FDA Finally Issues Definition of "GLUTEN FREE"!

FDA issued the update below DEFINING the term "Gluten Free".   As a Celiac, this is extremely exciting news! The reason this is a HUGE deal?  Us Celiac's need to know we can trust food products that are labeled "gluten free".  If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

My sincere hope is FDA will now test imported products that make "GLUTEN FREE" claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA's own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product - meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA's Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The "Compliance Date" for this final rule is August 5, 2014. If consumers see products labeled "gluten free" we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here's what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.

FDA defines “gluten-free” for food labeling
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 in the Federal Register.

TTB Issues Interim Policy for Labeling Gluten-Free Spirits

On May 24, 2012, U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages (TTB Ruling 2012-2).

Currently, there is no Food and Drug Administration (FDA) regulation that defines the term “gluten-free” (despite the GF communities outcry for one!).

FDA proposed to define gluten free as:

• an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid 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 the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
• 20 ppm or more gluten.

Pending the issuance of a final rule by FDA, TTB is providing interim guidance on the use of the term “gluten free” on alcohol beverage labels and advertisements subject to TTB’s authority. 

Alcohol Products Made from Gluten-Free Materials

TTB’s position is that the term “gluten-free” will be interpreted by consumers of alcohol beverages to mean that the product contains no gluten. TTB provided the example of wine fermented from grapes, or vodka distilled from potatoes. If there are good manufacturing practices – meaning no cross-contamination, no additives, no yeast, and no storage materials with gluten – a ‘gluten-free’ claim in the labeling of the alcohol beverage will be permissible in the interim period awaiting FDA’s final rule.

Alcohol Products Made from Gluten-Containing Materials 

FDA and TTB both assert that there are currently no scientifically valid testing methods to determine the gluten content of fermented products. This includes companies that undertake a process to remove the gluten from its alcohol beverages.

  

TTB’s position is that these methods cannot be used to substantiate a “gluten-free” claim at this time. Further, a “gluten-free” statement on labeling for a product made from gluten would be misleading.

However, the following statement is permissible: "Processed/Treated/Crafted to Remove Gluten". This statement must be accompanied with a conspicuous qualifying statement informing the consumer:

“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 -

  

“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.” 

The full interim policy can be found here. 

For more information regarding your company's strategy for remaining in compliance with FDA and TTB in order to break into the gluten-free consumer market, contact attorney Jennifer Diaz at (305) 260-1053 or by email at JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

Gluten Free Labeling is Coming - But, First, FDA Wants to Hear From YOU!!!!

Imagine a world where a manufacturer’s claims that their products are “gluten free” could be trusted by U.S. consumers.  Imagine a world where U.S. consumers were promised a definition of “gluten free” by the U.S. Food and Drug Administration (FDA), and the FDA held all manufacturers and importers to the same stringent standard….

Good news, we’re getting close!!

As of August 2, 2011, FDA has re-opened the comment period so that they can hear from YOU.  Yes, YOU!  FDA wants to hear from Celiacs, gluten sensitive consumers, et al. in the U.S.  Why, you ask?  Well, the FDA is firming up their definition of “gluten free”; and wants to know that the gluten free community is satisfied with the FDA’s finalized definition.  So, let’s make sure we tell the FDA what's important to us.  FDA has proposed a definition of "gluten free" in order for the term to be used on labeling of food products.

FDA’s proposed rule defines “gluten free” as products that do not contain:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. 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
4. 20 ppm (parts per million) or more gluten

FDA wants to hear from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days (until October 3, 2011). FDA prefers electronic comments, go to http://www.regulations.gov/ and

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”

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is tasked with making this happen, check out FDA's webpage which shows the safety assessment done to confirm 20 ppm is the correct standard to use.   

FDA held a conference call with industry, where the FDA allowed questions on opening up the comment period, and hopefully bringing truthful gluten free labeling to U.S. consumers soon.  Some questions asked where the methods in which FDA would test manufacturer’s products (answers were the Elisa R5 Mendez method, and Morinaga Method (currently used by the Japanese government for allergen labeling).  Presently, the Food Service and Products industry doesn't have to use these methods, but these are the methods FDA will use for enforcement.  

FDA is well aware that 20 ppm may not protect everyone, FDA wants your comments on this issue, what would truthful gluten free labeling be to you??  I was thinking about a range, 0-5 ppm, 5-10 ppm, 10-15 ppm, etc. to be included with “gluten free.”  FDA was also thinking about low/very low gluten labeling – but, what would be considered low?  What would be low or very low to you?  Tell the FDA!!

As far as timing goes, FDA will review the comments received, and is targeting the 3rd quarter of 2012 to publish a final rule.   

Yours truly asked the FDA about enforcement because I want to know how FDA will check on these products once these standards are implemented.  FDA advised there will be a compliance program set with the new rule, which will likely entail inspections, label review, (although I was hoping to hear about more lab testing of products).  Further, I asked about the size of FDA’s budget to assist in enforcement (once we all agree on definitions and a final rule comes to be…) but, there was no comment from the FDA on the budget to enforce (only a chuckle...).

We all think of the monsters out there who have preyed on Celiac’s/gluten free consumers, and did not in fact sell a gluten free product.  FDA will issue warning letters, seize products, issue injunctions, issue mandatory recalls, etc., when faced with manufacturers who are selling gluten free product that is NOT truly gluten free.

Let’s get to it, let’s tell the FDA you agree with 20 ppm, don’t agree, want low/very low standards (explaining what your tolerances are), or whatever your prospective may be.  FDA is listening, they want to hear from you, speak now!  You have until October 3 to have your voice heard before the final rule, and then, the hope is you will trust the products on your shelves that state, “gluten free”.