Methods and Procedures for Removing Harmful Constituents from Tobacco

General Information:
Document Type:                                 Sources Sought
Release Date:                                      March 19, 2013
Response Date:                                   March 31, 2013 at 5:00pm local time via e-mail to Christopher McGucken; Christopher.McGucken@fda.hhs.gov

 

Description:                                         Methods and Procedures for Removing Harmful Constituents from Tobacco

 

This is a Sources Sought (SS) to identify the capabilities of the marketplace of all interested parties, including academic institutions, businesses, or other public or private agencies.  Individual researchers in possession of these data are encouraged to work with their Business Office.

 

This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation.  No official solicitation exists; therefore, please do not request a copy of a solicitation.  If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list.  Telephone inquiries will not be accepted. 

 

The FDA makes no implied or in fact contract by issuing this notice. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received.   Do not send any material that requires a non-disclosure agreement or that may be business sensitive.  Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted.  Responses to this notice will not be returned.

 

 

Mission and Objectives:

 

Through the Family Smoking Prevention and Tobacco Control Act (“the Act”), the FDA has the authority to “regulate the levels of tar, nicotine, and other harmful components of tobacco products” (Sec 3(5) of the Act). Given this authority, the FDA is interested in exploring the capability, methods and costs of reducing and/or removing nitrosamines, nicotine and/or polyaromatic hydrocarbons (PAHs) from tobacco.

 

 

 

 

 

Sources Sought Instructions:

                                    

Please complete Part A, Technical Capability and Specification Questionnaire, describing your company’s capabilities; Part B, and Size of Business and Part C, Estimated Dollar Value Range.

 

Responses shall be:

 

Ø  identified with the SS number;

Ø  Submitted to the email as indicated above.

 

FDA makes no implied or in fact contract by issuing this SS. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received.  

 

Part A. Technical Capability

 

Specification Questionnaire:

 

Does your company have the technology and capability to reduce and/or eliminate nitrosamine(s), nicotine and/or PAHs from tobacco? If so:

• 
  
• Please describe the specific methods for each: nitrosamines, nicotine and PAHs.
  
• What is the reliability and consistency of the removal/reduction process(es)?
  
• What are the limitations associated with the process(es)?
  
• How does this process impact other tobacco-related constituents or other characteristics of the tobacco?
  

 

Does your company have the capability to manufacture tobacco products (including cigarettes) that have reduced or eliminated nitrosamine(s), nicotine and/or PAHs?

• 
  
• What is the impact of using such modified tobacco on the manufacturing process and on the finished tobacco product (including cigarettes), including but not limited to:
  
  • 
    
  • Changes to other components and constituents in the finished tobacco product.
    
  • Impact on the palatability of the finished product.
    
  • Ability to use the tobacco in existing commercial manufacturing or other tobacco product production processes.
    
  
  
  
• What is the reliability and consistency of the manufacturing process?
  
• What are the limitations associated with the manufacturing?
  
• What is the timeframe for manufacturing the tobacco products (including cigarettes)?
  
• What does your company consider “small” and “large” batches of products (including cigarettes)?
  

 

Part B.  Size of Business

 

State whether your company is a large business, small business (and also state your socioeconomic status), College/University, or is a non-profit organization.

 

Part C. Estimated Dollar Value Range

 

What are the costs associated for obtaining and/or using the removal/reduction technology, such as licensing costs, new or altered equipment, manufacturing changes?

 

What is the cost range for small and large batches of manufacturing products by each specification (no/low nitrosamines, no/low nicotine, and no/low PAHs)?