Contains Nonbinding Recommendations 
 
Guidance on Labeling of Foods That Need 
Refrigeration by Consumers 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
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 electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://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-1996-
D-0012. 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-2371. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
February 1997 
 
 
   
 
  Contains Nonbinding Recommendations 
Table of Contents 
I. Background
 
II. Inadequacy of Current Labeling
 
III. Labeling Options Considered
 
IV. Consumer Education
 
V. References
 
   
 
  Contains Nonbinding Recommendations 
Guidance on Labeling of Foods That Need 
Refrigeration by Consumers 
 
 
This guidance represents 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. Background  
Refrigeration has long been used to retard deterioration of the flavor, color, and texture of foods. 
More importantly, refrigeration helps maintain the microbiological safety of potentially 
hazardous foods. Temperature abuse, i.e., failure to maintain foods at appropriate temperatures, 
may result in the outgrowth of microorganisms that may have contaminated the foods before, or 
at the time of, harvest or during processing, handling, or storage. The rate of growth of these 
microorganisms is reduced as the storage temperature is lowered. Proper refrigeration, therefore, 
prevents or slows the growth of human pathogens and spoilage microorganisms and reduces the 
likelihood of foodborne illness.  
Refrigeration is only one of many individual factors, called barriers, that can be used to control 
microbiological risks. It is, for many foods, the only practicable barrier to reduce or prevent 
pathogen growth. Examples of other types of barriers include acidification (pH  4.6), use of 
preservatives, such as salt, and low water activity (a    0.85). Barriers used individually, or in 
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combination with each other, may reduce or retard pathogenic microbial growth.  
In the past, consumers could generally tell if a product were perishable by its packaging or lack 
of packaging. Products in a can or a jar were generally considered to be shelfstable (i.e., products 
that can be stored on the shelf without spoilage), at least until opened. However, todays new 
packaging technologies have changed this situation. Many liquids or semiliquids in flexible 
packages have airtight liners and are shelf-stable. Vacuum packed foods or foods packaged in 
modified (oxygen reduced) atmospheres, which are shelf-stable, may appear to the consumer to 
be safe to eat, even if they have been temperature abused. These foods may not have developed 
organoleptic signs (such as deterioration of color, flavor, texture, etc.) that consumers associate 
with spoiled or unsafe foods. However, foods in these packages may present a potential hazard 
if, once opened, they are stored unrefrigerated.  
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Recently, there have been reports of botulism food poisonings resulting from consumption of 
food that had been temperature abused by consumers, even though the products were labeled 
keep refrigerated. FDA is concerned that such foods are not labeled adequately or 
conspicuously enough to advise consumers that the product must be refrigerated to maintain its 
safety. The specific foods implicated in the botulism poisonings were clam chowder and black 
bean dip. Packaging for both of these products could have made the food appear shelf-stable to 
the consumer.  
The potential for foodborne illness from temperature abused foods is widely recognized. Efforts 
to reduce this health risk in potentially hazardous foods that need refrigeration to ensure their 
safety and quality have included voluntary use of label statements such as keep refrigerated 
and refrigerate after opening. Use of such label statements no longer provides meaningful 
consumer information because the same label statements appear both on foods needing 
refrigeration to ensure safety and foods needing refrigeration to maintain quality. NACMCF has 
made specific recommendations for label statements on potentially hazardous foods (Ref. 1) to 
address this problem. NFPA has developed guidelines for the food industry for voluntary label 
statements using the language in the NACMCF recommendation (Ref. 2). AFDO has endorsed 
the guidelines developed by NFPA (Ref. 3) and has recommended them to State regulatory 
agencies to assist those agencies in requiring and enforcing improved labeling (Ref. 4). Finally, 
CDC sent FDA a memorandum expressing concern about the recent botulism outbreaks and 
recommending, among other things, better labeling for foods requiring refrigeration (Ref. 5).  
II. Inadequacy of Current Labeling  
Because of the recent reports of botulism food poisonings from consumption of foods that had 
been temperature abused by consumers, FDA has evaluated the labeling on foods that must be 
refrigerated to prevent outgrowth of pathogens and has found that most of this labeling does not 
adequately advise the consumer of the need to keep the food refrigerated or of the health risk if it 
is not. For example, the packaging for the clam chowder and black bean dip that were implicated 
in the recent botulism poisonings made the foods appear shelf-stable. The clam chowder was 
packaged in a plastic bag inside a cardboard carton. The bean dip was packaged in a resealable 
plastic tub. These items were displayed in refrigerated cases in the supermarket. While both 
items had a keep refrigerated statement on their labels, consumers failed to maintain these 
products under refrigeration.  
Most consumers seem to understand that foods that are displayed only in the refrigerated section 
of a grocery store, such as dairy products, eggs, cold cuts, fresh meats, poultry, and seafood, 
must be refrigerated to maintain their quality. While it is unlikely that a majority of consumers 
are aware of the hazards and food safety issues that temperature abuse of these products can 
present, it is likely that most consumers will refrigerate these foods even in the absence of 
labeling instructions to do so for safety. Therefore, the fact that these foods are refrigerated does 
not really provide evidence of the effectiveness of the keep refrigerated instructions in their 
labeling.  
Foods such as mustard, salad dressings, jams, jellies, salsa, and spaghetti sauce bear a statement 
advising refrigeration once the product is opened to retard deterioration in the quality of the food. 
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Nonetheless, consumers often do not refrigerate these foods. Although consumers may notice a 
deterioration in flavor, color, or texture over time, they may not associate foodborne illness with 
consumption of these products. Therefore, consumers do not seem to associate safety concerns 
with the keep refrigerated or refrigerate after opening statements.  
The agency is concerned that consumers may not be aware that some newer, less traditional, 
packaged foods need refrigeration to maintain their safety. Some examples are fresh cut fruits 
and vegetables, food packaged in cardboard containers resembling shelfstable packages (such as 
the previously mentioned clam chowder and bean dip), and vacuum or modified (reduced 
oxygen) atmosphere packaged products in clear flexible packaging. Consumer understanding of 
the significance or reason for advising that a product be kept refrigerated is likely hampered by 
the rapidly expanding marketing of foods having convenient preparation and close to fresh 
product characteristics.  
In addition, as previously mentioned, the food industry is developing new types of foods with 
extended shelf life (i.e., the length of time that a product may be stored without deterioration) 
that have to be refrigerated. Foods known as partially processed or minimally processed may 
have received a heat process or other preservation treatment during manufacturing that reduces 
the microbiological load in the food but that does not render the food commercially sterile. 
These partially processed foods share the hazard common to all potentially hazardous foods, i.e., 
ability to support the growth of pathogens, unless they are refrigerated. Thus, if only a keep 
refrigerated label appears on these types of foods, and consumers choose not to pay attention to 
it, the consumers would be taking a significant risk.  
The agency is also concerned about the potential abuse of a category of products (e.g., low acid 
canned foods that are not otherwise preserved) that need refrigeration after being opened. The 
potential for temperature abuse of these products may be even greater than that for foods that 
need constant refrigeration. These products are generally displayed in a section of the store that 
is not refrigerated, and these products are provided in packaging similar to foods that do not need 
refrigeration even after opening. Even though these shelf-stable foods may bear storage 
instructions for the unused portion, the need for refrigeration is frequently not conveyed on the 
label, or not conveyed in a way that consumers can see and understand.  
Current labeling of shelf-stable packaged foods is not adequate because the same label 
statements, e.g., keep refrigerated or refrigerate after opening, appear both on foods that are 
potentially hazardous and on foods that do not pose a hazard but that are refrigerated to retard 
deterioration in quality. The labeling of potentially hazardous foods that need refrigeration 
should distinguish these products from products for which refrigeration is only to protect quality. 
FDA is concerned that, without adequate labeling on these potentially hazardous products, 
efforts by the food industry to develop new types of foods with extended shelf life prior to being 
refrigerated and while under refrigeration will result in more illnesses.  
Further, different formulations and processing methods for different versions of the same food, 
such as pumpkin pie, may or may not need refrigeration for safety. In addition, different versions 
of these foods can be displayed in different sections of the retail store, with the keep 
refrigerated statement on the version of the food that needs refrigeration as the only indication 
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that there is a difference in safety considerations among the versions of the product. Furthermore, 
the keep refrigerated statement often appears in small print and is placed on an obscure part of 
the label. Therefore, the consumer may not understand or interpret the keep refrigerated 
statement as an instruction about what must be done to maintain the safety of the product.  
Moreover, keep refrigerated or refrigerate after opening statements generally do not include 
the reason the product is to be refrigerated. The agency regards it as unlikely that most 
consumers know and are able to distinguish the underlying reasons for a keep refrigerated 
label statement when comparing products that bear that statement to maintain microbiological 
safety with products that bear that statement for maintaining quality. Therefore, consumers 
would have no reason to consider one such statement any more important for product safety than 
another. Thus, the statements keep refrigerated or refrigerate after opening alone are not 
adequate to appropriately alert consumers to the importance of properly handling potentially 
hazardous foods.  
III. Labeling Options Considered  
The agency has considered the recommendations offered by CDC, NACMCF, AFDO, and 
NFPA. In a memorandum dated February 14, 1995 (Ref. 5), CDC recommended that food labels 
advising refrigeration should be reviewed. CDC maintained that labels advising keep 
refrigerated may not be sufficient to warn consumers about the health risks associated with 
noncompliance. Further, CDC advised that for foods for which refrigeration is the only barrier to 
prevent growth of C. botulinum, the label should identify the risks of botulism if mishandled.  
FDA has also considered the labeling recommendations for foods requiring refrigeration by 
consumers that have been offered by NACMCF, NFPA, and AFDO (Refs. 1, 2, and 4). 
NACMCF maintained that consumers have difficulty distinguishing the differences among 
various label statements and their relationship to product safety. Therefore, it recommended that 
the following label statement be used on packaged food that poses a safety hazard if temperature 
abused: IMPORTANT MUST BE KEPT REFRIGERATED.  
Recommendations from NFPA and AFDO recognize two categories of foods. Group A foods are 
potentially hazardous, packaged, processed foods that must be refrigerated for safety reasons, 
and Group B foods are products that are intended to be refrigerated but that do not pose a safety 
hazard if temperature abused. The recommended label statement for Group A foods is: 
IMPORTANT: Must Be Kept Refrigerated.  
The recommended label statement for Group B foods is keep refrigerated, although such 
products would be allowed to utilize the Group A suggested label statement.  
A. Analysis of Options  
FDA agrees with CDC that the label statement keep refrigerated may not be sufficient to warn 
consumers about a health risk. However, the agency does not agree that the label should 
specifically identify the risk of botulism because it is not the only risk if foods that need 
refrigeration are temperature abused.  
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While FDA finds considerable merit in the labeling recommendations of NACMCF, NFPA, and 
AFDO, the agency is concerned that these recommendations do not inform consumers of the 
reasons for refrigeration of foods and do not fully differentiate the types of foods that should bear 
a keep refrigerated label. Moreover, the suggested label statements will not eliminate the 
confusion generated by the current voluntary label statements used on foods to be refrigerated, 
especially if foods that do not pose a safety hazard are permitted to bear the same labeling 
statements as those that do pose a safety hazard if not refrigerated.  
Having considered these recommendations, the agency is recommending an approach that is 
somewhat different than those suggested in the recommendations that it has received. In the 
agencys view, labeling will be more effective if it is more specific to the types of hazards that 
are presented, and to the types of storage conditions that are necessary, after the product is 
opened. In FDAs view, this specificity is provided if foods that need refrigeration are divided 
into three groups. The first group, Group A, are the foods that were in NFPAs and AFDOs 
Group A foods that are potentially hazardous and that must be kept refrigerated for safety 
reasons. Group B includes foods that are shelf-stable but that need refrigeration after opening for 
safety. Group C (described as Group B foods in the NFPA and AFDO recommendations) include 
foods that are refrigerated only to retard deterioration in quality.  
FDA has sought to craft label statements that will help consumers to differentiate among these 
types of foods. Phrases such as to maintain safety and for quality are essential in drawing a 
distinction between Groups A and B on the one hand and Group C on the other. Furthermore, the 
agency agrees with the recommendations of NACMCF, NFPA, and AFDO that the term 
Important would help to underscore this distinction and to indicate the significance of the 
statement. The phrase after opening, or some similar statement, is essential to distinguish 
Group B from Group A.  
Thus, the agency considers that the statement Important must be kept refrigerated to maintain 
safety for Group A foods is appropriate because it can adequately convey to consumers that 
continued refrigeration is mandatory to reduce safety risks. Similarly, the agency considers 
Important must be refrigerated after opening to maintain safety an appropriate label statement 
for Group B foods because such foods are shelfstable and may pose a health hazard only after 
opening. In contrast, refrigerate for quality or keep refrigerated for quality for Group C 
foods is sufficient, in the agencys opinion, to distinguish this category from Groups A and B and 
to inform consumers that refrigeration is only necessary to retard deterioration in product quality.  
B. Labeling Placement and Prominence  
In addition to label statements that are focused on the type of product and the risk it represents, 
placing the statements on the label in a way that gives them appropriate prominence is critical to 
ensuring that the label statements will be seen, read, and understood. The placement and 
prominence guidelines suggested by NFPA are particularly useful and helpful in this regard. 
NFPA recommended that the label statements be set off by the use of hairlines at the top and 
bottom of the statement area. The type should: (1) Be on a contrasting background; (2) utilize a 
single, easy-to-read style and size; (3) have at least one point leading (space between two lines of 
text); and (4) ensure that letters never touch. On Group A and B foods, the word 
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IMPORTANT should be in all capital letters, while the remaining words should use uppercase 
and lowercase letters, with the first letter in each word capitalized. The hairlined area should 
appear on the label prominently and conspicuously as compared to other words, statements, 
designs, or devices. FDA strongly agrees and urges all firms to follow these recommendations. 
In addition, the agency notes that its general approach to type size of label information is that it 
should be not less than one-sixteenth inch unless the package is too small to accommodate this 
type size. The agency encourages placement of this statement on the principal display panels, at 
least for group A and B foods. If the statement does not fit on the principal display, it should be 
placed on the information panel.  
C. FDA Labeling Policy  
To clarify this guidance, the agency has delineated each of the three groups and developed model 
statements for each:  
1. Group A Foods  
Group A foods are potentially hazardous foods, which, if subjected to temperature abuse, will 
support the growth of infectious or toxigenic microorganisms that may be present. Outgrowth of 
these microorganisms would render the food unsafe. Foods that must be refrigerated for food 
safety possess the following characteristics: (1) Product pH > 4.6; (2) water activity a  > 0.85; 
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(3) do not receive a thermal process or other treatment in the final package that is adequate to 
destroy foodborne pathogens that can grow under conditions of temperature abuse during storage 
and distribution; and (4) have no barriers (e.g., preservatives such as benzoates, salt, 
acidification), built into the product formulation that prevent the growth of foodborne pathogens 
that can grow under conditions of temperature abuse during storage and distribution.  
The appropriate label statement for Group A foods is:   
IMPORTANT Must Be Kept Refrigerated To Maintain Safety  
2. Group B Foods  
Group B includes those foods that are shelf-stable as a result of processing, but once opened, the 
unused portion is potentially hazardous unless refrigerated. These foods possess the following 
characteristics: (1) Product pH > 4.6; (2) water activity a  > 0.85; (3) receive a thermal process 
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or other treatment that is adequate to destroy or inactivate foodborne pathogens in the unopened 
package, but after opening, surviving or contaminating microorganisms can grow and render the 
product unsafe; and (4) have no barriers (for example, preservatives such as benzoates, salt, 
acidification) built into the product formulation to prevent the growth of foodborne pathogens 
after opening and subsequent storage under temperature abuse conditions.  
The appropriate label statement for Group B foods is:  
IMPORTANT Must Be Refrigerated After Opening To Maintain Safety  
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3. Group C Foods  
Group C are those foods that do not pose a safety hazard even after opening if temperature 
abused, but that may experience a more rapid deterioration in quality over time if not 
refrigerated. The manufacturer determines whether to include on the label a statement that 
refrigeration is needed to maintain the quality characteristics of the product to maximize 
acceptance by the consumer. These foods do not pose a safety problem. Foods in this group 
possess one or more of the following characteristics to ensure that the food does not present a 
hazard if temperature abused: (1) Product pH  4.6 to inhibit the outgrowth and toxin production 
of C. botulinum; or (2) water activity a   0.85; or (3) have barriers built into the formulation 
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(for example, preservative systems such as benzoates, salt, acidification) to prevent the growth of 
foodborne pathogens if the product is temperature abused.  
The suggested optional label statement for Group C foods is: Refrigerate for Quality or some 
other statement that explains to the consumer that the storage conditions are recommended to 
protect the quality of the product. To avoid confusion between refrigeration for safety purposes 
and refrigeration for quality reasons, Group A and Group B statements should not be used on 
Group C foods.  
The agency is publishing this document to provide this guidance by the quickest means to as 
many manufacturers as possible, so that they may begin using the label statements. If 
manufacturers follow this guidance, the consumer will have clear, concise, and prominent 
labeling information for maintaining the safety of potentially hazardous food products. Inclusion 
of these statements in the labeling of appropriate foods will help the consumer recognize when 
appropriate storage temperatures are needed to maintain the safety or quality of those foods. 
Such information will reduce the likelihood of temperature abuse of the food and, consequently, 
reduce the potential for foodborne illness and death.  
While this guidance is primarily intended to address the need for safe handling of potentially 
hazardous foods by consumers, the agency recognizes that there also is a need for safe handling 
during the transportation and distribution of these foods. The Food Safety and Inspection Service 
of the U.S. Department of Agriculture and FDA have jointly published an advance notice of 
proposed rulemaking in the Federal Register of November 22, 1996 (61 FR 59372) to solicit 
comments on approaches that the two agencies may take to foster safety improvements in the 
storage and transportation of potentially hazardous foods. Therefore, this guidance does not 
address how foods that need refrigeration during transportation and storage should be labeled.  
IV. Consumer Education  
Most consumers are not aware of the hazards associated with temperature abuse of foods needing 
refrigeration, especially foods that use newer, less traditional means of packaging. If firms follow 
the guidance set out in this document, it will help consumers to recognize the difference between 
the messages, refrigerate for safety and refrigerate for quality. The agency recognizes, 
however, that a coordinated public education campaign is needed to ensure that consumers 
understand the significance of the differences in these messages. Given the significance of the 
underlying problem, FDA intends to undertake an educational effort, including press releases and 
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consumer pamphlets. The agency requests the cooperation and assistance of industry and other 
private groups in this effort. The agency also requests comments on additional ways to educate 
the consumer.  
The guidance represented here reflects FDAs current thinking on safe handling labeling for 
foods that need refrigeration by the consumer. This document does not bind FDA and does not 
create or confer any rights, privileges, benefits, or immunities for or on any persons.  
Interested persons may submit written comments on the guidance to the Dockets Management 
Branch (address above). Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the docket number FDA-
1996-D-0012. The guidance and received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.  
V. References  
The following references have been placed on display in the Dockets Management Branch 
(address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday.  
1.  Recommendations of the National Advisory Committee on Microbiological Criteria for 
Foods for Refrigerated Foods Containing Cooked, Uncured Meat or Poultry Products that 
are Packaged for Extended Refrigerated Shelf Life and that are Ready-To-Eat or Prepared 
with Little or No Additional Heat Treatment, January 31, 1990.  
 
2.  Guidelines for the Development, Production, Distribution, and Handling of Refrigerated 
Foods, National Food Processors Association, 1989. 
 
3.  Letter from J. Corby, New York Department of Agriculture and Markets to A. DellAria, 
Virginia Department of Agriculture, September 8, 1995.  
 
4.  Memorandum from A. DellAria, AFDO, December 20, 1995.  
 
5.  Letter from P. Griffin and R. Tauxe, CDC to K. Wachsmuth, FDA, February 14, 1995.  
 
 
 
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