Document ID: FDA-2014-N-1051-0001
Agency: fda
Document Type: Notice
Title: Modified Risk Tobacco Product Applications: Applications for 10
Products Submitted by Swedish Match North America Inc.; Availability
Posted Date: 2014-08-27T04:00Z

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51183-51184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20394]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1051]

Modified Risk Tobacco Product Applications: Applications for 10 
Products Submitted by Swedish Match North America Inc.; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of modified risk tobacco product 
applications (MRTPAs) submitted by Swedish Match North America Inc. for 
10 tobacco products.

DATES: Submit either electronic or written comments on the applications 
by February 23, 2015. Please note, however, that it will be more likely 
that the Agency is able to consider your comments before referring the 
applications to the Tobacco Products Scientific Advisory Committee if 
you submit your comments by November 25, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
1-877-CTP-1373, AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) into law. The Tobacco Control Act grants FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
Section 911 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 387k) addresses the marketing and distribution of modified 
risk tobacco products (MRTPs). MRTPs are tobacco products that are sold 
or distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco products. Section 
911(a) of the FD&C Act prohibits the introduction or delivery for 
introduction into interstate commerce of any MRTP unless an order 
issued by FDA under section 911(g) of the FD&C Act is effective with 
respect to such product.
    Section 911(d) of the FD&C Act describes the information that must 
be included in an MRTPA, which must be filed and evaluated by FDA 
before an applicant can receive an order from FDA. FDA is required by 
section 911(e) of the FD&C Act to make an MRTPA available to the public 
(except for matters in the application that are trade secrets or 
otherwise confidential commercial information) and to request comments 
by interested persons on the information contained in the application 
and on the label, labeling, and advertising accompanying the 
application. The determination whether an order is appropriate under 
section 911of the FD&C Act is based on the

[[Page 51184]]

scientific information submitted by the applicant as well as the 
scientific evidence and other information that is made available to the 
Agency, including through public comments.
    Section 911(g) of the FD&C Act describes the demonstrations 
applicants must make to obtain an order from FDA under either section 
911(g)(1) or (g)(2). The applicant, Swedish Match North America Inc., 
is seeking an order under section 911(g)(1) for each of the 10 products 
that are the subject of the submitted MRTPAs.
    An order under section 911(g)(1) of the FD&C Act is for a modified 
risk tobacco product that significantly reduces harm and the risk of 
tobacco-related disease to individual tobacco users; and benefits the 
health of the population as a whole. A person seeking an order under 
section 911(g)(1) of the FD&C Act must show that the tobacco product, 
as it is actually used by consumers, will significantly reduce harm and 
the risk of tobacco-related disease to individual tobacco users and 
will benefit the health of the population as a whole taking into 
account both users of tobacco products and persons who do not currently 
use tobacco products. Section 911(g)(4) of the FD&C Act describes 
factors that FDA must take into account in evaluating whether a tobacco 
product benefits the health of individuals and the population as a 
whole.
    FDA is issuing this notice to inform the public that MRTPAs 
submitted by Swedish Match North America Inc. for the following 
products (identified by FDA Submission Tracking Numbers (STN) 
(MR0000020--MR0000029)) have been filed and are being made available 
for public comment for 180 days:
     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).
    FDA believes a 180-day comment period is appropriate because of the 
volume and complexity of the material being posted in the applications. 
If you submit comments that apply to some but not all 10 of the 
products, FDA asks that you identify the applicable product(s) using 
the STNs listed in this document in your comments. To encourage public 
participation consistent with section 911(e) of the FD&C Act, FDA is 
placing the MRTPAs (except for matters in the applications that are 
trade secrets or otherwise confidential commercial information) that 
are the subject of this notice on public display at the Division of 
Dockets Management (see DATES and ADDRESSES) and making them available 
electronically (see section III).

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.accessdata.fda.gov/Static/widgets/tobacco/
SMNAMRTPAFDA-2014-N-1051.html or http://www.regulations.gov.

    Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20394 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P