dear![names!of!fdastaff!redacted],! - gluten free watchdog · 2019-05-20 · may2019!!...
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May 2019 Re: Gluten-‐free claims on restaurant menus Dear [names of FDA staff redacted], There appears to be a growing trend among restaurants of labeling menu items gluten-‐free based solely on the ingredients used in the menu item without regard to potential cross contact that may occur in the kitchen. This is evidenced by various disclaimers on restaurant menus, including those stating that items marked gluten-‐free are not intended for people with celiac disease. It is also evidenced by the use of gluten-‐free claims even when there is a known source of gluten cross contact (e.g., a shared restaurant fryer). What FDA has stated online about restaurants and gluten-‐free claims
“FDA’s regulation established a federal definition of the term “gluten-‐free” for food manufacturers that voluntarily label FDA-‐regulated foods as “gluten-‐free.” The definition was intended to provide a reliable way for people with celiac disease to avoid gluten, and, given the public health significance of gluten, restaurants’ use of gluten-‐free labeling should be consistent with the federal definition.” “Some restaurants use the term “gluten-‐free” in their menus. The gluten-‐free final rule applies to packaged foods, which may be sold in some retail and food-‐service establishments such as some carry-‐out restaurants. However, given the public health significance of gluten-‐free labeling, restaurants making a gluten-‐free claim on their menus should be consistent with FDA’s definition.” “State and local governments play an important role in oversight of restaurants. FDA will continue to work with partners in state and local governments with respect to gluten-‐free labeling in restaurants.”
Excerpt of a statement provided by FDA to me for public posting In the strict sense, FDA requirements for gluten-‐free claims apply to only packaged foods that are subject to FDA labeling regulations. However, FDA stated the following
in regards to restaurants in the preamble to its final rule on gluten-‐free labeling (see 78 FR 47153 at 47173, issued 8/5/13): “with respect to restaurants, FDA guidance suggests that any use of an FDA-‐defined food labeling claim (e.g., “fat-‐free” or “cholesterol-‐free”) on restaurant menus should be consistent with the regulatory definitions.” Further, both FDA regulations at 21 CFR 101.13(q)(5) (see http://tinyurl.com/lfvknn7) and Chapter IV of FDA’s guidance document titled Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Food Establishments Selling Away-‐From-‐Home Food initially issued April 2008 (see http://tinyurl.com/mngrt4j) reiterate the agency’s position that restaurants should not use an FDA-‐defined nutrient content claim for foods sold in restaurants unless those foods meet regulatory requirements for the claim. A gluten-‐free claim is an avoidance claim and FDA has publicly expressed its opinion (in the Federal Register and in a guidance document) that it takes a similar approach to gluten-‐free claims made for foods sold in restaurants. Consequently, if restaurants or other retail food establishments wish to make “gluten-‐free” claims (or the synonymous claims “no gluten” “free of gluten” or “without gluten”) for any of their menu items, these foods should meet all of the requirements FDA has established for a food labeled gluten-‐free, including not containing 20 parts per million or more gluten, whether or not the presence of gluten is due to accidental cross-‐contact occurring in the kitchen. If restaurants cannot ensure that the foods they prepare fully comply with FDA’s definition of gluten-‐free, restaurants should not refer to their foods as being “gluten-‐free.” Problems Based on information on restaurant menus and restaurant websites provided to Gluten Free Watchdog by members of the community, many restaurants:
1. Appear unaware that foods designated as gluten-‐free on a menu should be gluten-‐free when served to the customer.
2. Lack an understanding that the designation gluten-‐free pertains to both the actual ingredients used to prepare a meal and the presence of gluten due to accidental or even intentional* cross-‐contact in the kitchen.
*Some restaurants mark menu items as gluten-‐free even though said items are cooked in a shared fryer with wheat-‐containing products. This may or may not be disclosed on a menu. See restaurant 7 below.
3. Include disclaimers regarding potential cross contact on gluten-‐free menus and meals designated as gluten-‐free.
4. Include wording in their disclaimers stating that gluten-‐free meals are not safe for customers with celiac disease.
5. Lack an understanding that the term “gluten-‐free” was defined to help people with celiac disease avoid gluten. 6. Have not been subject to any state or federal oversight regarding gluten-‐free claims.
Recommendation Many people with celiac disease greatly appreciate when restaurants identify meals that are free of or can be made without gluten ingredients. This provides them with a good starting point to ask questions of restaurant staff about cross contact precautions. Customers do not want restaurants to stop this practice. An FDA guidance document directed to restaurants on how to accurately represent menu items would be very helpful. This guidance could include information on:
A. Proper use of a gluten-‐free claim (i.e., meal is gluten-‐free when served to a patron as may occur in a dedicated gluten-‐free restaurant or a restaurant with well-‐trained staff who are well versed in the steps necessary to prevent cross contact in the kitchen). B. Recommendations for the use of an alternative claim when a restaurant can provide meals made with no gluten-‐containing ingredients and take precautions to prevent cross contact but can’t ensure that cross contact won’t occur (e.g., NG=no gluten-‐containing ingredients). C. Disallowance of the use of a gluten-‐free claim when it applies to ingredients only with little to no regard for the potential for cross contact.
Community Input Gluten Free Watchdog recently asked the community to submit photos of restaurant menus containing both a gluten-‐free claim and a precautionary statement pertaining to cross contact and lack of suitability for patrons with celiac disease. What follows on the next page is a sampling of these submissions. The Gluten Free Watchdog community is more than happy to provide FDA with additional examples. Hopefully the information provided in this letter helps to increase FDA awareness about the current use of gluten-‐free claims by restaurants. Thank you. Tricia Thompson, MS, RD Founder, Gluten Free Watchdog, LLC
Restaurant 1: Gluten-‐Free Pizza; Disclaimer includes “… our gluten-‐free items are not recommended for guests with celiac or any other gluten sensitive disorders.”
Restaurant 2: Gluten-‐free Menu; Disclaimer includes, “… we cannot guarantee hospital pureness for customers who have a strict celiac diet. We do offer our gluten-‐free menu for customers who prefer a diet without gluten.”
Restaurant 3: Gluten-‐Free Menu; Disclaimer reads, “[restaurant name] does not recommend them for customers with celiac disease.”
Restaurant 4: Circular advertises gluten-‐free pizza; There is no disclaimer on the circular; Website disclaimer states, “Customers with gluten sensitivities should exercise judgment in consuming these items.”
Restaurant 5: Designates menu items gluten-‐free; Disclaimer states “[Restaurant] does not recommend these items for guests with celiac disease.”
Restaurant 6: Designates menu items gluten-‐free: Disclaimer states, “Cross-‐contact with other food items that contain gluten is possible.”
Restaurant 7: Gluten Free Menu; Appears to use shared fryer. Disclaimer states, “There may be trace amounts of flour in fry oil”
Restaurant 8: Designates menu items as gluten-‐free; Disclaimer states, “We do not recommend it for those with celiac disease.”
Restaurant 9: National Park Service restaurant. Offers gluten-‐free options; Disclaimer states we “cannot ensure the (sic) cross contamination will never occur.”
Restaurant 10: Gluten-‐Free Menu; Disclaimer states “there may be a chance of cross contamination.”
Restaurant 11: Gluten-‐Free Menu; Disclaimer states, “Our fries are gluten free, but are prepared in a fryer that is used for foods containing gluten.”
Additional restaurant menu of interest: Items marked “G” to mean “Contains Gluten.”
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