G/TBT/N/USA/904  
 
30 April 2014  
(14-2639)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Food and Drug Administration (FDA), Health and Human Services 
(HHS) [921] 
Name and address (including telephon e and fax numbers, email and website 
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):  Tobacco 
products. Tobacco, tobacco products and related equipment (ICS 65.160). Cigars, cheroots, cigarillos and cigarettes, of tobacco or of tobacco substitutes. (HS 2402), Other 
manufactured tobacco and manufactured tobacco substitutes; "homogenized" or 
"reconstituted" tobacco; tobacco extracts and essences. (HS 2403). 
5. Title, number of pages and language(s) of the notified document:  Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and 
Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; 
Proposed Rule (67 pages, in English).     
6. Description of content:  The Food and Drug Administration (FDA) is proposing to deem 
products meeting the statutory definition of "tobacco product," except accessories of a 
proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA 
authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless 
tobacco, and any other tobacco products that  the Agency by regulation deems to be 
subject to the law. Option 1 of the proposed rule would extend the Agency's "tobacco 
product" authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of 
"tobacco product" in the FD&C Act. Option  2 of the proposed rule would extend the 
Agency's "tobacco product" authorities to all other categories of products, except premium cigars and the accessories of a prop osed deemed tobacco product, that meet 
the statutory definition of "tobacco product" in the FD&C Act. FDA also is proposing to 
prohibit the sale of "covered tobacco products" to individuals under the age of 18 and to 
require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to 
address the public health concerns associated with the use of tobacco products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human health or Safety; Prevention of deceptive practices and 
consumer protection. G/TBT/N/USA/904 
 
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  8. Relevant documents:   79 Federal Register (FR) 23141, 25 April 2014; Title 21 Code of 
Federal Regulations (CFR) Parts 1100, 1140, and 1143.  Will appear in the Federal Register when adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined To be determined 
10. Final date for comments:  9 July 2014 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
http://www.gpo.gov/fdsys/pkg/FR -2014-04-25/html /2014-09491.htm  
http://www.gpo.gov/fdsys/pkg/FR -2014-04-25/pd f/2014-09491.pdf