[Federal Register Volume 65, Number 202 (Wednesday, October 18, 2000)]
[Rules and Regulations]
[Pages 62282-62285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26248]


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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) * * *

 
------------------------------------------------------------------------
  Ranges of absorbency in grams\1\     Corresponding term of absorbency
------------------------------------------------------------------------
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.


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* * * * *

    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