Food Labeled Gluten-Free Must Now Comply With FDA Rules

August 7th, 2014

August 5th–The compliance date for the gluten-free labeling rule has finally arrived. Some basic (and not so basic) information about the rule has been posted on Gluten Free Watchdog. To read the post please see https://www.glutenfreewatchdog.org/blog/FOODS-LABELED-GLUTEN-FREE-MUST-NOW-BE-IN-COMPLIANCE-WITH-THE-FDA-GLUTEN-FREE-LABELING-RULE/38

 

Gluten Free Watchdog Product Alert: Boulder Canyon Malt Vinegar Chips

February 23rd, 2014

At least two (maybe three) varieties of Boulder Canyon malt vinegar and sea salt chips are labeled gluten-free and/or erroneously contain the Gluten Free Certification Organization (GFCO) Certified Gluten-Free mark (i.e. they were never certified by GFCO) and include the ingredients malt vinegar and malt extract. A pdf of the full report is available at https://www.glutenfreewatchdog.org/blog/Gluten-Free-Product-Alert-Boulder-Canyon-Malt-Vinegar-Chips/32

 

Restaurants and Gluten-Free Labeling Claims

January 28th, 2014

The following statement was drafted by Rhonda Kane, MS, RD, former Consumer Safety Officer, Food and Drug Administration (FDA). Current FDA staff reviewed and slightly revised this statement and granted me (Tricia Thompson, MS, RD) permission to post the revision at www.glutenfreedietitian.com:

In the strict sense, FDA requirements for gluten-free claims apply to only packaged foods that are subject to FDA labeling regulations. However, FDA stated the following in regards to restaurants in the preamble to its final rule on gluten-free labeling (see 78 FR 47153 at 47173, issued 8/5/13): “with respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (e.g., “fat-free” or “cholesterol-free”) on restaurant menus should be consistent with the regulatory definitions.”

Further, both FDA regulations at 21 CFR 101.13(q)(5) (see http://tinyurl.com/lfvknn7) and Chapter IV of FDA’s guidance document titled Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Food Establishments Selling Away-From-Home Food initially issued April 2008 (see http://tinyurl.com/mngrt4j) reiterate the agency’s position that restaurants should not use an FDA-defined nutrient content claim for foods sold in restaurants unless those foods meet regulatory requirements for the claim. A gluten-free claim is an avoidance claim and FDA has publicly expressed its opinion (in the Federal Register and in a guidance document) that it takes a similar approach to gluten-free claims made for foods sold in restaurants.

Consequently, if restaurants or other retail food establishments wish to make “gluten-free” claims (or the synonymous claims “no gluten” “free of gluten” or “without gluten”) for any of their menu items, these foods should meet all of the requirements FDA has established for a food labeled gluten-free, including not containing 20 parts per million or more gluten, whether or not the presence of gluten is due to accidental cross-contact occurring in the kitchen. If restaurants cannot ensure that the foods they prepare fully comply with FDA’s definition of gluten-free, restaurants should not refer to their foods as being “gluten-free.” State and local governments play an important role in oversight of restaurants and other retail food establishments and are responsible for conducting on-site inspections of those facilities to help ensure the safety of foods served to the public. FDA expects to work with their State and local government partners with respect to gluten-free claims for foods prepared and sold in restaurants.  FDA will consider enforcement action as needed, alone or with other agencies, to protect consumers. 

In addition, consumer advocacy/watchdog groups, other retail food establishments, manufacturers of foods labeled gluten-free, and consumers can play an important role in preventing restaurants from incorrectly using gluten-free claims for their menu items. For example, if a restaurant manager confirms that a menu item bearing a gluten-free claim is made with an ingredient prohibited by FDA regulations on gluten-free food labeling, or if any persons sensitive to gluten become sick after consuming restaurant foods claimed to be gluten-free, it is important that these cases be reported to both the overseeing state agency and to FDA (see Consumer Complaint Coordinators listed by state at http://tinyurl.com/k7cfrp2. It is believed that conducting outreach to restaurants and other retail food establishments to help educate them about FDA’s definition of gluten-free can be an effective tool to avoid inappropriate uses of the term gluten-free for foods sold by those facilities.

©Copyright January 28, 2014 by www.glutenfreedietitian.com

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Is Barley-Based “Gluten-Removed” Beer, such as Omission Safe for People with Celiac Disease?

January 1st, 2014

Gluten Free Watchdog has released a special report on the safety of Omission beer–a barley-based “gluten-removed” malt beverage.

The report is available at:

https://www.glutenfreewatchdog.org/blogPost.php?id=30

 

 

Gluten Free Watchdog’s Report on the Gluten Contamination of Spices

December 10th, 2013

A public version of this report has been posted at https://www.glutenfreewatchdog.org/blog.php?id=27

 

Do parents of children with celiac disease really have to worry that their children’s retainers contain gluten?

November 26th, 2013

By Amy Jones, MS, RD and Tricia Thompson, MS, RD

Many of you may have heard about the article “An Orthodontic Retainer Preventing Remission in Celiac Disease” recently published in the journal Clinical Pediatrics. In short, this is a case presentation of a 9 year old girl diagnosed with celiac disease. IgA tTG at diagnosis was 172 U/mL (normal defined as < 20). The authors state that despite a strict gluten-free diet her tissue transglutaminase remained elevated. However, when she removed her retainer which was found to contain a plasticized methacrylate polymer which may contain gluten her serology normalized.

A close look at the patient’s serology provided by the study authors shows that at her 6th month follow-up the patient’s tTG level had fallen to approximately 50 U/mL. At her 7th month follow-up, the patient’s tTG level was up slightly to approximately 55 U/mL. At her 8th month follow-up her tTG was approximately 52 U/mL. At this point the retainer was removed. By her 10 month follow-up tTG levels were around 0.

We are concerned that this case study may unnecessarily worry parents over their children’s retainers especially if only the title or the abstract of the study is read (Note to bloggers: it is irresponsible to write about a study if you have NOT read the ENTIRE article).

The lead author was contacted with the following questions:

  • Might these tTG levels represent a normal progression?
  • Did the child have the retainer the entire time she was on a gluten-free diet? If so, this would suggest the retainer had nothing to do with the “blip” that was seen in tTG levels.
  • Was it established that the retainer actually contained gluten or that it was “just” made with a material that may include gluten?
  • If it was established that the retainer did in fact contain gluten was the manufacturer of the retainer contacted to ask how much gluten was used to make it?

Zebunnissa Memon MD, responded that yes, the child had the retainer the entire time she was on a gluten-free diet but, “Only when she removed the retainer did her serology and symptoms improve.” Dr. Memon went on to say that, “The retainer was not tested. The ingredients from the manufacturer listed methylmethacrylate: a plasticized methacrylate polymer, in which gluten is a common additive. The manufacturer was contacted but they did not give us information.”

We responded further that, “Based on the information you provide in table 3, this child’s serology fell from 172 U/mL at diagnosis to 50 U/mL at her 6 month follow -up. If she was getting gluten from her retainer it seems unlikely that this would have happened.”

Dr. Memon responded, “This is actually a case that had puzzled us because it was very atypical of the usual celiac cases that we see. On the diet that this child was following, you would expect the serology to have normalized. We can say this because we knew how vigilant the mother was. The only factor that changed from the serology of 50 to the follow up where it had gone down significantly was that the retainer was removed. The diet remained the same. It is possible that the gluten source in the container (sic) was so minimal that it was just enough to prevent normalization of both serology and symptomatology.”

We are still not convinced that the retainer had anything to do with the slight increase seen in this patient’s tTG levels. According to Beth Israel Deaconess Celiac Disease Center, tTG has a half life of 6 months so it would be expected that levels should fall by half 6 months after diagnosis (http://www.bidmc.org/Centers-and-Departments/Departments/Digestive-Disease-Center/Celiac-Center/FAQ/DiagnosingCeliacDisease.aspx#normal). This patient’s tTG levels fell from 172 U/mL at diagnosis to approximately 50 U/mL (It is difficult to read the graph and exact numbers are not provided) at her 6 month follow-up. This is a fairly significant drop. It also is the case that by the time the patient’s retainer was removed at 8 months, tTG levels had decreased from about 55 U/mL to about 52 U/mL. In addition, the reference regarding methylmethacrylate as containing gluten is from 1971. We have been unable to find any additional references indicating that this substance contains gluten. Even if it does, methylmethacrylate is one product used to make this child’s retainer and gluten would be a “sub-ingredient” of this product. That enough gluten would leach from the retainer to cause an increase in tTG levels seems a bit extraordinary.

There is so much fear in the celiac disease community regarding unintentional sources of gluten especially among parents of children. We would hate to have parents worrying unnecessarily about their children’s retainers. There does not seem to be enough information provided in this case to demonstrate a true cause and effect between retainer use and tTG levels.

©Copyright November 2013 by Amy Jones, MS, RD and Tricia Thompson, MS, RD for www.glutenfreedietitian.com

Gluten contamination levels in labeled gluten-free foods: Two years worth of data from Gluten Free Watchdog

November 7th, 2013

Summary findings from two years of testing labeled gluten-free foods sold in the US was recently published in the Journal Practical Gastroenterology. See http://tinyurl.com/k58kx2d  

 

Survey Results: Rice, Arsenic, and Gluten-Free Diets

October 24th, 2013

Poster Presentation from the International Celiac Disease Symposium: Survey on Rice Consumption among US Adults with Celiac Disease: Impact on Inorganic Arsenic Intake

If we missed seeing you at ICDS2013 here is the link to the poster. Brian and I also presented on the issue of arsenic and rice at the Academy of Nutrition and Dietetics Food and Nutrition Conference.

Full size poster which looks best on screens and can be printed letter size with “resize to fit.”

Letter size poster which can be printed as is.

Please feel free to share these links.

Gluten Content of Labeled Gluten-Free Foods Sold in the US: Summary Findings from Gluten Free Watchdog

September 29th, 2013

The poster we presented at the International Celiac Disease Symposium has been posted at https://www.glutenfreewatchdog.org/blog.php?id=8. A more comprehensive report representing two years worth of data will be published in October in the journal Practical Gastroenterology. Thanks to everyone who supports this site through your subscriptions and sponsorships.

Free Webinar: Understanding the FDA’s Gluten-Free Labeling Rule: What You Need to Know

September 6th, 2013

Free Webinar: Understanding the FDA’s Gluten-Free Labeling Rule: What You Need to Know

Join NFCA as Tricia Thompson, MS, RD, expert celiac disease dietitian and Founder of Gluten Free Watchdog, provides an overview of the FDA’s gluten-free ruling and also discusses what is not covered by the rule. Matthew Cox, Marketing Director at Bob’s Red Mill Natural Foods, will share the perspective of a leading manufacturer of gluten-free products, as well as insights on how the new ruling may impact the food industry. NFCA and the panelists will also address your questions.

Following the Webinar, NFCA will publish a free follow-up resource featuring key details presented during this event.

When: Wednesday, September 18, 2013

Where: Your computer

Time: 8 to 9:15 p.m. EDT/5 to 6:15 p.m. PDT

To register:

http://www.celiaccentral.org/community/upcoming-nfca-events/free-webinar-explaining-fda-ruling-gluten-free-labeling-10199/