Everything but the gluten-free kitchen sink: Addressing your concerns about labeling, confusing ingredients, and the gluten content of food Part Two Tricia Thompson, MS, RD 1

 Owner/Founder of Gluten Free Watchdog, LLC  Creator Disclosure 2

 Confusing ingredients  Oats  Naturally gluten-free grains  Wheat starch  Gluten-removed beer  Brewer's yeast  Yeast extract & autolyzed yeast extract  Testing gluten-free foods for gluten Confusing Ingredients & Gluten Content of Food 3

Oats 4

 Under the FDA's gluten-free labeling rule, oats are considered a naturally gluten-free grain and are allowed in gluten-free foods  All criteria of the rule must be met  Oats included in a single ingredient food (e.g., rolled oats, oat flour, steel-cut oats) do not need to be certified gluten-free  Oats included in a multi-ingredient food (e.g., granola, oatmeal cookies, instant flavored oatmeal) do not need to be gluten-free or certified gluten-free Source: FDA Gluten-Free Labeling Rule, Aug 5, 2013 Oats: FDA Gluten-Free Rule 5

Get the okay from your dietitian or doctor BEFORE adding oats to your diet Eat ONLY those oats & oat products labeled gluten-free Enjoy up to 50 grams of gluten-free dry oats each day ½ cup dry rolled oats ¼ cup dry steel cut oats 1 packet instant oatmeal ½ cup granola Call dietitian or doctor if you have GI symptoms after adding oats to your diet Symptoms may be due to an increase in fiber intake Source: Celiac Disease Toolkit, Academy of Nutrition & Dietetics, 2011 Oats: Academy of Nutrition & Dietetics Consumer Recommendations 6

 If oats are a naturally gluten-free grain why should gluten-free consumers eat only those products containing oats that are labeled gluten-free?  Regular oats are highly likely to be contaminated with wheat and/or barley  Cross-contact can occur when oats are being grown, harvested, stored, transported, or processed Oats: Cross-Contact 7

Brand (4 lots tested in duplicate)Mean ppm Gluten McCann's< 3, 12, 23, 725 Country Choice<3, 120, 131, 210 Quaker338, 364, 971, 1807 Oats: Gluten Contamination Source: Thompson. NEJM. 351; 19:

 Specially produced gluten-free oats follow a purity protocol such as the following:  Using pure seeds  Growing the oats in fields that are not rotated with gluten-containing grain  Using dedicated or thoroughly cleaned equipment  Processing the oats in a dedicated facility  Testing the oats extensively Oats: Purity Protocol 9

 Some consumers look for the wording "gluten-free oats" or "certified gluten-free oats" in the ingredients list  If you do not see "gluten-free" in the ingredients list this does not necessarily mean that the oats used in the product are "regular" oats Oats: Confusing Ingredient Labeling 10

 According to personal correspondence with the FDA, "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… Technically it may be considered a misbranding violation…The firm has the option to state that the oats are gluten-free elsewhere on the label.” Oats: Use of "Gluten-Free" in the Ingredients List 11

 Choose oat products from manufacturers who  Source their oats from a supplier whose growers follow a purity protocol  As a general rule, oats and oat products certified gluten-free by a third party organization are a good choice  Some manufacturers choose not to use a third party certification but nonetheless follow a strict purity protocol or source their oats from a supplier of certified gluten-free oats  Test their product extensively  Are willing to answer consumer questions Oats: Choosing Oat Products (opinion) 12

Other Naturally Gluten-Free Grains 13

 Under the FDA's gluten-free labeling rule, naturally gluten-free grains, such as millet, sorghum, and teff are allowed in foods labeled gluten-free as long as all criteria of the rule are met  Like oats, naturally gluten-free grains may be contaminated with wheat, barley, and/or rye Naturally Gluten-Free Grains: FDA Gluten-Free Rule Source: FDA Gluten-Free Labeling Rule, Aug 5,

 Buy naturally gluten-free grains and flours that are labeled gluten-free  Buy grain-based foods that are labeled gluten-free  Rice crackers  Rice noodles  Buckwheat noodles  Corn tortillas Source: Celiac Disease Toolkit, Academy of Nutrition & Dietetics, 2011 Naturally Gluten-Free Grains: Academy of Nutrition & Dietetics Consumer Recommendations 15

 Naturally gluten-free grains may become contaminated with wheat, barley, or rye anywhere along the production line from the field to the packaging plant  US grain standards allow grains and beans to contain a certain percentage of other grains or "foreign material"  "Other grain" and "foreign material" are not included in the ingredients list  Even when the "other grain" is wheat, the word "wheat" does not need to be declared in the ingredients list, Contains statement, or an allergen advisory statement Source: Naturally Gluten-Free Grains: Cross Contact 16

 What we tested: 22 naturally gluten-free grains not labeled gluten-free  What we found: 9 products contained measurable gluten between 8.5 ppm and 2,295 ppm gluten  Of these 9 product, 4 contained an allergen advisory statement for wheat; 5 did not  Conclusion: A certain percentage of naturally gluten-free grains and flours are not gluten-free when purchased by consumers Source: Thompson, Lee, Grace. JADA. 2010:110; Naturally Gluten-Free Grains: Gluten Contamination 17

 Choose gluten-free grains and flours (and products made from them) that are labeled gluten-free  Do not assume that if a naturally gluten-free grain or flour NOT labeled gluten-free does NOT include an allergen advisory statement for wheat on product packaging it is safe to eat  Do NOT assume that the product with the allergen advisory statement is contaminated with gluten and the product without the allergen advisory statement is not contaminated with gluten Naturally Gluten-Free Grains: Choosing Products (opinion) 18

 Wheat starch IS allowed in labeled gluten-free foods as long as all criteria of the gluten-free labeling rule are met  Not all wheat starch is created equal  Wheat starch contains varying levels of gluten protein depending upon processing  What is sometimes referred to as "Codex wheat starch" or "gluten-free wheat starch" is used in some gluten-free foods, most commonly in the European Union  Manufacturers who choose to use wheat starch in their products should make sure it is of sufficient purity through testing of both the ingredient and the final product A Word about Wheat Starch 19

Gluten-Removed Beer 20

 Beers made with BOTH malted barley and hops are regulated by the Alcohol Tobacco Tax and Trade Bureau (TTB)  The TTB does not allow beer to be labeled gluten-free  Beers made without either malted barley OR hops OR both are regulated by the FDA  What is commonly thought of as "gluten-free" beer is regulated by FDA Gluten-Removed Beer: TTB Interim Policy 21

 The TTB will allow beer labels to include the statement, "Processed (or treated or crafted) to remove gluten" for products made with wheat, barley, rye, crossbred varieties of these grains OR any ingredients derived from these grains IF these grains or ingredients have been processed (or treated or crafted) to remove all or some of the gluten  The product label must also include the following statement, "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” Source: TTB Ruling, February 11, 2014 Gluten-Removed Beer: TTB, cont 22

 Whether“gluten-removed”beer should be consumed by people with gluten-related disorders remains highly controversial  It is difficult to quantify the amount of gluten in a product, such as beer when the protein has undergone hydrolysis (meaning it has been broken apart into smaller fragments)  A competitive ELISA is used to assess gluten content when the protein has been hydrolyzed Gluten-Removed Beer: Is it "Safe?" 23

 Questions remain as to whether the competitive R5 ELISA can accurately quantify peptide fragments into parts per million intact gluten protein  Neither the FDA nor the TTB consider the competitive R5 ELISA a validated assay for such purposes (i.e., quantifying gluten peptide fragments into parts per million of intact gluten protein) Gluten-Removed Beer: Is it Safe, cont 24

 Barley-based “gluten-removed” beers are treated with a prolidase enzyme such as Brewer’s Clarex  This enzyme breaks apart protein at the amino acid proline  The R5 ELISA detects the 5 amino acid sequence QQPFP where the P represents proline  Brewer’s Clarex may render the R5 ELISA ineffective at measuring gluten Gluten-Removed Beer: Brewer's Clarex 25

 Gluten-removed beers may be safe but until there is a test that can accurately detect and quantify the gluten protein in these beverages it may be best for individuals with celiac disease to err on the side of caution  For more information on gluten-removed beer please see: Gluten-Removed Beer: Opinion 26

Brewer's Yeast 27

 Brewer's yeast refers to the "live yeast" used to make beer AND the "spent yeast" which is a by-product of the beer brewing process (i.e., what is left of the yeast once it has been used to make beer)  Brewer's yeast used in food as a flavoring agent is typically spent yeast and as such may be contaminated with malt Source: Food Flavorings, 3rd edition. Aspen Publishers Brewer's Yeast: Definition 28

 The Academy of Nutrition and Dietetics currently recommends that if brewer's yeast is listed as an ingredient in a food NOT labeled gluten-free it should be avoided Source: Celiac Disease Toolkit, Academy of Nutrition & Dietetics, 2011 Brewer's Yeast: Academy of Nutrition and Dietetics Consumer Recommendation 29

 Spent yeast also may be the source of yeast extract and autolyzed yeast extract This issue first came to my attention in 2010 when testing the product Marmite – The primary ingredient in Marmite is yeast extract derived from spent yeast – Test results: Sandwich R5 ELISA 28 ppm, 31 ppm Competitive R5 ELISA 3,700 ppm gluten peptide, 3,400 ppm gluten peptide Source: free/ Spent Brewer's Yeast: As the Source of Yeast Extract 30

 You may start to come across products sold in the US that include the following in the ingredients list:  “autolyzed yeast extract (barley)”  “yeast extract (barley)”  Barley protein does not have to be declared under FALCPA in the US but some manufacturers are voluntarily declaring barley protein in the ingredients list  This is most likely a beneficial effect of Health Canada's food allergen labeling law which requires the declaration of all gluten sources in packaged food products, including barley Spent Brewer's Yeast: As a Source of Yeast Extract, cont 31

 It is my recommendation that individuals with gluten- related disorders avoid products NOT labeled gluten- free containing the ingredients yeast extract or autolyzed yeast extract unless the source is confirmed  We do not know at this time how often spent yeast is the source of yeast extract  In the US there is no way to know from the food label whether the ingredient yeast extract contains barley protein unless the manufacturer declares barley voluntarily Yeast Extract: Opinion 32

Testing Gluten-Free Foods for Gluten 33

 FDA does NOT require manufacturers who label food gluten-free to test for gluten contamination  Foods must contain less than 20 parts per million  The only way to ensure this level is met is to test  FDA does NOT provide recommendations to manufacturers regarding specific testing methods  The Agency has stated that if FDA tests food as part of rule enforcement they will use the R5 ELISA Mendez method and the Morinaga Wheat Protein ELISA Source: FDA Gluten-Free Labeling Rule, Aug 5, 2013 Testing: FDA Gluten-Free Rule 34

 Number of labeled gluten-free foods tested: 158 products (46 certified); food purchased from retail establishments, including grocery stores and online merchants based on convenience (readily available in Massachusetts) or because a food was requested to be tested through Gluten Free Watchdog  Note: This study is based on data from Gluten Free Watchdog ( Source: Thompson T, Simpson S. Eur J Clin Nutr Feb;69(2):143-6Eur J Clin Nutr. Testing: Gluten Free Watchdog Findings 35

 Categories of foods tested: baking ingredients, beverages, bread products, chili, condiments, cookies, crackers, entrees, flour, grains, gravy, hot cereal, mixes, nuts and seeds, pasta, ready-to-eat cereal, snack bars, snack food, soup, spices, supplements and tortillas Testing: Gluten Free Watchdog Findings, cont 36

 Assay used: Ridascreen Gliadin R5 Sandwich ELISA (R7001) with cocktail extraction solution. If the food was suspected of containing gluten protein fragments due to the use of certain fermented or hydrolyzed ingredients, it also was tested using the competitive R5 ELISA (Ridascreen Gliadin R7021) and extracted with ethanol Testing: Gluten Free Watchdog Findings, cont 37

 Results: Based on the highest extraction test result, 8 samples (5.1%) of tested food, including 2 that were certified had gluten levels greater than or equal to 20 parts per million of gluten Testing: Gluten Free Watchdog Findings, cont 38

 Oats: Choose products that are labeled gluten-free and use oats from suppliers of specially produced oats  Naturally gluten-free grains: Choose products that are labeled gluten-free  Wheat starch is allowed in labeled gluten-free foods  Gluten-removed beer: Avoid this product until there is an accurate test to assess gluten content  Brewer's yeast: Avoid foods containing brewer's yeast unless the product is labeled gluten-free  Yeast extract & autolyzed yeast extract: Do not eat foods containing these ingredients unless the product is labeled gluten- free or you clarify the source of the ingredient with the manufacturer  Testing: Gluten-free foods are not required to be tested for gluten Summary 39

Questions? Please contact me… Thank you! 40