80 FR 55124 - Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent; Guidance for Industry and Tobacco Retailers; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 177 (September 14, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.'' This guidance provides information to tobacco retailers on FDA's enforcement policy regarding certain so- called provisional tobacco products that become subject to not substantially equivalent (NSE) orders issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55124-55125]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1600]


Enforcement Policy for Certain (Provisional) Tobacco Products 
That the Food and Drug Administration Finds Not Substantially 
Equivalent; Guidance for Industry and Tobacco Retailers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Enforcement Policy 
for Certain (Provisional) Tobacco Products that FDA Finds Not 
Substantially Equivalent.'' This guidance provides information to 
tobacco retailers on FDA's enforcement policy regarding certain so-
called provisional tobacco products that become subject to not 
substantially equivalent (NSE) orders issued under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Center for Tobacco Products, Food and Drug Administration, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 
Silver Spring, MD 20993-2000. Send one self-addressed adhesive label to 
assist that office in processing your request or include a fax number 
to which the guidance document may be sent. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the guidance 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: Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000, 
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Enforcement Policy for Certain (Provisional) Tobacco 
Products that FDA Finds Not Substantially Equivalent.'' This guidance 
provides information to tobacco retailers on FDA's enforcement policy 
regarding certain so-called provisional tobacco products that become 
subject to NSE orders issued under the FD&C Act. We received several 
comments to the draft guidance (79 FR 10534, February 25, 2014), and 
those comments were considered as the guidance was finalized.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Enforcement Policy for Certain 
(Provisional) Tobacco Products that FDA Finds Not Substantially 
Equivalent.'' It does not

[[Page 55125]]

establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Comments

A. General Information About Submitting 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.

B. Public Availability of Comments

    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. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field titled ``Category (Required),'' 
on the ``Your Information'' page on www.regulations.gov. For this 
docket, however, FDA will not be following this general practice. 
Instead, FDA will post on http://www.regulations.gov comments to this 
docket that have been submitted by individuals in their individual 
capacity. If you wish to submit any information under a claim of 
confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your State/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: September 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23001 Filed 9-11-15; 8:45 am]
BILLING CODE 4164-01-P