. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/229 
9 January 2007 
 (07-0105) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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 (FDA) (236)  
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  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):   Over-the-counter human 
drugs, Internal analgesic, antipyretic, and an ti-rheumatic drug products (HS:  Chapter 3004; 
ICS:  11) 
5. Title, number of pages and language(s) of the notified document:   Internal Analgesic, 
Antipyretic, and Anti-rheumatic Drug Products for Over-the-Counter Human Use; Proposed 
Amendment of the Tentative Final Monograph;  Required Warnings and Other Labelling. 
(42 pages, English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
its over-the-counter (OTC) labelling regulations  and the tentative final monograph (TFM) 
for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include 
new warnings and other labelling requirements advising consumers about potential risks and 
when to consult a doctor. FDA is also propos ing to remove the alcohol warning in its 
regulations and add new warn ings and other labelling for all OTC IAAA drug products. 
The new labelling would be required for all OTC drug products containing an IAAA active 
ingredient whether marketed under an OT C drug monograph or an approved new drug 
application (NDA).  FDA is issuing this propo sal as part of its ongoing review of OTC drug 
products after considering the advice of its Nonprescription Drugs Advisory Committee 
(NDAC) and other available information. F DA is proposing these labelling changes because 
it has tentatively concluded they are necessar y for these ingredients to be considered 
generally recognized as safe and effective and not misbranded for OTC use. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health 
8. Relevant documents:   71 Federal Register (FR) 77314 26 December 2006; Title 21 Code 
of Federal Regulations (CFR) Pa rts 201 and 343. Will appear in the Federal Register when 
adopted. G/TBT/N/USA/229 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   25 May 2007 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Internet URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/E6-
21855.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/pdf/
E6-21855.pdf