FDA Gluten-Free Labeling Rule Finalized!

August 5th, 2013

My apologies for the long post. Each section stands alone and there is no reason to read this article in one sitting!! What is provided below is my personal compilation of information from the gluten-free labeling rule, the executive summary of the rule, the Q&A section written by FDA, and previous blog posts I have written on various issues. Please see the end of the article for links to sources.

Section One: Summary of the Rule

1. This rule applies to the labeling of foods as packaged (including dietary supplements) regulated by the Food and Drug Administration and intended for human use.

Note: This rule does not apply to pet foods, cosmetics, prescription and non prescription drugs, food regulated by the United States Department of Agriculture, and beverages regulated by the Alcohol Tobacco Tax and Trade Bureau.

2. A food labeled gluten-free:

Is inherently gluten-free (e.g., raw carrots)

OR

Adheres to the following criteria:

  • Does not contain an ingredient that is a gluten-containing grain (e.g., wheat)
  • Does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour)
  • May contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch) as long as use of that ingredient in the food does NOT cause the food to contain 20 ppm or more gluten

AND

Any unavoidable presence of gluten in the food is less than 20 ppm gluten.

Note: The FDA states in the Executive Summary of the rule that, “Manufacturers making a gluten-free claim must ensure that foods do not contain 20 ppm or more gluten, including the unavoidable presence of gluten due to cross-contact or migration from packaging materials.”

3. Terms synonymous with “gluten-free” when used on a food label are:

  • “No gluten”
  • “Free of gluten”
  • “Without gluten”

Food labels making the above claims must comply with the gluten-free labeling rule.

Note: The statements, “made with no gluten-containing ingredients” and “not made with gluten-containing ingredients” are allowed statements on food labels and these products do NOT have to comply with gluten-free labeling rules UNLESS a gluten-free claim also is made.

4. If a food is labeled gluten-free and also includes the word “wheat” in the ingredients list or Contains statement due to the use of ingredients such as “wheat starch” (which may contain residual wheat protein) the word “wheat” must be followed by an asterisk and the statement, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

Note: This stipulation applies to ingredients  in an FDA-regulated food as outlined in the Food Allergen Labeling and Consumer Protection Act. This stipulation does NOT apply to voluntary allergen advisory statements (e.g., processed in a facility that also processes wheat) related to manufacturer processing practices. These statements may be included on foods labeled gluten-free without additional clarifying language. However, foods with allergen advisory statements for wheat that also are labeled gluten-free must comply with the gluten-free labeling rule.

Section Two: Questions & Answers Related to the Gluten-Free Labeling Rule

Q: Do foods regulated by the USDA and beverages regulated by the TTB have to comply with the FDA’s gluten-free labeling rule?

A: No. The USDA regulates meat products, poultry products, egg products (dried, frozen, or liquid eggs, with or without added ingredients), and mixed food products that generally contain no more than 3% raw meat, or 2% or more cooked meat or poultry meat. The easiest way to tell whether a product is regulated by the USDA is to look for the egg products shield or the USDA mark of inspection.

A few years ago I was told the following about gluten-free labeling via email correspondence with the USDA, “FSIS 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 (i.e., 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 claim ‘gluten free’ across all food groups for consumers. FSIS will clarify this position through policy guidance published on its web-site.” Once I have more information, I will post it.

The FDA’s gluten-free labeling rule also does not apply to alcoholic beverages regulated by the TTB. The TTB regulates almost all alcoholic beverages–all distilled spirits, wines that contain 7% or more alcohol by volume, and malted beverages (e.g., beer) that are made with BOTH malted barley and hops.

The TTB has issued an interim policy on gluten-free labeling of alcoholic beverages under its jurisdiction. Under the interim policy, the TTB:

  1. Will not allow gluten-free claims to be included on product labels or in product advertising if the alcohol is made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains.
  2. Will allow gluten-free claims on products labels and in advertisements if the alcohol is made without wheat, barley, rye, or crossbred varieties of these grains OR ingredients derived from these grains. BUT producers must ensure that their raw ingredients and finished products (among other things) are NOT cross-contaminated with gluten.
  3. Will allow the statement, “Processed or treated or crafted to remove gluten” for products made with wheat, barley, rye, or 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 IF
    1. One of the following statements is also included on the product label or in the advertisement:
      1. “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
      2. “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.”

Q: Must manufacturers who label foods gluten-free test these foods for gluten?

A: NO.

Q: If the FDA tests food for gluten as part of rule enforcement what tests will they use?

A: At present the FDA states that they will use two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods (R5 ELISA from R-Biopharm and Wheat Protein ELISA Kit (gliadin) from Morinaga).

Q: How is the FDA handling foods made from hydrolyzed or fermented ingredients?

A: First a little background information… What is known as a sandwich ELISA is used to assess the gluten content of foods when the gluten protein is intact or relatively intact. With this type of assay, two epitopes or antibody binding sites are needed. When an ingredient or food is hydrolyzed or fermented the gluten protein is broken into smaller protein fragments. These peptides may no longer contain two epitopes. As a result gluten content may be underestimated if the food is assessed using a sandwich ELISA.

For example consider the following protein where “QQPFP” represents the epitope and “a” represents other amino acids:

aaaaaQQPFPaaaaaaaaaaaaaaaQQPFPaaaQQPFPaaaaaaQQPFP

If this protein undergoes hydrolysis, the following three fragments may result:

1. aaaaaQQPFP

2. aaaaaaaaaaaaaaaQQPFPaaaQQPFP

3. aaaaaaQQPFP

The sandwich R5 ELISA (which utilizes the R5 monoclonal antibody to potentially celiac toxic epitope QQPFP)  would be unable to measure the first or the third protein fragments because these peptides contain only one QQPFP epitope. Only the second protein fragment would be measured by the sandwich R5 ELISA.

When only one epitope or antibody binding site is available (which may be the case when ingredients/foods are fermented or hydrolyzed) a competitive ELISA (e.g., competitive R5 ELISA) should be used.

BUT the FDA does not consider these methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with the gluten-free labeling rule. The agency states, “Evidence in the scientific literature is currently lacking about a scientifically valid competitive ELISA method which confirms that any gluten peptides detected in a food sample can be accurately quantified in terms of ppm intact gluten protein.”

The FDA is planning rule-making for fermented or hydrolyzed foods or foods that use fermented or hydrolyzed ingredients. In the meantime, the FDA is allowing gluten-free claims on these products provided they meet all of the requirements for bearing a gluten-free claim even though the gluten content cannot be reliably measured. This proposed rule will include discussion of distilled vinegar, malt, malt extract, and beer under the jurisdiction of the FDA (i.e., beer that is NOT made from BOTH barley and hops).

Note: This provision applies to fermented or hydrolyzed ingredients derived from gluten-containing ingredients that have been processed to remove gluten, such as wheat starch hydrolysates (e.g., wheat-based glucose syrup, wheat-based maltodextrin). It does not apply to ingredients derived from gluten-containing grains that have not been processed to remove gluten (e.g., hydrolyzed wheat protein).

Note: It appears that the competitive R5 may have finally been validated. The AACC International very recently published a technical report on the findings of a collaborative study on the competitive R5 ELISA. One of the study authors sent me a pre-print version of the paper. This international collaborative study to validate the competitive R5 ELISA (Ridascreen Gliadin Competitive R7021, R-Biopharm) was jointly run by the Prolamin Working Group and AACCI. This multi-lab performance trial involved 16 labs and 7 foods/beverages. By means of comparison, when the sandwich R5 ELISA (Ridascreen Gliadin R7001, R-Biopharm) was validated in a collaborative trial with the Prolamin Working Group, 20 labs and 12 food samples were involved. To the best of my knowledge neither the FDA nor the TTB has commented publicly on this collaborative trial

Q: Is food served in restaurants covered by the gluten-free labeling rule?

A: The FDA does not provide a simple yes or no answer to this question. In their Q&A section it is stated, “With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (such as “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions. This same approach would be followed with respect to “gluten-free” claims made in restaurants and other retail food service establishments.” In the Executive Summary the following statement is made, “With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (e.g., “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions (Ref. 35).

Ref 35 is a document entitled, “Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods.” It contains nonbinding recommendations. The document goes on to say, “While ‘A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods’ represents the best advice of FDA, it does not have the force and effect of law” and “The use of the word should in Agency guidances means that something is suggested or recommended, but not required.” The entire guidance can be read at http://tinyurl.com/knqutmz 

Section Three: My thoughts…

There are several parts of the Gluten-Free Labeling Rule and Executive Summary that in my opinion are going to require further guidance from the FDA, including (but by no means limited to):

  • Providing examples of ingredients not processed to remove gluten. The only example provided in the final rule is wheat flour. Does this class of ingredients still include hydrolyzed wheat protein and barley malt?
  • Providing examples of ingredients processed to remove gluten. Does this class of ingredients still include wheat starch hydrolysates?
  • Clarifying their position on restaurant menu items making a gluten-free claim. A clear yes or no response followed by an explanation would help clear up confusion.
  • Clarifying which hydrolyzed and fermented ingredients may be included in labeled gluten-free foods while the FDA rule making on foods containing fermented and hydrolyzed ingredients is pending. Is barley malt allowed? Is hydrolyzed wheat protein allowed? Are wheat starch hydrolysates allowed?

There are several parts of the Gluten-Free Labeling Rule that require consumer and manufacturer education. One of the biggest:

  • Explaining to consumers (especially those who are new to the gluten-free diet) that just because any inherently gluten-free food may be labeled gluten-free, including bottled water and raw carrots does NOT mean that all items purchased at a grocery store must be labeled gluten-free. Many foods and beverages have a low to no risk of cross-contact with gluten-containing grains (e.g., bottled water). While other foods have a much higher risk (e.g., grains and flours).

Just a word about the 20 ppm gluten threshold…

Some of you may have been hoping for a lower gluten threshold level. If so, please take comfort in the results of gluten testing on labeled gluten-free foods that we are seeing at Gluten Free Watchdog. For those of you who will be attending the International Celiac Disease Symposium, Thomas Grace and I have a scientific poster summarizing two years worth of findings. Please come by during the poster sessions and say hello.

There is so much more that could be written but this is enough for now. If you have any questions, please let me know.

Sources

Food Labeling; Gluten-Free Labeling of Foods. Available at: http://tinyurl.com/q9l4ykn

Questions and Answers: Gluten-Free Food Labeling Rule Final. Available at: http://tinyurl.com/q6zezf7

Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods. Available at: http://tinyurl.com/knqutmz

Gluten Testing: Hydrolyzed Gluten. Available at: http://www.glutenfreedietitian.com/newsletter/gluten-testing-hydrolyzed-gluten/

Labeling of USDA-Regulated Foods Straight from the USDA. Available at: http://www.glutenfreedietitian.com/newsletter/2009/11/11/labeling-of-usda-regulated-foods-straight-from-the-usda/

TTB’s Interim Policy on Gluten-Free Labeling of Alcoholic Beverages. Available at: http://www.glutenfreedietitian.com/newsletter/2012/07/20/ttbs-interim-policy-on-gluten-free-labeling-of-alcoholic-beverages-2/

Omission Beer: The Controversy over Gluten-Free Labeling of Malt Based Beverages Continues. Available at: http://www.glutenfreedietitian.com/newsletter/2013/06/30/omission-beer-the-controversy-over-gluten-free-labeling-of-malt-based-beverages-continues/

 

© August 5, 2013 by Tricia Thompson, MS, RD. All Rights Reserved. No part of this article may be reprinted without the express written permission of Tricia Thompson.

Omission Beer: The controversy over gluten-free labeling of malt-based beverages continues

June 30th, 2013

Update July 12, 2013.

I don’t know about all of you but I am getting a little fatigued from the beer “issue.” BUT …

Last evening I was forwarded some documents related to Craft Brew Alliance (Omission). According to the email included with these documents they are not considered confidential and will be in the public domain soon (when they are, I will post the links). When I have more information regarding how the scientific community views the information contained in these documents I will pass it along. In the meantime, one of the documents reads in part:

“Given our commitment to scientific inquiry and the advancement of analytical gluten detection methods, Omission has been working with several international laboratory groups that have expertise in using LC/MS techniques to detect gluten. Earlier this year, one of our partners, DSM Food Specialties, completed research on our products. The results show that Omission beers are devoid of known toxic epitopes, the specific peptide sequences and reactive sites in gluten molecules that cause reactions in the human small intestine. These same beers were tested using the R5 Competitive ELISA and were found to lack any measureable gluten content. Mass spectrometry currently is not scientifically validated or conclusive, but this method holds much promise, and may eventually become an important alternative for the detection and verification of gluten.”

With release of this information it appears that Omission is trying to respond to issues raised by some in the scientific community, including:

Health Canada: “Recent tests by Canada’s public health agency found gluten fragments in beers from Spain and Belgium that use a gluten-removal process similar to Craft Brew’s. It’s unclear whether the fragments are a health concern, Health Canada spokeswoman Blossom Leung said via email.” Source: http://tinyurl.com/l6naj2f

An author of the competitive R5 ELISA validation study:  In personal email correspondence I was advised that the detection of gluten fragments by the R5 antibody is still under discussion because LC-MS can detect fragments in beers that have been found to be gluten-free by ELISA.

Steve Taylor, PhD:  His comments can be read below in the original post and also at the link above.

I am NOT very knowledgeable about mass spectrometry and liquid chromatography and can not offer an opinion at this time on the information released by Omission. It will be helpful if Omission submits their research to a peer-reviewed scientific journal for evaluation. Hopefully those exceedingly well-versed in testing hydrolyzed/fermented foods and beverages for gluten will comment soon.

………………………………………….

I’d said all I wanted to say about Omission Beer and other “gluten removed” barley malt-based beverages but then a quote from Steve Taylor, PhD, Co-Director of the Food Allergen Research and Resource Program (FARRP) caught my eye. In the article “Gluten-removed or gluten-free: Craft Brew Alliance presses Omission beer’s case” by Brent Hunsberger of The Oregonian, Dr. Taylor is quoted as stating, “I’m concerned that there might be big pieces of gluten protein left in this beer that are still potentially hazardous.”

Bottom Line: If Steve Taylor is concerned about this beer containing gluten then all individuals with celiac disease should be concerned about drinking this beer.

Background: Many of you have been following the controversy over whether Omission Beer should be allowed to label its barley malt-based beer gluten-free. Under the interim policy on the labeling of alcoholic beverages released by the Tobacco, Tax, and Trade Bureau (TTB) in May of 2012, the answer is no. Instead the TTB interim policy allows the statement, “Processed or treated or crafted to remove gluten” for products made with wheat, barley, rye, or 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.

Both the Food and Drug Administration (FDA) and the TTB appear to be on the same page when it comes to assessing the gluten content of fermented or hydrolyzed foods. The FDA writes in its August 3, 2011 Federal Register Notice regarding gluten-free labeling that, “FDA recognizes that for some food matrices (e.g., fermented or hydrolyzed foods), there are not currently available validated methods that can be used to accurately determine if these foods contain < 20 ppm gluten.” The TTB writes in their interim policy on gluten content statements that they agree “with FDA that there are no scientifically valid methods for accurately measuring the gluten content of fermented products…”

BUT Craft Brew Alliance, the manufacturers of Omission Beer disagrees. On April 15, 2013 three members of Craft Brew Alliance along with a representative from the law firm Patton Boggs, LLC met with two members of the Office of Management and Budget/Office of Information and Regulatory Affairs. The OIRA reviews draft regulations including the proposed gluten-free labeling rule. It is the case that the TTB and not the FDA regulates malt-based beer including Omission. However, based on my read of reporting done on this issue Craft Brew Alliance wants FDA to acknowledge in the final gluten-free labeling rule that a scientifically valid test for accurately measuring the gluten content of fermented and hydrolyzed products DOES exist.

So is there a scientifically valid test for measuring the gluten content of fermented and hydrolyzed products? The competitive R5 ELISA is used to assess foods that are highly hydrolyzed or fermented. It appears that the competitive R5 may have finally been validated. The AACC International very recently published a technical report on the findings of a collaborative study on the competitive R5 ELISA. One of the study authors sent me a pre-print version of the paper. This international collaborative study to validate the competitive R5 ELISA (Ridascreen Gliadin Competitive R7021, R-Biopharm) was jointly run by the Prolamin Working Group and AACCI. This multi-lab performance trial involved 16 labs and 7 foods/beverages. By means of comparison, when the sandwich R5 ELISA (Ridascreen Gliadin R7001, R-Biopharm) was validated in a collaborative trial with the Prolamin Working Group, 20 labs and 12 food samples were involved.  To the best of my knowledge neither the FDA nor the TTB has commented publicly on this collaborative trial.

Regardless of assay validation, Dr. Taylor raises another important issue in The Oregonian that has gone largely unstated… The R5 ELISA detects the amino acid sequence QQPFP. This sequence may be broken apart by the enzyme used by Craft Brew Alliance to “remove” barley protein from Omission beer. If this is the case, the sequence will not be detected when this product is tested using the R5 ELISA. BUT this does not mean the beer is free of other toxic peptides.

Something to think about: Beer seems to elicit an emotional reaction in individuals with celiac disease. Would we be having this discussion if the product in question was soy sauce? Probably not but the issue is the same. Omission contains hydrolyzed barley protein and soy sauce contains hydrolyzed wheat protein. Some in the soy sauce industry claim the wheat protein in their product is completely hydrolyzed because this is the only way to achieve the umami flavor characteristic of the condiment. How would individuals with celiac disease feel if soy sauce containing hydrolyzed wheat protein was allowed to be labeled gluten-free?

Note: I have written extensively on why historically it has been so difficult to test hydrolyzed products for gluten including at http://www.glutenfreedietitian.com/newsletter/gluten-free-labeling-of-alcoholic-beverages-update/ and http://www.glutenfreedietitian.com/newsletter/beer/

For more information see Gluten-removed or gluten-free: Craft Brew Alliance presses Omission beer’s case by By Brent Hunsberger of The Oregonian http://tinyurl.com/l6naj2f

© June, 2013 by Tricia Thompson, MS, RD. All Rights Reserved. 

 

Hair styling products: Must they be gluten-free?

May 15th, 2013

If you have celiac disease, do you really need to worry about gluten in hair styling products? Let’s take a logical look at this issue.

Remember that parts per million of gluten is a proportion—ppm tells you how many parts out of a million parts are made up of a contaminant (e.g., gluten). If a product (food or hair wax) contains 20 parts per million (ppm) of gluten it contains close to 0.6 milligrams of gluten in each ounce of product. If a product (food or hair wax) contains 100 ppm gluten it contains close to 3 milligrams of gluten in each ounce of product. But remember, you presumably do not eat hair wax. If you do (joking of course!), the wax probably would impact your ability to breathe long before it caused a gluten reaction.

If you are still concerned you can do what I did during a recent morning and look at the products you use in your hair. In my case—a shampoo, “defrizzer”, and styling wax. Using the styling wax as an example—it is a 1.5 ounce container. It probably lasts me at least 30 days (maybe 60). At 20 ppm gluten, the entire container would contain about 0.9 milligrams gluten. Divided by 30 (days), the amount of gluten used in my hair from this product would be 0.03 milligrams. At 100 ppm gluten, the entire container would contain 4.5 milligrams of gluten. Divided by 30 (days), the amount of gluten used in my hair from this product would be 0.15 milligrams. Now assuming I evenly spread product throughout my hair the amount that would be on any area I touched would be truly microscopic. The amount that would be transferred to my fingers and stay put until I either put my fingers directly in my mouth or touched something going into my mouth would be infinitesimal (never mind that all of us should wash our hands before sticking our fingers in our mouth or preparing food).

Also, keep in mind that Thomas Grace and I recently tested six lipsticks, glosses, and lotions containing various gluten-derived ingredients. Products were tested in duplicate using both the sandwich and competitive R5 ELISAs. In other words each product was tested four times. All tests conducted on all products were below the lower limit of quantification for gluten (5 parts per million of gluten for the sandwich and 10 parts per million of gluten for the competitive).

Individuals with celiac disease have a lot to be concerned about when it comes to gluten. Hair styling products should not be one of them.

© May 15, 2013 by Tricia Thompson, MS, RD. All Rights Reserved.

This article may not be reposted, reprinted, or republished, without the express written permission of Tricia Thompson

Update on gluten-free status of yeast extract

February 7th, 2013

Individuals with celiac disease and other gluten-related disorders have long been advised to avoid foods containing the ingredient “brewer’s yeast” but not the ingredients “yeast extract” or “autolyzed yeast extract.”

My current recommendation when either yeast extract or autolyzed yeast extract is listed as an ingredient in foods NOT labeled gluten-free is to contact the manufacturer and ask whether spent yeast from beer manufacturing is the source. Here’s why…

In 2010 I tested the yeast extract spread Marmite for gluten http://www.glutenfreedietitian.com/newsletter/is-marmite-gluten-free/. Marmite was assessed for gluten contamination as part of preliminary testing for a planned large study on yeast extract derived from brewer’s yeast (the primary ingredient in Marmite is yeast extract from spent yeast arising as a by-product of beer making). Brewer’s yeast, when used as an ingredient in food, may be a by-product of the beer brewing process and as such may be contaminated with malt and grain.

The planned study has not taken place due to lack of funding. If anyone is interested in helping to fund a study on yeast extract, please contact me.

The results of the testing on Marmite are as follows:

Sandwich R5 ELISA
Extraction One: 28 ppm gluten
Extraction Two: 31 ppm gluten

Lower limit of quantification for this assay is 5 ppm gluten

Competitive R5 ELISA*
Extraction One: 3,700 ppm gluten peptide
Extraction Two: 3,400 ppm gluten peptide

Lower limit of quantification for this assay is 1,250 ppm gluten peptide

*At the time this testing was conducted results of the competitive R5 ELISA were reported as gluten peptides.

Health Canadarecently revised their allergen labeling law. Under the new regulations which took effect August 4, 2012, all gluten sources in packaged food products (including barley) must be declared. Barley is now showing up on food labels containing yeast extract. The Canadian Celiac Association (CCA) has done some preliminary testing on yeast extract. As a result of the new allergen regulations and the preliminary test results, the CCA in the latest edition of the Pocket Dictionary Acceptability of Foods & Food Ingredients for the Gluten-Free Diet, is advising individuals with celiac disease to avoid consuming products containing yeast extract when “the ingredient list identifies barley protein as part of yeast extract.”

We do not know at this time how often spent yeast is the source of yeast extract (this is why a large survey of yeast extract manufacturers would come in handy). Unfortunately, in the US barley protein is not included under the Food Allergen Labeling and Consumer Protection Act. So in the US(unlike Canada) there is no way to know from the food label whether the ingredient yeast extract contains barley protein. While this is not cause for undue alarm it is important to clarify with manufacturers whether spent yeast is the source of yeast extract in a food product not labeled gluten-free.

Thank you to Canadian dietitians extraordinaire Alexandra Anca, MHSc., RD and Shelley Case, BSc, RD for help compiling this information.

Copyright © 2013 by Tricia Thompson, MS, RD. All rights reserved. This article may not be reprinted, reposted, or republished without the express written permission of Tricia Thompson.

Good Greens Product Alert: Gluten-Free Bars Contain Wheat Sprout Powder

January 15th, 2013

Gluten Free Watchdog has issued a product alert. Please see https://www.glutenfreewatchdog.org/blog.php?id=7

 

Free Webinar: It’s Not Just Food Anymore: An Update on Gluten-Free Alcoholic Beverage Labeling

December 20th, 2012

Brought to you by NFCA

Topic: “It’s Not Just Food Anymore: An Update on Gluten-Free Alcoholic Beverage Labeling”

Date:  Tuesday, January 22, 2013

Time: 8:30 p.m. EDT / 5:30 p.m. PST

Speaker: Tricia Thompson, MS, RD; The Gluten Free Dietitian, Nutrition Consultant Celiac Disease, Founder Gluten Free Watchdog, LLC

Those newly diagnosed with celiac disease and non-celiac gluten sensitivity almost immediately realize that traditional beer is no longer an option during happy hour. Perhaps the most popular alcoholic beverage, traditional beer is brewed using malted barley. If beer is off limits, what other alcoholic beverages and liquors can a person living gluten-free enjoy? Join NFCA as Tricia Thompson, MS, RD, Founder of GlutenFreeWatchdog.org, reviews a hot topic – current gluten-free labeling policies of alcoholic beverages as proposed by the U.S. Department of the Treasury Alcohol and Tobacco Tax and Trade Bureau’s Interim Policy established in May 2012.*

*The TTB has stated that this Interim Policy was released pending a ruling from the FDA. Once the FDA releases a final rule on labeling of food as gluten-free, the TTB will decide whether any revisions are needed.

To register, visit

http://www.celiaccentral.org/community/Upcoming-Events/Upcoming-NFCA-Events/193/month–201301/vobid–8738/

 

Free Book Offer

December 3rd, 2012

New Subscriber Offer! Have you been thinking about subscribing to Gluten Free Watchdog? Here is an added incentive… through December 17th (or while supplies last), new subscribers to GFW will be mailed a free copy of The Academy of Nutrition and Dietetics Easy Gluten-Free: Expert Nutrition Advice with More than 100 Recipes. Simply subscribe through the subscription page at GFW http://www.glutenfreewatchdog.org/subscribe.php. Send me an email http://www.glutenfreewatchdog.org/contact.php letting me know you subscribed and include your mailing address.

This offer applies to new subscribers who utilize the subscription page at http://www.glutenfreewatchdog.org/subscribe.php. Books can be shipped to US addresses only.

New Website: CeliacNow.org

November 14th, 2012

Please check out the new website from our friends at The Celiac Center at Beth Israel Deaconess Medical Center:

www.CeliacNow.org launches on November 14, 2012

If the above link does not work please try www.celiacnow.com

The Celiac Center at Beth Israel Deaconess Medical Center in Boston, MA is proud to announce the availability of its free, comprehensive website for the nutritional management of celiac disease. Medical management topics will be added shortly.  This dedicated website is written by expert BIDMC Celiac Center clinicians and our colleagues, and edited by expert gastroenterologists and dietitians. Three different levels are provided for each topic, from very basic to more advanced, to appeal to a variety of readers, including clinicians. We’ve included Key Points, Take Home Messages, graphics, handouts, quizzes, a glossary, and many resources. It is also meant for those with non-celiac gluten sensitivity.

Sign up to receive our Celiac Center emails with topic updates, center events, and research opportunities.

Thank you,

The Clinicians of the Celiac Center

Beth Israel Deaconess Medical Center

Boston, MA

www.bidmc.org/celiaccenter

www.CeliacNow.org

Gluten Content of Wine Aged in Oak Barrels Sealed with Wheat Paste

October 10th, 2012

Amy Jones, MS, RD, Lisa Almenoff, MS, RD, Luke Emerson-Mason (Bia Diagnostics), Thomas Grace (Bia Diagnostics), Kristin Voorhees (NFCA), Cheryl McEvoy (NFCA) and FA (winery) contributed to the birth of this article.

Bottom Line: Two bottles of wine aged in oak barrels sealed with a wheat flour paste were tested for gluten using both the sandwich and competitive R5 ELISA. All results were below the lower limit of quantification for gluten for these assays of 5 and 10 parts per million, respectively.

The TTB and Gluten-Free Labeling of Alcohol

On May 24th 2012 the Tobacco Tax and Trade Bureau (TTB) released an interim policy on the labeling of alcoholic beverages under its jurisdiction. The TTB regulates almost all alcoholic beverages. Exceptions include beer made without malted barley, wines containing less than 7% alcohol by volume, and hard ciders containing less than 7% alcohol by volume. The aforementioned beverages are regulated by the Food and Drug Administration.

In the past, the TTB has not allowed gluten-free claims on beverages under their jurisdiction stating the following to me in written correspondence, “The Bureau considers labels that declare a product to be “gluten free” or lead to the impression that a product is safe for those who suffer from celiac disease as making health claims, which are prohibited.”

The new TTB policy contains several changes and clarifications regarding the labeling of alcoholic beverages. This has been driven in part by the beverage industry, some of whom wish to include gluten-free claims on product packaging.

Under the Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages, the TTB will not allow gluten-free claims to be included on product labels or in product advertising if the alcohol is made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains. This means that traditional beer made with barley malt can NOT be labeled or advertised as gluten-free. Distilled alcohol that uses wheat, barley, or rye as a starting material can NOT be labeled or advertised as gluten-free.

The Interim Policy goes on to state, “Many alcohol beverage products subject to the FAA Act are produced without any ingredients that contain gluten. For example, a wine fermented from grapes, or a vodka distilled from potatoes, may be “gluten-free” if the producer used good manufacturing practices, took adequate precautions to prevent cross-contamination, and did not use additives, yeast, or storage materials that contained gluten. Under this interim policy, TTB will allow the use of a “gluten-free” claim in the labeling and advertising of such products. As always, it will be the responsibility of the importer or bottler of the product to ensure that the claim is truthful and accurate.”

Based on my interpretation of the policy (refer to bolded section), a vintner would NOT be able to label a wine gluten-free if the product was aged (stored) in oak barrels sealed with a gluten-containing flour paste.

Aging Wine

According to the winery we communicated with, it is standard practice in the wine barrel making business to seal the tops of barrels with a flour paste. We were also told the following:

1. In general, red wines such as Cabernet Sauvignon, Merlot, Zinfandel and red blends at a price point equal or higher than $12.00 tend to be aged a little longer and in actual oak barrels.

2. All wine barrels are made of one oak species which is white oak.

3. Aging wine in barrels is still a widely used practice, although many wineries use barrel alternatives.

4. It is a standard practice in the wine cooperage business to seal the heads of barrels with a flour paste.

5. The staves of the barrels do not need any type of sealant.

6. The amount of flour paste to seal the barrel heads is minimal.

7. Using barrel alternatives for aging wine eliminates the need for the flour paste.

8. However, it is common for wineries to create the final wine blend with a percentage of wine aged in barrels blended with wine aged in barrel alternatives.

Testing

The winery told us the two wines they make that contain the highest percentage of wine aged in oak barrels—Cabernet Sauvignon and Merlot. One bottle of each of these wines was purchased from a mail-order company and shipped directly to Bia Diagnostics for testing. Each bottle was tested using the sandwich R5 ELISA (R7001) with cocktail extraction (R7006) and the competitive R5 ELISA (R7021). All tests were run in duplicate (2 extractions).

Cabernet Sauvignon

Sandwich R5 ELISA extraction 1: < 5 ppm gluten

Sandwich R5 ELISA extraction 2: < 5 ppm gluten

Competitive R5 ELISA extraction 1: < 10 ppm gluten

Competitive R5 ELISA extraction 2: < 10 ppm gluten

Merlot

Sandwich R5 ELISA extraction 1: < 5 ppm gluten

Sandwich R5 ELISA extraction 2: < 5 ppm gluten

Competitive R5 ELISA extraction 1: < 10 ppm gluten

Competitive R5 ELISA extraction 2: < 10 ppm gluten

Why Both the Sandwich and Competitive R5 ELISAs Were Used

Wine is a fermented product. When testing a product that has been fermented the competitive ELISA should be used. This is because protein that has gone through fermentation may become hydrolyzed (broken down). If one of the starting materials in an alcohol is wheat, barley, or rye OR if there is concern that contamination may have occurred prior to fermentation OR if hydrolyzed gluten is used as a fining agent, it is very important to use the competitive R5 ELISA. That said, both the Food and Drug Administration and the TTB believe that currently there are no validated methods available to accurately assess the gluten content of fermented products. This is because the competitive R5 ELISA has not been formally validated in a multi-laboratory ring trial.

In the case of wine aged in oak barrels sealed with a wheat flour paste, the situation is somewhat different. Any wheat that might leach into the wine would not be fermented or hydrolyzed. The sandwich R5 ELISA should be able to accurately assess gluten that may have made its way into wine as a result of being aged in this manner.

My Thoughts

Wine has always been considered naturally gluten-free. Wine aged in oak barrels sealed with wheat paste appears to be gluten-free. Because the possibility of gluten in wine is an issue that consumers are slowly becoming aware of, it is important for vintners to be fully transparent about their practices. However, the TTB should consider allowing wine aged in oak barrels sealed with a gluten-containing paste to be labeled gluten-free based on testing with the sandwich R5 ELISA. Because wine is a fermented product, the competitive ELISA also can be used to help ensure that hydrolyzed gluten protein is not present in the final product at levels considered harmful to individuals with celiac disease.

The TTB policy statement is available at http://www.ttb.gov/rulings/2012-2.pdf

© 2012 by Tricia Thompson, MS, RD. All rights reserved. This article may not be reprinted, reposted, or republished without the express written permission of Tricia Thompson.

Arsenic and Rice: Update for Gluten-Free Consumers

September 29th, 2012

I first covered the issue of arsenic and rice in 2009 at the urging of a concerned consumer. That initial article can be accessed at http://www.glutenfreedietitian.com/newsletter/gluten-free-diet-arsenic-and-rice/. The present article could not have been written without the helpful and generous email correspondence from arsenic researchers at Dartmouth College.

Arsenic is a naturally occurring element that is found in both organic (carbon-containing) and inorganic (non-carbon-containing) forms. It may be present in soil, water, and air. Inorganic arsenic is a known carcinogen and ingestion may cause an increased risk of certain cancers. Ingestion of inorganic arsenic can also affect the skin and gastrointestinal tract.

Arsenic and the World Health Organization

The World Health Organization (WHO) calls arsenic exposure “a major public health concern.” According to the WHO, inorganic arsenic is very toxic while organic arsenic is less harmful. “Human exposure to elevated levels of inorganic arsenic occurs mainly through the consumption of groundwater containing naturally high levels of inorganic arsenic, food prepared with this water and food crops irrigated with high-arsenic water sources.” Public health measures are called for to decrease exposure to arsenic. While at one time the WHO had a provisional tolerable weekly intake of inorganic arsenic, this provisional intake has been withdrawn and a new tolerable weekly intake has not been set.

Arsenic and Water

The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have limits on the amount of total arsenic that may be found in drinking water and bottled water, respectively. This amount is 0.01 mg of arsenic per liter or 10 micrograms per liter (10 ppb). Keep in mind though that just because drinking water is allowed to contain 10 ppb arsenic does not mean that it does.

Based on allowed amounts, two liters (approximately 8 cups) of water should contain a maximum of 20 micrograms of total arsenic (arsenic in drinking water is inorganic).

Arsenic and Food

According to the European Food Safety Authority, several foods may contain inorganic arsenic and contribute to an individual’s exposure, including rice and rice-based products. Rice is an issue because it is grown under flooded conditions. This practice leads to the high mobilization of soil arsenic into the rice plant. That rice is a source of inorganic arsenic is particularly concerning to the gluten-free community especially among those who have a largely rice-based diet.

The EPA has set a Reference Dose for chronic oral exposure to inorganic arsenic of 0.0003 mg per kg of body weight per day. The EPA defines the Reference Dose as, “an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without appreciable risk of deleterious noncancer effects during a lifetime.”

What this Means

Using the EPA equation (mg/kg/d) and myself as an example, the math is as follows: Divide weight in pounds by 2.2 (132 /2.2= 60). Then Multiply 60 kg by 0.0003 (60 x 0.0003=0.018). My inorganic arsenic intake from food and water should be limited to 0.018 mg (or 18 micrograms) per day.

Arsenic Test Results

The FDA has not yet set limits for the amount of inorganic arsenic in food. However, the agency is actively investigating the arsenic content of rice and recently released results of analytical testing on rice and rice products. They provided a summary of their findings to date.

The 49 samples of non basmati rice assessed by the FDA had an average inorganic arsenic level of 6.7 micrograms per serving (45 grams/1 cup cooked).

The 52 samples of basmati rice assessed by the FDA had an average inorganic arsenic level of 3.5 micrograms per serving (45 grams dry/1 cup cooked).

The 32 samples of rice cereal assessed by the FDA had an average inorganic arsenic level of 3.5 micrograms per serving (30 grams dry/1 cup).

The 32 samples of rice cakes assessed by the FDA had an average inorganic arsenic level of 5.4 micrograms per serving (30 grams dry/2 rice cakes).

The 28 samples of rice beverages assessed by the FDA had an average inorganic arsenic level of 3.8 micrograms per serving (1 cup).

Steps Concerned Consumers Can Take:

1. Find out how much arsenic is in your tap, well, or bottled water. Knowing this amount will give you some idea of the amount of rice and rice-based products you can eat and still fall within the EPA’s reference dose for inorganic arsenic. For information on tap water, you can call your local water department. If you use well water, you will have to test it for arsenic yourself. If you drink bottled water, you can call the company. Test results on bottled water conducted by the Natural Resources Defense Council are available at: http://www.nrdc.org/water/drinking/bw/appa.asp. Testing was done several years ago.

2. Change the source of and cooking method for rice. If you would like to continue eating rice, Dr. Andrew Meharg from the Institute of Biology and Environmental Sciences, University of Aberdeen, Aberdeen, UK and a world renowned expert on arsenic, offered the following advice when I interviewed him in 2009:

a. Source rice from low arsenic areas. California rice is lower in arsenic than South Central rice.

b. Use high water to rice volumes similar to when cooking pasta. Discard the water during cooking. This practice will remove a large portion of the inorganic arsenic.

3. Replace at least some of the rice you eat with other gluten-free grains. Dr. Meharg also recommends not having such a strong dependence on rice products and switching to using other grains if possible. Look  closely at the rice-based products you are eating to see where you can make substitutions. Some suggestions include:

a. Instead of rice cakes try Real Foods Corn Thins http://cornthins.com/prodOriginal.aspx

b. Instead of rice pasta try Mrs. Leeper’s Corn Pasta http://www.mrsleepers.com/products.html,  Ancient Harvest Quinoa Pasta made from corn and quinoa http://www.quinoa.net/145/163.html,  or King Soba Buckwheat Noodles http://www.kingsoba.com/organic-noodles-buckwheat.php.

c. Instead of hot rice cereal try gluten-free oatmeal, Ruth’s Chia Goodness cereal http://www.ruthshempfoods.com/,  Pocono Cream of Buckwheat http://thebirkettmills.com/shop/organic/pocono-cream-of-buckwheat, or teff hot cereal (see recipe below).

d. Instead of ready-to-eat cereal based on rice try Nature’s Path Mesa Sunrise Flakes http://us.naturespath.com/, or Envirokidz Gorilla Munch Cereal http://us.naturespath.com/.

e. Instead of rice-based beverages try soy-based beverages.

f. Try recipes that substitute buckwheat, millet, quinoa, teff, and sorghum for rice.

My Personal Thoughts

I eat a lot of plain rice. It is one of the few foods that sit well in my stomach. When I look at the amount of inorganic arsenic allowed in water, there doesn’t seem to be much room for arsenic in food. However, as already mentioned, just because water is allowed to contain a certain amount of arsenic does not mean that all tap and bottled water contains maximum amounts. This is similar to the issue with gluten-free foods. While up to (but not including) 20 ppm gluten is allowed under the proposed FDA  rule, the vast majority of foods tested through Gluten Free Watchdog are testing below 5 ppm. Having investigated the arsenic levels of my tap and bottled water, I will be decreasing but not giving up completely the rice in my diet.

Words of Wisdom

Over the past couple days I have been communicating with premier arsenic researchers at Dartmouth College. Brian Jackson, PhD, Director of the Trace Element Analysis Core Facility at Dartmouth, wrote the following to me in an email, “It’s important to consider that we are talking about effects of long term low level exposures and these limits are based on extrapolations from effects at higher levels of exposure assuming a worst case linear correlation. Also, not all arsenic in food is inorganic arsenic and not all inorganic arsenic will necessarily be adsorbed by the body. The limits are aimed at reducing population-level health effects and it’s hard to comprehend what that means on an individual basis. Added to that, there may be offsetting health benefits to a gluten free diet. Don’t get me wrong, I think we need much more product testing and limits to remove products that are high in inorganic arsenic; we need to push for more regulation but we don’t need to hit the panic button either.”

Teff Hot Cereal

(Originally published in The Gluten-Free Nutrition Guide by Tricia Thompson. McGraw-Hill; 2008)

If you like hot cereal, then you may want to give this nutritious recipe a try. Cooked teff grain has a nice nutty, chewy texture and a mild flavor.

¾ cup water

¼ cup uncooked teff grain

¼ cup raisins (or any other dried fruit)

1 tablespoon unsweetened dried coconut

1 tablespoon yogurt

1 tablespoon maple syrup

In a small saucepan bring water to a boil. Add teff and raisins. Cover and reduce heat to low (maintain a simmer). Cook until all the water is absorbed. Top with coconut, yogurt, and maple syrup.

Makes 1 serving

References

US Environmental Protection Agency. Arsenic Compounds. 2007. Available at: http://www.epa.gov/ttnatw01/hlthef/arsenic.html

US Environmental Protection Agency. Basic Information about Arsenic in Drinking Water. 2012. Available at: http://water.epa.gov/drink/contaminants/basicinformation/arsenic.cfm.

US Environmental Protection Agency. Inorganic Arsenic. 2007. Available at: http://www.epa.gov/teach/chem_summ/Arsenic_summary.pdf

US Geological Survey. Arsenic in Groundwater in the United States. 2011. Available at: http://water.usgs.gov/nawqa/trace/arsenic/

World Health Organization. Exposure to Arsenic: A Major Public Health Concern. 2010. Available at: http://www.who.int/ipcs/features/arsenic.pdf

US Food and Drug Administration. Bottled Water: Arsenic. 2011. Available at: http://tinyurl.com/4rexje2

US Food and Drug Administration. Arsenic in Rice. 2012. Available at: http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Metals/ucm319870.htm

© 2012 by Tricia Thompson, MS, RD. All rights reserved.

This article may not be reprinted, reposted, or republished without the express written permission of Tricia Thompson