Foods Labeled Gluten-Free Must Now be in Compliance with the FDA Gluten-Free Labeling Rule
August 5th–The compliance date for the gluten-free labeling rule has finally arrived. Here is some basic (and not so basic) information about the rule.
Section One: Summary of the Rule
1. This rule applies to the labeling of foods as packaged (including dietary supplements) regulated by the Food and Drug Administration and intended for human use.
Note: This rule does not cover pet foods, cosmetics, prescription and non prescription drugs, food regulated by the United States Department of Agriculture, and beverages regulated by the Alcohol Tobacco Tax and Trade Bureau.
2. A food voluntarily labeled gluten-free:
Is inherently gluten-free (e.g., a bag of raw carrots)
OR
Adheres to the following criteria:
- Does not contain an ingredient that is a gluten-containing grain (e.g., wheat)
- Does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour)
- May contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch) as long as use of that ingredient in the food does NOT cause the food to contain 20 parts per million (ppm) or more gluten
AND
Any unavoidable presence of gluten in the food is less than 20 ppm gluten.
Note: The FDA states in the Executive Summary of the rule that, “Manufacturers making a gluten-free claim must ensure that foods do not contain 20 ppm or more gluten, including the unavoidable presence of gluten due to cross-contact or migration from packaging materials.”
3. Terms FDA considers synonymous with “gluten-free” when used on a food label are:
- “No gluten”
- “Free of gluten”
- “Without gluten”
Food labels making the above claims must comply with the gluten-free labeling rule.
Note: The statements, “made with no gluten-containing ingredients” and “not made with gluten-containing ingredients” are allowed statements on food labels and these products do NOT have to comply with gluten-free labeling rules UNLESS a gluten-free claim also is made.
4. If a food is labeled gluten-free and also includes the word “wheat” in the ingredients list or Contains statement due to the use of ingredients such as “wheat starch” (which may contain residual wheat protein) the word “wheat” must be followed by an asterisk leading to another asterisk and the statement, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”
Note: This stipulation applies to ingredients in an FDA-regulated food as outlined in the Food Allergen Labeling and Consumer Protection Act. This stipulation does NOT apply to voluntary allergen advisory statements (e.g., processed in a facility that also processes wheat) related to manufacturer processing practices. These statements may be included on foods labeled gluten-free without additional clarifying language. However, foods with allergen advisory statements for wheat that also are labeled gluten-free must comply with the gluten-free labeling rule (e.g., they must contain less than 20 ppm gluten).
For more information on the gluten-free labeling rule please see the following FDA resources:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm402549.htm
Section Two: Questions & Answers Related to the Gluten-Free Labeling Rule
Q1: Are foods regulated by the USDA and alcoholic beverages regulated by the TTB covered by the FDA gluten-free labeling rule?
A1: No. The USDA regulates meat products, poultry products, egg products (dried, frozen, or liquid eggs, with or without added ingredients), and mixed food products that generally contain more than 3% raw meat, or 2% or more cooked meat or poultry meat. The easiest way to tell whether a product is regulated by the USDA is to look for the egg products shield or the USDA mark of inspection on product packaging.
However, it appears likely that foods regulated by the USDA that are labeled gluten-free are voluntarily following the FDA’s gluten-free labeling rule. A few years ago I was told the following about gluten-free labeling via email correspondence with the USDA (this information was reconfirmed as accurate on August 29, 2013 by FSIS), “FSIS is not planning at this time to conduct rulemaking to define ‘gluten free.’ Rather, once FDA’s final rule becomes effective, if a meat, poultry, or egg product establishment chooses to make the claim ‘gluten free’ they will need to follow the requirements for the use of the claim in FDA’s regulations. This is similar to what FSIS has required when establishments choose to make health claims and label trans-fat on meat, poultry, and egg products (i.e., FSIS allows the use of FDA regulated health claims and the declaration of trans-fat on labels provided the establishments follows FDA’s regulations). This would ensure consistency for the use of the claim ‘gluten free’ across all food groups for consumers. FSIS will clarify this position through policy guidance published on its web-site.” To the best of my knowledge, a policy guidance document on gluten-free labeling has not yet been posted on the FSIS website.
In addition, foods regulated by the USDA and labeled gluten-free must undergo a label approval process. Information regarding gluten-free claims can be found in the USDA’s final rule on generic labeling. The claim gluten-free is considered a “negative claim” and as such is still subject to label approval. In addition, the USDA states the following in the online question and answer document on generic labeling:
“If there is a formulation change to a label that was previously approved with a special claim such as “natural”or “gluten free,” will the label need to be re-submitted for approval?
In this case, the label would need to be resubmitted if the change involved the addition of a new ingredient not listed in the formula of the previously approved label. LPDS would need to evaluate the addition of a new ingredient to verify whether the product continues to qualify for the natural or gluten free claim. If no new ingredients are added and ingredients in the formula are only being removed or changing in order of predominance, the label does not need to be resubmitted and may be generically approved.”
For more information on USDA labeling, see http://www.glutenfreedietitian.com/newsletter/2009/11/11/labeling-of-usda-regulated-foods-straight-from-the-usda/
For more information on USDA’s updated label approval process, see http://www.gpo.gov/fdsys/pkg/FR-2013-11-07/html/2013-26639.htm
The FDA’s gluten-free labeling rule also does not cover alcoholic beverages regulated by the TTB. The TTB regulates almost all alcoholic beverages–all distilled spirits, wines that contain 7% or more alcohol by volume, and malt beverages (e.g., beer) that are made with BOTH malted barley and hops.
BUT the TTB actually has an interim definition of gluten-free that is stricter than the FDA gluten-free labeling rule. In January of 2014, the TTB issued an updated interim policy on gluten-free labeling of alcoholic beverages under its jurisdiction. Under the interim policy, the TTB:
- Will not allow gluten-free claims to be included on product labels or in product advertising if the alcohol is made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains.
- Will allow gluten-free claims on products labels and in advertisements if the alcohol is made without wheat, barley, rye, or crossbred varieties of these grains OR ingredients derived from these grains. BUT producers must ensure that their raw ingredients and finished products (among other things) are NOT cross-contaminated with gluten.
- Will allow the statement, “Processed or treated or crafted to remove gluten” for products made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains IF these grains or ingredients have been processed (or treated or crafted) to remove all or some of the gluten IF
- One of the following statements is also included on the product label or in the advertisement:
- “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.”
- One of the following statements is also included on the product label or in the advertisement:
In addition, all alcoholic beverages regulated by the TTB must go through a label approval process.
For more information on beers processed to remove gluten, please see https://www.glutenfreewatchdog.org/reports/Gluten_Removed_Barley_Based_Beers_Jan_14.pdf
For more information on the TTB’s revised interim rule see http://www.ttb.gov/rulings/2014-2.pdf
Q2: Must manufacturers who label foods gluten-free test these foods for gluten?
A2: NO.
Q3: If the FDA tests food for gluten as part of rule enforcement what tests will they use?
A3: At present the FDA states that they will use two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods (R5 ELISA from R-Biopharm and Wheat Protein ELISA Kit (gliadin) from Morinaga).
Q4: How is the FDA handling foods that are hydrolyzed or fermented or made using hydrolyzed or fermented ingredients?
A4: The FDA is planning rule-making for gluten-free claims on fermented or hydrolyzed foods or foods that use fermented or hydrolyzed ingredients. In the meantime, the FDA is allowing gluten-free claims on these products provided they meet all of the requirements for bearing a gluten-free claim even though the gluten content cannot be reliably measured.
Note: This provision applies to fermented or hydrolyzed ingredients derived from gluten-containing foods and ingredients that have been processed to remove gluten, such as wheat starch hydrolysates (e.g., wheat-based glucose syrup, wheat-based maltodextrin). It does not apply to ingredients derived from gluten-containing grains that have not been processed to remove gluten (e.g., malt, malt extract, malt syrup).
For information on what the FDA has to say about the use of malt in labeled gluten-free foods, see https://www.glutenfreewatchdog.org/blog/Boulder-Canyon-Chips–FDA-Webinar-Statement-on-Use-of-Malt-Extract-in-Gluten-Free-Foods/33
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Detailed background information on testing hydrolyzed and fermented foods (please skip the area between the dotted lines if you are not interested in the science)
What is known as a sandwich ELISA is used to assess the gluten content of foods when the gluten protein is intact or relatively intact. With this type of assay, two epitopes or antibody binding sites are needed. When an ingredient or food is hydrolyzed or fermented the gluten protein is broken into smaller protein fragments. These peptides may no longer contain two epitopes. As a result gluten content may be underestimated if the food is assessed using a sandwich ELISA.
For example consider the following protein where “QQPFP” represents the epitope and “a” represents other amino acids:
aaaaaQQPFPaaaaaaaaaaaaaaaQQPFPaaaQQPFPaaaaaaQQPFP
If this protein undergoes hydrolysis, the following three fragments may result:
1. aaaaaQQPFP
2. aaaaaaaaaaaaaaaQQPFPaaaQQPFP
3. aaaaaaQQPFP
The sandwich R5 ELISA (which utilizes the R5 monoclonal antibody to the epitope QQPFP) would be unable to measure the first or the third protein fragments because these peptides contain only one QQPFP epitope. Only the second protein fragment would be measured by the sandwich R5 ELISA.
When only one epitope or antibody binding site is available (which may be the case when ingredients/foods are fermented or hydrolyzed) a competitive ELISA (e.g., competitive R5 ELISA) should be used.
BUT the FDA does not consider these methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with the gluten-free labeling rule. The agency states, “Evidence in the scientific literature is currently lacking about a scientifically valid competitive ELISA method which confirms that any gluten peptides detected in a food sample can be accurately quantified in terms of ppm intact gluten protein.”
The AACC International recently published a technical report on the findings of a collaborative study on the competitive R5 ELISA. One of the study authors sent me a pre-print version of the paper. This international collaborative study to validate the competitive R5 ELISA (Ridascreen Gliadin Competitive R7021, R-Biopharm) was jointly run by the Prolamin Working Group and AACCI. This multi-lab performance trial involved 16 labs and 7 foods/beverages. By means of comparison, when the sandwich R5 ELISA (Ridascreen Gliadin R7001, R-Biopharm) was validated in a collaborative trial with the Prolamin Working Group, 20 labs and 12 food samples were involved. To the best of my knowledge neither the FDA nor the TTB has commented publicly on this collaborative trial.
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Q5: Is food served in restaurants covered by the gluten-free labeling rule?
A5: No. The FDA gluten-free labeling rule applies only to packaged foods. However, the FDA strongly encourages restaurants that choose to use the federally defined claim “gluten-free” on restaurant menus to comply with the criteria of the rule. Consumers are encouraged to continue to ask questions when they dine out, including inquiring about the steps a restaurant takes to decrease/prevent cross contact with gluten-containing foods.
For more information on restaurants and the gluten-free labeling rule, please see http://www.glutenfreedietitian.com/newsletter/2014/01/28/restaurants-and-gluten-free-labeling-claims/
Section Three: Compliance
I have written an entire post on issues related to compliance and reporting possible misbranded products to the FDA. Please see https://www.glutenfreewatchdog.org/blog/Action-Alert-Notifying-the-FDA-about-Misbranded-Gluten-Free-Products/37
Section Four: My thoughts…
There are several parts of the Gluten-Free Labeling Rule and Executive Summary of the rule that in my opinion require further guidance from the FDA, including (but by no means limited to):
- Providing examples of ingredients not processed to remove gluten. The only example provided in the final rule is wheat flour.
- Providing examples of ingredients processed to remove gluten. The only example provided is wheat starch.
- Clarifying which hydrolyzed and fermented ingredients may be included in labeled gluten-free foods while the FDA rule making on foods containing fermented and hydrolyzed ingredients is pending.
Just a word about the 20 ppm gluten threshold…
Some of you may have been hoping for a lower gluten threshold level. If so, please take comfort in the results of gluten testing on labeled gluten-free foods that we are seeing at Gluten Free Watchdog. For details, see the study published in Practical Gastroenterology http://www.medicine.virginia.edu/clinical/departments/medicine/divisions/digestive-health/nutrition-support-team/nutrition-articles/Parrish_Oct_13%20-2.pdf
Watch for a more extensive study on the gluten content of labeled gluten-free foods.
© August 5, 2014 by Tricia Thompson, MS, RD. All Rights Reserved. No part of this article may be reprinted without the express written permission of Tricia Thompson.
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