Contains Nonbinding Recommendations 
Guidance for Industry 
Gluten-Free Labeling of Foods 
Small Entity Compliance Guide 
Additional copies are available from: 
Office of Nutrition, Labeling, and Dietary Supplements 
Food Labeling and Standards Staff (HFS-820) 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-2371 
http://www.fda.gov/FoodGuidances  
You may submit either electronic or written comments regarding this guidance at any time.  
Submit electronic comments to http://www.regulations.gov.  Submit written comments on the 
guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
June 2014  Contains Nonbinding Recommendations 
 
Table of Contents  
 
I.     Introduction  
II.   Background    
III. Questions and Answers 
  2  Contains Nonbinding Recommendations 
 
 
Guidance for Industry1  
Gluten-Free Labeling of Foods  
Small Entity Compliance Guide  
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
 
 
 
I.  Introduction  
 
On August 5, 2013, FDA (or we) published in the Federal Register a final rule that established a 
regulatory definition of the term gluten-free for voluntary use in the labeling of foods (see 78 FR 
47154).  The rule implements part of the Food Allergen Labeling and Consumer Protection Act of 
2004, Title II of Public Law 108-282, enacted on August 2, 2004, which directed the Secretary of 
Health and Human Services to issue a regulation to define and permit use of the food labeling term 
gluten-free.  Firms are not required to label their foods gluten-free, but if firms whose foods are 
regulated by FDA voluntarily choose to make this labeling claim, those products must conform to our 
definition for a gluten-free food.  This final rule is intended to provide a uniform definition of the 
term gluten-free so that consumers, particularly those who have celiac disease, will know what it 
means when they see it on the labeling of food.   
 
The final rule became effective on September 4, 2013, but August 5, 2014 is the date when FDA-
regulated foods labeled gluten-free must comply with all requirements established by the final rule.  
However, we encourage manufacturers that wish to make a gluten-free claim for their foods to 
comply voluntarily before this date.   
 
We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Public Law 104-121).  This guidance document 
restates in plain language the requirements set forth in the regulation at 21 CFR 101.91 concerning use 
of the term gluten-free in the labeling of foods.  The gluten-free regulation is binding and has the 
full force and effect of law. 
                                                 
1 This guidance has been prepared by the Food Labeling and Standards Staff, Office of Nutrition, Labeling, and 
Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.   
 
  3  Contains Nonbinding Recommendations 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the 
word should in our guidances means that something is suggested or recommended, but not required.   
 
In the remainder of this guidance, you refers to entities that choose to make a gluten-free 
claim on their food labels.  We have organized this guidance in a question/answer format and 
also identify the relevant regulation in parentheses after each answer.   
  
II.  Background  
 
Celiac disease is a hereditary, chronic inflammatory disorder of the small intestines triggered by the 
ingestion of certain storage proteins, referred to as gluten, occurring in wheat, rye, barley, and 
crossbreeds of these grains.  In such individuals, the consumption of gluten stimulates the production 
of antibodies and inflammatory cells, resulting in an abnormal immune response which damages the 
tiny, fingerlike protrusions called villi, that line the small intestine and function to absorb nutrients 
from food.  Over time, continued dietary exposure to gluten can destroy the intestinal villi of 
individuals with celiac disease, leading to a lack of absorption of nutrients and a wide variety of other 
health problems.    
 
The symptoms and clinical manifestations of celiac disease are highly variable among affected 
individuals and differ in severity.  Symptoms of celiac disease may be:  (1) Classical, affecting the 
digestive tract (e.g., abdominal bloating; cramping and pain; chronic diarrhea; vomiting; constipation) 
and resulting in gastrointestinal malabsorption; or (2) atypical, affecting mainly other parts of the 
body (e.g., fatigue; irritability; behavior changes; bone or joint pain; tingling numbness in the legs; 
ulcers in the mouth; tooth discoloration or loss of enamel; itchy skin rash with blisters called 
dermatitis herpetiformis).  A large portion of the subpopulation that has celiac disease may not 
experience any symptoms at all, and these individuals are classified as having either the silent or 
latent form of celiac disease.  Persons who have the silent form of celiac disease have most of the 
diagnostic features commonly seen in individuals with classical or atypical celiac disease, such as 
specific serum antibodies and evidence of damaged intestinal villi.  Those who have the latent form of 
celiac disease have specific serum antibodies, but no evidence of damaged intestinal villi.  In addition 
to the aforementioned clinical symptoms and ailments, celiac disease is associated with a number of 
significant health problems and disorders, including iron-deficiency anemia, vitamin deficiencies, 
protein-calorie malnutrition, weight loss, short stature, growth retardation in children, delayed puberty, 
infertility, miscarriage, and osteoporosis.  Individuals with unmanaged celiac disease are at an 
increased risk of developing other serious medical conditions, such as Type I diabetes mellitus, 
intestinal cancers, and both intestinal and extraintestinal non-Hodgkin's lymphomas. 
 
Celiac disease has no cure, but individuals who have this disease are advised to avoid all sources of 
gluten in their diet.  Over time, strictly avoiding consumption of gluten can resolve the symptoms, 
mitigate and possibly reverse the damage, and reduce the associated health risks of celiac disease.  
 
III.  Questions and Answers   
  4  Contains Nonbinding Recommendations 
 
1.  Who is subject to the rule? 
 
The rule does not require anyone to use the term gluten-free on a food label.  However, if 
you choose to label your food as gluten-free, the rule defines what we mean by gluten-
free and also establishes requirements regarding the use of the claim. 
 
2.  What does the term gluten-containing grain mean?   
 
The term gluten-containing grain means wheat, rye, barley, and other grains produced by 
breeding wheat, rye, or barley with each other or breeding them with different grains.  For 
example, triticale is produced by breeding wheat with rye, and so triticale also is considered to be a 
gluten-containing grain under the rule.   
 
Specifically, the rule defines gluten-containing grain as: 
   
any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross 
between wheat and rye): 
  Wheat, including any species belonging to the genus Triticum; 
  Rye, including any species belonging to the genus Secale; or 
  Barley, including any species belonging to the genus Hordeum. 
 
(21 CFR 101.91(a)(1)) 
 
3.  What does the term gluten mean?  
 
The term gluten means the proteins that naturally occur in a gluten-containing grain and that 
may cause adverse health effects in persons with celiac disease. Examples of such proteins are 
called prolamins and glutelins. 
 
(21 CFR 101.91(a)(2)) 
 
4.  What does the food labeling claim gluten-free mean? 
   
The labeling claim that a food is gluten-free means that the food bearing the claim in its labeling 
does not contain any of the following ingredients:     
 
  An ingredient that is a gluten-containing grain;  or  
 
  An ingredient that is made from a gluten-containing grain and that has not been processed to 
remove gluten.  For example, wheat flour is an ingredient made from wheat that has not been 
processed to remove the naturally occurring gluten in wheat.  Therefore, wheat flour cannot be 
used as an ingredient to make a food labeled gluten-free; or 
 
  5  Contains Nonbinding Recommendations 
  An ingredient that is made from a gluten-containing grain and that has been processed to 
remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten. 
For example, wheat starch is an ingredient made from wheat that has been processed to 
remove gluten.  However, the use of this ingredient must result in under 20 parts per million 
gluten in the finished food for the food to be labeled gluten-free.    
 
A gluten-free claim also can appear on the labels of foods that inherently do not contain gluten 
(e.g. raw carrots and grapefruit juice).   
 
Additionally, any unavoidable presence of gluten in a food bearing a gluten-free claim, whether 
manufactured to be gluten-free or inherently free of gluten, must be below 20 ppm gluten.  This 
means that foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-
contact with gluten-containing grains or other gluten-containing ingredients.   
 
Twenty ppm gluten is a concentration level rather than an absolute quantity of gluten in a food.  It 
is equivalent to 20 milligrams of gluten per 1 kilogram (or 1000 grams (g)) of food.   
  
(21 CFR 101.91(a)(3))  
 
5. Does the rule require a gluten-free claim to appear in a particular size or color? 
 
No.  The rule does not require the claim to be in any particular size or color. 
 
6. Does the gluten-free label claim have to appear in a particular place on the food label? 
 
No.  The rule does not limit where you place the gluten-free claim on the product. 
 
7. How can I determine the gluten content of my food? 
 
The rule does not require you to use any specific method to determine a foods gluten content.  
However, there are scientifically valid methods2 that can reliably detect the presence of 20 ppm 
gluten in a variety of foods, including both raw and cooked or baked products.  For example, 
certain enzyme-linked immunosorbent assay (ELISA) based methods can be used reliably and 
consistently to detect gluten at 20 ppm levels.  These test methods are used by testing laboratories. 
 
We will use scientifically valid test methods to determine compliance with the gluten-free labeling 
requirements.  
 
8.   Am I required to test my food for gluten to make a gluten-free claim on my food labels?  
 
                                                 
2 For purposes of this guidance, a scientifically valid  method for purposes of substantiating a gluten-free claim 
for foods matrices where formally validated methods (e.g., that underwent a multi-laboratory performance 
evaluation) do not exist is one that is accurate, precise, and specific for its intended purpose and where the results of 
the method evaluation are published in the peer-reviewed scientific literature.  In other words, a scientifically valid 
test is one that consistently and reliably does what it is intended to do. 
  6  Contains Nonbinding Recommendations 
The rule does not require you to test for the presence of gluten in your starting ingredients or 
finished foods labeled gluten-free.  However, you are responsible for ensuring that foods bearing 
a gluten-free claim meet our requirements, including that any unavoidable gluten present in a food 
labeled gluten-free is less than 20 ppm.  We encourage you to use effective measures to ensure that 
any foods labeled as gluten-free comply with our requirements; such measures may include: 
 
  testing the ingredients to determine their gluten content;  
  requesting certificates of gluten analysis from ingredient suppliers; or 
  participating in a third-party gluten-free certification program. 
 
If you choose to have someone, such as a laboratory, test ingredients for their gluten content, we 
suggest that you consider whether the laboratory is capable of testing food ingredients for gluten 
and ask what type of test it uses.  For example, we are aware that the R5-Mendez Method 
(sometimes referred to as the ELISA R5 Mendez Method) and another test method known as the 
Morinaga method can be used to detect gluten in a variety of food matrices. 
 
9.  When will FDA consider a food labeled gluten-free to be misbranded? 
 
We will consider a food labeled gluten-free to be misbranded if its labeling: 
 
  States gluten-free, but the food does not meet all of our requirements for a gluten-free 
claim;  
 
  States no gluten, free of gluten, or without gluten, but the food does not meet all of 
our requirements for a gluten-free claim; or   
 
  States both gluten-free and either the term wheat appears in the ingredient list (e.g., 
wheat starch) or in a separate Contains wheat statement to meet our food allergen 
labeling requirements, but additional wording is absent that would clarify that the food still 
meets our requirements for a gluten-free claim.  In such cases when both the terms 
wheat and gluten-free are declared on the same food label, the word wheat must be 
followed immediately by an asterisk or other symbol that refers to this same asterisk or 
other symbol with the words, The wheat has been processed to allow this food to meet the 
Food and Drug Administration (FDA) requirements for gluten-free foods.  
 
(21 CFR 101.91(b)) 
 
10. Can I make a different claim, such as low gluten or very low gluten? 
 
The rule does not define terms such as low gluten or very low gluten.  If you use such claims, 
we will evaluate them, on a case-by-case basis, to determine if the claim is truthful and not 
misleading.  We discourage the use of claims other than gluten-free and will evaluate any such 
statements under sections 403(a)(1) and 201(n) of the Federal Food, Drug, and Cosmetic Act 
(which require labels to be truthful and not misleading).   
 
  7  Contains Nonbinding Recommendations 
11. What type of method will FDA use if it decides to analyze a food labeled gluten-free 
to determine if it complies with the agencys definition of gluten-free?  
 
We will use a scientifically valid method that can reliably detect the presence of 20 ppm 
gluten in a variety of food substances, including both raw and cooked or baked products.  We 
will also issue a separate proposed rule regarding the way that we intend to determine 
compliance for hydrolyzed and fermented foods wishing to make a gluten-free claim.  
 
(21 CFR 101.91(c)) 
 
12. What happens if I label my food as gluten-free and the food is not in compliance with 
the gluten-free regulation, such as it has a gluten level above 20 ppm? 
 
If you label your food as gluten-free, but it is not in compliance with the gluten-free 
regulation, such as its gluten content level is above 20 ppm, then it would be misbranded 
under the Federal Food, Drug, and Cosmetic Act, and FDA could take regulatory action.  
  8