G/TBT/N/USA/1953  
12 December 2022  
(22-9251) 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) [1984]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification 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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Investigational new drug applications; Pharmaceutics (ICS code(s): 11.120); Domestic 
safety (ICS code(s): 13.120)  
5. Title, number of pages and language(s) of the notified document:  Investigational 
New Drug Applications; Exemptions for Clinical Investigations To Evaluate a Drug Use of 
a Product Lawfully Marketed as a Conventional  Food, Dietary Supplement, or Cosmetic; 
(16 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, the 
Agency, or we) is proposing to amend its regulations on investigational new drug 
applications (INDs)  to exempt from the IND requirements certain clinical investigations 
of lawfully marketed foods for human consumption (including both conventional foods 
and d ietary supplements) and cosmetics when the product is to be studied to evaluate its 
use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products 
would not have to be conducted under an IND when, among other things, the study is 
not intended to support a drug development plan or a labeling change that would cause 
the lawfully marketed product to become an unlawfully marketed drug, and the study 
does not present a potential for significant risk to the health, safety, or welfare of subjects. 
Though exempt from the IND requirements, such investigations would still be subject to 
other regulations designed to protect the rights and safety of subjects, including 
requirements for informed consent and review by institutional review boar ds (IRBs). By 
exempting from the IND requirements certain clinical investigations of products lawfully 
marketed as a food or cosmetic, the proposed provisions are intended to reduce the 
regulatory burden of conducting such studies while retaining protectio ns for human 
subjects.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Cost saving and productivity 
enhancement  G/TBT/N/USA/1953  
 
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  8. Relevant documents:   
87 Federal Register (FR) 75536, 9 December 2022; Title 21 Code of Federal Regulations 
(CFR) Part 312:  
https://www.govinfo.gov/content/pkg/FR -2022-12-09/html/2022 -26728.htm  
https://www.govinfo.gov/content/pkg/FR -2022-12-09/pdf/2022 -26728.pdf  
This proposed rule is identified by Docket Number FDA -2019-N-2650. The Docket Folder 
is available from Regulations.gov at https://www.regulations.gov/docket/FDA -2019-N-
2650/document  and provides access to primary documents as well as comments received. 
Documents are also accessible from Regulations.gov  by searching the Docket Number. 
WTO Members and their stakeholders are asked to submit co mments to the USA TBT 
Enquiry Point  by or before 4pm Eastern Time  on 9 March 2023. Comments received by 
the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with 
the regulator and will also be submitted to the Docket  on Regulations.gov if received 
within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  9 March 2022  
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/2022/TBT/USA/22_8519_00_e.pdf