PRACTICE APPLICATIONS
Topics of Professional Interest
The Gluten-Free Labeling Rule: What Registered Dietitian Nutritionists Need to Know to Help Clients with Gluten-Related Disorders
O
N AUGUST 5, 2013, THE US Food and Drug Administration (FDA) published the final rule on gluten-free labeling.1 This rule defines the claim gluten-free when voluntarily used on food labels. The rule went into effect on September 4, 2013, and had a compliance date of August 5, 2014. All products labeled on or after August 5, 2014, bearing a gluten-free claim on product packaging that fall under the labeling jurisdiction of the FDA must be in compliance. Consumers and registered dietitian nutritionists (RDNs) should be mindful that products labeled before the compliance date may be on store shelves for a period of time. The rule is intended to make it easier for individuals, specifically those with celiac disease, to identify foods that do not contain gluten and are thus safe and appropriate for them to eat. Many aspects of gluten-free labeling remain confusing to consumers, including which products are covered under the rule, which ingredients can and cannot be included in a product labeled glutenfree, and how information is reported to the FDA when there is the possibility of misbranding. The purpose of this article is to help clarify areas of consumer confusion and provide information to help increase understanding of the gluten-free labeling rule.
WHAT THE RULE SAYS If a food includes a gluten-free claim on product packaging or any of the terms considered by the FDA to be synonymous with a gluten-free claim, namely no gluten, free of gluten, or without gluten, then the food must either inherently not contain gluten
This article was written by Tricia Thompson, MS, RD, founder, Gluten Free Watchdog, LLC, Manchester, MA. http://dx.doi.org/10.1016/j.jand.2014.10.001
ª 2015 by the Academy of Nutrition and Dietetics.
(eg, bottled water, bag of raw carrots) or meet all of the following criteria1:
not contain an ingredient that is a gluten-containing grain (eg, wheat); not contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (eg, wheat flour); and not contain an ingredient that is derived from a gluten-containing grain that has been processed to remove gluten (eg, wheat starch) if use of that ingredient causes the final food product to contain 20 or more parts per million (ppm) of gluten.
All food carrying a gluten-free claim also must contain less than 20 ppm gluten, including from cross-contact. In addition, if a food product is labeled gluten-free and includes the word “wheat” in the ingredients list or “Contains” statement due to use of ingredients that may contain wheat protein, such as wheat starch or wheat starch hydrolysates (eg, glucose syrup [wheat], maltodextrin [wheat]), then the word “wheat” must be immediately followed by an asterisk or similar symbol that notes the following verbiage included on the label, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”1
WHAT THE RULE DOES AND DOES NOT COVER The FDA’s gluten-free labeling rule covers packaged food, including supplements, intended for human consumption that fall under the labeling jurisdiction of the FDA. It does not cover foods regulated by the US Department of Agriculture (USDA), alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB),
cosmetics, or medications (either prescription or nonprescription).
USDA-Regulated Foods The USDA regulates meat products (eg, packaged lunch meats like salami, hot dogs, bacon), poultry products (eg, seasoned turkey breast, frozen chicken tenders, canned chicken), egg products (eg, dried, frozen, or liquid eggs with or without added ingredients), and mixed food products that contain, in general, more than 3% raw meat or 2% or more cooked meat or poultry meat (eg, some beef stew, some meat-based chili).2 If an egg product is under the labeling jurisdiction of the USDA, then the label will contain an egg products shield. If a mixed food product is under the labeling jurisdiction of the USDA, then the label will contain a USDA mark of inspection. Foods regulated by the USDA are not covered under the FDA’s gluten-free labeling rule. Regardless, a glutenfree claim on a USDA-regulated food should have the same meaning as a gluten-free claim on an FDA-regulated food. This is because the USDA has stated and recently reconfirmed the following with regard to gluten-free labeling of USDA-regulated foods: FSIS [Food Safety and Inspection Service] is not planning at this time to conduct rulemaking to define “gluten free.” Rather, once FDA’s final rule becomes effective, if a meat, poultry, or egg product establishment chooses to make the claim “gluten free” they will need to follow the requirements for the use of the claim in FDA’s regulations. This is similar to what FSIS has required when establishments choose to make health claims and label trans-fat on meat, poultry, and egg products (ie, FSIS allows the use of FDA-regulated health claims and the declaration of trans-fat on labels provided the establishments follows FDA’s regulations). This would ensure consistency for the use of the
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PRACTICE APPLICATIONS claim “gluten free” across all food groups for consumers. FSIS will clarify this position through policy guidance published on its website.3 Interestingly, unlike the FDA, which does not preapprove labels for food products, the USDA requires foods making gluten-free claims to undergo a label approval process.4 The USDA recently changed its label preapproval process and now allows generic approval (labels do not have to be submitted) for many products. Labels making “negative claims” must still be submitted for approval. A gluten-free claim is considered a “negative claim,” which is defined by the USDA as a statement referring to the absence of an ingredient or other component of a food.4
TTB-Regulated Alcoholic Beverages The TTB regulates almost all alcoholic beverages, including distilled spirits, wines that contain 7% or more alcohol by volume, and malt beverages (eg, beer) that are made using both malted barley and hops.5 The FDA regulates wine containing less than 7% alcohol by volume and malt beverages (eg, beer) made without either malted barley or hops (or both).5,6 Beverages regulated by the TTB are not covered under the FDA’s gluten-free labeling rule. However, the TTB issued a revised interim policy on gluten content statements in the labeling and advertising of alcoholic beverages under its labeling jurisdiction.7 This interim policy is based in large part on the FDA rule. In brief, this policy states that: A gluten-free claim may be used on product labels and in advertising on alcoholic beverages if the product meets the criteria stipulated by the FDA for a gluten-free claim. The TTB considers products that may use a gluten-free claim to be those beverages such as wine fermented from fruit and distilled alcohol made from ingredients other than wheat, barley, and rye. B If a gluten-free claim is included on a label, appropriate measures must be in place “to prevent cross-contact with gluten-containing grains during production, processing, storage, or other handling practices.” 14
The TTB does not currently believe that fermented beverages made using malted barley or distilled beverages made from wheat, barley, or rye should qualify for a gluten-free claim. The agency believes that current gluten testing methodology for fermented and distilled products “are inappropriate due to the lack of recognized standards and methodologies that provide a meaningful quantitative analysis of the sample that can be related to 20 ppm intact gluten.” B However, products made from a gluten-containing grain that have been processed to remove gluten may include the claim “processed to remove gluten” but the label must also state one of the following: Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten. OR
This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.
Cosmetics The FDA regulates the labeling of cosmetics; however, the FDA’s gluten-free labeling rule does not cover cosmetics. There are no FDA rules or guidance documents that specifically address the use of gluten-free claims on cosmetic labels.8 However, the FDA has not objected to gluten-free claims on cosmetics but such claims must be accurate and not misleading.8 A cosmetic is defined as “a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”9
Medications The FDA regulates the labeling of medications, including prescription and
JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS
nonprescription medication; however, the gluten-free labeling rule does not cover medications. In 2011, the FDA published in the Federal Register a request for information and comments on gluten in drug products.10 The FDA is currently evaluating the comments they received.5 To my knowledge, no further information has been publicly released.
LABELING ISSUES CAUSING CONFUSION There can be areas of confusion among consumers, manufacturers, and RDNs related to the gluten-free labeling rule. Following are examples of some of these areas.
Products Labeled Gluten-Free that also Contain Wheat Foods may be labeled gluten-free and include wheat in the ingredients list or “Contains” statement. This may occur if wheat starch or ingredients that may be made from wheat starch, such as glucose syrup or maltodextrin, are included in a food labeled gluten-free. Under the Food Allergen Labeling and Consumer Protection Act, if an ingredient in a food product includes any wheat protein, then the word “wheat” must be included in the ingredients list or “Contains” statement.11 Under the FDA’s gluten-free labeling rule, wheat starch and wheat starch hydrolysates are considered ingredients processed to remove gluten.1 These ingredients are allowed in foods labeled glutenfree as long as the final food product contains less than 20 ppm gluten. As mentioned previously, the FDA requires additional labeling on foods making a gluten-free claim that also include wheat in the ingredients list or “Contains” statement. The word “wheat” must be followed by an asterisk (or other symbol) that leads to another asterisk noting the verbiage, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”
Malt, Malt Extract, and Malt Flavoring Foods labeled gluten-free may not contain the ingredients malt, malt extract, or malt flavoring. As defined in the Code of Federal Regulations, these ingredients are made from barley unless another source is named.12,13 The FDA recently clarified during an January 2015 Volume 115 Number 1
PRACTICE APPLICATIONS Academy of Nutrition and Dietetics webinar that they consider these ingredients to be among those not processed to remove gluten and they are not allowed in gluten-free foods.14,15 Unfortunately, this appears to be an area of confusion for manufacturers. During the past few years, many manufacturers have incorrectly included malt ingredients in their foods labeled glutenfree.16-19 Now that there is a gluten-free labeling rule that the FDA will be enforcing, products labeled gluten-free containing malt ingredients can be reported to the FDA as misbranded, as discussed further in this article.
Wheat Grass, Barley Grass, Rye Grass Foods labeled gluten-free may contain the grasses from gluten-containing grains. The FDA has clarified that, “The young grasses of the plants belonging to genera Triticum, Secale, and Hordeum are different from the grains wheat, rye, and barley these plants produce at maturity” and that “any grass (or grass juice) could be used as an ingredient to make a food labeled gluten-free, provided that the food does not contain 20 ppm or more gluten.”20
Oats Oats may be included in single-ingredient and multi-ingredient foods labeled gluten-free as long as all criteria for gluten-free labeling are met, including that the food does not contain 20 ppm or more gluten.1 In single-ingredient oat products (eg, rolled oats, steel cut oats), there is no stipulation in the gluten-free rule that the oats have to be specially produced or certified gluten-free. The same is true for multi-ingredient products where oat ingredients, such as oat flour, are used. It is important for manufacturers to know that “regular” oats that have not been specially produced to be gluten-free are highly likely to be contaminated with gluten.21 In addition, the term gluten-free is not allowed to be used in the ingredients list to describe oats (or any other ingredient), although many manufacturers use this verbiage and consumers may find it useful. The FDA recently stated that, “‘Gluten-free’ is not part of the common or usual name for an ingredient. In addition, the term could be considered intervening material in the ingredient statement.”22 The agency went on to say that, January 2015 Volume 115 Number 1
“Technically it may be considered a misbranding violation; however, FDA has discretion to take enforcement action against a firm for various violations. We look at food labels on a caseby-case basis for various violations before determining whether we would use our resources to take action against a firm. The firm has the option to state that the oats are gluten-free elsewhere on the label.”
May Contain Statements “May contain” statements, also known as allergen advisory statements, are not the same as “Contains” statements. “Contains” statements are regulated under the Food Allergen Labeling and Consumer Protection Act. Currently, “may contain” statements are not defined by any federal regulations. Allergen advisory statements, such as “manufactured in a facility that also processes wheat” are used to provide consumers with information on food processing procedures. Because they are voluntary and unregulated, some manufacturers use them, whereas others do not. Regardless, products labeled gluten-free that also include a “may contain” statement for wheat must contain less than 20 ppm gluten.5
Testing of Foods Labeled GlutenFree The FDA does not require foods that are labeled gluten-free to be tested for gluten content.5 The agency does provide recommendations to manufacturers on how to help ensure that food labeled gluten-free is in compliance.5 These recommendations include “conducting in-house gluten testing of starting ingredients or finished foods; employing a third-party laboratory to conduct in-house gluten testing; requesting certificates of gluten analysis from ingredient suppliers; or participating in a third-party glutenfree certification program.” The FDA also mentions the specific assays they will use if necessary as part of rule enforcement. At present, these assays are the R5 Mendez method and the Morinaga method.5 Both of these assays are known as sandwich ELISAs (enzyme-linked immunosorbent assays). These assays are used to test relatively intact gluten protein in food. The R5 method is widely used in food laboratories in the United
States. Use of the Morinaga method in US food laboratories is limited. The R5 Mendez method has been previously discussed in the Journal of the American Dietetic Association.23
Restaurants The gluten-free labeling rule applies only to packaged foods that are subject to FDA labeling regulations.5,24 However, the FDA does suggest that any use of an FDA-defined food labeling claim used on restaurant menus (including a gluten-free claim) be consistent with regulatory definitions.5,24 Many restaurants currently provide separate gluten-free menus, gluten-free sections of menus, or identify gluten-free menu options with a “GF” or similar symbol. It is important for consumers to continue to ask restaurants about their gluten-free claims and the steps taken to decrease the risk of cross-contact with gluten-containing foods.
TRUSTING THE GLUTEN-FREE LABEL Consumers and RDNs should be able to trust the gluten-free label. The Academy of Nutrition and Dietetics Celiac Disease Toolkit states the following regarding foods that are labeled gluten-free: “The manufacturer has determined that this product is gluten-free. This product may be used as part of a gluten-free diet.”25 Manufacturers self-determine compliance with the gluten-free labeling rule. There have been three recent studies on the gluten content of labeled gluten-free food sold in the United States.26-28 Although findings vary slightly between the studies, the majority of products (95% to 99%) tested contained less than 20 ppm gluten. For consumers who are concerned about the 1% to 5% of labeled glutenfree foods that may not be glutenfree, there are a couple steps they can take to increase their confidence in the food they are eating:
Continue reading the ingredients list even when the food is labeled gluten-free. Malt, malt extract, and malt syrup are some of the ingredients that may be improperly included in gluten-free foods. B If consumers come across a food product they believe is misbranded by being labeled gluten-free, they can contact an FDA consumer
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PRACTICE APPLICATIONS
complaint coordinator in their area. Contact information is available at: http:// www.fda.gov/Safety/Reporta Problem/ConsumerComplaint Coordinators/default.htm Contact the manufacturer and ask whether they are testing their food for gluten. If they are testing, ask them which test they are using. Ideally, the manufacturer should be testing (at least periodically) using a fully validated assay, such as the R5 ELISA Mendez method. As previously mentioned, this is one of the assays the FDA has stated the Agency will use if testing is conducted as part of rule enforcement.5 B If consumers believe that a product labeled gluten-free made them sick, they can contact the Adverse Event Reporting System at 240/ 402-2405. Consumers can also contact FDA’s MedWatch at 1-800-FDA-1088.
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THE TAKEAWAY Some aspects of the gluten-free labeling rule may cause confusion for clients. Working with an RDN well-versed on the gluten-free diet in general and the gluten-free labeling rule specifically should go a long way toward easing concerns. Now that enforcement of the rule has started, the FDA may experience an increase in consumer complaints of possible product label misbranding. Making sure that clients understand what ingredients are allowed and not allowed in foods labeled gluten-free will help prevent unnecessary complaints. It also is important to stress to clients who are concerned about the veracity of the gluten-free claim that based on recent research, the majority of labeled glutenfree products are testing below 20 ppm gluten. Additional published research on the gluten content of more foods will help further decrease concerns and/or identify potentially problematic products that may require increased diligence when making food choices.
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References 1.
16
US Food and Drug Administration. Federal Register. Final Rule; Document 78 FR 47154: Food labeling; gluten-free labeling of foods. https://www.federalregister.gov/articles/20 13/08/05/2013-18813/food-labeling-glutenfree-labeling-of-foods. Accessed May 6, 2014.
14.
US Department of Agriculture. A guide to federal food labeling requirements for meat, poultry, and egg products. http:// www.fsis.usda.gov/shared/PDF/Labeling_ Requirements_Guide.pdf. Published August 2007. Accessed July 22, 2014. Thompson T. Labeling of USDA-regulated foods straight from the USDA. GlutenFree Dietitian website. http://www. glutenfreedietitian.com/newsletter/2009/ 11/11labeling-of-usda-regulated-foods-st raight-from-the-usda/. Updated August 2013. Accessed July 22, 2014. US Department of Agriculture. Questions and answers concerning the recently published generic labeling final rule. http://www.fsis.usda.gov/wps/portal/fsis/ topics/regulatory-compliance/labeling/lab eling-policies/faq-generic-labeling. Published July 7, 2014. Accessed July 22, 2014. US Food and Drug Administration. Questions and answers: gluten-free food labeling final rule. http://www.fda.gov/Food/ GuidanceRegulation/GuidanceDocuments RegulatoryInformation/Allergens/ucm362 880.htm. Accessed July 22, 2014. Department of the Treasury. Classification of brewed products as “beer” under the internal revenue code of 1986 and as “malt beverages” under the Federal Alcohol Administration Act. http://www. ttb.gov/rulings/2008-3.pdf. Published July 7, 2008. Accessed July 22, 2014. Department of the Treasury. Revised interim policy on gluten content statements in the labeling and advertising of wine, distilled spirits, and malt beverages. http:// www.ttb.gov/rulings/2014-2.pdf. Published February 11, 2014. Accessed July 22, 2014. Thompson T, Grace T. Gluten in cosmetics: Is there reason for concern. J Acad Nutr Diet. 2012;112(9):1316-1319. US Food and Drug Administration. Cosmetic labeling guide. http://www.fda. gov/cosmetics/labeling/regulations/ucm1 26444.htm#clgb. Updated May 6, 2014. Accessed July 22, 2014. US Food and Drug Administration. Federal Register. Gluten in drug products; request for information and comments. [Docket No. FDAe2011eNe0842]. http://www. gpo.gov/fdsys/pkg/FR-2011-12-21/pdf/201 1-32551.pdf. Accessed July 22, 2014. US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108e282). http://www.fda.gov/ downloads/Food/GuidanceRegulation/UC M179394.pdf. Published August 2004. Accessed May 6, 2014. US Food and Drug Administration. Code of Federal Regulations. Malt. 21CFR184. 1443a. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? fr¼184.1443a&SearchTerm¼malt. Revised April 1, 2013. Accessed May 6, 2014. US Food and Drug Administration. Code of Federal Regulations. Malt syrup/malt extract. 21CFR184.1445. http://www.access data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR Search.cfm?fr¼184.1445&SearchTerm¼malt. Revised April 1, 2013. Accessed May 6, 2014. Gluten Free Watchdog. Boulder Canyon chips and FDA webinar statement on use of malt extract in gluten-free foods. https:// www.glutenfreewatchdog.org/blog/Bould
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er-Canyon-ChipseFDA-Webinar-Stateme nt-on-Use-of-Malt-Extract-in-Gluten-FreeFoods/33. Accessed May 6, 2014. 15.
Medical Nutrition Practice Group. Webinar: New rules for gluten-free labeling: Get the facts from the experts. https:// www.glutenfreewatchdog.org/blog/Bould er-Canyon-Chips--FDA-Webinar-Statementon-Use-of-Malt-Extract-in-Gluten-FreeFoods/33. Accessed December 8, 2014.
16.
Gluten Free Watchdog. Product alert: Greens Plus bar contains malt yet labeled gluten-free. https://www.glutenfreewatch dog.org/blog/Product-alert-Greens-Plus-ba r-contains-malt-yet-labeled-gluten-free/35. Accessed May 6, 2014.
17.
Gluten Free Watchdog. Gluten Free Watchdog Product alert: Boulder Canyon malt vinegar chips. https://www.gluten freewatchdog.org/blog/Gluten-Free-Watch dog-Product-Alert-Boulder-Canyon-MaltVinegar-Chips/32. Accessed May 6, 2014.
18.
Gluten Free Watchdog. Product labeled gluten-free contains barley malt extract. https://www.glutenfreewatchdog.org/blog/ Product-Labeled-Gluten-Free-Contains-Bar ley-Malt-Extract-/11. Accessed May 6, 2014.
19.
Gluten-Free Dietitian. Barley malt extract in Van’s products. http://www.glutenfreedie titian.com/newsletter/barley-malt-extractand-vans-products/. Accessed May 6, 2014.
20.
Gluten-Free Dietitian. Can products containing wheat and barley grass be labeled gluten-free. http://www.glutenfreedietiti an.com/newsletter/2010/09/20/can-produ cts-containing-wheat-and-barley-grass-belabeled-gluten-free/. Accessed May 6, 2014.
21.
Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004;351(19):2021-2022.
22.
Gluten Free Watchdog. The use of oats in gluten-free foods. https://www.glutenfree watchdog.org/blog/Special-Report-The-Useof-Oats-in-Gluten-Free-Foods/36. Accessed July 22, 2014.
23.
Thompson T, Mendez E. Commercial assays to assess gluten content of gluten-free foods: Why they are not created equal. J Am Diet Assoc. 2008;108(10):1682-1687.
24.
Gluten-Free Dietitian. Restaurants and gluten-free labeling claims. http://www. glutenfreedietitian.com/newsletter/2014/ 01/28/restaurants-and-gluten-free-label ing-claims/. Accessed July 22, 2014.
25.
Academy of Nutrition and Dietetics. Celiac Disease Toolkit. Chicago, IL: Academy of Nutrition and Dietetics; 2011.
26.
Thompson T, Grace T. Gluten content of selected labeled gluten-free foods sold in the US. Prac Gastroenterol. 2013; 10-16. http://www.practicalgastro.com/ pdf/October13/Thompson.pdf. Accessed September 24, 2014.
27.
Thompson T, Simpson S. A comparison of gluten levels in labeled gluten-free and certified gluten-free foods sold in the United States [published online ahead of print October 1, 2014]. Eur J Clin Nutr. http://dx.doi.org/10.1038/ejcn.2014.211.
28.
Sharma GM, Pereira M, Williams KM. Gluten detection in foods available in the United States—A market survey [published online ahead of print]. Food Chem. 2015;169:120-126. http://dx.doi.org/10.1 016/j.foodchem.2014.07.134. Accessed November 14, 2014.
January 2015 Volume 115 Number 1
Topics of Professional Interest
The Gluten-Free Labeling Rule: What Registered Dietitian Nutritionists Need to Know to Help Clients with Gluten-Related Disorders
O
N AUGUST 5, 2013, THE US Food and Drug Administration (FDA) published the final rule on gluten-free labeling.1 This rule defines the claim gluten-free when voluntarily used on food labels. The rule went into effect on September 4, 2013, and had a compliance date of August 5, 2014. All products labeled on or after August 5, 2014, bearing a gluten-free claim on product packaging that fall under the labeling jurisdiction of the FDA must be in compliance. Consumers and registered dietitian nutritionists (RDNs) should be mindful that products labeled before the compliance date may be on store shelves for a period of time. The rule is intended to make it easier for individuals, specifically those with celiac disease, to identify foods that do not contain gluten and are thus safe and appropriate for them to eat. Many aspects of gluten-free labeling remain confusing to consumers, including which products are covered under the rule, which ingredients can and cannot be included in a product labeled glutenfree, and how information is reported to the FDA when there is the possibility of misbranding. The purpose of this article is to help clarify areas of consumer confusion and provide information to help increase understanding of the gluten-free labeling rule.
WHAT THE RULE SAYS If a food includes a gluten-free claim on product packaging or any of the terms considered by the FDA to be synonymous with a gluten-free claim, namely no gluten, free of gluten, or without gluten, then the food must either inherently not contain gluten
This article was written by Tricia Thompson, MS, RD, founder, Gluten Free Watchdog, LLC, Manchester, MA. http://dx.doi.org/10.1016/j.jand.2014.10.001
ª 2015 by the Academy of Nutrition and Dietetics.
(eg, bottled water, bag of raw carrots) or meet all of the following criteria1:
not contain an ingredient that is a gluten-containing grain (eg, wheat); not contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (eg, wheat flour); and not contain an ingredient that is derived from a gluten-containing grain that has been processed to remove gluten (eg, wheat starch) if use of that ingredient causes the final food product to contain 20 or more parts per million (ppm) of gluten.
All food carrying a gluten-free claim also must contain less than 20 ppm gluten, including from cross-contact. In addition, if a food product is labeled gluten-free and includes the word “wheat” in the ingredients list or “Contains” statement due to use of ingredients that may contain wheat protein, such as wheat starch or wheat starch hydrolysates (eg, glucose syrup [wheat], maltodextrin [wheat]), then the word “wheat” must be immediately followed by an asterisk or similar symbol that notes the following verbiage included on the label, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”1
WHAT THE RULE DOES AND DOES NOT COVER The FDA’s gluten-free labeling rule covers packaged food, including supplements, intended for human consumption that fall under the labeling jurisdiction of the FDA. It does not cover foods regulated by the US Department of Agriculture (USDA), alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB),
cosmetics, or medications (either prescription or nonprescription).
USDA-Regulated Foods The USDA regulates meat products (eg, packaged lunch meats like salami, hot dogs, bacon), poultry products (eg, seasoned turkey breast, frozen chicken tenders, canned chicken), egg products (eg, dried, frozen, or liquid eggs with or without added ingredients), and mixed food products that contain, in general, more than 3% raw meat or 2% or more cooked meat or poultry meat (eg, some beef stew, some meat-based chili).2 If an egg product is under the labeling jurisdiction of the USDA, then the label will contain an egg products shield. If a mixed food product is under the labeling jurisdiction of the USDA, then the label will contain a USDA mark of inspection. Foods regulated by the USDA are not covered under the FDA’s gluten-free labeling rule. Regardless, a glutenfree claim on a USDA-regulated food should have the same meaning as a gluten-free claim on an FDA-regulated food. This is because the USDA has stated and recently reconfirmed the following with regard to gluten-free labeling of USDA-regulated foods: FSIS [Food Safety and Inspection Service] is not planning at this time to conduct rulemaking to define “gluten free.” Rather, once FDA’s final rule becomes effective, if a meat, poultry, or egg product establishment chooses to make the claim “gluten free” they will need to follow the requirements for the use of the claim in FDA’s regulations. This is similar to what FSIS has required when establishments choose to make health claims and label trans-fat on meat, poultry, and egg products (ie, FSIS allows the use of FDA-regulated health claims and the declaration of trans-fat on labels provided the establishments follows FDA’s regulations). This would ensure consistency for the use of the
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PRACTICE APPLICATIONS claim “gluten free” across all food groups for consumers. FSIS will clarify this position through policy guidance published on its website.3 Interestingly, unlike the FDA, which does not preapprove labels for food products, the USDA requires foods making gluten-free claims to undergo a label approval process.4 The USDA recently changed its label preapproval process and now allows generic approval (labels do not have to be submitted) for many products. Labels making “negative claims” must still be submitted for approval. A gluten-free claim is considered a “negative claim,” which is defined by the USDA as a statement referring to the absence of an ingredient or other component of a food.4
TTB-Regulated Alcoholic Beverages The TTB regulates almost all alcoholic beverages, including distilled spirits, wines that contain 7% or more alcohol by volume, and malt beverages (eg, beer) that are made using both malted barley and hops.5 The FDA regulates wine containing less than 7% alcohol by volume and malt beverages (eg, beer) made without either malted barley or hops (or both).5,6 Beverages regulated by the TTB are not covered under the FDA’s gluten-free labeling rule. However, the TTB issued a revised interim policy on gluten content statements in the labeling and advertising of alcoholic beverages under its labeling jurisdiction.7 This interim policy is based in large part on the FDA rule. In brief, this policy states that: A gluten-free claim may be used on product labels and in advertising on alcoholic beverages if the product meets the criteria stipulated by the FDA for a gluten-free claim. The TTB considers products that may use a gluten-free claim to be those beverages such as wine fermented from fruit and distilled alcohol made from ingredients other than wheat, barley, and rye. B If a gluten-free claim is included on a label, appropriate measures must be in place “to prevent cross-contact with gluten-containing grains during production, processing, storage, or other handling practices.” 14
The TTB does not currently believe that fermented beverages made using malted barley or distilled beverages made from wheat, barley, or rye should qualify for a gluten-free claim. The agency believes that current gluten testing methodology for fermented and distilled products “are inappropriate due to the lack of recognized standards and methodologies that provide a meaningful quantitative analysis of the sample that can be related to 20 ppm intact gluten.” B However, products made from a gluten-containing grain that have been processed to remove gluten may include the claim “processed to remove gluten” but the label must also state one of the following: Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten. OR
This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.
Cosmetics The FDA regulates the labeling of cosmetics; however, the FDA’s gluten-free labeling rule does not cover cosmetics. There are no FDA rules or guidance documents that specifically address the use of gluten-free claims on cosmetic labels.8 However, the FDA has not objected to gluten-free claims on cosmetics but such claims must be accurate and not misleading.8 A cosmetic is defined as “a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”9
Medications The FDA regulates the labeling of medications, including prescription and
JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS
nonprescription medication; however, the gluten-free labeling rule does not cover medications. In 2011, the FDA published in the Federal Register a request for information and comments on gluten in drug products.10 The FDA is currently evaluating the comments they received.5 To my knowledge, no further information has been publicly released.
LABELING ISSUES CAUSING CONFUSION There can be areas of confusion among consumers, manufacturers, and RDNs related to the gluten-free labeling rule. Following are examples of some of these areas.
Products Labeled Gluten-Free that also Contain Wheat Foods may be labeled gluten-free and include wheat in the ingredients list or “Contains” statement. This may occur if wheat starch or ingredients that may be made from wheat starch, such as glucose syrup or maltodextrin, are included in a food labeled gluten-free. Under the Food Allergen Labeling and Consumer Protection Act, if an ingredient in a food product includes any wheat protein, then the word “wheat” must be included in the ingredients list or “Contains” statement.11 Under the FDA’s gluten-free labeling rule, wheat starch and wheat starch hydrolysates are considered ingredients processed to remove gluten.1 These ingredients are allowed in foods labeled glutenfree as long as the final food product contains less than 20 ppm gluten. As mentioned previously, the FDA requires additional labeling on foods making a gluten-free claim that also include wheat in the ingredients list or “Contains” statement. The word “wheat” must be followed by an asterisk (or other symbol) that leads to another asterisk noting the verbiage, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”
Malt, Malt Extract, and Malt Flavoring Foods labeled gluten-free may not contain the ingredients malt, malt extract, or malt flavoring. As defined in the Code of Federal Regulations, these ingredients are made from barley unless another source is named.12,13 The FDA recently clarified during an January 2015 Volume 115 Number 1
PRACTICE APPLICATIONS Academy of Nutrition and Dietetics webinar that they consider these ingredients to be among those not processed to remove gluten and they are not allowed in gluten-free foods.14,15 Unfortunately, this appears to be an area of confusion for manufacturers. During the past few years, many manufacturers have incorrectly included malt ingredients in their foods labeled glutenfree.16-19 Now that there is a gluten-free labeling rule that the FDA will be enforcing, products labeled gluten-free containing malt ingredients can be reported to the FDA as misbranded, as discussed further in this article.
Wheat Grass, Barley Grass, Rye Grass Foods labeled gluten-free may contain the grasses from gluten-containing grains. The FDA has clarified that, “The young grasses of the plants belonging to genera Triticum, Secale, and Hordeum are different from the grains wheat, rye, and barley these plants produce at maturity” and that “any grass (or grass juice) could be used as an ingredient to make a food labeled gluten-free, provided that the food does not contain 20 ppm or more gluten.”20
Oats Oats may be included in single-ingredient and multi-ingredient foods labeled gluten-free as long as all criteria for gluten-free labeling are met, including that the food does not contain 20 ppm or more gluten.1 In single-ingredient oat products (eg, rolled oats, steel cut oats), there is no stipulation in the gluten-free rule that the oats have to be specially produced or certified gluten-free. The same is true for multi-ingredient products where oat ingredients, such as oat flour, are used. It is important for manufacturers to know that “regular” oats that have not been specially produced to be gluten-free are highly likely to be contaminated with gluten.21 In addition, the term gluten-free is not allowed to be used in the ingredients list to describe oats (or any other ingredient), although many manufacturers use this verbiage and consumers may find it useful. The FDA recently stated that, “‘Gluten-free’ is not part of the common or usual name for an ingredient. In addition, the term could be considered intervening material in the ingredient statement.”22 The agency went on to say that, January 2015 Volume 115 Number 1
“Technically it may be considered a misbranding violation; however, FDA has discretion to take enforcement action against a firm for various violations. We look at food labels on a caseby-case basis for various violations before determining whether we would use our resources to take action against a firm. The firm has the option to state that the oats are gluten-free elsewhere on the label.”
May Contain Statements “May contain” statements, also known as allergen advisory statements, are not the same as “Contains” statements. “Contains” statements are regulated under the Food Allergen Labeling and Consumer Protection Act. Currently, “may contain” statements are not defined by any federal regulations. Allergen advisory statements, such as “manufactured in a facility that also processes wheat” are used to provide consumers with information on food processing procedures. Because they are voluntary and unregulated, some manufacturers use them, whereas others do not. Regardless, products labeled gluten-free that also include a “may contain” statement for wheat must contain less than 20 ppm gluten.5
Testing of Foods Labeled GlutenFree The FDA does not require foods that are labeled gluten-free to be tested for gluten content.5 The agency does provide recommendations to manufacturers on how to help ensure that food labeled gluten-free is in compliance.5 These recommendations include “conducting in-house gluten testing of starting ingredients or finished foods; employing a third-party laboratory to conduct in-house gluten testing; requesting certificates of gluten analysis from ingredient suppliers; or participating in a third-party glutenfree certification program.” The FDA also mentions the specific assays they will use if necessary as part of rule enforcement. At present, these assays are the R5 Mendez method and the Morinaga method.5 Both of these assays are known as sandwich ELISAs (enzyme-linked immunosorbent assays). These assays are used to test relatively intact gluten protein in food. The R5 method is widely used in food laboratories in the United
States. Use of the Morinaga method in US food laboratories is limited. The R5 Mendez method has been previously discussed in the Journal of the American Dietetic Association.23
Restaurants The gluten-free labeling rule applies only to packaged foods that are subject to FDA labeling regulations.5,24 However, the FDA does suggest that any use of an FDA-defined food labeling claim used on restaurant menus (including a gluten-free claim) be consistent with regulatory definitions.5,24 Many restaurants currently provide separate gluten-free menus, gluten-free sections of menus, or identify gluten-free menu options with a “GF” or similar symbol. It is important for consumers to continue to ask restaurants about their gluten-free claims and the steps taken to decrease the risk of cross-contact with gluten-containing foods.
TRUSTING THE GLUTEN-FREE LABEL Consumers and RDNs should be able to trust the gluten-free label. The Academy of Nutrition and Dietetics Celiac Disease Toolkit states the following regarding foods that are labeled gluten-free: “The manufacturer has determined that this product is gluten-free. This product may be used as part of a gluten-free diet.”25 Manufacturers self-determine compliance with the gluten-free labeling rule. There have been three recent studies on the gluten content of labeled gluten-free food sold in the United States.26-28 Although findings vary slightly between the studies, the majority of products (95% to 99%) tested contained less than 20 ppm gluten. For consumers who are concerned about the 1% to 5% of labeled glutenfree foods that may not be glutenfree, there are a couple steps they can take to increase their confidence in the food they are eating:
Continue reading the ingredients list even when the food is labeled gluten-free. Malt, malt extract, and malt syrup are some of the ingredients that may be improperly included in gluten-free foods. B If consumers come across a food product they believe is misbranded by being labeled gluten-free, they can contact an FDA consumer
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PRACTICE APPLICATIONS
complaint coordinator in their area. Contact information is available at: http:// www.fda.gov/Safety/Reporta Problem/ConsumerComplaint Coordinators/default.htm Contact the manufacturer and ask whether they are testing their food for gluten. If they are testing, ask them which test they are using. Ideally, the manufacturer should be testing (at least periodically) using a fully validated assay, such as the R5 ELISA Mendez method. As previously mentioned, this is one of the assays the FDA has stated the Agency will use if testing is conducted as part of rule enforcement.5 B If consumers believe that a product labeled gluten-free made them sick, they can contact the Adverse Event Reporting System at 240/ 402-2405. Consumers can also contact FDA’s MedWatch at 1-800-FDA-1088.
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THE TAKEAWAY Some aspects of the gluten-free labeling rule may cause confusion for clients. Working with an RDN well-versed on the gluten-free diet in general and the gluten-free labeling rule specifically should go a long way toward easing concerns. Now that enforcement of the rule has started, the FDA may experience an increase in consumer complaints of possible product label misbranding. Making sure that clients understand what ingredients are allowed and not allowed in foods labeled gluten-free will help prevent unnecessary complaints. It also is important to stress to clients who are concerned about the veracity of the gluten-free claim that based on recent research, the majority of labeled glutenfree products are testing below 20 ppm gluten. Additional published research on the gluten content of more foods will help further decrease concerns and/or identify potentially problematic products that may require increased diligence when making food choices.
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References 1.
16
US Food and Drug Administration. Federal Register. Final Rule; Document 78 FR 47154: Food labeling; gluten-free labeling of foods. https://www.federalregister.gov/articles/20 13/08/05/2013-18813/food-labeling-glutenfree-labeling-of-foods. Accessed May 6, 2014.
14.
US Department of Agriculture. A guide to federal food labeling requirements for meat, poultry, and egg products. http:// www.fsis.usda.gov/shared/PDF/Labeling_ Requirements_Guide.pdf. Published August 2007. Accessed July 22, 2014. Thompson T. Labeling of USDA-regulated foods straight from the USDA. GlutenFree Dietitian website. http://www. glutenfreedietitian.com/newsletter/2009/ 11/11labeling-of-usda-regulated-foods-st raight-from-the-usda/. Updated August 2013. Accessed July 22, 2014. US Department of Agriculture. Questions and answers concerning the recently published generic labeling final rule. http://www.fsis.usda.gov/wps/portal/fsis/ topics/regulatory-compliance/labeling/lab eling-policies/faq-generic-labeling. Published July 7, 2014. Accessed July 22, 2014. US Food and Drug Administration. Questions and answers: gluten-free food labeling final rule. http://www.fda.gov/Food/ GuidanceRegulation/GuidanceDocuments RegulatoryInformation/Allergens/ucm362 880.htm. Accessed July 22, 2014. Department of the Treasury. Classification of brewed products as “beer” under the internal revenue code of 1986 and as “malt beverages” under the Federal Alcohol Administration Act. http://www. ttb.gov/rulings/2008-3.pdf. Published July 7, 2008. Accessed July 22, 2014. Department of the Treasury. Revised interim policy on gluten content statements in the labeling and advertising of wine, distilled spirits, and malt beverages. http:// www.ttb.gov/rulings/2014-2.pdf. Published February 11, 2014. Accessed July 22, 2014. Thompson T, Grace T. Gluten in cosmetics: Is there reason for concern. J Acad Nutr Diet. 2012;112(9):1316-1319. US Food and Drug Administration. Cosmetic labeling guide. http://www.fda. gov/cosmetics/labeling/regulations/ucm1 26444.htm#clgb. Updated May 6, 2014. Accessed July 22, 2014. US Food and Drug Administration. Federal Register. Gluten in drug products; request for information and comments. [Docket No. FDAe2011eNe0842]. http://www. gpo.gov/fdsys/pkg/FR-2011-12-21/pdf/201 1-32551.pdf. Accessed July 22, 2014. US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108e282). http://www.fda.gov/ downloads/Food/GuidanceRegulation/UC M179394.pdf. Published August 2004. Accessed May 6, 2014. US Food and Drug Administration. Code of Federal Regulations. Malt. 21CFR184. 1443a. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? fr¼184.1443a&SearchTerm¼malt. Revised April 1, 2013. Accessed May 6, 2014. US Food and Drug Administration. Code of Federal Regulations. Malt syrup/malt extract. 21CFR184.1445. http://www.access data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR Search.cfm?fr¼184.1445&SearchTerm¼malt. Revised April 1, 2013. Accessed May 6, 2014. Gluten Free Watchdog. Boulder Canyon chips and FDA webinar statement on use of malt extract in gluten-free foods. https:// www.glutenfreewatchdog.org/blog/Bould
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er-Canyon-ChipseFDA-Webinar-Stateme nt-on-Use-of-Malt-Extract-in-Gluten-FreeFoods/33. Accessed May 6, 2014. 15.
Medical Nutrition Practice Group. Webinar: New rules for gluten-free labeling: Get the facts from the experts. https:// www.glutenfreewatchdog.org/blog/Bould er-Canyon-Chips--FDA-Webinar-Statementon-Use-of-Malt-Extract-in-Gluten-FreeFoods/33. Accessed December 8, 2014.
16.
Gluten Free Watchdog. Product alert: Greens Plus bar contains malt yet labeled gluten-free. https://www.glutenfreewatch dog.org/blog/Product-alert-Greens-Plus-ba r-contains-malt-yet-labeled-gluten-free/35. Accessed May 6, 2014.
17.
Gluten Free Watchdog. Gluten Free Watchdog Product alert: Boulder Canyon malt vinegar chips. https://www.gluten freewatchdog.org/blog/Gluten-Free-Watch dog-Product-Alert-Boulder-Canyon-MaltVinegar-Chips/32. Accessed May 6, 2014.
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Gluten Free Watchdog. Product labeled gluten-free contains barley malt extract. https://www.glutenfreewatchdog.org/blog/ Product-Labeled-Gluten-Free-Contains-Bar ley-Malt-Extract-/11. Accessed May 6, 2014.
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Gluten-Free Dietitian. Barley malt extract in Van’s products. http://www.glutenfreedie titian.com/newsletter/barley-malt-extractand-vans-products/. Accessed May 6, 2014.
20.
Gluten-Free Dietitian. Can products containing wheat and barley grass be labeled gluten-free. http://www.glutenfreedietiti an.com/newsletter/2010/09/20/can-produ cts-containing-wheat-and-barley-grass-belabeled-gluten-free/. Accessed May 6, 2014.
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Thompson T. Gluten contamination of commercial oat products in the United States. N Engl J Med. 2004;351(19):2021-2022.
22.
Gluten Free Watchdog. The use of oats in gluten-free foods. https://www.glutenfree watchdog.org/blog/Special-Report-The-Useof-Oats-in-Gluten-Free-Foods/36. Accessed July 22, 2014.
23.
Thompson T, Mendez E. Commercial assays to assess gluten content of gluten-free foods: Why they are not created equal. J Am Diet Assoc. 2008;108(10):1682-1687.
24.
Gluten-Free Dietitian. Restaurants and gluten-free labeling claims. http://www. glutenfreedietitian.com/newsletter/2014/ 01/28/restaurants-and-gluten-free-label ing-claims/. Accessed July 22, 2014.
25.
Academy of Nutrition and Dietetics. Celiac Disease Toolkit. Chicago, IL: Academy of Nutrition and Dietetics; 2011.
26.
Thompson T, Grace T. Gluten content of selected labeled gluten-free foods sold in the US. Prac Gastroenterol. 2013; 10-16. http://www.practicalgastro.com/ pdf/October13/Thompson.pdf. Accessed September 24, 2014.
27.
Thompson T, Simpson S. A comparison of gluten levels in labeled gluten-free and certified gluten-free foods sold in the United States [published online ahead of print October 1, 2014]. Eur J Clin Nutr. http://dx.doi.org/10.1038/ejcn.2014.211.
28.
Sharma GM, Pereira M, Williams KM. Gluten detection in foods available in the United States—A market survey [published online ahead of print]. Food Chem. 2015;169:120-126. http://dx.doi.org/10.1 016/j.foodchem.2014.07.134. Accessed November 14, 2014.
January 2015 Volume 115 Number 1
