G/TBT/N/USA/1006  
 
3 July 2015  
(15-3420)  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) [1024] 
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 : 
Please submit comments to: USA WTO TBT Enquiry Point 
Email: ncsci@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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Tobacco products and 
liquid nicotine. Unmanufactured tobacco; tobacco refuse. (HS: 2401), 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). Tobacco, tobacco 
products and related equipment (ICS: 65.160) 
5. Title, number of pages and langua ge(s) of the notified document: Nicotine Exposure 
Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products (5 pages, in English)  
6. Description of content: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of "tobacco products" 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), and restrictions regarding the sale and distribution of such tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information 
that may inform regulatory actions FDA might take with respect to nicotine exposure 
warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, 
and potentially for other tobacco products including, but not limited to, novel tobacco 
products such as dissolvables, lotions, gels, and drinks. In April 2014, FDA published a proposed rule seeking to deem products m eeting the statutory definition of "tobacco 
product", except accessories to proposed deemed tobacco products, to be subject to the 
FD&C Act, as amended by the Tobacco Control Ac t. Specifically, the proposed rule seeks to 
extend the Agency's "tobacco product" authorities to those products that meet the statutory definition of "tobacco product", prohibiting the sale of "covered tobacco products" 
to individuals under the age of 18, and requirin g the display of health warnings on certain 
tobacco product packages and in advertisements. The deeming rulemaking does not address the issues raised in this ANPRM.  G/TBT/N/USA/1006 
 
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  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  
8. Relevant documents:  
 80 Federal Register (FR) 37555, 1 July 2015; Title 21 Code of Federal Regulations 
(CFR) Part 1100, 1140 and 1143. Will appear in the Federal Register when adopted. 
 G/TBT/N/USA/904 – 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: http://www.gpo.gov/fdsys/pkg/FR- 2014-04-25/html/2014-09491.htm  
http://www.gpo.gov/fdsys/pkg/FR- 2014-04-25/pdf/ 2014-09491.pdf  
9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined   
10. Final date for comments: 31 August 2015 
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/crnattachm ents/2015/TBT/USA/15_2592_00_e.pdf