Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Questions and Answers Regarding Food 
Allergens, Including the Food Allergen 
Labeling Requirements of the Federal 
Food, Drug, and Cosmetic Act  
 (Edition 5): Guidance for Industry 
Draft Guidance 
This guidance is being distributed for comment purposes only. 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 
within 60 days of publication in the Federal Register of the notice announcing the availability of 
the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written 
comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number FDA-2022-D-0099 listed in the notice of availability that publishes in the 
Federal Register.  
For questions regarding this draft document contact Carol DLima at the Center for Food Safety 
and Applied Nutrition (CFSAN) at 240-402-2371 or Carol.Dlima@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
November 2022  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents 
I. Introduction ............................................................................................................................... 3 
II. Questions and Answers ........................................................................................................... 5 
A. General Information ............................................................................................................... 5 
B.Types of Foods That Fall Under the Food Allergen Labeling Requirements of
the FD&C Act ............................................................................................................................. 6 
C. Food Sources ........................................................................................................................ 12 
D. The Food Allergen Labeling Requirements of the FD&C Act ............................................ 15 
E. Dietary Supplements ............................................................................................................. 21 
2  Contains Nonbinding Recommendations 
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Questions and Answers Regarding Food 
Allergens, Including the Food Allergen 
Labeling Requirements of the Federal 
Food, Drug, and Cosmetic Act  
 (Edition 5): Guidance for Industry1  
 
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.     
I.  Introduction 
As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) requires that the label of a food that is fabricated from two or more ingredients 
declare each ingredient by its common or usual name (except that spices, flavorings, and 
noncertified colors can be declared as such) (21 U.S.C. 343(i)).  However, consumers may be 
unfamiliar with the common or usual name of an ingredient and may not recognize that certain 
ingredients contain or are derived from a food allergen.  The Food Allergen Labeling and 
Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004 
and, in part, amended the FD&C Act by defining the term major food allergen (21 U.S.C. 
321(qq)) and stating that foods regulated under the FD&C Act are misbranded unless they 
declare the presence of each major food allergen on the product label using the name of the food 
source from which the major food allergen is derived.  Section 403(w)(1) of the FD&C Act sets 
forth the requirements for declaring the presence of each major food allergen on the product 
label.  In addition, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 
(FASTER Act) (Public Law 117-11) was enacted in April 2021 and, in part, amended the 
 
 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
 
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definition of major food allergen in section 201(qq) of the FD&C Act to include sesame, 
effective January 1, 2023. 
 
This is a revision of the fourth edition of a guidance document originally entitled Questions and 
Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer 
Protection Act of 2004 that contains revised and new questions and answers relating to food 
allergens, including questions and answers about FALCPA and the FASTER Act.  Editorial 
changes, such as renumbering and organizational changes have also been made in this revision.  
FDA expects to continue to issue subsequent editions of this guidance document by revising 
existing questions and answers and by adding new questions and answers.    
 
This draft guidance document accompanies the final guidance document, Questions and 
Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the 
Federal Food, Drug, and Cosmetic Act (Edition 5).  FDA is issuing this draft guidance 
document to receive comments on the new and revised questions and answers, and, as 
appropriate, will move the questions and answers to the final guidance document, after 
reviewing comments and incorporating any changes to the question and answer, when 
appropriate.  Note that a question and answer that is in the final guidance document may be 
withdrawn and moved to a new or revised draft guidance document if FDA determines that the 
question and answer should be revised in some respect and reissued in draft for comment.  A 
question and answer also may be withdrawn and removed from the guidance documents if, for 
instance, the issue addressed in the question and answer is addressed elsewhere.  For ease of 
reference, a question and answer retains the same number when it moves from the draft guidance 
document to the final guidance document and we use the term RESERVED after some 
question numbers, where appropriate, to facilitate this process. 
 
For more information related to allergens, please see 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Alle
rgens/default.htm. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 FDA guidances means that something is suggested or recommended, but not 
required.   
   
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II.  Questions and Answers 
A.   General Information  
A.1  What foods and food groups are designated as major food allergens? 
Under section 201(qq) of the FD&C Act, a major food allergen is one of the following foods, 
from one of the following food groups, or an ingredient that contains protein derived from one of 
the following: 
 
Foods  Food Groups 
Milk  Fish (such as bass, flounder, cod)  
Crustacean shellfish (such as 
Eggs 
crab, lobster, shrimp) 
Tree nuts (such as almonds, 
Peanuts 
walnuts, pecans) 
Wheat   
Soybeans   
Sesame  
 
(effective date January 1, 2023) 
 
A.2  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5).  
A.3  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
A.4  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
A.5  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
  
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B.  Types of Foods That Fall Under the Food Allergen Labeling 
Requirements of the FD&C Act 
B.1  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
B.2   Are food ingredients and finished foods subject to the food allergen labeling 
requirements of the FD&C Act?   
Yes.  Whether packaged in containers or in bulk for consumers or other food manufacturers, 
food ingredients and finished foods (including those used to make dietary supplements, such as 
liquids, solids, powders, capsules, softgels, and tablets) that contain a major food allergen must 
comply with the allergen labeling requirements of section 403(w) of the FD&C Act.  Food 
manufacturers, in particular, need to know if any major food allergens are present in the food 
ingredients they use to manufacture other products to ensure that ingredients containing major 
food allergens are properly handled and that finished product labels comply with the FD&C Act. 
 
B.3  Do the food allergen labeling requirements of the FD&C Act apply to bulk 
containers, such as reusable totes or containers of bulk food shipped for further 
processing, labeling, or repacking between manufacturers, repackers or 
distributors?  Can foods subject to these requirements be exempted through the use 
of a labeling agreement under 21 CFR 101.100(d)(2)?  
The food allergen labeling requirements of the FD&C Act apply to bulk containers such as 
reusable totes or containers of bulk food shipped for further processing, labeling, or repacking 
between manufacturers, repackers or distributors (See Figure 1 below).  While a food shipment 
may be exempt from most of the mandatory food labeling requirements through the use of a 
labeling agreement in accordance with 21 CFR 101.100(d), these regulations do not provide an 
exemption for allergen labeling requirements.  Consistent with section 403(f) and (w) of the 
FD&C Act, major food allergen information must be prominently placed on the container with 
such conspicuousness so as to render it likely to be read.  
  
 
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Figure 1. Example of a reusable tote of fish declaring the allergen in a Contains statement. 
B.4  I purchase spice mixes and seasoning mixes that might contain major food allergens 
in bulk for my food manufacturing facilities.   
(a) How do I declare spice mixes in the ingredient list of the finished product and 
how do I declare an incidental additive that might contain an allergen that is 
present in a spice mix?  
 
In general, foods that are made from two or more ingredients must declare the common or usual 
name of each ingredient contained in the food (21 CFR 101.4(a)(1)).  However, spice mixes may 
be declared simply as spices on the finished product label (21 CFR 101.4(b)(1) and 101.22(h) 
and section 403(i)(2) of the FD&C Act).  If a major food allergen might be present as an 
incidental additive in the spice mix, you still must declare it as a major food allergen (section 
403(w) of the Act).  For the finished product, you could declare it parenthetically after the term 
spice in the ingredient list, or in a separate Contains statement, or both.  See Figure 2 below 
for an example. 
 
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Figure 2. Example of a snack bag declaring the major food allergen wheat using the 
Contains statement.  In this situation, wheat flour is used as an anticaking agent in the spices 
ingredient, but it is an incidental additive in the finished chips products; therefore, since wheat is 
not declared in the ingredient list in this example, it must be declared in the Contains statement 
(section 403(w)(4) of the FD&C Act). 
(b) How do I declare seasoning mixes in the ingredient list of the finished product?  
 
A seasoning mix may contain ingredients that are not spices, e.g., salt.  Therefore, if you add a 
seasoning mix ingredient to your product, you must declare the sub-ingredients of the seasoning 
mix by their common or usual names in the ingredient list of your finished food (21 CFR 101.4).  
If major food allergens are present in the seasoning mix and the common or usual name of the 
ingredient does not include the source of the major food allergen, then you must declare the 
presence of all major food allergens in the ingredient list, the Contains statement, or both 
(section 403(w) of the FD&C Act).  See Figure 3 below. 
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Figure 3. Example of two ways the allergen can be declared on a seasoning mix packet.  The first 
is in the ingredient list and the second is in a Contains statement. 
B.5  How should sesame be declared if it is used in a spice blend? 
If sesame is used as an ingredient as part of a spice blend and is declared using the collective 
term spice or spices in accordance with 403(i) of the FD&C Act, such that its common or 
usual name does not appear in the ingredient list, it should be declared in a Contains statement 
or in a parenthetical after the collective term spice or spices in the ingredient list, i.e., 
Contains sesame or spices (sesame)2. 
 
 
2 Declaration of sesame will be required under the FASTER Act after January 1, 2023.    
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B.6  Are foods, including dietary supplements, derived from roots, leaves, stems, or bark 
of the same plant that bears tree nuts subject to the food allergen labeling 
requirements of the FD&C Act?  What about wheatgrass or coconut sugar? 
No.  Roots, leaves, stems, bark, or other parts that are distinct from the tree nut portion of the 
plant are not major food allergens.  For example, if a dietary supplement is derived from the 
leaves of the Ginkgo biloba L. plant, not the Ginkgo nut, and no other ingredients containing 
proteins derived from the Ginkgo nut or any other major food allergen were used to make 
the dietary supplement, the food allergen labeling requirements would not apply to the dietary 
supplement labeling.  In the same way, the food allergen labeling requirements would not apply 
to wheatgrass or coconut sugar from coconut sap.  
 
B.7  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
B.8  Which species of fish does FDA consider allergenic? 
For purposes of section 201 (qq) of the FD&C Act, FDA interprets fish as 
consisting of three categories:  
  Jawless fish, such as hagfish and lampreys  
  Bony fish, such as trout, flounder, bass, salmon, tilapia, cod, mackerel, 
tuna, and grouper  
  Cartilaginous fish, such as shark, rays, and skates    
 
B.9  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
B.10  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
B.11  Are pet foods or animal feeds subject to the food allergen labeling requirements of 
the FD&C Act?  
No.  FDA interprets section 403(w) of the FD&C Act to apply only to foods for human 
consumption and to not apply to pet foods or animal feeds. 
  
B.12  Are prescription or over-the-counter drugs, cosmetics, or household cleaning 
products subject to the food allergen labeling requirements of the FD&C Act?   
 
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No.  FDA interprets section 403(w) of the FD&C Act to apply only to foods intended for human 
consumption and to not apply to prescription or over-the-counter drugs, cosmetics (such as face 
powder, body lotion, or bath soap), or household cleaning products (such as laundry detergent).   
 
B.13  Are foods packaged for airline and other transportation carriers subject to the food 
allergen labeling requirements of the FD&C Act? 
Yes.  All packaged foods served or sold onboard airlines and other transportation carriers are 
subject to section 403(w) of the FD&C Act and also must comply with all other labeling 
requirements that apply to packaged foods (21 CFR parts 1 and 101) as provided under the 
FD&C Act.  Because these foods must have an ingredient list (see 21 CFR 101.4), the major 
food allergens could either be declared in the ingredient list, a separate Contains statement, or 
both.  
  
B.14  Are proteins from major food allergens, produced in other sources through the use 
of genetic engineering, subject to the food allergen labeling requirements of the 
FD&C Act?  
Yes. The FD&C Act was intended to protect people with food allergies who could not determine 
what allergens were in their foods without labeling.  Section 201(qq) of the FD&C Act (21 
U.S.C. 321(qq)) defines a major food allergen as [m]ilk, egg, fish (e.g., bass, flounder, or cod), 
Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), 
wheat, peanuts, soybeans, and sesame effective January 20233 and also as a food ingredient that 
contains protein derived from these foods.  Food ingredients that include proteins derived from a 
major food allergen (e.g., through chemical, biochemical, mechanical, fermentation, or 
bioengineering processes) may be capable of eliciting an allergic reaction and their presence is 
not obvious without declaration of the allergen.  An example of such a product would be protein 
that is derived from cow milk but produced via fermentation in a non-milk food source, such as a 
genetically engineered strain of yeast.  In this example, the protein produced by fermentation 
may be identical (or sufficiently similar) to the protein in milk such that it could be capable of 
binding to specific antibodies and causing allergic reactions to people sensitive to proteins in 
milk.  Further, these proteins are derived from major food allergens because they are produced 
in a manner that uses the major food allergens DNA sequence.  Therefore, we consider proteins 
from major food allergens, produced in other sources through the use of genetic engineering, to 
be derived from major food allergens and require allergen labeling under the FD&C Act. Such 
food ingredients should be declared in a way that makes the relationship to the source allergen 
clear. Some examples of how that could be achieved are: Contains milk-derived protein or 
[ingredient name] (milk-derived protein). 
 
 
3 Declaration of sesame will be required under the FASTER Act after January 1, 2023.  
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C. Food Sources  
The questions in this section give additional information on the terms that must be used to 
declare major food allergens on the label.  The FD&C Act requires that the name of the food 
source from which the major food allergen is derived be declared on the label as follows:  
  Milk 
  Egg 
  The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod) 
  The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp) 
  The specific type of tree nut (e.g., almond, pecans, or walnuts) 
  Wheat 
  Peanuts 
  Soybeans  
  Sesame (effective date January 1, 2023) 
 
C.1  For purposes of complying with the food allergen labeling requirements of the 
FD&C Act, what is milk?  
For purposes of the definition of a major food allergen under section 201(qq) of the FD&C 
Act, FDA has historically interpreted milk as milk from the domesticated cow.  Please also 
see question B.14. 
 
C.2  For purposes of complying with the food allergen labeling requirements of the 
FD&C Act, what are eggs?   
For purposes of the definition of a major food allergen under section 201(qq) of the FD&C 
Act, FDA has historically interpreted eggs as eggs from the domesticated chicken.  Please 
also see question B.14. 
 
C.3  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
C.4  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal 
Food, Drug, and Cosmetic Act (Edition 5). 
C.5  For the purpose of complying with the food allergen labeling requirements of the 
FD&C Act, what are tree nuts? 
 
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Under section 201(qq) of the FD&C Act, the definition of a major food allergen includes 
tree nuts (21 U.S.C. 321(qq)).  FDA is aware that there is no universally accepted botanical 
definition of the term tree nut.  Authoritative botanical references use many different 
botanical terms (e.g., berry, capsule, drupe, fruit, nut, and seed) to describe the embryo of a 
tree that can form into a dry, hard fruit considered to be a tree nut.  Sometimes multiple, 
interchangeable botanical terms are used to describe the same tree nut.   
 
In addition to the tree nuts specifically cited in the definition of major food allergen in 
section 201(qq) of the FD&C Act (i.e., almonds, pecans, and walnuts) the table below lists 
examples of other tree nuts.  We list tree nuts mentioned in the Senate Committee Report on 
FALCPA,4 tree nuts identified by other federal agencies, tree nuts commonly marketed in the 
United States, and tree nuts that have been the subject of multiple questions to FDA.  Each 
example is also recognized as a tree nut by one or more authoritative botanical references, 
and either the tree nut or its derivative (e.g., oil) has a documented history of use as a food for 
human consumption. 
 
This list is not intended to be exhaustive because hundreds of types of tree nuts exist.  Food 
manufacturers are responsible for knowing the identity and content of all ingredients they use 
to make their products and whether the ingredients are or contain tree nuts or their proteins.  
Manufacturers are also responsible for declaring the specific type of nut as required by 21 
U.S.C. 343(w)(2) and should use the common or usual name (or standardized common name 
as noted in Herbs of Commerce (21 CFR 101.4(h) for dietary supplements) listed below to 
declare the specific type of nut.   
   
 
 
4 U.S. Senate. Senate Health, Education, Labor, and Pensions Committee. Minor Use and Minor Species Animal 
Health Act of 2003. (108 S. Rpt. 226). https://www.congress.gov/congressional-report/108th-congress/senate-
report/226/1 
 
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Table 1. Examples of Tree nuts with their Common or Usual names and Scientific Names. 
Scientific name                                          
Common or usual name 
(Family name is identified in parentheses.) 
Prunus dulcis (Mill.) D.A. Webb  
Almond 
(Rosaceae) 
Fagus spp. 
Beech nut (American, European) 
(Fagaceae) 
Black walnut  Juglans nigra L. 
  (Juglandaceae) 
Bertholletia excelsa Humb. & Bonpl. 
Brazil nut 
(Lecythidaceae) 
Juglans cinerea L. 
Butternut 
(Juglandaceae)  
Juglans californica S. Watson 
California walnut  
(Juglandaceae) 
Anacardium occidentale L. 
Cashew 
(Anacardiaceae) 
Chestnut (American, Chinese,  Castanea spp. 
European/Spanish, Japanese)  (Fagaceae) 
Castanea pumila (L.) Mill. 
Chinquapin 
(Fagaceae) 
Cocos nucifera L. 
Coconut 
(Palmae (alternative name Arecaceae)) 
Cola acuminata (P. Beauv.) Schott & Endl. Or 
Cola nut/Kola nut  Cola nitida (Vent.) A. Chev. 
(Malvaceae (also placed in Sterculiaceae)) 
Corylus spp. 
Filbert/Hazelnut 
(Betulaceae) 
Ginkgo biloba L. 
Ginkgo nut 
(Ginkgoaceae) 
Juglans ailantifolia Carriere var. cordiformis 
Heartnut/Japanese walnut  (Makino) Rehder 
(Juglandaceae) 
Carya ovata (Mill.) K. Koch 
Hickory nut 
(Juglandaceae)  
Macadamia spp. 
Macadamia nut/Bush nut 
(Proteaceae) 
Elaeis spp. 
Palm nut 
(Palmae (alternative name Arecaceae)) 
Carya illinoinensis (Wangenh.) K. Koch 
Pecan 
(Juglandaceae) 
Canarium ovatum Engl.  
Pili nut 
(Burseraceae) 
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Scientific name                                          
Common or usual name 
(Family name is identified in parentheses.) 
Pinus spp. 
Pine nut/Pinon nut 
(Pineaceae)  
Pistacia vera L. 
Pistachio 
(Anacardiaceae) 
Vitellaria paradoxa C.F. Gaertn. 
Sheanut/Shea nut 
(Sapotaceae) 
Walnut (English, Persian)   Juglans regia L. 
  (Juglandaceae) 
 
The scientific names for the tree nuts included in the table further clarify their identity.  This 
list uses broad scientific categories and uses the abbreviation spp. to indicate multiple 
species within a genus that represent tree nuts known by the corresponding common or usual 
name.  However, the same genus may include other species that are not tree nuts and that 
currently have no human food use.  Therefore, the fact that a particular species falls within a 
scientific category identified on this list does not mean that the species is appropriate for 
human food use.   
 
C.6  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
C.7  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
C.8  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
D. The Food Allergen Labeling Requirements of the FD&C Act 
D.1  Where are the major food allergens required to be declared on the food label? 
The food source of a major food allergen must be declared either in the ingredient list or in a 
Contains statement printed immediately after, or adjacent to, the ingredient list (section 
403(w)(1) of the FD&C Act).  If the food source is declared in the ingredient list and a 
Contains statement is also used, then the food source of all of the major food allergens present 
in the food also are to be declared in the Contains statement, even if they are declared in the 
ingredient list (section 403(w)(1) of the FD&C Act).  See Figure 4 below. 
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Figure 4. Examples of three ways that allergens can be declared on a mock candy bar.  In the 
first candy bar, milk and soy are declared as part of the common or usual name of the 
ingredients, but wheat, egg, and peanut are not, so they are declared in parenthesis after the 
common or usual name of the ingredient.  In the second example, instead of declaring the 
allergens in parenthesis like in the first candy bar, the major food allergens are declared in the 
Contains statement.  In the third example, in the ingredient list, wheat and milk are clearly 
declared and egg is declared in parenthesis next to ovalbumin, and consumers are made aware 
that the natural flavor is made from peanuts. 
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D.2  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
D.3  Under the food allergen labeling requirements of the FD&C Act, must individual 
units within a multiunit package have a Contains statement if each unit is not 
fully labeled? 
The unit containers in a multiunit or multicomponent retail food package are exempt from 
certain labeling requirements under 21 CFR 1.24(a)(14); however, such foods are not exempt 
from allergen labeling requirements, as section 403(w) of the FD&C Act is not listed as one of 
the exempted sections in that regulation.  If the food is or contains a major food allergen, a 
Contains statement must be used (or the information can appear in the ingredient list if one is 
present).  We suggest placing the allergen information near the statement of identity in the 
absence of an ingredient list. 
 
However, no labeling is needed, including allergen labeling, if the individual unit is an 
unlabeled inner sleeve intended solely for protection of the product, such as sleeves of crackers, 
and does not contain any written, printed, or graphic matter.    
 
D.4  If an ingredient that contains a major food allergen is derived from several different 
species of the allergenic source, does each source need to be declared on the label? 
Yes.  If an ingredient is derived from several different species of an allergenic source, each 
source must be declared on the label, e.g., Fish gelatin (cod, haddock, pollock) or 
Contains cod, haddock, pollock (see section 403(w)(2) of the FD&C Act).  
 
D.5  Is the name of the food source required to be declared in the ingredient list more 
than once if the food contains multiple ingredients that are or contain the same 
major food allergen? 
No.  The name of the food source is required to be declared only once in the ingredient 
statement, even if the food contains multiple ingredients that are or contain that same major 
food allergen, unless the name of the food source that appears elsewhere in the ingredient list 
appears as part of the name of a food ingredient that is not a major food allergen (see section 
403(w)(1)(B)(ii) of the FD&C Act).  For example, both sodium caseinate and nonfat dry milk 
are derived from milk.  If the ingredient list identifies sodium caseinate and nonfat dry milk as 
ingredients, the declaration of milk as part of the common or usual name nonfat dry milk 
would be sufficient.    
 
D.6  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
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D.7  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
D.8  Lactose is a milk sugar and ghee is a milk-derived fat.  As a manufacturer, do I have 
to declare milk on the label if I use these ingredients? 
The FD&C Act requires labeling of a food or ingredient that is or contains protein from a major 
food allergen (section 403(w) and 201(qq)).  Ingredients derived from a major food allergen that 
do not contain proteins are not subject to FDAs allergen labeling requirements and would not be 
subject to the labeling requirements described in section 403(w)(1) of the FD&C Act.  If your 
major food allergen-derived ingredient is processed using technology that reliably produces a 
protein-free ingredient and you can ensure that the ingredient does not contain protein, then you 
would not have to declare the major food allergen on the label.  While lactose is a milk sugar and 
ghee is a milk-derived fat, we understand that there is commonly residual protein from milk in 
these ingredients.  When that is the case, lactose and ghee must be labeled in accordance with 
section 403(w)(1) of the FD&C Act.  However, the manufacturer may consider the Food 
Allergen Labeling Exemptions Petition and Notification process if the firm believes that their 
ingredient qualifies for an exemption from section 403(w) of the FD&C Act. 
D.9  When is a food ingredient derived from a major food allergen not subject to the 
food allergen labeling requirements of the FD&C Act?   
Food ingredients, including flavors, colors, highly refined oils, and incidental additives, derived 
from a major food allergen are not subject to the food allergen labeling requirements of the 
FD&C Act when the food ingredients do not contain a protein from the major food allergen e.g., 
highly refined soybean oil.  If the food ingredient contained such protein, then a petition or a 
notification would have to be submitted to FDA via the Food Allergen Labeling Exemptions 
Petition and Notification process in order to be exempted from the allergen labeling requirements 
of the FD&C Act.   
 
D.10  As a manufacturer, how do I label a major food allergen that is also an incidental 
additive? 
While you do not have to list incidental additives in the ingredient list (21 CFR 101.100(a)(3)), if 
an incidental additive contains a major food allergen, then you would have to declare the food 
source of the major food allergen (21 U.S.C. 343(w)(4)).  For example, if you use wheat flour on 
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the processing belt while processing rice crackers (as a processing aid), and do not declare 
wheat in the ingredient list, then you must list wheat in a Contains statement.   
 
D.11  As a manufacturer, how do I label oils derived from a major food allergen? 
The source of highly refined oils (highly refined oils are intended to signify refined, bleached, 
deodorized oils) that are derived from major food allergens are not required to be declared under 
section 403(w) of the FD&C Act.  However, under the general ingredient labeling requirements, 
the source of all oils (whether highly refined or not) must be included as part of the common or 
usual name of the oil in the ingredient list on the label (such as soybean oil) (21 CFR 
101.4(b)(14)).  If a highly refined oil is exempt from ingredient labeling because it is an 
incidental additive in accordance with 21 CFR 101.100, there is no additional allergen labeling 
requirement in the FD&C Act. 
 
If an oil that is derived from a major food allergen is not highly refined, then the source of the oil 
is required to be declared on the label in accordance with section 403(w) of the FD&C Act.  
Such labeling can be accomplished by either declaring the oil by its common or usual name in 
the ingredient list or declaring the source of the oil in a Contains statement, or both. 
 
D.12  May a Contains statement be used to alert consumers to the presence of: (a) food 
allergens other than the major food allergens defined in the Act; and (b) food 
substances that are not food allergens to which individuals may be sensitive?  
No.  The purpose of the Contains statement as required by section 403(w) of the FD&C Act is 
to declare the presence of major food allergens.  If the Contains statement was used to list: (a) 
food allergens other than the major food allergens; or (b) food substances that are not food 
allergens to which individuals may be sensitive, it may become more difficult for consumers to 
easily determine if a food contains a major food allergen, which would undermine the purpose of 
the Contains statement.  Therefore, reserving the use of the Contains statement for its 
intended purpose enhances the clarity and directness of communicating information about the 
major food allergens for allergic consumers. 
 
However, voluntary information that is truthful and not misleading may lawfully appear on the 
food label if it is consistent with other FDA labeling requirements.  Thus, manufacturers could 
include voluntary information, such as the following, that is separate from the Contains 
statement that is required by section 403(w) of the FD&C Act:   
a.  A manufacturer may alert consumers about the presence of a food allergen, other than a 
major food allergen, in a separate statement on the food label (such as Other Allergen 
Information: mustard). 
b.  A manufacturer may alert consumers about the presence of a substance other than a food 
allergen to which they may be sensitive in a separate statement on the food label (such as 
Other Information: Includes gluten) or in the ingredient list.  
 
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D.13  Is a major food allergen that has been unintentionally incorporated in a food as the 
result of cross-contact subject to the food allergen labeling requirements of the 
FD&C Act? 
No.  The food allergen labeling requirements of the FD&C Act do not apply to a major food 
allergen that is unintentionally incorporated in a food as a result of cross-contact.  In the 
context of food allergens, cross-contact occurs when an allergenic food is unintentionally 
incorporated into another food that is not intended to contain that allergenic food.  Cross-
contact may result from many causes including customary methods of growing and harvesting 
crops, as well as from the use of shared storage, transportation, or production equipment.  
 
However, allergen cross-contact is recognized as a potential hazard for consumers.  FDA has 
established requirements for food allergen preventive controls, as well as good manufacturing 
practices to protect food against food allergen cross-contact, in the Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food regulations in 21 CFR part 117.  When these measures are not able to completely 
eliminate allergen cross-contact, some manufacturers have chosen to include allergen advisory 
statements to warn consumers about potential allergen cross-contact.   
 
D.14  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
D.15  I repackage bulk ingredients for retail sale.  Sometimes I package spices and 
peanuts on the same equipment.  Can I label my product may contain peanuts? 
If you package peanuts, which are a major food allergen, and spices on the same equipment, you 
must follow current good manufacturing practices to prevent allergen cross-contact (21 CFR part 
117.10(b), 117.20(b)(2), 117.35 (d)-(f), 117.40(a)-(b), 117.80(a)-(c), 117.93)).  Food facilities 
that are subject to the preventive controls requirements in 21 CFR part 117 must conduct a 
hazard analysis and implement a food safety plan that may include allergen controls for proper 
labeling and the prevention of allergen cross-contact (see 21 CFR 117.135(c)(2) in the Current 
Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human 
Food).  While advisory labeling that is truthful and not misleading may be acceptable in certain 
circumstances, please note that advisory labels cannot be used in lieu of good manufacturing 
practices and preventive controls.   
 
D.16  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
 
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D.17  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
D.18  RESERVED  See the final guidance Questions and Answers Regarding Food 
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, 
Drug, and Cosmetic Act (Edition 5). 
E. Dietary Supplements 
E.1  What types of dietary supplement ingredients are subject to the food allergen 
labeling requirements of the FD&C Act?  
Section 403(w) of the FD&C Act applies to ingredients used to make dietary supplements that 
are or contain a major food allergen.  This includes the following types of ingredients:  
  Dietary ingredients  defined as, among other things, a vitamin, mineral, herb or other 
botanical, an amino acid, a dietary substance for use by man to supplement the diet by 
increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or 
combination of any such ingredients.  Protein, if intended for use to supplement the diet 
by increasing the total dietary intake, is an example of a dietary ingredient (see section 
201(ff) of the FD&C Act).  
  Source ingredients  an ingredient that supplies the dietary ingredient.  Sodium 
caseinate (derived from milk) is an example of a source ingredient for the dietary 
ingredient protein (see 21 CFR 101.36(d)).  
  Other ingredients  examples of ingredients other than dietary ingredients or source 
ingredients include excipients, fillers, artificial colors, artificial sweeteners, flavors, or 
binders (21 CFR 101.4(g)).   
 
E.2  When the major food allergen is already declared within the Supplement Facts 
label, must the allergen be declared elsewhere on the dietary supplements label? 
No.  We will consider the food allergen labeling requirements of the FD&C Act to be satisfied 
when the major food allergen is declared within a Supplement Facts label.  FDA regulations 
(such as 21 CFR 101.36, 101.4(a)(1), and 101.4(g) and (h)) specify how dietary supplements 
must be labeled.  When a source ingredient that supplies a dietary ingredient is identified in 
parentheses within the Supplement Facts label, or when the name of the dietary ingredient or its 
synonym is the source ingredient, it need not be repeated in the ingredient list that appears 
outside of the Supplement Facts label (see 21 CFR 101.36(d)).  The complete listing of 
ingredients may be determined by consulting both the Supplement Facts label and any ingredient 
list on the dietary supplement label.  
 
E.3  Where on the dietary supplement label should a Contains statement be printed?  
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When an ingredient list is present on the dietary supplement label, any Contains statement also 
included on the label must be printed immediately after, or adjacent to, the ingredient list (see 
section 403(w)(1)(A) of the FD&C Act).  However, when the label of a dietary supplement does 
not include an ingredient list, FDA will consider the food allergen labeling requirements to be 
satisfied if any Contains statement is printed outside and immediately after, or adjacent to, the 
Supplement Facts label. 
 
E.4  How should manufacturers label a dietary supplement when it contains a dietary 
ingredient that is or contains a major food allergen, but the name of the dietary 
ingredient does not identify the major food allergen? 
Firms may declare the food source of the major food allergen as follows to comply with section 
403(w) of the FD&C Act:    
  Parenthetically within the Supplement Facts label immediately after the name of the 
dietary ingredient.  For example, if the dietary ingredient is bovine colostrum and the 
allergen is milk, declare bovine colostrum (milk) within the Supplement Facts label; 
or 
  Parenthetically in the ingredient list (e.g., Ingredients:  bovine colostrum (milk)...); 
or  
  Separately in a Contains statement printed immediately after, or adjacent to, the 
ingredient list or the Supplement Facts label (e.g., Contains Milk). 
 
E.5  How should firms label a dietary supplement when it contains a dietary ingredient 
which has a source ingredient that is or contains a major food allergen, but the 
name of the source ingredient does not identify the name of the major food allergen? 
The firm may declare the food source of the major food allergen as follows to comply with 
section 403(w) of the FD&C Act:   
  Parenthetically within the Supplement Facts label immediately after the name of the 
source ingredient.  For example, if the source ingredient of the dietary ingredient 
protein is sodium caseinate, declare protein (as sodium caseinate) (milk) within the 
Supplement Facts label; or 
  Parenthetically in the ingredient list (e.g., Ingredients:  sodium caseinate (milk)...); 
or  
  Separately in a Contains statement printed immediately after, or adjacent to, the 
ingredient list or the Supplement Facts label (e.g., Contains Milk). 
 
E.6  For other ingredients in dietary supplements, where do firms declare the major food 
allergen?  
For other ingredients (such as an excipient, filler, binder, or flavor) that are not dietary or source 
ingredients, the food source name of the major food allergen must be declared either in an 
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ingredient list or in a separate Contains statement in accordance with section 403(w)(1)(A) of 
the FD&C Act.  
 
E.7  Must a separate Contains statement be provided on the label of a dietary 
supplement if all major food allergens are declared either within the Supplement 
Facts label or in an ingredient list? 
No.  A separate Contains statement is not needed if the major food allergens are declared 
either within the Supplement Facts label or in an ingredient list.  However, if a Contains 
statement is used, the source of all of the major food allergens in the dietary supplement are to be 
included in the Contains statement. 
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