FDA Advisory Meeting to Discuss Modified Risk Tobacco Product Applications (MRTPAs)

April 9-10, 2015 TPSAC Meeting Notice

Tobacco Products Scientific Advisory Committee 

Date: April 9-10, 2015

Time: The meeting will be held on April 9, 2015 from 8:30 a.m. to 5 p.m. and on April 10, 2015 from 8 a.m. to 5 p.m.  The meeting will be closed to the public from 4 p.m. to 5 p.m. on April 9, 2015.

Location: 
Food and Drug Administration
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002 

Webcast:
Seating for this meeting may be limited, so the public is encouraged to watch the free webcast instead of traveling to the meeting.  The link for the webcast will be available approximately 15 minutes prior to the beginning of the meeting each day and can be accessed on the TPSAC page. 

Agenda:  On April 9-10, 2015, the Committee will discuss modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products:

• MR0000020: General Loose, smokeless tobacco, loose snus, 1.59 oz (45g), cardboard can (SKU 4852);
• MR0000021: General Dry Mint Portion Original Mini, smokeless tobacco, snus portions, 0.21 oz (6g), 20—0.3g portions, plastic can (SKU 4800);
• MR0000022: General Portion Original Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4880);
• MR0000023: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4877);
• MR0000024: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4878);
• MR0000025: General Mint Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4352);
• MR0000026: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4876);
• MR0000027: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4875);
• MR0000028: General Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4881); and
• MR0000029: General Wintergreen Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4882).

Meeting Materials:  Links to meeting materials will be added as they become available.  FDA intends to make the background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and will be posted on FDA’s website after the meeting.

Public Participation Information:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. 

Written submissions may be made to the contact person on or before March 20, 2015.  Please send 20 paper copies, and one electronic copy,  of your submission to: 

Caryn Cohen, M.S.
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Copies must be received by 4 p.m. (Eastern) on March 20, 2015.

Regulatory Doctor provides regulatory consulting and training services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS)