Answers
06/20/1989

<TITLE>Tampon Absorbency Labeling</TITLE>
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                                June 20, 1989 

            FDA PROPOSES NEW TERMS FOR TAMPON ABSORBENCY LABELING 
    In response to approximately 275 comments from consumers, consumer
groups and manufacturers, FDA is re-proposing its tampon-labeling 
regulation.  A key change in the re-proposal is a switch from an absorbency 
scale designated by the letters, A to F, which some commenters felt might be
confusing, to new, standardized absorbency terms -- low, medium,
medium-high, high, very high and highest absorbency.
    The following may be used to answer questions.
    The purpose of the labeling is to help women use the lowest absorbency
they can, in order to reduce their risk of toxic shock syndrome, or TSS.
Tampon use has been associated with this rare but sometimes fatal condition,
and the risk rises with increasing tampon absorbency. 
    Although traditional terms such as "regular," "super" and "super plus"
represent increasing absorbency within the same brand, these terms may
represent different absorbencies from brand to brand.  This makes it
particularly difficult for people switching between brands to determine 
which absorbency to buy.
    On Sept. 23, 1988, FDA proposed that absorbency information appear on 
the tampon box in the form of a letter, with A providing the lowest 
absorbency.  That proposal would have allowed manufacturers to continue to
use traditional terms (regular, super, etc.) without requiring that these 
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terms be standardized or correspond with the new absorbency ranges. 
    Nearly all comments supported the basic concept of standardized 
absorbency labeling.  However, some people were concerned that designating
the proposed absorbency ranges as "A" through "F" might be confusing.  They 
said, for example, that purchasers might not know whether "A" represented 
the highest or lowest absorbency. 
    Many people suggested that the traditional absorbency terms (regular, 
super, etc.) be standardized to correspond with the six proposed absorbency 
ranges.  FDA has decided not to make this change because it could lead to 
confusion among brand-loyal customers.  For example, if the terms were
standardized, a product previously called "super" might now have to be
called "regular" or be changed in absorbency to correspond to the new 
standard. 
    FDA is proposing that the proposed standardized absorbency descriptions 
appear more prominently on the package, and separate from, the traditional
designation (regular, super, etc.) if still used. 
    The six absorbency ranges in the re-proposal are: 
Range of absorbency                         Term to be used 
  (in grams)
6 and under                                 Low absorbency
6-9                                         Medium absorbency 
9-12                                        Medium-high absorbency
12-15                                       High absorbency 
l5-l8                                       Very high absorbency
over 18                                     Highest absorbency
    By looking for a tampon with the lowest absorbency designation that 
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meets her needs, a woman can choose the product that minimizes risk.  If a
woman switches brands, she can look for a tampon labeled with the same
standardized absorbency term as the tampon she has been using.
    Along with the absorbency designation, tampon boxes would also be 
required to include advice that, to minimize toxic shock syndrome risk, a 
woman should select the lowest absorbency needed to control menstrual flow. 
This type of warning has been required since 1982, along with a listing of
toxic shock symptoms -- sudden fever (usually 102 degrees or more) and
vomiting, diarrhea, fainting or nearly fainting when standing up, dizziness 
and a rash that looks like sunburn.  However, the existing regulation 
permitted this information to appear in the package insert instead of on the
box.
    Comments on the reproposal should be sent by Aug. 11, 1989, to the FDA
Dockets Management Branch (HFA-305), Room 4-62, 5600 Fishers Lane,
Rockville, Md. 20857. 
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