Document ID: FDA-2019-N-0994-0001
Agency: fda
Document Type: Notice
Title: Modified Risk Tobacco Product Applications for VLNTM King and VLNTM Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group, Inc.
Posted Date: 2019-07-25T04:00Z

[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35869-35871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0994]

Modified Risk Tobacco Product Applications for VLNTM King and 
VLNTM Menthol King, Combusted, Filtered Cigarettes, 
Submitted by 22nd Century Group, Inc.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of modified risk tobacco product 
applications (MRTPAs) for VLNTM King and VLNTM 
Menthol King, combusted, filtered cigarettes, submitted by 22nd Century 
Group, Inc.

DATES: Electronic or written comments on the application may be 
submitted beginning July 25, 2019. FDA will establish a closing date 
for the comment period as described in section I.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-0994 for ``Modified Risk Tobacco Product Applications for 
VLNTM King and VLNTM Menthol King, Combusted, 
Filtered Cigarettes Submitted by 22nd Century Group Inc.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not

[[Page 35870]]

in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read the electronic and 
written/paper comments received, go to https://www.regulations.gov and 
insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, 
AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 911 of the Federal Food, Drug, and Cosmetic Act (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 pursuant to 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 a 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 a 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 of whether an order is appropriate under section 911 
of the FD&C Act is based on the 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, 22nd Century Group, Inc., is 
seeking an order under section 911(g)(2) of the FD&C Act.
    FDA may issue an order under section 911(g)(2) of the FD&C Act with 
respect to a tobacco product that does not satisfy the section 
911(g)(1) standard. A person seeking an order under section 911(g)(2) 
of the FD&C Act must show that:
     Such an order would be appropriate to promote the public 
health;
     any aspect of the label, labeling, and advertising for the 
product that would cause the product to be an MRTP is limited to an 
explicit or implicit representation that the tobacco product or its 
smoke does not contain or is free of a substance or contains a reduced 
level of a substance, or presents a reduced exposure to a substance in 
tobacco smoke;
     scientific evidence is not available and, using the best 
available scientific methods, cannot be made available without 
conducting long-term epidemiological studies for an application to meet 
the standards for obtaining an order under section 911(g)(1);
     the scientific evidence that is available without 
conducting long-term epidemiological studies demonstrates that a 
measurable and substantial reduction in morbidity or mortality among 
individual tobacco users is reasonably likely in subsequent studies;
     the magnitude of overall reductions in exposure to the 
substance or substances which are the subject of the application is 
substantial, such substance or substances are harmful, and the product 
as actually used exposes consumers to the specified reduced level of 
the substance or substances;
     the product as actually used by consumers will not expose 
them to higher levels of other harmful substances compared to the 
similar types of tobacco products then on the market unless such 
increases are minimal and the reasonably likely overall impact of use 
of the product remains a substantial and measurable reduction in 
overall morbidity and mortality among individual tobacco users;
     testing of actual consumer perception shows that, as the 
applicant proposes to label and market the product, consumers will not 
be misled into believing that the product is or has been demonstrated 
to be less harmful or presents or has been demonstrated to present less 
of a risk of disease than one or more other commercially marketed 
tobacco products; and
     issuance of an order with respect to the application is 
expected to 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 satisfies the 
requirements in section 911(g)(2).
    FDA is issuing this notice to inform the public that the MRTPAs for 
the following products submitted by 22nd Century Group, Inc. have been 
filed and are being made available for public comment:

 MR0000140: VLNTM King
 MR0000141: VLNTM Menthol King

    FDA will post the application documents, including any amendments, 
to its website for the MRTPAs (see section II) for public comment on a 
rolling basis as they are redacted in accordance with applicable laws. 
In this document, FDA is announcing the availability of the first batch 
of application documents for public comment. FDA intends to establish a 
closing date for the comment period that is both at least 180 days 
after the date of this notice and at least 30 days after the final 
documents from the applications are made available for public comment. 
FDA will announce the closing date at least 30 days in advance. FDA 
believes that this comment period is appropriate given the volume and 
complexity of the applications being posted.
    FDA will notify the public about the availability of additional 
application documents and the comment period closing date via the 
Agency's web page for the MRTPAs (see section II) and by other means of 
public communication, such as by email to individuals who have signed 
up to receive email alerts. FDA does not intend to issue additional 
notices in the Federal Register regarding the availability of 
additional application documents, including amendments, or the comment 
period for these MRTPAs. To receive email alerts, visit FDA's email 
subscription service management website (https://updates.fda.gov/subscriptionmanagement), provide an email address, scroll down to the 
``Tobacco'' heading, select ``Modified Risk Tobacco Product Application 
Update,'' and click ``Submit.'' To encourage public participation

[[Page 35871]]

consistent with section 911(e) of the FD&C Act, FDA is making the 
redacted MRTPAs that are the subject of this notice available 
electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the documents at 
https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications.

    Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15831 Filed 7-24-19; 8:45 am]
 BILLING CODE 4164-01-P