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FDA Guidelines: Labels
Statements for Refrigerated Foods
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| Action: Notice, Federal Register, Vol. 62, No. 26,
February 24, 1997
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| On February 23, 1997 a "guidance" document appeared
in the Federal Register relating to the labeling of foods that need refrigeration
to maintain safety and/or quality. Below, a summary of the major points in the guidance
document is provided. Note that this document is not a regulation, and therefore it does
not have the force of law or a specific effective date.
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| One of the apparent motivating factors behind this guidance
document was several recent outbreaks of botulism in foods that were not refrigerated by
consumers because they were packaged in a manner suggesting that they might be
shelf-stable (e.g., a clam chowder product packaged in a plastic bag inside a cardboard
carton and a bean dip packaged in a resealable plastic tub). However, both foods had a
"keep refrigerated" statement on their labels.
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| The Agency expressed concern in the Federal Register
notice that consumers may not be aware that some newer, less traditional packaged foods
need refrigeration. Examples of such products mentioned by FDA include fresh cut fruits
and vegetables, vacuum or modified atmosphere packaged products in clear flexible
packaging, and foods packaged in cardboard containers resembling shelf-stable packages.
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| FDA is also concerned that traditional label statements such
as "keep refrigerated" do not help consumers distinguish between products that must
be refrigerated for safety reasons and those that may be refrigerated to
prevent loss of quality.
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| The new guidance document announced in the Federal Register
establishes three categories of foods:
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| Group "A" foods are those that must be kept
refrigerated at all times during their shelf life to prevent the growth of infectious or
toxigenic microorganisms. The FDA is strongly urging the use of the following label
statement (preferably on the principal display panel) for all Group "A" products:
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IMPORTANT Must
be Kept Refrigerated To Maintain Safety
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| Group "B" foods are those that are shelf-stable as a
result of processing but that, once opened, the unused portion is potentially hazardous
unless refrigerated. The recommended statement for this group of products is:
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IMPORTANT
Must Be Refrigerated After Opening to Maintain Safety
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| FDA recommends the following specific formatting for there
statement: (1) must be on a contracting background; (2) utilize a single, easy-to-read
style and size; (3) have at least one point leading (space between two lines of text); (4)
and ensure that letters never touch. Hairlines should be used above and below the
statement. The word "IMPORTANT" should be capitalized and the remaining
words should use both upper and lower case letters.
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| Group "C" foods are those that do not pose a safety
hazard after opening even if temperature abused, but that may experience a more rapid
deterioration in quality over time if not refrigerated. FDA does not urge specific wording
for Group "C" products, but provides instead a "suggested
optional" label statement:
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Refrigerate
for Quality
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| For additional information or a copy of the document, please
contact Certified Laboratories at 1-800-CERT LAB.
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| Return
to the Refrigerated Foods page
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