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

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1 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

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

3 Confusing Ingredients & Gluten Content of Food 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

4 Oats

5 Oats: FDA Gluten-Free Rule 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

6 Oats: Academy of Nutrition & Dietetics Consumer Recommendations 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

7 Oats: Cross-Contact 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

8 Oats: Gluten Contamination Brand (4 lots tested in duplicate) Mean ppm Gluten McCann's < 3, 12, 23, 725 Country Choice <3, 120, 131, 210 Quaker 338, 364, 971, 1807 Source: Thompson. NEJM. 351; 19:

9 Oats: Purity Protocol 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

10 Oats: Confusing Ingredient Labeling 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

11 Oats: Use of "Gluten-Free" in the Ingredients List 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.

12 Oats: Choosing Oat Products (opinion) 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

13 Other Naturally Gluten-Free Grains

14 Naturally Gluten-Free Grains: FDA Gluten-Free Rule 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 Source: FDA Gluten-Free Labeling Rule, Aug 5, 2013

15 Naturally Gluten-Free Grains: Academy of Nutrition & Dietetics Consumer Recommendations 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

16 Naturally Gluten-Free Grains: Cross Contact 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:

17 Naturally Gluten-Free Grains: Gluten Contamination 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;

18 Naturally Gluten-Free Grains: Choosing Products (opinion) 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

19 A Word about Wheat Starch 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

20 Gluten-Removed Beer

21 Gluten-Removed Beer: TTB Interim Policy 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

22 Gluten-Removed Beer: TTB, cont 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

23 Gluten-Removed Beer: Is it "Safe?" 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

24 Gluten-Removed Beer: Is it Safe, cont 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)

25 Gluten-Removed Beer: Brewer's Clarex 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

26 Gluten-Removed Beer: Opinion 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:

27 Brewer's Yeast

28 Brewer's Yeast: Definition 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

29 Brewer's Yeast: Academy of Nutrition and Dietetics Consumer Recommendation 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

30 Spent Brewer's Yeast: As the Source of Yeast Extract 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:

31 Spent Brewer's Yeast: As a Source of Yeast Extract, cont 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

32 Yeast Extract: Opinion It is my recommendation that individuals with glutenrelated disorders avoid products NOT labeled glutenfree 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

33 Testing Gluten-Free Foods for Gluten

34 Testing: FDA Gluten-Free Rule 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

35 Testing: Gluten Free Watchdog Findings 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):143-6

36 Testing: Gluten Free Watchdog Findings, cont 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

37 Testing: Gluten Free Watchdog Findings, cont 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

38 Testing: Gluten Free Watchdog Findings, cont 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

39 Summary 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 glutenfree or you clarify the source of the ingredient with the manufacturer Testing: Gluten-free foods are not required to be tested for gluten

40 Thank you! Questions? Please contact me

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