[Federal Register Volume 65, Number 202 (Wednesday, October 18, 2000)]
[Proposed Rules]
[Pages 62317-62319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 00N-1520]


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

AGENCY: Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its menstrual tampon labeling regulation to change the current term for 
tampons that absorb 6 grams (g) and under of fluid. A tampon with 6 g 
or less absorbency is currently required to

[[Page 62318]]

be labeled as ``junior''. FDA is proposing to change the term to 
``light''. The term ``junior'' implies that it is only for younger, 
teenage women, while in fact, women of any age with light menstrual 
flow may find this tampon useful. FDA wishes to encourage 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 enables consumers to 
compare the absorbency of one brand and style of tampons with the 
absorbency of other brands and styles. FDA is issuing this proposed 
rule under the Federal Food, Drug, and Cosmetic Act (the act).

DATES: Submit written comments on the proposed rule by January 16, 
2001. See section II of this document for the proposed effective date 
of a final rule based on this document.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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. Recently, the agency proposed a term for 15 to 18 g absorbency 
tampons (``ultra''). FDA is finalizing that rule elsewhere in this 
issue of the Federal Register. When commenting on that proposed rule, 
several tampon manufacturers suggested changing the term for the 6 g 
and under tampon from ``junior'' to ``light'', because ``junior'' 
implies for teenagers only. These manufacturers argued that, in 
reality, the least absorbent tampon should be used by all women, 
commensurate with the amount of their menstrual flow. The age or size 
of a women should not be a deciding factor. The agency agrees that this 
term change would help woman decide which tampon they should use.
    FDA is aware of literature suggesting that the lowest absorbency of 
tampon that is effective should be chosen, to minimize the risk of TSS. 
FDA believes that using the term ``light'' for low absorbency tampons 
(rather than ``junior'') will help women make the appropriate 
selection.
    Tampons are currently classified into class II (special controls) 
(see 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 of 
the regulations (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 (21 U.S.C. 
360(k)) and subpart E of part 807. Under Sec. 807.87(e), a premarket 
notification for a device is to contain, among other things, labeling 
for the device.

II. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 90 days after the date of publication of the 
final rule in the Federal Register.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 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 proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the proposed rule is not a significant regulatory 
action as defined by the Executive Order 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 
with this product would incur no additional costs because of this rule. 
That small entity would already be required to identify the absorbency 
ranges of its tampons. The agency, therefore, certifies that the 
proposed 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 proposed rule, 
because the proposed rule is not expected to result in any 1-year 
expenditure that would exceed $100 million adjusted for inflation.

V. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by January 16, 
2001. Two copies of any comments are to be submitted except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

VI. Paperwork Reduction Act of 1995

    This proposed 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 proposed rule requires public disclosure, on labeling, of 
information supplied by FDA to tampon manufacturers. 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.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 801 be amended as follows:

[[Page 62319]]

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 by revising the table in paragraph 
(e)(1) 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                          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.
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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: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-26249 Filed 10-17-00; 8:45 am]
BILLING CODE 4160-01-F