G/TBT/N/USA/1351  
 
21 March 2018  
(18-1718) 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) [1373]  
Name and address (including telephone 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:   
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): Tobacco 
products ; Tobacco and manufactured tobacco substitutes (HS 24). Domestic safety 
(ICS 13.120), Tobacco, tobacco products and related equipment (ICS 65.160).  
5. Title, number of pages and language(s) of the notified document: Tobacco Product 
Standard for Nicotine Level of Combusted Cigarettes (26 page(s), in En glish)   
6. Description of content: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to obtain information for consideration in 
developing a tobacco product standard to set the maximum nicotine level for cigarettes. 
Because tobacco -related harms ultimately result from addiction to the nicotine in such 
products, causing repeated use and exposure to toxicants, FDA is considering taking this 
action to reduce the level of nicotine in these products so they are  minimally addictive or 
nonaddictive, using the best available science to determine a level that is appropriate for 
the protection of the public health. FDA is using the term "nonaddictive" in this document 
specifically in the context of a potentially nona ddictive cigarette. We acknowledge the 
highly addictive potential of nicotine itself depending upon the route of delivery. As 
discussed elsewhere in this document, questions remain with respect to the precise level of 
nicotine in cigarettes that might rend er them either minimally addictive or nonaddictive for 
specific members or segments of the population. We envision the potential circumstance 
where nicotine levels in cigarettes do not spur or sustain addiction for some portion of 
potential smokers. This c ould give addicted users the choice and ability to quit more easily, 
and it could help to prevent experimenters (mainly youth) from initiating regular use and 
becoming regular smokers. The scope of products covered by any potential product 
standard will be  one issue for comment in the ANPRM. Any additional scientific data and 
research relevant to the empirical basis for regulatory decisions related to a nicotine 
tobacco product standard is another issue for comment in the ANPRM.  G/TBT/N/USA/1351  
 
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  7. Objective and rationale,  including the nature of urgent problems where 
applicable: Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:  83 Federal Register (FR) 11818, 16 March 2018; Title  21 Code of 
Federal Regul ations (CFR) Part 1130.   Will appear in the Federal Register when adopted.   
9. Proposed date of adoption: To be determined  
Proposed date of entry into force: To be determined  
10. Final date for comments: 14 June 2018  
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/2018/TBT/USA/18_1584_00_e.pdf