[Federal Register: October 18, 2000 (Volume 65, Number 202)]
[Rules and Regulations]
[Page 62282-62285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc00-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. 98N-0970]
Medical Devices; Labeling for Menstrual Tampon for the ``Ultra''
Absorbency
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
that amends its menstrual tampon labeling regulation to add the term
``ultra'' absorbency for tampons that absorb 15 to 18 grams (g) of
fluid with the syngyna test. At present, FDA requires standardized
terms to be used for the labeling of a menstrual tampon to indicate its
particular absorbency. This rule enables consumers to compare the
absorbency of one brand and style of tampon with the absorbency of
other brands and styles. FDA is issuing this final rule under the
Federal Food, Drug, and Cosmetic Act (the act) to ensure that labeling
of menstrual tampons is not misleading. Elsewhere in this issue of the
Federal Register, FDA is proposing to change the standardized menstrual
tampon term ``junior'' to ``light''.
DATES: This rule is effective January 16, 2001.
FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 26, 1989 (54 FR 43766), FDA
published a final rule which, among other things, amended its menstrual
tampon labeling regulation to standardize the existing absorbency terms
(``junior'', ``regular'', ``super'', and ``super plus'') to correspond
with the following four absorbency ranges: Less than 6 g; 6 to 9 g; 9
to 12 g; and 12 to 15 g of fluid, as measured by the syngyna test. The
1989 final rule did not include terms for tampons with absorbency in
the 15 to 18 g range. Tampon manufacturers have asserted that many
women need tampons with this higher level of absorbency to manage their
heavy menstrual flow. See 54 FR 43766 to 43769.
Tampons are currently classified into class II (special controls)
at 21 CFR 884.5460 and 884.5470. Any person who is required to register
under section 510 of the act (21 U.S.C. 360) and part 807 (21 CFR part
807) and who intends to begin the introduction or delivery for
introduction into interstate commerce of a tampon for commercial
distribution is required to submit a premarket notification to FDA at
least 90 days before making such introduction or delivery in accordance
with section 510(k) of the act and subpart E of part 807. Under
Sec. 807.87(e), a 510(k) premarket notification for a menstrual tampon
must contain, among other thing, the proposed labeling for the tampon.
Section 801.430 (21 CFR 801.430) spells out the specific labeling
required for tampons with 15 g or less of absorbency, including
standardized terms for absorbency as determined by testing with the
specified syngyna methodology. Because the regulation currently
provides no uniform labeling term for tampons that absorb 15 to 18 g of
fluid with the syngyna test, the agency is requiring that such tampons
be labeled as ``ultra'' absorbency. FDA has recently cleared a
menstrual tampons product in this absorbency range, and they are
available to women in the United States. FDA believes that designating
a standard term for this absorbency range will improve consumer
understanding of tampons across brands and allow for better adherence
to advice in the tampon labeling about toxic shock syndrome (TSS).
II. The Proposed Rule
In the Federal Register of January 21, 1999 (64 FR 3255 through
3257), FDA published a proposed rule to add the term ``ultra'' to
describe tampons with a 15 to 18 g absorbency as measured by the
syngyna test. The 90-day comment period closed on April 21, 1999.
The agency received nine comments from individuals, tampon
manufacturers, one trade association, and one from a member of the U.S.
Congress. Besides comments specific to use of the term ``ultra'', other
comments addressed FDA's 1995 draft guidance document on the
preparation of 510(k) premarket notifications for menstrual tampons
(Ref. 1). Several comments recommended changing the currently used term
for tampon absorbency less than 6 g, from ``junior'' to ``light''. A
summary of the written comments and FDA's response to the comments is
provided in section III of this document.
III. Response to Comments
1. Two comments from manufacturers supported the term ``ultra''.
They noted that the term ``ultra'' is defined in Webster's Dictionary
(and others) as ``going beyond what is usual or ordinary'' and ``going
beyond others''. These comments also noted that menstrual tampons with
this absorbency are called ``Ultra Plus'' in Canada. Comments from two
other manufacturers did not favor the term ``ultra'' for this tampon
absorbency. They argued that ``ultra'' implies the product is more
compact in size, more concentrated, more environmentally sound, or
possibly superior. The comments noted that ``ultra'' is a proprietary
term carrying one or more of these meanings for a variety of other
household products, such as dishwashing detergents and sanitary
napkins. These manufacturers proposed the terms ``extra'' or ``extra
plus''.
FDA concludes that the term ``Ultra'' is suitable to identify the
absorbency of tampons in the range of 15 to 18 g. FDA
[[Page 62283]]
believes that the term ``Ultra'' fits more clearly within the current
scheme of tampon absorbency terminology than the terms ``extra'' or
``extra plus''. The term ``ultra'' better conveys to the consumer
absorbency abilities that are beyond ``Super'' and ``Super Plus'' and
is less confusing to consumers than the terms ``extra'' or ``extra
plus''.
Manufacturers must now define this absorbency in their labeling
along with the other absorbency categories to help consumers understand
the meaning of this new term. As before, labeling will continue to be
required to inform consumers that they should use the lowest absorbency
suitable for their needs, as well as alternating use of tampons with
use of menstrual pads. FDA does not permit manufacturers to promote
tampons for a wear time longer than 8 hours.
2. Five comments suggested changes in tampon labeling related to
the wording of the consumer information on TSS. At present, under
Sec. 801.430(d)(2), the tampon labeling regulation requires that TSS
incidence be reported in the package insert as 1 to 17 cases of TSS per
100,000 menstruating women and girls per year. These five comments
requested that this labeling be revised to reflect more recent data
that indicate the rate of TSS has declined. There were also various
comments on FDA's draft guidance document on preparing 510(k) premarket
notifications on menstrual tampons, dated May 25, 1995 (Ref. 1).
These comments were beyond the scope of the proposed rule. FDA
recognizes that TSS incidence in the United States has dropped since
this labeling regulation was issued in 1989. See response to comment
number 6. FDA will consider these suggestions for revisions to the
labeling regulation to update the TSS incidence information. Regarding
the second set of comments, FDA is currently working to improve the
1995 510(k) guidance document, and the suggested changes will be
considered during that process. FDA intends to issue a draft updated
guidance document within a few months.
3. Five comments suggested changing the absorbency term ``junior'',
used for tampons with the lowest absorbency (less than 6 g), to
``light''. They suggested that the term ``junior'' implied such tampons
were only for young teenagers.
This comment also was beyond the scope of this rulemaking. However,
FDA agrees that the term ``light'' is more appropriate than ``junior''
for tampons with absorbency less than 6 g. A proposed rule to change
the term ``junior'' to ``light'' appears elsewhere in this issue of the
Federal Register.
4. One comment asked why FDA did not propose a new term for tampon
absorbency in the 15 to 18 g range when the other terms were issued in
the regulation in 1989.
The intent of the 1989 regulation was to standardize terms
currently in use so that consumers had clear information to make the
best choices regardless of which brand they purchased. Although the
absorbencies varied across brands, most manufacturers had no more than
four different absorbencies of tampons on the market. Most companies
chose to modify their products to match the standardized absorbency
categories and keep the established terms. Immediately prior to
issuance of the labeling regulation in 1989, only one marketed tampon
was in the 15 to 18 g range. The manufacturer of this tampon chose to
reduce its absorbency to 12 to 15 g and continue to use the term
``super plus''. In the preamble to the final regulation standardizing
absorbency terms, FDA stated that anyone who wished to market a tampon
that absorbs more than 15 g of fluid would be required to submit a
510(k). The agency would then determine whether the labeling submitted
for the device was appropriate and whether the tampon required
premarket approval under section 515 of the act (21 U.S.C. 360e). FDA
did receive and clear a 510(k) for such a product earlier this year.
5. One comment asked how FDA would institute monitoring procedures
for tracking the potential risk of increase in TSS cases.
FDA requires laboratory testing for all tampon products, as
appropriate, depending on changes to materials or design. The agency
already has in place Mandatory Device Reporting (MDR) requirements for
manufacturers to identify and monitor reports of serious events related
to device use, including menstrual TSS. In 510(k) premarket
notifications, manufacturers of tampons with 15 to 18 g absorbency will
provide FDA with their specific plans for monitoring trends in TSS
complaints with use of their own tampon brands. The manufacturer of the
product already cleared has such a plan in place. In the postmarket
setting and as part of its regular MDR Program and User Facility
Reporting Program, FDA will actively review any reports received on
adverse events, as well as the Centers for Disease Control and
Prevention (CDC) reports on menstrual-TSS.
CDC has tracked TSS reports in the United States for 20 years, and
produces periodic morbidity/mortality reports. CDC recently has
published a TSS surveillance update, reviewing reports from 1979 to
1996 (Ref. 2). These reports show a marked drop in TSS cases in the
early 1980's with a relatively flat, extremely low number of TSS
reports since approximately 1986. For instance, in 1996, there were
five definite and four probable menstrual-related TSS cases reported to
CDC.
The agency also notes that tampons with an absorbency as high as 18
g are currently marketed in other countries with very low TSS rates
(Ref. 3). It appears that a number of factors may play a role in the
etiology and risk of menstrual-related TSS, including tampon materials,
continuous tampon use versus alternating use between tampons and
menstrual pads, the presence of oxygen in the vaginal environment, and
awareness of TSS symptoms and seeking early treatment. Standardized
absorbency terms are intended to minimize the risk of menstrual-TSS
with tampon use. This rule is consistent with purpose of the 1989
regulation, which is to ensure that standardized labeling gives women
the information they need to make appropriate choices among all brands.
FDA does not believe that this final rule will increase the risk of TSS
for women who use tampons in accordance with the labeling.
6. One comment asked about the steps that might be taken to improve
consumer decisionmaking about choosing the appropriate tampon
absorbency.
FDA agrees that women should have a good understanding about tampon
absorbency in order to make the best possible choice when purchasing
tampons. In the United States, there are several public awareness
initiatives in place. For nearly 20 years, FDA, CDC, and tampon
manufacturers have all played a part in this process. Education
programs at the local level have been contributing partners, as well.
FDA believes that the current low TSS rates in the United States are a
reflection of these highly effective public awareness initiatives. FDA
expects that these programs, coupled with good tampon labeling, will
ensure continued good choice patterns among tampon users in the United
States.
IV. Environmental Impact
The agency has determined under 21 CFR 25.30 (k) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
[[Page 62284]]
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this final rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. There currently are no small entities marketing a
tampon of this absorbency. Any small entity that decided to enter the
market with this product would incur no additional costs because of
this rule because the small entity would already be required to
identify the absorbency ranges of its tampons.
The agency therefore certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement of anticipated costs and
benefits before proposing any rule that may result in an expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million in any one year (adjusted annually for
inflation). The Unfunded Mandates Reform Act does not require FDA to
prepare a statement of costs and benefits for the final rule, because
the final rule is not expected to result in any 1-year expenditure that
would exceed $100 million adjusted for inflation.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effect on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule does not contain information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Although the agency submitted the proposed labeling for public
comment as an information collection in the proposed rule, FDA now
concludes that the labeling requirement is not subject to review by OMB
because it does not constitute a ``collection of information'' under
the PRA. Rather, the proposed labeling is a ``public disclosure of
information originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
VIII. References
The following references have been placed on display in the Docket
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Guidance for the Content of Premarket Notifications for
Menstrual Tampons (draft, May 25, 1995).
2. Hajjeh, R. A., A. Reingold, A. Weil, K. Shutt, A. Schuchat,
and B. Perkins, ``Toxic Shock Syndrome in the United States:
Surveillance Update, 1979-1996,'' Emerging Infectious Diseases; vol.
5, no. 6, pp. 807-810, November/December 1999.
3. TSS rates in Canada, U.K., Germany--where 15 to 18 g tampons
are already available, Medical Affairs and Regulatory Affairs at
Personal Products Co. at Skillman, NJ.
List of Subjects in 21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drug, 21 CFR
part 801 is amended as follows:
PART 801--LABELING
1. The authority citation for 21 CFR part 801 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
2. Section 801.430 is amended in paragraph (e)(1) by revising the
table to read as follows:
Sec. 801.430 User labeling for menstrual tampons.
* * * * *
(e) * * *
(1) * * *
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Ranges of absorbency in grams\1\ Corresponding term of absorbency
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6 and under Junior 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.
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\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.
[[Page 62285]]
* * * * *
Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-26248 Filed 10-17-00; 8:45 am]
BILLING CODE 4160-01-F