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NFCA Heads to Washington D.C. to Ask for Gluten-Free Labeling Rule Clarification on Restaurant Menu Claims from the FDA

September 30, 2014

NFCA Heads to Washington D.C. to Ask for Gluten-Free Labeling Rule Clarification on Restaurant Menu Claims from the FDA

Jennifer North, National Foundation for Celiac Awareness (NFCA) Vice President, delivered the following comments to the U.S. Food and Drug Administration (FDA) Food Advisory Committee on behalf of those living with gluten-related disorders.


Note:

Since the gluten-free labeling rule was finalized on August 5, 2013 and put into effect a year later, confusion has surrounded what it means for restaurants. In a dramatic effort to keep those on a gluten-free diet for medical reasons safe from gluten exposure, NFCA Vice President Jennifer North traveled to Washington, D.C. to speak with the U.S. FDA Food Advisory Committee and highlight the negative impact of this confusion on the gluten-free community. The following statement was delivered to the FDA by Jennifer on September 30, 2014.

Statement to the Food and Drug Administration’s Food Advisory Committee

“Thank you, Karen Strambler, Chairman Durst, and thanks to the members of the Food Advisory Committee, for hosting this meeting and enabling me to address the group.

My name is Jennifer North and I am the Vice President of the National Foundation for Celiac Awareness. I represent approximately 21 million people who require the gluten-free diet for health reasons, including those with celiac disease, a genetic autoimmune disease that could lead to cancer, infertility and recurrent miscarriage and the onset of other autoimmune diseases if left undiagnosed or untreated.

The NFCA is an evidence-based organization with an international Scientific/Medical Advisory Council. We just completed an FDA grant to research the potential impact of gluten in medication. Through our GREAT Kitchens program, we provide accredited gluten-free training to over 1,000 learners from over 180 restaurants and colleges each year. Our media campaigns introduce the idea that the gluten-free diet is not a fad, but, in fact, a medical necessity for those with celiac disease and other gluten-related disorders. Our media efforts reached a quarter of a billion people thus far in 2014. We secured the Associated Press’ Big Story of the Day on August 5, the compliance date of the FDA’s gluten-free labeling rule. We also hosted two free webinars on the topic, one including Suzanne Wolcoff, a representative of the FDA as a presenter.

As a passive observer, it may seem that life has never been better for someone looking for gluten-free options. Despite the growth of the marketplace to over $20 billion annually and the availability of gluten-free food in gas stations and convenience stores, the gluten-free diet is proving to be emotionally and logistically difficult to navigate.

The gluten-free community lives in fear of food every day.

Their concerns have a basis. Research from the Mayo Clinic shows that nearly 70% of people with celiac disease who maintain a gluten-free diet continue to have intestinal damage from inadvertent gluten exposure.

Last week, the NFCA engaged 350,000 people in a social media dialogue about getting glutened in restaurants. Eating out remains the most critical quality of life issue affecting the gluten-free community today. A recent study found that people with celiac disease rate the gluten-free diet as an equivalent treatment burden as those with end-stage renal failure rate dialysis. I hope you find that as shocking as we do. And we hope you will agree that it is completely unacceptable.

We salute the FDA for finalizing the gluten-free labeling rule, which was mandated as part of the Food Allergen Labeling Consumer Protection Act (FALPCA) and protects consumers whose health is dependent on their ability to access safe, gluten-free food.

I am here today to ask for your support in seeking clarity from the FDA about references to the obligations of restaurants and foodservice operators in meeting the requirements of the ruling in order to make a gluten-free menu claim.

The health of those with celiac disease and non-celiac gluten sensitivity depends on foodservice operators being educated and transparent. We welcome the efforts of the FDA in acting to protect our interests. However, FALPCA is designed for packaged foods and was vetted by the packaged foods industry. The regulation centers not only around the prohibition of gluten containing ingredients, but also requires the validation of less than 20 ppm of gluten residue in the finished product.

The FDA’s statements in its Q&A and guidance document indicate that while the ruling applies to package products, it does expect restaurants to comply. It also states that it may engage state and local bodies in enforcing the ruling in the foodservice setting.

This is problematic because the restaurant setting is not typically a closed, well-controlled and predictable system where testing of samples are representative of the overall risk. It is not cost effective for restaurants to test every dish between the kitchen and the table and testing for gluten residue requires advanced technical knowledge.

With ambiguous language and lack of specific guidance for the foodservice sector, many restaurant operators are holding back on labeling gluten-free items on their menus or are, increasingly, using terminology that confuses consumers like “low-gluten”, “gluten-friendly” or “gluten-free ingredients.”

To back up what we were hearing anecdotally, we launched a survey which received nearly 150 responses from a wide variety of operators representing all geographies across the US. The majority of respondents were individual owner-operators, but multi-unit regional chains, colleges and universities and K-12 school districts also responded.

Our findings show that 89% of respondents either believe the ruling applies to them or are unsure of whether or not the ruling applies to them. 12% report that the rule will change their menu claims and over a third are not sure what to do with their menu claim.

While we certainly want to discourage restaurants who are unable to safely and consistently offer gluten free dishes from doing so, our survey shows that even restaurants who have in-depth training and strict controls in place are unclear about whether or not they are able to continue to identify gluten-free dishes to their customers.

We are concerned that this will limit accessibility of gluten-free food and quash the great strides we have made in bringing gluten-free food safety to the forefront by working with the largest manufacturers and distributers in the foodservice space, a group of loyal chef ambassadors and partner organizations like the National Restaurant Association.

Please stand with us as we seek formal guidance from the FDA that will provide a basis of understanding for how it expects foodservice operators to legally and responsibly serve those who must adhere to the gluten-free diet for health reasons.

We appreciate the opportunity to bring these concerns forward and thank you for your role in protecting our community from negative health outcomes that are costly to our healthcare system and costly to American families affected by these medical conditions.

Thank you.”

Jennifer North
Vice President
National Foundation for Celiac Awareness

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