Sec. 555.250 Major Food Allergen 
Labeling and Cross-contact 
Draft Compliance Policy Guide 
Guidance for FDA Staff 
This draft compliance policy guide is being distributed for comment purposes only. 
Although you can submit 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10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before 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comments on the draft guidance within 60 days of publication in the Federal Register of 
the notice announcing the availability of the draft guidance.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 the 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-2023-D-1103 listed in the notice of availability that publishes in the Federal 
Register. 
For questions regarding this draft document contact the Center for Food Safety and 
Applied Nutrition (CFSAN) at CFSANCompliancePolicy@FDA.HHS.GOV. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Office of Regulatory Affairs 
May 2023  Contains Nonbinding Recommendations              
Draft  Not for Implementation 
 
 
Table of Contents 
 
I. Introduction ----------------------------------------------------------------------------------------- 3 
II. Background ---------------------------------------------------------------------------------------- 3 
III. Policy ---------------------------------------------------------------------------------------------- 8 
IV. Regulatory Action Guidance ------------------------------------------------------------------- 9 
V. Specimen Charges ------------------------------------------------------------------------------ 13 
   
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Sec. 555.250 Major Food Allergen Labeling 
and Cross-contact 
Draft Compliance Policy Guide 
Guidance for FDA Staff 
 
This draft guidance, when finalized, will represent the current thinking of the Food and 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 
 
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff 
on FDAs enforcement policy regarding major food allergen labeling and cross-contact.  
See section II.B for more information about major food allergens, which are defined in 
section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
321(qq)).  
 
In general, FDAs guidance documents do not establish legally enforceable 
responsibilities.  Instead, guidances describe FDAs 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. 
 
II. Background 
 
A. Food Allergies 
 
Food allergies affect millions of Americans and their families.  Each year, FDA receives 
reports about consumers who experienced adverse reactions following exposure to 
hazards posed by food allergens.  A food allergen is the food or component(s) (often a 
protein) of a food that elicit specific immunologic reactions.  Food allergies are abnormal 
responses of the immune system to foods that most individuals can eat safely.  While 
many different types of food allergies have been identified, food allergies that are 
recognized to be the most severe and immediately life-threatening are those that are 
mediated by immunoglobulin E (IgE) antibodies.  
 
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Adverse allergic reactions may result from a single eating occasion of the food allergen 
and can vary in severity from self-limiting gastrointestinal symptoms or skin rashes to 
severe symptoms of anaphylaxis, which may include wheezing, laryngeal edema, and/or 
shock and can be fatal. There are currently no effective treatments for preventing all 
allergic reactions from food allergen exposures; thus, to prevent adverse health 
consequences, food allergic consumers need to be able to identify and avoid food allergen 
hazards.       
 
B. Definition of Major Food Allergens 
Section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defines a major food 
allergen, in part, as any of the following: 
milk,  
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. 
 
Section 201(qq)(2)(A) of the FD&C Act (21 U.S.C. 321(qq)(2)(A)) excludes highly 
refined oils1 derived from one of the major food allergens and any ingredient derived 
from highly refined oils from the definition of major food allergen.  Also, raw 
agricultural commodities such as fresh fruits and vegetables in their natural state are not 
subject to the allergen labeling requirements under section 403(w) of the FD&C Act (21 
U.S.C. 343(w)).   
 
Section 201(qq)(2)(B) of the FD&C Act (21 U.S.C. 321(qq)(2)(B)) excludes a food 
ingredient that is exempt under sections 403(w)(6) and (7) of the FD&C Act (21 U.S.C. 
343(w)(6) and (7)) from the definition of major food allergen.  Under section 403(w)(6) 
of the FD&C Act (21 U.S.C. 343(w)(6)), a person may submit a petition to FDA to 
exempt a food ingredient from the allergen labeling requirements.  The burden is on the 
petitioner to provide evidence that the food ingredient does not cause an allergic response 
that poses a risk to human health (403(w)(6)(C) of the FD&C Act (21 U.S.C. 
343(w)(6)(C))).  Under section 403(w)(7) of the FD&C Act (21 U.S.C. 343(w)(7)), a 
person can file a notification establishing that the food ingredient does not contain 
 
1 The Senate Report 108-226 that accompanied the Food Allergen Labeling and Consumer Protection Act 
of 2004 stated that highly refined oils are intended to signify refined, bleached, deodorized oils.  Senate 
Report 108-226 is available at: https://www.congress.gov/congressional-report/108th-congress/senate-
report/226 
 
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allergenic protein.  Food allergen petitions2 and notifications3 submitted under sections 
403(w)(6) and (7) of the FD&C Act (21 U.S.C. 343(w)(6) and (7)) and FDAs responses 
are posted on FDAs website.   
 
C. Labeling Requirements Applicable to Major Food Allergens4 
 
Major food allergens used as ingredients in packaged foods and regulated under the 
FD&C Act must be declared by the name of the food source from which the major food 
allergen is derived either in the ingredient list or the Contains statement (section 
403(w) of the FD&C Act (21 U.S.C. 343(w))).  The ingredient list on a food label is the 
listing of each ingredient in descending order of predominance by weight (21 CFR 
101.4).  The name of the food source from which the major food allergen is derived 
means the name described in section 201(qq)(1) of the FD&C Act (21 U.S.C. 
321(qq)(1)), provided that, in the case of a tree nut, fish, or Crustacean shellfish, the term 
means the name of the specific type of nut or species of fish or Crustacean shellfish 
(section 403(w)(2) of the FD&C Act (21 U.S.C. 343(w)(2))).  The use of both the 
ingredient list and the Contains statement for declaration of the presence of major food 
allergens is limited to major food allergen ingredients in a food.  
 
For food that is made from two or more ingredients, the label must bear the common or 
usual name of each such ingredient (section 403(i)(2) of the FD&C Act (21 U.S.C. 343 
(i)(2))).  For major food allergens, if the common or usual name of the ingredient does 
not include the name of the food source from which the major food allergen is derived, 
food allergen labeling requirements may be met if the name of the ingredient is followed 
in parenthesis by the name of the food source, e.g., whey (milk).  However, the name 
of the food source is not required when the common or usual name of the ingredient uses 
the name of the food source from which the major food allergen is derived (e.g., 
buttermilk) or if the name of the food source appears elsewhere in the ingredient list as 
part of the name of a food ingredient that is a major food allergen (e.g., whey would not 
need to include (milk) in the ingredient list if buttermilk is listed as another ingredient) 
(section 403(w)(1)(B) of the FD&C Act (21 U.S.C. 343(w)(1)(B))).  
 
The food allergen labeling requirements also may be met by using a Contains statement 
immediately after or adjacent to the ingredient list with the name of the food source from 
which the major food allergen is derived (section 403(w)(1)(A) of the FD&C Act (21 
U.S.C. 343(w)(1)(A))).  If a Contains statement is used on a food label, then the food 
 
2 Inventory of petitions received under section 403(w)(6) of the FD&C Act (21 U.S.C. 343(w)(6)) for 
exemptions from food allergen labeling, available at: Inventory of Petitions Received under 21 U.S.C. 
343(w)(6) for Exemptions from Food Allergen Labeling | FDA.  
3 Inventory of notifications received under section 403(w)(7) of the FD&C Act (21 U.S.C. 343(w)(7)) for 
exemptions from food allergen labeling, available at: https://www.fda.gov/food/food-labeling-
nutrition/inventory-notifications-received-under-21-usc-343w7-exemptions-food-allergen-labeling. 
4 For more information on food allergens, including labeling requirements, see FDA Guidance for Industry: 
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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source of all major food allergens present in the food are to be declared in the Contains 
statement, even if they are already declared in the ingredient list.5   
 
With some exceptions, FDA regulations allow the use of collective terms for specific 
ingredients and exempt the labeling of incidental additives in the ingredient list.  For 
example, spices, natural flavor, and artificial flavor may be declared using a collective 
term (e.g., spice, natural flavor, or artificial flavor, respectively) without 
identifying the particular spice or flavor (21 CFR 101.22(h)(1)).  Additionally, some 
colorings may be declared using a collective term, e.g., Color Added (see 21 CFR 
101.22(k)(2)).  Incidental additives that are present in a food at insignificant levels and do 
not have any technical or functional effect in that food are exempt from the ingredient 
declaration requirements (see 21 CFR 101.100(a)(3)).  However, a flavoring, coloring, or 
incidental additive that is, or that bears or contains, a major food allergen is subject to the 
labeling requirements of section 403(w) of the FD&C Act (21 U.S.C. 343(w)); therefore, 
in such cases, the label must identify the food source of the major food allergen, e.g., 
natural flavor (milk) (section 403(w)(4) of the FD&C Act or 21 U.S.C. 343(w)(4)).  
Additionally, 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 section 403(i) of the 
FD&C Act, such that its common or usual name does not appear in the ingredient list, it 
is to 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).  
 
D. Allergen Cross-contact and Manufacturing Requirements Applicable to 
Preventing Cross-contact due to Major Food Allergens 
 
Allergen cross-contact is the unintentional incorporation of a food allergen into a food as 
defined in FDAs rule titled, Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food in 21 CFR part 117 (part 117).  
Part 117 defines food allergen to mean a major food allergen as defined in section 
201(qq) of the FD&C Act (21 U.S.C. 321(qq)).  Allergen cross-contact occurs between 
foods that have different food allergen profiles (i.e., the food allergen sources present or 
absent in a food).   
 
Allergen cross-contact may occur due to practices such as failure to adequately clean 
shared equipment, failure to properly segregate allergens, improper rework addition, or 
improper production scheduling.  The likelihood of unintended allergen presence (i.e., 
presence of an allergen due to cross-contact) can be impacted by various factors, such as 
the characteristics of the food, the distribution of the allergen within a food 
(homogeneous versus particulate), the type of manufacturing process, equipment used, 
and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning).  
 
 
5 FDA may regard a product to be misbranded under section 403(a)(1) of the FD&C (21 U.S.C. 343(a)(1)) 
when the food source of all major food allergens used as ingredients are declared in the ingredient list but 
the Contains statement also present on the label does not list the food source of all major food allergens. 
See section III.C. (Incomplete or inconsistent allergen information).  
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The food allergen labeling requirements of the FD&C Act only apply to a major food 
allergen that is an ingredient of the product (see Section II. C).  Major food allergens 
unintentionally incorporated into a food are not to be declared in the ingredient list or the 
Contains statement.  Instead, firms must comply with applicable requirements to 
address allergen cross-contact.  Part 117 establishes requirements applicable to 
establishments that manufacture, process, pack, or hold human food.  Part 117 includes 
current good manufacturing practice (CGMP) requirements (primarily in subpart B, with 
associated requirements in subparts A and F) to prevent allergen cross-contact.  Part 117 
also establishes specific requirements (commonly called preventive controls 
requirements; primarily in subparts C and G, with associated requirements in subparts 
A, D, E, and F) for domestic and foreign facilities that are required to register under 
section 415 of the FD&C Act (21 U.S.C. 350d) to establish and implement hazard 
analysis and risk-based preventive controls for human food as mandated by section 418 
of the FD&C Act (21 U.S.C. 350g).  With a few exceptions, these preventive controls 
requirements specify that food facilities must implement a food safety plan that includes 
a hazard analysis to identify known or reasonably foreseeable hazards that require a 
preventive control (see 21 CFR 117.126).  Preventive controls must significantly 
minimize or prevent hazards (see 21 CFR 117.135).  When a hazard requiring a 
preventive control is a major food allergen, preventive controls must ensure that the food 
manufactured, processed, packed, or held by the facility will not be adulterated under 
section 402 of the FD&C Act (21 U.S.C. 342(a)) or misbranded under section 403(w) of 
the FD&C Act (21 U.S.C. 343(w)) (see 21 CFR 117.135).  For example, inadequate 
sanitation control, such as failure to adequately clean shared equipment between 
production runs of products with different allergen profiles to significantly minimize or 
prevent allergen cross-contact, may render the product adulterated under section 
402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)).  As another example, inadequate 
allergen label controls, such as failure to check the product label to ensure major food 
allergen ingredients intended to be in the food are labeled as required, may result in a 
product misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)).  
 
Part 117 provides for several exemptions from the preventive controls requirements.  For 
example, the preventive controls requirements do not apply to a facility that is a qualified 
facility as defined in part 117 (see 21 CFR 117.5(a)).  As another example, the preventive 
controls requirements do not apply with respect to activities that are subject to hazard 
analysis and critical control point (HACCP) requirements in 21 CFR part 120 (for juice) 
or 21 CFR part 123 (for seafood) if a facility is required to comply with, and is in 
compliance with, 21 CFR part 120 or 21 CFR part 123, respectively, with respect to such 
activities (see the exemptions in 21 CFR 117.5(b) and (c)).  However, qualified facilities 
and juice and seafood processors must address major allergens cross-contact through the 
application of CGMPs (see 21 CFR 117 subpart B).  Juice and seafood processors should 
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also consider allergen cross-contact under the standard sanitary operational procedures or 
in the HACCP plan under 21 CFR parts 120 and 123, respectively.6  
 
E. Voluntary Allergen Information on Food Products (e.g., Allergen Advisory 
Statements and Allergen-free Claims.) 
 
Separate from the food allergen labeling requirements of the FD&C Act, firms may 
voluntarily place other information or statements on the labels of food products to 
disclose information about allergens to consumers.  For example, firms may choose to 
voluntarily place allergen advisory statements7 on products to alert consumers to the 
possible presence of major food allergens due to cross-contact.  Some examples of 
allergen advisory statements include, may contain [allergen], or produced in a facility 
that also uses [allergen].  Allergen advisory statements are not a substitute for adherence 
to current good manufacturing practices and, when used by a facility, food allergen 
preventive controls.  In addition, any allergen advisory statement must be truthful and not 
misleading (section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1))).   
 
Firms also may place voluntary statements to provide information to consumers that 
certain allergens are absent from the product (e.g., allergen-free claim).  Other than the 
term gluten-free which is defined in 21 CFR 101.91,8 there are no regulations defining 
specific conditions (e.g., allergen levels) for a product to make a free claim from a 
major food allergen source.  If voluntary allergen-free claims are used, they must be 
truthful and not misleading in accordance with section 403(a)(1) of the FD&C Act (21 
U.S.C. 343(a)(1)).  For example, if a product label or labeling were to have a milk-free 
or similar claim, FDA would expect there to be no milk allergen in the product.  
 
III. Policy 
 
Allergen violations may be due to failure to meet allergen labeling requirements, lack of 
adequate controls to significantly minimize or prevent allergen cross-contact, or 
incomplete or inconsistent allergen information on the label.  Our regulatory approach in 
addressing allergen violations will be case-by-case and dependent on the facts of each 
situation.  
 
A. Undeclared allergen/misbranding: 
 
FDA generally regards a product to be misbranded under section 403(w) of the FD&C 
Act (21 U.S.C. 343(w)) when: 
 
6 For additional information, see FDA guidance documents: Guidance for Industry: Juice Hazard Analysis 
Critical Control Point Hazards and Controls Guidance, First Edition; Guidance for Industry: Juice HACCP 
and the FDA Food Safety Modernization Act; Fish and Fishery Products Hazards and Controls, Fourth 
Edition; and Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act 
7 Allergen advisory statements are also known as precautionary allergen labeling (PAL). 
8 Enforcement policy related to the gluten-free labeling requirements (21 CFR 101.91) is outside the scope 
of this CPG.  
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The food is formulated to contain a major food allergen as an ingredient and fails 
to declare on the label the major food allergen by the name of the food source 
from which the major food allergen is derived in either the ingredient list or the 
Contains statement as required. 
 
FDA generally regards a product to be misbranded under section 403(i)(2) of the FD&C 
Act (21 U.S.C. 343(i)(2)) when: 
The food is fabricated from two or more ingredients but fails to declare on the 
label the common or usual name of the ingredient in the ingredient list as 
required.  
 
B. Allergen cross-contact/adulteration: 
  
FDA generally regards a product to be adulterated under section 402(a)(4) of the FD&C 
Act (21 U.S.C. 342(a)(4)) when case-by-case review of the evidence, including 
inspectional evidence or other information, demonstrates that allergen cross-contact may 
render the product injurious to health.  
 
When there is evidence of inadequate allergen cross-contact controls, FDA may deem a 
product adulterated under section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), even 
when the product bears an allergen advisory statement.  
 
C. Incomplete or inconsistent allergen information/misbranding:  
 
FDA generally regards a product to be misbranded under section 403(a)(1) of the FD&C 
Act (21 U.S.C. 343(a)(1)) when case-by-case review of the evidence shows incomplete or 
inconsistent product information regarding major food allergens to be false or misleading. 
 
IV. Regulatory Action Guidance 
 
A. General Approach 
 
The discussion in this section represents criteria for recommending domestic or import 
regulatory action to CFSAN, Office of Compliance, Division of Enforcement (HFS-605), 
the Office of Regulatory Affairs (ORAs) Office of Human and Animal Food Operations 
(OHAFO), or the Office of Import Operations (OIO).  When appropriate, FDA staff 
should consult CFSAN through the Office of Compliance, Compliance Policy Staff 
(HFS-605) for questions relating to allergen health hazard.9 
 
 
9 FDA has not established a threshold for any major food allergen.  However, FDA recognizes that 
published data on population threshold dose responses to various food allergens are becoming available and 
that these published data are beginning to raise the possibility that some low-level exposures to some major 
food allergens may not pose a health hazard to the majority of food allergic individuals.  
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If an allergen misbranding or adulteration situation presents a reasonable likelihood of 
serious adverse health consequences or death to humans or animals, immediate action to 
remove the food from commerce should be considered.  If the firm does not initiate a 
voluntary recall, FDA will consider other appropriate actions to remove product from 
commerce, such as mandatory recall or administrative detention.  When appropriate, 
FDA may also consider suspension of facility registration.  
 
Field staff should pay particular attention to situations where allergens are added as 
intended ingredients of food but not declared on the label as required, or situations where 
allergen cross-contact may occur because of poor CGMPs, inadequate preventive 
controls, or inadequate controls under the juice or seafood HACCP regulations.  
 
If the origin of allergen presence or possible presence (e.g., detected by testing or 
suspected because of adverse consumer reaction(s), respectively) in the product is not 
known, it may be necessary to follow up with the firm to obtain additional information 
(e.g., product formulation, ingredient information, and information about other products 
made on the same line or in the same process environment) to understand whether the 
allergen was added as an intended ingredient or was present due to cross-contact. 
 
Field staff should also contact CFSAN/Office of Compliance/Division of Enforcement if: 
1) the label includes incomplete or inconsistent allergen information; or 2) the firm 
provides information (e.g., notification or petition for exemption from food allergen 
labeling) to justify not labeling major food allergens.  
 
When appropriate, important information to be collected and sent to CFSAN for review 
includes: 
 
  Product label (all sides), including the statement of identity, ingredient list, 
Contains statement, any voluntary statements (e.g., allergen advisory 
statement,10 and allergen-free claims), serving size, and net quantity statement; 
 
  Pictures of product with and without packaging;  
 
  Relevant product formulation and processing information; 
 
  FDA or state inspectional evidence or compliance actions, including historical 
information if appropriate; 
 
  Analytical testing results (e.g., testing done by FDA, state, firm, or private labs) 
and information related to the testing (e.g., methodology, sample description, 
 
10 While allergen advisory statements are not the same as allergen labeling, survey data in North America 
suggest that these statements may deter some food allergic consumers from consuming the product. Thus, 
presence of allergen advisory statements may be considered a health risk mitigating factor when allergen 
cross-contact is appropriately managed consistent with CGMPs, preventive controls, or other controls (e.g., 
HACCP). 
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number and size of samples taken, lot information, location of the sample taken, 
and likely source of allergen);  
 
  Information or evidence submitted by firm (e.g., product information, 
manufacturing information, health hazard information, or risk assessment); and/or 
 
  Consumer adverse reactions, complaints, or other issues about the product 
reported to FDA by the firm, consumers, or other stakeholders. 
 
B. Undeclared allergen/misbranding 
 
Labeling violation occurs when the food is formulated to contain a major food allergen as 
an ingredient and the label does not declare the major food allergen in either the 
ingredient list or in a Contains statement in accordance with section 403(w) of the 
FD&C Act (21 U.S.C. 343(w)).  Examples may include:  
 
  The product label declares an ingredient (e.g., whey) derived from a major food 
allergen, but the label does not declare the food source of the major food allergen 
(e.g., milk) in either the ingredient list or in a separate Contains statement.  
 
  The product formulation includes an ingredient containing a major food allergen 
as a component of a food that can be declared in the ingredient list using a 
collective term (e.g., a flavoring, coloring, or spice) or as an incidental additive, 
but fails to declare the food source of the major food allergen, including sesame, 
in either the ingredient list or in a separate Contains statement.  
 
Labeling violations also occur when the food is formulated to contain a major food 
allergen and the label does not declare the major food allergen ingredient or the food 
source of the major food allergen in accordance with section 403(i)(2) and section 403(w) 
of the FD&C Act, respectively (21 U.S.C. 343(i)(2) and 343(w), respectively).  For 
example: 
 
  The product formulation contains an allergen-containing ingredient (e.g., whey), 
but the label neither declares the common or usual name of the ingredient (e.g., 
whey) in the ingredient list, nor is the major food allergen (e.g., milk) declared in 
either the ingredient list or in a separate Contains statement. 
 
  The product declares an ingredient (e.g., mayonnaise) that is comprised of sub-
ingredients, at least one of which is a major food allergen (e.g., egg), but the 
label fails to declare the major food allergen (e.g., egg) either in the ingredient 
list or in a separate Contains statement.  
 
  The product label declares tree nut, fish, or Crustacean shellfish, but fails 
to declare the type of tree nut (e.g., cashews), the species of fish (e.g., tilapia), or 
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the species of Crustacean shellfish (e.g., crab), respectively, in either the 
ingredient list or in a separate Contains statement.  
 
  The product label fails to declare the correct type of tree nut, the correct species 
of fish, or the correct species of Crustacean shellfish in either the ingredient list 
or in a separate Contains statement.  For example, the only major food allergen 
declared in the ingredient list or the Contains statement is pistachios, but the 
only major food allergen in the product formulation is actually cashews. 
 
C. Allergen cross-contact /adulteration 
 
Adulteration due to allergen cross-contact occurs when inspectional evidence or other 
information indicates that the firm does not have appropriate CGMPs, preventive 
controls, or other controls (e.g., HACCP) to significantly minimize or prevent allergen 
cross-contact.  This includes:  
 
  Inadequate CGMPs that resulted in failure to ensure that personnel practices, plant 
equipment and utensils, and other activities do not lead to allergen cross-contact;   
 
  Inadequate sanitation controls (e.g., cleaning) that resulted in allergen cross-
contact from shared equipment or utensils; 
 
  Inadequate food allergen controls (e.g., lack of controls during ingredient or 
product storage, handling, and use) that resulted in cross-contact; and  
 
  Not addressing allergen cross-contact under the juice or seafood HACCP 
regulations when necessary (e.g., either through the standard sanitary operational 
procedures or the HACCP plan). 
 
When there is no inspectional evidence, FDA will consider a variety of factors, such as 
information from the firm, levels of allergen found, product labeling, consumer adverse 
events, and other relevant information.   
 
When analytical testing results are available for unintended allergen presence, consult 
with the CFSAN/Office of Compliance/Compliance Policy Staff on the health hazard 
posed by the product.  Case-by-case evidence review will include several factors in 
determining allergen health hazard posed by unintended allergen presence, such as: 
 
  Estimated exposure to unintended allergen presence per eating occasion.  This 
will be based on information on the level of the allergen or the percent usage of 
allergen in product and estimated amount of product consumed per eating 
occasion to estimate an amount of allergen (in gram amounts) consumed per 
eating occasion;  
 
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  Likelihood of product consumption by allergic consumers and any mitigating 
allergen information on product; and  
 
  Other evidence if available and as appropriate, such as evidence of insanitary 
practices, type of allergen control problem resulting in cross-contact, 
characteristics of allergen residues due cross-contact (e.g., particulates, dusts, 
etc.), and consumer adverse reaction(s) associated with product.11 
 
D. Incomplete or inconsistent allergen information/misbranding 
 
Incomplete or inconsistent allergen information occurs when there are discrepancies in 
allergen information on the label.  Examples include: 
 
  The food is formulated to contain a major food allergen ingredient and has a 
Contains statement; however, the major food allergen is only declared in the 
ingredient list but is not declared in the Contains statement; 
 
  The food bears an allergen-free type of claim, but there is evidence (e.g., label 
statement, visual evidence, inspectional evidence, or analytical testing results) to 
suggest that the food contains that specific major food allergen; and 
 
  Other incomplete or inconsistent allergen information on the label.  This will be 
determined based on case-by-case review of available information, such as 
product label, product information, evidence of major food allergen presence, 
adverse event reports, and other factors. 
 
V. Specimen Charges 
 
Domestic Action 
 
Allergen labeling 
The article is misbranded within the meaning of section 403(w) of the FD&C Act (21 
U.S.C. 343(w)), in that the label fails to declare all major food allergens present in the 
product, namely [insert the undeclared major food allergen(s)], as required by section 
403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)).  
 
Ingredient declaration 
The article is misbranded within the meaning of section 403(i)(2) of the FD&C Act (21 
U.S.C. 343(i)(2)), in that it is fabricated from two or more ingredients, and its label fails 
to bear the common or usual name of each such ingredient. 
 
 
11 In general, if the product is associated with adverse reactions in allergic consumers, this provides some 
evidence of unintended allergen presence or allergen hazard in product or that that labeling information or 
other factors did not effectively mitigate health risk from exposure to the allergen hazard in the product.  
  13    Contains Nonbinding Recommendations              
Draft  Not for Implementation 
False or Misleading 
The article is misbranded within the meaning of section 403(a)(1) of the FD&C Act (21 
U.S.C. 343(a)(1)), in that the labeling is false or misleading.     
Manufacturing conditions 
The article is adulterated within the meaning of section 402(a)(4) of the FD&C Act (21 
U.S.C. 342(a)(4)), in that it has been prepared, packed, and held under insanitary 
conditions whereby it may have been rendered injurious to health. 
Import Refusal 
Allergen labeling 
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act (21 U.S.C. 381(a)(3)) in that it appears to be misbranded within the meaning of 
section 403(w) of the FD&C Act (21 U.S.C. 343(w)) in that it appears that the label fails 
to declare all major food allergens present in the product, namely [insert the undeclared 
major food allergen(s)] as required by section 403(w)(1) of the FD&C Act (21 U.S.C. 
343(w)(1)).   
Ingredient declaration 
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act (21 U.S.C. 381(a)(3)) in that it appears to be misbranded within the meaning of 
section 403(i)(2) of the FD&C Act (21 U.S.C. 343(i)(2)) in that it appears the food is 
fabricated from two or more ingredients and the label does not list the common or usual 
name of each such ingredient.  
False or Misleading 
The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act 
(21 U.S.C. 381(a)(3)) in that it appears to be misbranded within the meaning of section 
403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)) because the labeling appears to be false 
or misleading.   
Manufacturing conditions 
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act (21 U.S.C. 381(a)(3)) in that it appears to be adulterated within the meaning of 
section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)) because it appears that the food 
was prepared, packed, or held under insanitary conditions whereby it may have been 
rendered injurious to health. 
Issued: 04/19/2001 
Revised: 5/2005, 5/2023 
14