WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/546
9 November 2000
(00-4732)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Food and Drug Administration (23)
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Menstrual Tampons
(HS Chapter 5601)
5. Title, number of pages and language(s) of the notified document:   Medical Devices;
Labelling for Menstrual Tampons;  Ranges of Absorbency, Change from "Junior" to "Light"
(3 pages, English)
6. Description of content:   The Administration 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 a 6 g or less absorbency is currently required to be labelled as
"junior".  The Administration is proposing to chan ge 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.  The Administration wishes to encourage women
to use the lowest absorbency tampon appropriate for their flow to help minimize the risk of
toxic shock syndrome.  At present, the Admini stration requires standardized terms to be used
for the labeling of a menstrual tampon to indicate its particular absorbency.  This proposed
rule is being issued under the Federal Food, Drug, and Cosmetic Act.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To enable consumers to compare the absorbency  of one brand and style of tampons with the
absorbency of other brands and styles.
8. Relevant documents:   65 FR 62317, 18 October 2000; 21 CFR Part 801.   Will appear in the
Federal Register when adopted.
9. Proposed date of adoption:  To be determined
Proposed date of entry into force:
10. Final date for comments:   16 January 2001
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:   The text is also available on the Internet at:
http://www.access.gpo.gov/nara/index.html