G/TBT/N/USA/1519  
22 August 2019  
(19-5397) 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 AME RICA  
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) [1546]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
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):  Packaging, 
tobacco products; Tobacco and manufactured tobacco substitutes (HS 24); Graphical 
symbols (ICS 01.080), Tobacco, tobacco products and related equipment (ICS 65.160)  
5. Title, number of pages and language(s) of the notified document:  Tobacco 
Products; Required Warnings for Cigarette Packages and Advertisements (45 page(s), in 
English)  
6. Description of content:  The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a proposed rule to establish new required cigarette health warning s for cigarette 
packages and advertisements. The proposed rule would implement a provision of the 
Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires 
FDA to issue regulations requiring color graphics depicting the negative  health 
consequences of smoking to accompany new textual warning statements. The Tobacco 
Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to 
require each cigarette package and advertisement to bear one of the new requir ed 
warnings. This proposed rule, once finalized, would specify the color graphics that must 
accompany the new textual warning statements. FDA is proposing to take this action to 
promote greater public understanding of the negative health consequences of ci garette 
smoking.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Protection of human health or safety  
8. Relevant documents:  84 Federal Register (FR) 42754, 16 August 2019; Title 21 Code of 
Federal Regulations (CFR) Part 1141:  
https://www.govinf o.gov/content/pkg/FR -2019-08-16/html/2019 -17481.htm  
https://www.govinfo.go v/content/pkg/FR -2019-08-16/pdf/2019 -17481.pdf  
G/TBT/N/USA/596 and subsequent addenda  G/TBT/N/USA/1519  
 
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  Supporting Documents:  
Reference 66 - Tobacco Control Monograph 21, 2016 re Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements  
Reference 79 - Perceived Message Effectiveness Measures in Tobacco Education 
Campaigns_A Systematic Review, 2018 re Tobacco Products; Required Warnings for 
Cigarette Packages and Advertisements  
Reference 145 - The Impact of Strengthening Cigarette Pack Warnings, 2016 re Tobacco 
Products; Required Warnings for Cigarette Packages and Advertisements   
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  15 October 2019  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2019/TBT/USA/19_4631_00_e.pdf