reaction that causes damage to the small intestine and does not allow food to be properly absorbed. Contact with gluten, even small amounts, can cause infertility and an increased risk to certain cancers and health problems. Indeed, even when there are no symptoms present, damage can still occur to the small intestines.
In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (P.L. 108-282) which gave the FDA until 2008 to create a definition for what a gluten-free product actually means. We have since seen that deadline come and pass without resolution.
In the meantime, the $2.6 billion gluten-free industry has seen many products labeled gluten-free that vary greatly with regard to the amount of gluten actually present. A number of gluten-free food makers go to great lengths, and thus cost, to ensure their products contain no gluten or come into contact with gluten during manufacturing. Others, however, make full use of the gluten-free label while failing to reach the advertised standard, in some cases putting the health of consumers with CD at risk.
Defining what it means to be gluten-free is not an insurmountable task. Other countries have successfully determined what the label gluten-free should mean for their citizens. While we appreciate the hard work the FDA has put into the task of defining this term for the past seven years, it is time to finish that process and establish a federal standard. We urge you to act now to develop a final rule creating a definition for gluten-free products. Thank you for your attention to this important matter.
Sincerely,
Representative James Moran
Delegate Madeleine Bordallo
Representative Gerry Connolly
Representative Joe Courtney
Representative Dennis Kucinich
Representative Betty McCollum
Representative Jared Polis
Gluten-Free Labeling Summit
It is a Big Deal
The Summit, held on May 4th in the nation’s Capitol Washington, DC, was quite simply AMAZING. Not only did master GF bakers assemble a record setting 11 foot tall cake, news of the event traveled like wildfire across the country. Better yet, it served as a calling card for Celiac Advocates when visiting Capitol Hill. A dozen meetings were held over the course of the day. Without exception, lawmakers and staff were very interested in learning about the need for GF labeling and expressed concern about the FDA’s delays in producing the rules mandated by the Food Allergen Labeling and Consumer Protection Act (FALCPA).
The evening reception had its own excitement. People crowded the room to watch the final tier and piping go on the cake. Rep. Nita Lowey (NY), sponsor of FALCPA, and the National Celiac Awareness Month legislation, stopped by to see the cake and speak to members of the community she has long sought to help. She said she would see to it that the GF labeling rules got done, and made a point to ask FDA about it that night!
The thousands of letters sent to the FDA by Celiac Advocates had an impact on the FDA. As the surprise guest of the night FDA’s Deputy Commissioner for Foods Michael Taylor who had accepted the ACDA’s invitation to speak at the Summit. He acknowledged the ACDA’s effort in pressing FDA to complete the GF labeling rules. To the crowd, he said very clearly, “you have gotten our attention, FDA is now listening.” After addressing the group, Taylor received a healthy round of applause.
Although Rep. Betty McCollum arrived after the formal program ended, she was interested in learning more about current research and how she might be able to advance the cause. She spoke at length with ACDA Members, Dr. Alessio Fasano (Center for Celiac Research), Cynthia Kupper (GIG), along with Executive Director Andrea Levario, and President Beth Hillson.
Individuals departed with wonderful shopping bags filled with gluten-free goodies from the event sponsors: Whole Foods, Enjoy Life Foods, Glutino, King Arthur Flour, Food Tastes Good, and magazines from Gluten-Free Living, Living Without and Delight. More importantly, they were armed with a renewed sense of community and commitment to improving the lives of all with celiac disease and gluten-sensitivity.
Archives
Scientific American Article Details History of Celiac Disease Diagnosis and Treatment
New Research Identifies Differences Between Celiac Disease And Gluten Sensitivity
$45 Million Private Donation for Celiac Research To UMaryland School of Medicine
ACDA Members Present Comments to USDA On National School Lunch Program
ACDA Press Release on FDA Proposal for GF Labeling
National Celiac Awareness Measure Garners Unprecedented Support
Press Release on Passage of the Food Allergen Labeling and Consumer Protection Act
Representative Lowey Thanks Task Force for Help with Labeling Bill
House Appropriations Committee Hears First Ever Testimony on Celiac Disease
Task Force Testimony on Juvenile Diabetes and Celiac Disease
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