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Contact: Rita T. Hopkins, Executive Director
Gluten-Free Labeling Rules Moving Forward
FDA Takes Action on Anniversary of the Food Allergen Labeling Law
Los Angeles, CA – August 2, 2011 – The Food and Drug Administration announced today that it is reopening the public comment period on the gluten-free labeling proposal it issued in 2007, mandated by a seven-year-old allergen labeling law.
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, opening up a 60-day comment period for both the gluten-free labeling proposal and the safety assessment which will run from August 3, 2011, the date of FDA’s published notice in the Federal Register, through October 2nd, 2011. The docket number is FDA-2005-N-0404 and comments can be submitted by going to www.regulations.gov.
The news coincides with the seventh anniversary of the landmark Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) in Congress. The Celiac Disease Foundation (CDF) applauds the Food and Drug Administration’s actions today, bringing it one crucial step closer to fulfilling the Act’s mandate on gluten-free labeling rules. The time allotted for additional comments will ensure FDA’s ability to compile the best scientific, evidence-based information to help in establishing the country’s first ever standard for gluten-free products.
After the passage of FALCPA, the American Celiac Disease Alliance (ACDA) was founded as a nonprofit national advocacy organization for Celiac disease in the United States. Representatives from the scientific research community, Celiac disease organizations, food manufacturers, patients and physicians make up the membership of ACDA. The Alliance’s advocacy efforts were responsible for tasking the Food and Drug Administration with proposing rules for voluntary gluten-free labeling by 2006 and finalizing the rules by 2008. The FDA issued proposed rules in 2007, but the final rules have not been issued yet.
The gluten-free labeling rules are highly anticipated by the national Celiac disease and gluten intolerant community. Celiac disease is one of the world’s most common genetic disorders, affecting one percent of the world’s population, including an estimated three million people in the United States. The only known treatment for Celiac disease is a strict gluten-free diet. Under current labeling laws, it is difficult, even impossible, to tell whether packaged food is safe for people following the medically-prescribed gluten-free diet.
CDF also recognizes dedicated members of Congress who passed FALCPA, and the elected officials who continue to work with the FDA to finalize the gluten-free labeling rules. Over the years, CDF members have also been instrumental in advocating for the rules to be finalized and are close to seeing the results of their passion and dedication.
During Celiac Disease Awareness Month in May of this year, in response to a major effort by the American Celiac Disease Alliance, the Celiac Disease Foundation, other national organizations and grassroots advocates, Deputy Commissioner for Foods Michael Taylor publicly renewed FDA’s commitment to finalize the gluten-free labeling rules. Today’s reopening of the comment period and release of the FDA’s safety assessment are welcome evidence that the FDA is fully engaged in getting the job done. We look forward with anticipation to the final gluten-free labeling rules.
“Celiac Disease Foundation applauds the continuing efforts of Michael Taylor and Rhonda Kane of the FDA, as well as Senators Ron Wyden (OR) and Patrick Leahy (VT), and New York Representative, Nita Lowey, for continuing to pursue this legislation. The resulting regulation will enable every person in the U.S. with Celiac disease to follow the medically-required gluten-free diet with confidence,” said Elaine Monarch, CDF Founder and founding member of the American Celiac Disease Alliance.
Celiac Disease Foundation is a national non-profit, public benefit corporation dedicated to providing services and support regarding Celiac Disease and Dermatitis Herpetiformis, through programs of awareness, education, advocacy and research.
For more information on Celiac Disease Foundation or Celiac disease, contact the CDF office at 818.990.2354 or visit the website at www.celiac.org.