Today is the Day: FDA Gluten-Free Labeling Rules

Today is a big day in the gluten-free and celiac community. Starting today, manufacturers of gluten-free products are required to abide by the FDA guidelines if they want to use the words "gluten-free" on their package. This is actually a HUGE win for our community and long overdue.

When I was on the National Foundation for Celiac Awareness webinar with the FDA two weeks ago, the speaker reiterated multiple times that these new rules are for the benefit of those with Celiac. Under these new rules, the manufactures using the "gluten-free label" must be compliant with 20ppm or less of gluten.

There are a lot more stipulations that are part of these new rules. Instead of writing them all out, I would like to point you to other websites that did a great job summarizing these new FDA gluten-free guidelines.


Foods Labeled Gluten-Free Must Now Be in Compliance with the FDA Gluten-Free Labeling Rule by Gluten-Free Watchdog

National Foundation for Celiac Awareness FDA Gluten-Free Labeling Rule by the NFCA

10 Things to Know About the FDA’s Gluten Free Labeling Rule by Amy Leger

All You Need to Know About the New Gluten-Free Labeling Rule by Simply Gluten-Free

Aug 5th Gluten Free FDA Labeling Just a Start by Celiac and the Beast

U.S. Gluten-Free Label Rules in Effect August 5 by Allergic Living

While I understand that not everyone agrees with all of these new FDA guidelines, I honestly cannot believe this day is here at all. As someone living with Celiac Disease for 33 years, I feel like our community has come a VERY long way in my lifetime. We are all our own advocates and the celiac community put up a good fight to get others to take our labeling needs seriously.

Congratulations to everyone that has contributed to this gluten-free labeling cause over the past 10+ years. This is just the beginning!


If you have also written about the new FDA labeling rules, please include your link in the comments below. I would prefer to keep this section as a resource page and not a place where you want to complain about the new guidelines. Thank you for your cooperation.

CSA Responds to Revised TTB Gluten-Free Alcohol Labeling Policy

Yesterday when the Alcohol and Tobacco Tax and Trade Bureau (TTB) released its "Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages", I immediately reached out the Celiac Sprue Association.

As you may remember, I had some very interesting emails with the CSA staff back in November when they decided to endorse Omission Beer with the CSA Recongition Seal. Omission Beer is a barley-based beer and cannot legally be labeled "gluten-free" as per the TTB policy. I was curious to see if the CSA would stand by their endorsement now that the labeling policy had been revised.

Here is what the Celiac Sprue Association had to say:

Mary is out of the state this week at a conference, and she has asked me to respond to your inquiry.  The February 11, 2014 updated TTB policy on gluten-free labeling, based upon the TTB’s review of the FDA final rule, is basically a restatement of the TTB’s interim policy.  CSA’s certification of Omission beer was based upon the product meeting all of CSA’s Recognition Seal certification requirements, and obviously, the TTB policy has no bearing on the CSA certification process.  It is our understanding that Craft Brew will comply with the requirements of the TTB, as will CSA. Neither label will use the terms “gluten-free”.  Craft Brew will use the statements required by the TTB regarding removal of gluten, and the CSA Recogniton Seal will continue, as in the past, to not use the terms “gluten-free”.  As you know, there is currently no available test to determine any product to be absolutely gluten-free, and even under the FDA final ruling, products allowed to be labeled “gluten-free” may likely contain gluten.  As always, the purpose of CSA Recogntion Seal is to provide consumers with additional information so they can make informed choices on the products they purchase and consume.

Larry Brauer
CSA Special Projects

Based on this email, the CSA will continue to endorse Omission Beer despite the law stating Omission cannot legally be labeled gluten-free. This does not sit well with me and continue to feel that that Celiac Sprue Association doesn't have the celiac community in its best interest.

How do you feel about this revised labeling policy for alcohol and the continued endorsement by the CSA of a gluten-derived beer?

Breaking News: TTB Updates Gluten Policy for Beverage Alcohol

I just received this email and think it is very important to share with the gluten-free community regarding how the TTB will allow the term "gluten-free" on alcoholic beverages.  Please share!

We have completed our review of how the U.S. Food and Drug Administration (FDA) final rule on the use of the term "gluten‐free" in the labeling of products under FDA’s labeling jurisdiction impacts TTB’s interim policy on gluten content statements in the labeling and advertising of wines, distilled spirits, and malt beverages that we previously set forth in TTB Ruling 2012‐2.

As a result of our review and consultation with FDA, we are updating our policy on gluten labeling.  Given the important consumer health considerations relating to “gluten-free” claims, TTB believes that it is important to adopt an approach on this issue that is as consistent as possible with the regulations that FDA issued.

Under our updated policy, alcohol beverages that are made from ingredients that do not contain gluten (such as wines fermented from grapes or other fruit and distilled spirits distilled from materials other than gluten-containing grains) may continue to make “gluten-free” claims in the same way allowed in the new FDA regulations for inherently gluten-free products.

Consistent with the new FDA regulations, TTB will continue to consider “gluten-free” label claims for alcohol beverages that are made from gluten-containing grains to be misleading to consumers who are seeking to avoid the consumption of gluten for health reasons.   However, products made from gluten-containing grains may be labeled  with a statement that the product was “Processed,” “Treated,” or “Crafted” to remove gluten, if that claim is made together with a qualifying statement that warns the consumer that the gluten content of the product cannot be determined and that the product may contain gluten.

TTB may revise this policy after FDA issues a final rule or other guidance with respect to fermented and hydrolyzed products.   In the interim, we remind consumers that the FDA has determined there is still no scientifically valid way to evaluate the claims that beers made from gluten-containing grains can be processed in a way that removes gluten and that there is inadequate evidence about whether such methods are effective.

Our Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages (TTB Ruling 2014-2) can be found on our Website at:  http://www.ttb.gov/rulings/2014-2.pdf.

Please contact me with any questions.

Tom

Director, Congressional and Public Affairs
Alcohol and Tobacco Tax and Trade Bureau
Office:  202-453-2180

A Week to Remember: Celiac Sprue Association and Omission Beer

It has been quite a crazy week in the celiac community. It all started with a press release from the Celiac Sprue Association recognizing Omission Beer by giving it the CSA Recognition Seal. It continued with my posts and follow-up responses from the CSA which, in my opinion, only made things worse and the community more convinced. And it is ending with me giving a summary of links from this week. I think this story is far from over, but I would like to put my involvement to rest for a while. The Facebook comments are starting to become offensive; the emails of people who are too afraid to comment publicly are becoming combative; and the tweets are obviously showing that I have pissed off a number of people.

I would like to reiterate that my initial post and subsequent posts have been my opinions of why I do not support to endorsement by the CSA and not about me telling you not to drink Omission Beer. Yes, I am sure I lost a few readers and Twitter followers this week but I am fine with that. I did my research, presented both sides of the story, and never once told you not to drink Omission Beer. I was fair from start to end and for that I owe no apologies.

I think the most ironic part of this mess is that I am currently in Portland, Oregon, home to Omission Beer for this entire week. Sigh.

In case you missed it, you can read all of the information following these links:

Confusing Celiac Sprue Association Endorsement of Omission Beer
A Response from the Celiac Sprue Association on Omission Endorsement on 11/19/2013
Additional Statements from Celiac Sprue Association Endorsement of Omission Beer

Some great bloggers also chimed in with their take on this story:

• Is Barley-Based Omission Beer Really 'Risk-Free' for Celiacs? by Jane Anderson
• Gluten in Beer? Little is Clear. (On Omission, "English Beer," The Gluten Summit, and Other Mysteries) by Sprue Story
• Celiac Sprue Association SELLS OUT to Omission Beer by Kirsten Berman, Gluten Free Gal
• Is Omission Beer Really “Risk-Free” for Celiacs?? by Gluten Dude
• Is Omission Beer Gluten-Free Enough for You? by Gluten-Free Traveller
• Celiac Sprue Association Challenges Authority of FDA and TTB, Stating Omission Beer is Gluten-Free by by: Peter Olins, PhD and Gillian Olins, PhD
• Gluten Free Beer Drinkers: Time to Get Educated on Omission Beer by Amy Leger

And with that, I would like to toast the end of this story for the time being...  CHEERS!  

Additional Statements from Celiac Sprue Association Endorsement of Omission Beer

Today, I received two emails from Mary Schluckebier today based on my previous post about my confusion over the the CSA endorsement of Omission Beer.

The first email was in response to my letter to the Celiac Sprue Association Board of Directors. Mary's responses are in red font.

Hello CSA board members

I saw your press release about your endorsement of Omission Beer yesterday followed by an onslaught of Tweets, Facebook posts, and blogs both supporting your endorsement as well as objecting your endorsement. As a lifelong Celiac, I find your endorsement of a product that is derived from gluten very troubling. I have maintained a gluten-free diet since 1981 and the CSA was the very first organization to support my family after my diagnosis. For you to now come out and not only support a product that is made from gluten but to also contradict your very own definitions of gluten is confusing and disappointing. "CSA materials encourage everyone to develop their own definition for gluten-free. For the CSA Recognition Seal there is a definition. When you were diagnosed there was no other management than to eliminated products from the prohibited grains. Now we have DNA and amino acid sequencing of proteins from many varieties of the grains. The celiac toxic fractions of the grain storage proteins are being identified. So now we know it is not the entire grain that must be eliminated.  More  of these products will be coming into the marketplace labeled gluten-free either in the US and already in many other countries."

I have put together a post about your endorsement of Omission Beer as well as evidence that proves why legally this beer cannot be labeled gluten-free by the TTB ("CSA Recognition Seal does not use the term gluten-free; we support the TTB current stance on labeling products using the grains") on my website, Gluten-Free Fun. I encourage you to respond to my post and explain your endorsement to the celiac community that contradicts your own information. I would like to give you a fair opportunity for a public response and with your permission will repost any comments you may have or link back to any statements you make on your own website. ("please check the update date on CSA website pages, we were hacked a couple of weeks ago and some pages reverted to older information. We have caught most but not all old pages.")

The page I continually refer to is the "Defining The Term Gluten Free" page which is linked directly from the CSA homepage. Interestingly, this page has been updated in the hour it took me to put together this post.

I also received this follow-up email also from Mary Schluckebier today.

CSA supports celiac disease management as an exercise in constant risk assessment and personal decision-making. “Risk-free” standing alone in the headline was confusing since CSA Recognition Seal designates the most risk-free choices in the marketplace. Few things in life are risk free.

CSA does not endorse any product. The CSA Recognition Seal does not use the term gluten-free. The CSA Recognition Seal is the highest standard based communication tool currently available to the celiac community.  The licenses must be renewed annually.  All information sent to CSA, from members and non-members, about a product is considered in the annual review. CSA asks the questions and does the digging, you want  us to do. CSA welcomes your feedback  related to any product marketed to the celiac community. (It is still unknown –what part of the prohibited grains sets off the abnormal responses in those with non-celiac gluten sensitivity. So CSA would like comments from you too.) 

The final FDA definition for products labeled gluten-free opened up some options that are likely to be more confusing in the marketplace.  Our random checking of products will likely lead to more ways to communicate the findings.  Tell us what you are including in your food plan?  Members of the Celiac Sprue Association know that CSA encourages meaningful, verifiable  innovation in widening the options of products suitable for the celiac diet. Qualifying for the CSA Recognition Seal for Innovative products has more steps than qualifying for the naturally gluten-free category.  In the process CSA gathers and shares information with governmental agencies, including the TTB, USDA and FDA, education based researchers, innovative industrialists and most important the CSA members.

Mary Schluckebier
Executive Director | Celiac Sprue Association
1941 S 42nd Street | Suite 522 | Omaha, NE 68105
Toll Free 877-CSA-4-CSA (1-877-272-4272)   Ext 1006| Fax: 402-643-4108
Cell 402-672-4892   mary.s@csaceliacs.org    www.csaceliacs.org

I'm sorry to say but I find this response weak. Mary clearly states below that the "CSA does not endorse any product" while their press release says "Celiac Sprue Association Recognizes Omission Beer as Risk-Free for Celiacs." The Google dictionary definition of endorsement is "an act of giving one's public approval or support to someone or something." In addition, I feel that Mary gives a CYA (cover your a$$) statement by saying "Few things in life are risk free." This email doesn't do much for me except for me to reiterate my initial confusion over their "recognition" (ahem) of their "endorsement" (cough) of Omission Beer.

Celiac Sprue Association, you are endorsing, recognizing, publicly supporting, whatever you want to call it Omission Beer with your CSA Recognition Seal and your press release to the world. It doesn't matter what words you use because you are putting your stamp of approval on this product as "risk-free" for Celiacs even though it contradicts your definition of gluten-free, specifically requirement # 4.

I appreciate the Celiac Sprue Association making a statement and allowing me to present this information to my readers, but I still do not support their decision to put the CSA Recognition Seal on this product. I would also like to point out that NEVER once did I tell my readers not to drink Omission Beer. I've received some nasty emails, Facebook comments, and Tweets this past week that told me I cannot tell others what to eat or drink. Throughout the week, I have simply presented the facts and information sent to me from the Celiac Sprue Association as well as highlight public information that is available on their website. As with any product, restaurant review, etc. I put up here on my personal website, it is up to you to make your decisions as someone living with Celiac what goes into your body. Your Celiac is NOT my Celiac and I have never claimed it to be.

A Response from the Celiac Sprue Association on Omission Endorsement on 11/19/2013

This morning, I wrote to the entire executive board of the Celiac Sprue Association in response to their endorsement of Omission Beer. You can read my post with links here with links back to the TTB and FDA labeling rulings.

A few hours later, I received this email response from Mary Schluckebier, the executive director of the CSA, about their endorsement.

Erin, Thank you for the opportunity.  I will get a better statement to you tomorrow.  This is and example of innovation and research working. Over the past year CSA received Omission’s application and  has considered, gathered information and research from outside of the brewery and from Omission. We have worked with the TTB. It was somewhat of a surprise that they would be able to earn the CSA Recognition Seal.  I will have some additional statements for you tomorrow.  When the known barley celiac toxic amino acid sequences of the proteins that were in the beginning ingredients are absent as validated by beginning and ending mass spectrometry that represents a product that has been rendered non-celiac toxic.   Mathematically, this would place the product below 5 ppm.

Mary Schluckebier
Executive Director | Celiac Sprue Association
1941 S 42nd Street | Suite 522 | Omaha, NE 68105
Toll Free 877-CSA-4-CSA (1-877-272-4272)   Ext 1006| Fax: 402-643-4108
Cell 402-672-4892   mary.s@csaceliacs.org    www.csaceliacs.org

Well, this is confusing. Mary admits that it is surprising that Omission earned the CSA Recognition Seal and that they need a stronger statement. I look forward to further statements from the CSA and will post to my readers as soon as I have it.

In addition, Mary also provided me with the following information via an email attachment which I have uploaded for public viewing and/or personal download to Google Drive:

Celiac Sprue Association Qualifies Omission Beer
for the prestigious Celiac Sprue Association Recognition Seal

Q&A

How could Omission Beer, made with malted barley, be certified to bear the CSA Recognition Seal if barley is one of the forbidden grains?
We have very strict standards for earning our Recognition Seal, and Omission beers clearly meet those standards. Omission beers have undergone mass spec analysis which we carefully reviewed and the analysis showed that the protein remaining in the product is free of known celiac toxic fractions. To further validate that the enzymatic process eliminates the celiac toxic fractions, the Competitive ELISA testing methodology is used on each batch which consistently shows no detectable gluten.

Previously CSA would not offer its certification to products made from ingredients that contained gluten. What has changed? Are you weakening your standards?

Our standards remain as stringent as ever. Indeed, they are tougher than the FDA's new guidelines. We are ‘celiacs helping celiacs’ and we take our mission seriously. What's changing is that innovation in processes for making and testing gluten-free products continues to advance and we take advantage of the tools and information as it becomes available. We encourage innovation because it creates opportunities for more risk free choices, and better quality of life for celiacs and those with gluten related disorders.

The FDA and the TTB so far have refused to allow Omission Beer to be labeled as gluten free
because, in their view, sufficient scientific validation does not exist for detecting gluten in fermented beverages. Do you disagree?

We have reviewed every aspect of Omission production and testing processes. We tested the product independently, as we do every product under consideration for our Recognition Seal, and we further examined the mass spectrometry analysis conducted on Omission, which validated the elimination of known toxic amino acid sequences.

In addition, we reviewed documentation of raw ingredient sourcing, allergen control and sanitation plans, training procedures for controlling cross-contamination, and an inspection of packaging materials. Based on our review of all of this information, we are confident in our determination that Omission beers meet our requirements for the CSA Recognition Seal.

What's your view of the future of gluten-free designations?
On behalf of those with celiac disease, we support innovation in product manufacturing processes and gluten detection that help provide more choices. Living a gluten-free lifestyle is challenging, and for those searching for gluten free products, the risk of illness is significant. We applaud companies like the makers of Omission for their leadership and commitment to making great-tasting, quality products for people with gluten related
disorders, and for their role in advancing scientifically sound gluten detection methods, such as mass spectrometry.

About Celiac Sprue Association
The Celiac Sprue Association is a trusted source of information about the gluten-free products consumers rely on and enjoy every day. In keeping with its founding principles, CSA amplifies members’ efforts for good health by encouraging quality nutrition, responsible business practices, scientific research, education, testing and outreach. Public health and food labeling policy solutions continue to develop through a genuine partnership with policymakers and other stakeholders. Contact us through www.csaceliacs.org or celiacs@csaceliacs.org.

---

The CSA also updated their website to include a link explaining the "Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages"  Based on this link, it looks like you can gain a CSA Recognition Seal even if the FDA and TTB cannot label you gluten-free. Well, isn't that interesting. The LAW says you cannot slap gluten-free on your label, but the oldest Celiac organization in the country says "We approve of Omission Beer, drink up!" No thanks Celiac Sprue Association, even if you are buying!

This story is far from over. I look forward to hearing what else the CSA has to say. They look to be supporting innovation while putting a sensitive community at possible risk of reaction.

I'd like to note that I have gotten a lot of comments and emails today both supporting my post and against my post telling me I am wrong. The intention of my post is to present you the facts as to why Omission cannot legally be labeled gluten-free while giving my opinion about why I think the endorsement by the CSA is poor judgement. Ultimately, it is your personal decision to drink Omission Beer or not. I never once told you not to drink this beer, so please don't email me again and tell me otherwise.  

Confusing Celiac Sprue Association Endorsement of Omission Beer

Yesterday on the Omission Beer Facebook page, I saw this picture announcing Omission Beer is now endorsed by the Celiac Sprue Association (CSA): 

Note to readers: I was linking to a photo on the Omission Facebook page.
It looks like they took their post down! 

There was also a press release that made the newswires directly from the Celiac Sprue Association announcing their endorsement of Omission Beer.

I struggle tremendously with this endorsement. WHY? Omission Beer is made from gluten. PERIOD. 

From the Omission website:

According to federal guidelines, we aren’t legally allowed to claim that Omission beer is gluten-free outside of Oregon because the beer is brewed with malted barley. While the FDA proposed to define the term “gluten-free,” that definition has not been formally adopted by the organization.

Part of the definition proposed in 2007, and again in 2011, states that a product may not be labeled as gluten-free if it contains “an ingredient that is derived from a prohibited grain that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.”

While Omission beer does contain barley, one of the “prohibited grains” in this definition, all batches are tested by an independent lab using the R5 Competitive ELISA to ensure that gluten levels meet our standards.  Although scientific evidence supports the testing, the evidence is not conclusive.  All Omission beer test results can be viewed at: www.omissiontests.com.

If you are going by the information from their own website, Omission Beer isn't allowed to be labeled gluten-free. 

In August 2013, the FDA passed new labeling legislation for gluten-free food that says:

"In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food "gluten-free" if the food does not contain any of the following: 

• an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains 
• an ingredient derived from these grains and that has not been processed to remove gluten 
• an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten"

This means that technically under the new FDA labeling law Omission can be labeled gluten-free because the ingredient (barley) is processed to remove the gluten to less than 20 parts per million.

BUT... The FDA law does NOT apply to malted beverages and beer is a malted beverage.

According to the FDA website:

"The final rule applies to all FDA-regulated foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops."

My next stop was the TTB website. The TTB issued a statement on August 22, 2013 that says:

"We are currently reviewing our policy on gluten content statements in the labeling and
advertising of wines, distilled spirits, and malt beverages in light of the recent U.S. Food and
Drug Administration (FDA) final rule on the use of the term "gluten‐free" for products under
FDA’s labeling jurisdiction.    

While we are reviewing this, we would like to remind industry members that TTB Ruling 2012‐2, Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages, is still in force for alcohol beverage products that are subject to TTB’s labeling regulations under the Federal Alcohol Administration Act."

The ruling from 2012

"TTB will allow use of the statement “Processed or Treated or Crafted to remove gluten ,” together with a qualifying statement to inform consumers that: (1) the product was made from a grain that contains gluten; (2) there is currently no valid test to verify the gluten content of fermented products; and (3) the finished product may contain gluten. Because the current tests used to measure the gluten content of fermented products have not been scientifically validated, such statements may not include any reference to the level of gluten in the product. TTB believes that the qualifying statement is necessary to avoid misleading consumers about the gluten content of these products because of the serious health consequences associated with the consumption of gluten by individuals with celiac disease."

The very last sentence of this paragraph is what makes the Celiac Sprue Association endorsement of Omission Beer so troubling to me. The TTB, the governing body that can label this beer gluten-free for not, states they do not want consumers with celiac disease to be mislead by malted beverages crafted to remove gluten. As of today, Omission Beer cannot put the words "gluten-free" on their labels yet the oldest national celiac association in the country is putting their stamp of approval and logo on the Omission Beer bottles. It just doesn't makes sense to me! All of the facts show that legally this product is not gluten-free. The Celiac Sprue Association is misleading the Celiac community.

The CSA website says:

CSA Recognition Seal products are tested using the most sensitive ELISA test presently available in the United States. Validation of "free of wheat, barley, rye and common oats" in tests with a lower limit of quantification of 5 parts per million. Company submit the analysis of ingredients and manufacturing procedures (HACCP) to assure the products meet the requirements for the CSA Recognition Seal.

The most recent Omission testing of their Pale Ale from November 4, 2013 has the beer testing at less than 10ppm and not at the standards that the CSA claim they test (less than 5 ppm) to on their website. The CSA contradicts its own requirement #4:

"CSA-recognition seal definition: Requirement #4—Ingredients “specially processed to remove gluten”—(e.g. food starch, wheat starch, distilled alcohols and vinegars from WBRO grain sources): Not allowed—with present available commercial methodology the extent or consistency of the processes is not measurable. "

I personally think the Celiac Sprue Association made a HUGE mistake endorsing Omission Beer. As of today, Omission Beer cannot legally be labeled "gluten-free" under the current TTB laws. Period. Additionally, if you look at all of the definitions of "gluten-free" on the Celiac Sprue Association website, Omission Beer does not meet those requirements. I have nothing personal against Omission Beer but I now question the judgement of the Celiac Sprue Association with their endorsement of this product that cannot legally be labeled gluten-free. I will also now question all  all future endorsements that come from the Celiac Sprue Association.

Celiac Sprue Association, you have contradicted your own definitions of gluten-free by endorsing a product derived from gluten. What made you do it?  Please rethink this endorsement or update your website immediately to reflect that you now support products that are made from gluten. 

Food Labeling: Gluten-Free Labeling of Foods

It's official. The US Government has released the Federal Register for the gluten-free labeling regulations. You can find the entire document here.


AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ‘‘gluten- free’’ for voluntary use in the labeling of foods. The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten- containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ‘‘no gluten,’’ ‘‘free of gluten,’’ or ‘‘without gluten’’ in its labeling and fails to meet the requirements for a ‘‘gluten-free’’ claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ‘‘wheat’’ in the ingredient list or in a separate ‘‘Contains wheat’’ statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ‘‘gluten-free’’ claim. Establishing a definition of the term ‘‘gluten-free’’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371, FAX: 301– 436–2636, email: GlutenFreeFinalRule Questions@fda.hhs.gov.

READ THE ENTIRE REPORT FROM THE FEDERAL REGISTER HERE

BREAKING NEWS: FDA Defines “Gluten-Free” for Food Labeling

There is HUGE news for our gluten-free community today. After a 9-year discussion, the FDA has finally define gluten-free labeling regulations. This is a tremendous step forward for those of us living with Celiac Disease who require a gluten-free diet to survive. 

I have included the full text of the FDA press release below, as well as some links to major news outlets.

Washington Post: Nine years after Congress’s request, FDA defines ‘gluten-free’

New York Times: F.D.A. Sets Standard for Foods Labeled Gluten Free

USA Today: FDA issues new rules on gluten labeling

FDA for Consumers: What is Gluten-Free? FDA Has An Answer

Official Press Release

FDA defines “gluten-free” for food labeling

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm

New rule provides standard definition to protect the health of Americans with celiac disease 

The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling.  This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.” 

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.” 

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains.  In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers. 

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published today in the Federal Register.

For more information:

• FDA: Gluten-Free Labeling
• FDA: Gluten-Free Labeling Final Rule Q&A
• Consumer Update
   

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

# # #

NFCA to Launch First Joint Gluten-Free Certification Program Endorsed in US and Canada

Exciting news came through the gluten-free news wire yesterday. Read on for more information. 

National Foundation for Celiac Awareness Forms North American Partnership to Launch First Joint Gluten-Free Certification Program Endorsed in US and Canada | NFCA

The Gluten-Free Certification Program (GFCP) and the National Foundation for Celiac Awareness (NFCA) are pleased to announce their alliance. NFCA’s certification trademark provides customers with a trusted and easily identifiable source of safe gluten-free products.

Ambler, Pa. (July 16, 2013) - The National Foundation for Celiac Awareness (NFCA), a non-profit organization serving individuals with celiac disease and other gluten-related disorders, has formed an alliance with the Gluten-Free Certification Program, developed by Canadian Celiac Association (CCA), to launch the first gluten-free certification program endorsed in the US and Canada by leading celiac disease organizations in North America.

“The GFCP alliance means consumers with celiac disease and gluten sensitivity will have more choices, greater assurance and an easier way to identify gluten-free products that are trusted and safe,” said Alice Bast, President of the National Foundation for Celiac Awareness. “The GFCP has already achieved great success in Canada, and we are eager to expand its benefits to our community here in the US.”

The Gluten-Free Certification Program (GFCP) will provide consumer guidance and protection by differentiating certified products from the increasing clutter of gluten-free claims in the marketplace. The GFCP requires annual certification audits conducted by independent ISO accredited auditing companies, which ensure that certified products meet the industry’s most stringent gluten-free food safety requirements in the US and Canada. This third party relationship is a critical and defining part of the GFCP, as it eliminates any conflict of interest between the manufacturer’s relationship with the program, its certifying bodies and/or the NFCA.

Gluten-free consumers can now shop with confidence by looking for the trusted NFCA certification trademark on product packages.

“We at the GFCP are very excited about our partnership with the NFCA. By combining the endorsement of the NFCA and their strong industry relationships, together with the technical strengths of our program, I am confident we will be able to deliver a comprehensive value proposition that is yet to be seen in the US marketplace,” said Paul Valder, President of the Gluten-Free Certification Program.

Celiac disease is an autoimmune disorder that affects an estimated 1 in 133 Americans. Eighty-three percent of people with celiac disease are undiagnosed or misdiagnosed. The disease can cause debilitating symptoms and, if left untreated, lead to life-threatening health conditions. There is no cure, but celiac disease can be treated with a strict, lifelong gluten-free diet.

NFCA advocates on behalf of the millions of Americans suffering from celiac disease and other gluten-related disorders who are frustrated by the uncertainty of identifying gluten-free products that are essential to their well-being.

“NFCA shares the CCA’s mission to protect consumers with celiac disease and non-celiac gluten sensitivity and will lend a strong voice to the call for safety and accountability as demonstrated by GFCP standards,” said Peter Taylor, Executive Director of the Canadian Celiac Association. “We embrace their participation in this important cross-border commitment."

To learn more about the NFCA endorsed Gluten-Free Certification Program, visit http://www.gf-cert.org.

###

About the National Foundation for Celiac Awareness
The National Foundation for Celiac Awareness (NFCA) is a US-based 501(c)(3) non-profit organization that drives diagnoses of celiac disease and other gluten-related disorders and improves the quality of life for those on a lifelong gluten-free diet. For more information visitwww.CeliacCentral.org.

About the Gluten-Free Certification Program
The Gluten-Free Certification Program (GFCP) was developed so consumers can shop with confidence by selecting those safe, reliable and gluten-free products displaying the GFCP trademark and is endorsed by the National Foundation for Celiac Awareness and the Canadian Celiac Association.

The GFCP is a voluntary certification program designed to help brand owners differentiate their glutenfree products from the increasing clutter of gluten-free claims in the market place, by displaying the GFCP trademark. Based on a robust third-party audit certification process at the manufacturing facility, the GFCP verifies the ability to regularly meet stringent requirements, when managing gluten as part of their food safety programs.

Gluten on Capitol Hill

I came across this article this morning. Looks like, we are one step closer to getting some regulations around gluten-free labeling on medications. As the article states "Just as consumers deserve to know if their food contains gluten, it is critical that consumers know if medications contain gluten." Although we need labeling for both food and medications, let's hope this drug bill passes sooner rather than later!

Dem bill would require drugs to disclose gluten - The Hill's Healthwatch

Update on FDA's Gluten-Free Food Labeling Regulations

I received this email last week while I was traveling. This is a great first step to labeling of our gluten-free food. Read on for more information.

Dear Friends, 

Last week, we reached out to you and other stakeholders serving the needs of those with gluten-related disorders asking you to join us in expressing support for the completion of the FDA's gluten-free food labeling regulation.

As noted in the initial letter, the community hoped to gather 25,000 signatures within 30 days on a 'We the People' petition posted to WhiteHouse.gov. With only days to meet the target, we reached out to you to add close to 6,000 names to the petition. Not only was this goal met; it was exceeded by 2,000 signatures! This was an amazing feat that clearly demonstrated the positive results of a community working together.

The purpose of this petition was to reinforce for administration officials the importance of clear labeling that enforces gluten-free standards. Without question, that goal was accomplished.

So what's next? According to the White House website, administration officials will respond to the petition in a timely manner. It is possible that the recent storm on the East coast and the elections may factor into the timing of this review and response. Hopefully, it will include news announcing completion of the labeling rules. We promise to keep you abreast of any news or new developments. You can also follow along here.

This effort could not have been successful without your participation. Thank you for supporting the needs of the gluten-free community!

Best,

American Celiac Disease Alliance

Celiac Disease Foundation

Gluten Intolerance Group

National Foundation for Celiac Awareness

Gluten-Free Labeling Update

6:45am, October 30, 2012: I wrote this post yesterday before things got really bad here in NYC. I am devastated as I wake up this morning and see the reports of what Hurricane Sandy has done to NYC, Long Island, and all up and down the East Coast. I am ok, but waiting to see what daylight brings. My thoughts and prayers are with everyone affected by Sandy. More updates to come, but for now here is my post from yesterday. 

While I am sitting here in the middle of Hurricane Sandy, I received an email that actually made me smile. This is an email from not one, but FOUR national Celiac associations in the United States. I think an email like this is unprecedented. All four major Celiac organizations are urging you to sign the petition to help urge the government to complete the gluten-free food labeling rules. The deadline for this petition is this THURSDAY!! If you have not signed this petition yet, I encourage you to do so. If not for me, then do it for yourself. Thank you to the four national Celiac associations that are helping to spread the word about this labeling law.

Dear Friends, 

In 2004, the historic Food Allergen Labeling and Consumer Protection Act (FALCPA) was passed, making life significantly easier for individuals with food allergies to manage their potentially life-threatening health condition. The celiac disease community worked for those requirements understanding that the benefits would flow to them as well. 

Today, only one provision of FALCPA remains to be implemented - setting a standard for gluten-free food labeling rules. 

To help educate decision-makers about the need for this standard, the celiac disease community is taking advantage of a new forum to make sure its voice is heard loud and clear. 

A "We the People" petition was launched earlier this month, urging government officials to complete the gluten-free food labeling rules. Located on the White House website, it has already garnered 16,000 signatures, and officials will be required to respond if 25,000 signatures are gathered by Thursday, November 1st. 

We are reaching out to all stakeholders who serve the needs of those with gluten-related disorders, including patients and their families, healthcare providers and gluten-free businesses, to join us in this important effort. By adding your name, you will help to reinforce the strength of our unified voice. We aim for officials to understand that gluten-free labeling rules matter in the lives of thousands of Americans. You can help to support the government in its ruling process by signing the petition today. 

With the storm on the East coast this week, our thoughts and prayers are with our community members who are in emergency conditions. The rest of the national community will redouble efforts to shoulder the petition effort in support, and seek ways to help after the storm. 

We hope that you will take a few minutes to read and sign the petition. Once you have signed your name, we invite you to share the message with others who are committed to ensuring that individuals with celiac disease have safe gluten-free food options. Additional background can be found here.

Thank you in advance for supporting the needs of the gluten-free community and helping its members achieve optimal health.

Best,
National Foundation for Celiac AwarenessAmerican Celiac Disease AllianceCeliac Disease FoundationGluten Intolerance Group

Finalize Standards for GLUTEN-FREE Labeling

The Food Allergen Labeling and Consumer Protection Act required Health and Human Services to set a gluten-free labeling rule by 2008 to aid people with celiac disease, a life-threatening autoimmune condition. The only known treatment is a strict gluten-free diet.

An estimated 3 million Americans have celiac and even more may have non-celiac gluten sensitivity. Without adequate labeling, those on a medically prescribed gluten-free diet struggle to make safe food choices and stay well.

Children with celiac cannot participate in the National School Lunch Program when food service staff cannot determine if products are gluten-free.

Congress did its part by passing the law. It is up to the White House to protect the health of millions of adults and children by finalizing the rule NOW.

Signatures needed by November 1, 2012: 25,000

Sign the petition today: http://wh.gov/Be7R

Gluten in Medicine Identification Act

The Gluten in Medicine Identification Act of 2012 would "require the label of drugs intended for human use to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient." When the NFCA asked for our help back in May, I immediately reached out to my US Representative Carolyn Maloney asking her to support this Act. Yesterday she responded:

Dear Ms. Smith:

Thank you for contacting me in support of The Gluten in Medicine Identification Act of 2012 (H.R. 4972). As your Representative, I welcome the opportunity to respond to your inquiry.

You will be happy to know we are in compete agreement on this issue. I fully support The Gluten in Medicine Identification Act, and am one of the bill's co-sponsors. Sufferers of gluten allergies at times must wait days before a pharmacist or health professional can inform a patient if a required medicine contains ingredients derived from wheat. This is due to ambiguously labeled products that list wheat derived ingredients as "starch". The Gluten in Medicine Identification Act will amend the Federal Food, Drug, and Cosmetic Act to include a provision which requires drug manufactures to label drugs which contain gluten containing ingredients. The Gluten in Medicine Identification Act will help the millions of Americans who suffer from Celiac Disease and Non-Celiac Gluten Sensitivity who must keep to a strict gluten free diet.

Again, thank you for sharing your comments with me. Please do not hesitate to contact me if I can be of further assistance.

Sincerely,
CAROLYN B. MALONEY
Member of Congress

It is nice to know that Rep. Maloney as well as the bill's 9 co-sponsors are taking our plight to the rest of Congress. We take medicine to get better, not to get worse. Without clear labeling, Celiacs take a major risk every time they take medication that does not have a full list of ingredients. As someone that takes thyroid medicine every day, this makes me nervous. (BTW, my meds are totally safe. It says so on the insert and I have spoken to the pharmaceutical manufacturer on more than one occasion.)

Unfortunately, this bill only has a 2% chance of being enacted according to the GovTrack website. It is not too late to ask your local representative to support the Gluten in Medicine Identification Act today. The ACDA makes it easy for you to contact your Rep directly with this website: http://www.capwiz.com/celiac/issues/alert/?alertid=61277271&type=CO.

A Glimpse at 'Gluten-Free' Food Labeling from the FDA

From the FDA website: A Glimpse at 'Gluten-Free' Food Labeling

Whether in muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, says Stefano Luccioli, M.D., a Food and Drug Administration (FDA) allergist and immunologist. They need to know whether a food contains gluten.

From the FDA website: Read the rest of the article here.

---

FDA NEWS RELEASE

For Immediate Release: Aug. 2, 2011
Media Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Trade Inquiries: Stephen King, 240-402-1407, stephen.king@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reopens comment period on proposed ‘gluten-free’ food labeling rule
Rule would help by creating a uniform and enforceable definition

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.

People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the United States population is estimated to have the disease.

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.

The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.

To submit your comments electronically to the docket go to www.regulations.gov
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Include docket number FDA-2005-N-0404 on each page of your written comments.

For more information:

Federal Register Notice (scroll to FDA--temporary link will update when document publishes on Aug. 3):
http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1

Gluten-Free Portal (scroll to Gluten-Free):
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/default.htm#gluten

FDA’s Proposed Rule on the Gluten-Free Labeling of Foods: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm

Questions and Answers on the Gluten-Free Labeling Proposed Rule:
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/ucm265309.htm

Consumer Update on the Gluten-Free Labeling Proposed Rule:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA to Make Announcement TODAY Regarding Gluten-Free Food Labeling

I first saw this on the Celiac Sprue Association's Facebook page and then read it in a Delight Gluten-Free email blast this morning. Who's calling in?

FDA to Make Announcement TODAY Regarding Gluten-Free Food Labeling

WHAT: A stakeholder teleconference regarding FDA's proposed rule on gluten-free labeling of foods

WHO:
-- Michael R. Taylor, J.D., Deputy Commissioner for Foods, FDA
-- Michael M. Landa, J.D., Acting Director, Center for Food Safety and Applied Nutrition, FDA

WHEN: Tuesday, August 2, 2011 at 4:00 p.m. ET

HOW: The teleconference will be held Tuesday, August 2, 2011 from 4:00 to 5:00 p.m. ET. The toll-free number is 800-369-1976 (inside the United States) and 312-470-7298 (international). The password is CFSAN.

A replay will be available one hour after the teleconference ends until September 2, 2011. To hear the replay, callers can dial 866-415-8391. International callers will need to dial 203-369-0700.

Celiac Disease on ABCnews Health

Here is an interesting video that was posted on ABCnews Health yesterday.




Activists Protest Delayed Gluten-Free Label Standard

By JANE E. ALLEN, ABC News Medical Unit
May 4, 2011

The Food and Drug Administration has dragged its feet in setting a standard for gluten-free foods, say activists who today are assembling a one-ton, 15-foot-high gluten-free cake symbolizing how much their lives depend upon strictly avoiding a protein found in most bakery goods, pasta, beer and even some cold cuts and salad dressings.

Read on...

Take Action: Gluten-Free Legislation

There has been a lot of hype lately surrounding the lack of support from the FDA when it comes to mandatory labeling of gluten-free products. There are some fundraising events going on promoting this cause but it has been unclear to me exactly how lawmakers are directly involved with the events and where your donations are going. Raising awareness is one thing, but having a member of the government be intimately involved and actually take action is another thing. Lucky for us New Yorkers, there is some progressive action going on in our gluten-free community.

New York City Council Member Daniel Dromm has introduced two pieces of legislation concerning gluten: Int. No. 502 and Res. No. 689. The passage of these bills in New York City will hopefully increase understanding nationwide about celiac disease and the importance of proper labeling. I have included the text of these resolutions below. The latter resolution is most relevant to our NYC gluten-free community. Council Member Dromm has a very personal connection to Celiac Disease, his mother has it and so does one of his former interns.

For my readers in New York City, I encourage you to to contact your Council Members to ensure they are signed on as co-sponsors of these pieces of legislation. To figure out who represents you, constituents can go to: http://council.nyc.gov/html/members/members.shtml. I urge you all to sign up to co-sponsor this legislation. It is your right as a gluten-free American!

Thank you Council Member Dromm for proposing this legislation and for supporting the gluten-free community.


Int. No. 502
By Council Members Dromm and Cabrera

A Local Law to amend the administrative code of the city of New York, in relation to gluten and food establishments.

Be it enacted by the Council as follows:

Section 1. Chapter one of title 17 of the administrative code of the city of New York is amended by adding a new section 17-198 to read as follows:

§17-198 Posting of gluten information.
a. Definitions.
1. "Covered food service establishment" shall mean a food service establishment within the city of New York that is one of a group of 15 or more food service establishments doing business nationally, offering for sale substantially the same menu items, in servings that are standardized for portion size and content, that operate under common ownership or control, or as franchised outlets of a parent business, or do business under the same name.

2. "Food service establishment" shall have the meaning as such term is defined in section 81.03 of the health code of the city of New York, except that it shall apply exclusively to places where food is sold and space is designated specifically as an eating area.

3. "Menu" shall mean a printed list or pictorial display of a food item or items, and their price(s), that are available for sale from a covered food service establishment and shall include menus distributed or provided outside of such establishment.

4 "Menu board" shall mean any list or pictorial display of a food item or items, and their price(s) posted in and visible within a covered food service establishment or outside of a covered food service establishment for the purpose of ordering from a drive-through window.

5. "Menu item" shall mean any individual food item, or combination of food items, listed or displayed on a menu board or menu that is sold by a covered food service establishment.

6. "Food item tag" shall mean a label or tag that identifies any food item displayed for sale at a covered food service establishment.

b. Scope and applicability. This section shall apply to menu items that are served in portions the size and content of which are standardized at a covered food service establishment. This section shall not apply to menu items that are listed on a menu or menu board for less than 30 days in a calendar year.

c. Posting gluten information for menu items. All menu boards and menus in any covered food service establishment shall indicate which menu items contain gluten. Such information shall be listed clearly and conspicuously, adjacent or in close proximity to such menu items so as to be clearly associated with the menu item, using a font and format that is at least as prominent, in size and appearance, as that used to post either the name or price of the menu item.

1. Food item tags. When a food item is displayed for sale with a food item tag, any such food that contains gluten shall include that it contains gluten in a font size and format at least as prominent as the font size of the name of the food item.

2. Drive-through windows. Gluten content information at drive-through windows shall be displayed on either the drive-through menu board, or on an adjacent sign visible at or prior to the point of ordering, so long as the gluten content for each menu item is clearly and conspicuously posted on the sign adjacent to their respective menu item names on the drive-through menu board.

d. Penalties. Any covered food service establishment that violates subdivision c of this section of the code or any of the rules promulgated thereunder shall be liable for a civil penalty not to exceed one hundred dollars for each violation.

e. Instruction and testing on gluten. The department shall require instruction and testing on gluten as part of any food protection course provided pursuant to Article 81 of the health code of the city of New York.
§2. This local law shall take effect one hundred eighty days after its enactment into law, provided that, the commissioner may promulgate any rules necessary for implementing and carrying out the provisions of this section prior to its effective date.


Res. No. 689
By Council Members Dromm, Brewer, Koppell, Mendez, Nelson, Reyna, Rose, Sanders Jr., Williams and Lappin

Resolution calling on the United States Food and Drug Administration to make "gluten-free" labeling of foods mandatory.

Whereas, The number of Americans with celiac disease, a chronic inflammatory disorder of the small intestine and gluten intolerances has been estimated to be 1 in 133; and

Whereas, Celiac disease is triggered by ingesting certain proteins, commonly referred to as "gluten" which is naturally present in some cereal grains; and

Whereas, In those suffering from celiac disease gluten causes a variety of serious health problems including: iron deficiency anemia, delayed puberty, infertility, osteoporosis, hepatitis, peripheral neuropathy, ataxia, and epilepsy; and

Whereas, The United States Food and Drug Administration (FDA) proposed a rule to make "gluten-free" labeling voluntary for food product manufacturers; and

Whereas, The proposed rule seeks to define "gluten-free" for food labeling purposes in order to ensure that consumers know what is in the food products they purchase; and

Whereas, There is no regulatory definition of the term "gluten-free" in the United States; and

Whereas, However, a standardized definition of the term "gluten-free" would assist food product manufacturers by providing them with a clear definition of the term, thereby eliminating any uncertainty as to how they may label their products; and

Whereas, A standardized definition of the term "gluten-free" can serve to
protect the public health by providing consumers with celiac disease, and others who must avoid gluten in their diet, with the assurance that food products bearing this labeling meet a clear standard established and enforced by FDA; and

Whereas, For those who must closely monitor the potential use of gluten in their diets, the mandatory labeling of foods as "gluten-free" would help those individuals better regulate their diets; now, therefore, be it

Resolved, That the Council of the City of New York calls upon the United States Food and Drug Administration to make "gluten-free" labeling of foods mandatory.

The Public Health Crisis No One Is Talking About

I just got back from the Czech Republic last night. I am tired but have lots I want to share with my readers about traveling gluten-free overseas. This will come in the next few days. In the meantime, I wanted to share this article that was published on the Huffington Post while I was gone. The author, Sasha Cagen, is not only a Celiac but she is a world traveler. I love these people that embrace the gluten-free lifestyle overseas! The article is well-written and the comments are quite thought-provoking. Enjoy!

The Public Health Crisis No One Is Talking About
by Sasha Cagen

Imagine there is a food additive that slowly poisons you and can even kill you. Now imagine you have no way of knowing whether it is in your foods. Three million American celiacs and I find ourselves in this situation. We have been patiently waiting for the FDA to pass a gluten labeling law while Brazil, the European Union, and Australia acted years ago.

On May 4, activists will be baking a 12-foot gluten-free cake in Washington, DC to get the FDA and Congress to take long-overdue action on this public health crisis. It's high time the U.S. caught up with the rest of the world.

Read more...