[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.430]
[Page 36-41]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 801_LABELING--Table of Contents
Subpart H_Special Requirements for Specific Devices
Sec. 801.430 User labeling for menstrual tampons.
(a) This section applies to scented or scented deodorized menstrual
tampons as identified in Sec. 884.5460 and unscented menstrual tampons
as identified in Sec. 884.5470 of this chapter.
(b) Data show that toxic shock syndrome (TSS), a rare but serious
and sometimes fatal disease, is associated with the use of menstrual
tampons. To protect the public and to minimize the serious adverse
effects of TSS, menstrual tampons shall be labeled as set forth in
paragraphs (c), (d), and (e) of this section and tested for absorbency
as set forth in paragraph (f) of this section.
(c) If the information specified in paragraph (d) of this section is
to be included as a package insert, the following alert statement shall
appear prominently and legibly on the package label:
Attention: Tampons are associated with Toxic Shock Syndrome (TSS).
TSS is a rare but serious disease that may cause death. Read and save
the enclosed information.
(d) The labeling of menstrual tampons shall contain the following
consumer information prominently and legibly, in such terms as to render
the information likely to be read and understood by the ordinary
individual under customary conditions of purchase and use:
(1)(i) Warning signs of TSS, e.g., sudden fever (usually 102[deg] or
more) and vomiting, diarrhea, fainting or near fainting when standing
up, dizziness, or a rash that looks like a sunburn;
(ii) What to do if these or other signs of TSS appear, including the
need to remove the tampon at once and seek medical attention
immediately;
(2) The risk of TSS to all women using tampons during their
menstrual period, especially the reported higher risks to women under 30
years of age and teenage girls, the estimated incidence of TSS of 1 to
17 per 100,000 menstruating women and girls per year, and the risk of
death from contracting TSS;
(3) The advisability of using tampons with the minimum absorbency
needed to control menstrual flow in order to reduce the risk of
contracting TSS;
(4) Avoiding the risk of getting tampon-associated TSS by not using
tampons, and reducing the risk of getting TSS by alternating tampon use
with sanitary napkin use during menstrual periods; and
[[Page 37]]
(5) The need to seek medical attention before again using tampons if
TSS warning signs have occurred in the past, or if women have any
questions about TSS or tampon use.
(e) The statements required by paragraph (e) of this section shall
be prominently and legibly placed on the package label of menstrual
tampons in conformance with section 502(c) of the Federal Food, Drug,
and Cosmetic Act (the act) (unless the menstrual tampons are exempt
under paragraph (g) of this section).
(1) Menstrual tampon package labels shall bear one of the following
absorbency terms representing the absorbency of the production run, lot,
or batch as measured by the test described in paragraph (f)(2) of this
section;
------------------------------------------------------------------------
Ranges of absorbency in grams\1\ Corresponding term of absorbency
------------------------------------------------------------------------
6 and under Light absorbency
------------------------------------------------------------------------
6 to 9 Regular absorbency
------------------------------------------------------------------------
9 to 12 Super absorbency
------------------------------------------------------------------------
12 to 15 Super plus absorbency
------------------------------------------------------------------------
15 to 18 Ultra absorbency
------------------------------------------------------------------------
Above 18 No term
------------------------------------------------------------------------
\1\These ranges are defined, respectively, as follows: Less than or
equal to 6 grams (g); greater than 6 g up to and including 9 g;
greater than 9 g up to and including 12 g; greater than 12 g up to and
including 15 g; greater than 15 g up to and including 18 g; and
greater than 18 g.
(2) The package label shall include an explanation of the ranges of
absorbency and a description of how consumers can use a range of
absorbency, and its corresponding absorbency term, to make comparisons
of absorbency of tampons to allow selection of the tampons with the
minimum absorbency needed to control menstrual flow in order to reduce
the risk of contracting TSS.
(f) A manufacturer shall measure the absorbency of individual
tampons using the test method specified in paragraph (f)(2) of this
section and calculate the mean absorbency of a production run, lot, or
batch by rounding to the nearest 0.1 gram.
(1) A manufacturer shall design and implement a sampling plan that
includes collection of probability samples of adequate size to yield
consistent tolerance intervals such that the probability is 90 percent
that at least 90 percent of the absorbencies of individual tampons
within a brand and type are within the range of absorbency stated on the
package label.
(2) In the absorbency test, an unlubricated condom, with tensile
strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according
to the procedure in the American Society for Testing and Materials
(ASTM) D 3492-97, ``Standard Specification for Rubber Contraceptives
(Male Condoms)'' \1\ for determining tensile strength, which is
incorporated by reference in accordance with 5 U.S.C. 552(a), is
attached to the large end of a glass chamber (or a chamber made from
hard transparent plastic) with a rubber band (see figure 1) and pushed
through the small end of the chamber using a smooth, finished rod. The
condom is pulled through until all slack is removed. The tip of the
condom is cut off and the remaining end of the condom is stretched over
the end of the tube and secured with a rubber band. A preweighed (to the
nearest 0.01 gram) tampon is placed within the condom membrane so that
the center of gravity of the tampon is at the center of the chamber. An
infusion needle (14 gauge) is inserted through the septum created by the
condom tip until it contacts the end of the tampon. The outer chamber is
filled with water pumped from a temperature-controlled waterbath to
maintain the average temperature at 271 [deg]C.
The water returns to the waterbath as shown in figure 2. Syngyna fluid
(10 grams sodium chloride, 0.5 gram Certified Reagent Acid Fushsin,
1,000 milliliters distilled water) is then pumped through the infusion
needle at a rate of 50 milliliters per hour. The test shall be
terminated
[[Page 38]]
when the tampon is saturated and the first drop of fluid exits the
apparatus. (The test result shall be discarded if fluid is detected in
the folds of the condom before the tampon is saturated). The water is
then drained and the tampon is removed and immediately weighed to the
nearest 0.01 gram. The absorbency of the tampon is determined by
subtracting its dry weight from this value. The condom shall be replaced
after 10 tests or at the end of the day during which the condom is used
in testing, whichever occurs first.
---------------------------------------------------------------------------
\1\ Copies of the standard are available from the American Society
for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA
19428, or available for inspection at the Center for Devices and
Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD
20850, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
---------------------------------------------------------------------------
[[Page 39]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.026
[[Page 40]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.027
(3) The Food and Drug Administration may permit the use of an
absorbency test method different from the test method specified in this
section if each of the following conditions is met:
(i) The manufacturer presents evidence, in the form of a citizen
petition
[[Page 41]]
submitted in accordance with the requirements of Sec. 10.30 of this
chapter, demonstrating that the alternative test method will yield
results that are equivalent to the results yielded by the test method
specified in this section; and
(ii) FDA approves the method and has published notice of its
approval of the alternative test method in the Federal Register.
(g) Any menstrual tampon intended to be dispensed by a vending
machine is exempt from the requirements of this section.
(h) Any menstrual tampon that is not labeled as required by
paragraphs (c), (d), and (e) of this section and that is initially
introduced or initially delivered for introduction into commerce after
March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of
the act.
(Information collection requirements contained in paragraphs (e) and (f)
were approved by the Office of Management and Budget under control
number 0910-0257)
[47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989;
55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July
18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR
52171, Aug. 25, 2004]