[Federal Register: August 25, 2004 (Volume 69, Number 164)]
[Rules and Regulations]               
[Page 52170-52171]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au04-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 2000N-1520]

 
Medical Devices; Labeling for Menstrual Tampons; Ranges of 
Absorbency, Change From ``Junior'' to ``Light''

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 change the 
current term for tampons that absorb 6 grams (g) and under of fluid. A 
tampon with absorbency of 6 g or less is currently required to be 
labeled as ``junior''. FDA is changing the term ``junior'' to 
``light''. The term ``junior'' implies that the tampon is only for 
younger or teenage women when, in fact, it may be appropriate for women 
of any age with light menstrual flow. FDA encourages women to use the 
lowest absorbency tampon appropriate for their flow to help minimize 
the risk of Toxic Shock Syndrome (TSS). At present, FDA requires 
standardized terms to be used for the labeling of a menstrual tampon to 
indicate its particular absorbency. This rule enables women to compare 
the absorbency of one brand and style of tampons 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.

DATES: This rule is effective February 27, 2006.

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) corresponding to the following 
four absorbency ranges: Less than 6, 6 to 9, 9 to 12, and 12 to 15 g of 
fluid. FDA announced the availability of the term for 15 to 18 g 
absorbency tampons (``ultra'') in the Federal Register of October 18, 
2000 (65 FR 62317). When commenting on that proposed rule, 
manufacturers argued that women should use the least absorbent tampon 
necessary and that the amount of their menstrual flow, not the age or 
size of a woman, should determine the absorbency of the tampon she 
should use. FDA is also aware of literature suggesting that, to 
minimize the risk of TSS, the lowest absorbency of tampon that is 
effective should be chosen.

II. The Proposed Rule

    In the Federal Register of October 18, 2000, FDA published a 
proposed rule to amend its tampon labeling regulation to change the 
current term for tampons that absorb 6 g and under of fluid. FDA 
proposed this change because it believes that changing the standard 
term for this absorbency range from ``junior'' to ``light'' will 
improve consumer understanding of tampons across brands, and it will 
make it easier for women to adhere to advice in the tampon labeling 
about reducing the risk of TSS. The 90-day comment period closed on 
January 16, 2001. The agency received comments from two tampon 
manufacturers.

III. Response to Comments

    (Comment 1) Both companies supported FDA's proposal to change the 
absorbency term for tampons that absorb 0 to 6 g of fluid from 
``junior'' to ``light''. They agreed with the agency's position that 
this change will reduce the mistaken impression held by many women that 
the term ``junior'' means the tampons are intended only for younger or 
teenage women, rather than referring to the amount of menstrual flow.
    Comments from both manufacturers noted that the proposed effective 
date of 90 days after publication of the final rule in the Federal 
Register would not allow sufficient time for manufacturers to deplete 
their inventories of existing packaging materials or revise labeling 
and artwork on retail packages. Both companies recommended the agency 
allow a 24-month period following publication of the final rule in the 
Federal Register during which tampons that absorb 6 g or less of fluid 
could be sold with either a ``junior'' or a ``light'' designation. One 
company recommended that only those tampons which have a valid date 
code within 24 months of publication of the final rule in the Federal 
Register be allowed to carry the ``junior'' designation.
    (Response) Based on available information regarding labeling of 
these devices, FDA has concluded that 18 months after publication of 
the final rule should be sufficient for manufacturers to implement the 
``light'' absorbency designation on their product package labeling.
    (Comment 2) Comments from the manufacturers also suggested that the 
change to ``light absorbency'' in the U.S. tampon labeling regulation 
will result in inconsistency with current Canadian tampon labeling 
requirements. Both companies recommended agency harmonization with the 
Canadian requirements so that the same tampon absorbency terms are 
acceptable in both the United States and Canada.
    (Response) The agency intends to work with the Canadian device 
authorities to harmonize required absorbency terms for tampons.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) and (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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). 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. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
order

[[Page 52171]]

and so is not subject to review under 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. Any small entity that decided to enter the market 
for this product would incur no additional costs because of this rule, 
as that entity would already be required to identify the absorbency 
ranges of its tampons. Because this rule imposes minimal costs, the 
agency 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, which includes an assessment 
of anticipated costs and benefits, before proposing any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. The current threshold after adjustment for 
inflation is $110 million. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.
    The purpose of this final rule is to amend the menstrual tampon 
labeling regulation changing the current absorbency term ``junior'' to 
``light'' to improve consumer understanding of tampon absorbency rates. 
All manufacturers of menstrual tampons with an absorbency range of less 
than or equal to 6 g will have to change their package labels and any 
other labeling using the term ``junior'' in reference to these 
products. This is a minor label change because it only requires 
changing one word on the labeling and will not affect label formatting 
or the space requirements. Manufacturers should incur minor or no 
incremental costs as a result of this rule because they will have 18 
months in which to implement the changes and the change can be 
incorporated when new labels are ordered. The 18-month implementation 
period should also allow manufacturers to deplete their current label 
inventory.
    The Small Business Administration (SBA) classifies a medical device 
entity as ``small'' if it has fewer than 500 employees. There are about 
10 domestic manufacturers that will be affected by this rule, 5 of 
which meet SBA's definition of a small entity. Frequent relabeling is a 
cost of doing business in the consumer health products market. Some 
companies will be able to incorporate this labeling change at no 
additional cost when making other voluntary label changes. The 
incremental cost of a minor label change such as this is between $600 
and $3,000, depending on the type of packaging and printing method. A 
manufacturer will incur this cost for each individual package size it 
markets that contains tampons with an absorbency rate of 6 g or less. 
The incremental cost to relabel is less than 1 percent of the small 
entities' product revenues. Therefore, the final rule will not have a 
significant economic impact on small entities.

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 effects 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 Executive 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 (44 U.S.C. 3501-3520). This 
rule requires tampon manufacturers to provide specific wording supplied 
by FDA on their labeling. Such information is not included in the 
definition of ``collection of information'' under the Paperwork 
Reduction Act regulation (5 CFR 1320.3(c)(3)).

List of Subjects in 21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
801 is amended as follows:

PART 801--LABELING

0
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.

0
2. Section 801.430 is amended by revising the table in paragraph (e)(1) 
to read as follows:


Sec.  801.430  User labeling for menstrual tampons.

* * * * *
    (e) * * *
    (1) * * *

------------------------------------------------------------------------
  Ranges of absorbency in grams\1\     Corresponding term of absorbency
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6 and under                          Light absorbency
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6 to 9                               Regular absorbency
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9 to 12                              Super absorbency
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12 to 15                             Super plus absorbency
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15 to 18                             Ultra absorbency
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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.

* * * * *

    Dated: August 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19488 Filed 8-24-04; 8:45 am]

BILLING CODE 4160-01-S