Document ID: FDA-2013-D-1600-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Tobacco Retailers; Enforcement Policy
for Certain (Provisional) Tobacco Products That the Food and Drug
Administration Finds Not Substantially Equivalent; Availability
Posted Date: 2014-02-25T05:00Z

[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Page 10534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03978]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry and Tobacco Retailers; Enforcement 
Policy for Certain (Provisional) Tobacco Products That the Food and 
Drug Administration Finds Not Substantially Equivalent; 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availability of the draft guidance entitled ``Enforcement Policy for 
Certain (Provisional) Tobacco Products That FDA Finds Not Substantially 
Equivalent.'' This draft guidance provides information to tobacco 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 28, 2014.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send 
one self-addressed adhesive label to assist that office in processing 
your request or include a fax number to which the guidance may be sent. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373, email: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for tobacco 
retailers entitled ``Enforcement Policy for Certain (Provisional) 
Tobacco Products That FDA Finds Not Substantially Equivalent.'' In this 
draft guidance, FDA provides information on its enforcement policy 
regarding so-called provisional tobacco products that become subject to 
NSE orders under the FD&C Act. The provisional products addressed by 
this draft guidance are tobacco products that were first introduced or 
delivered for introduction into interstate commerce for commercial 
distribution after February 15, 2007, and prior to March 22, 2011, and 
for which a section 905(j) (21 U.S.C. 387e(j)) (or substantial 
equivalent) report was submitted no later than March 22, 2011. Because 
the FD&C Act permitted this specific group of products to remain on the 
market pending FDA's review of the report, there will very likely be 
products at retail locations within the United States when FDA issues 
an order finding a tobacco product NSE. This draft guidance explains 
that FDA does not intend to take enforcement action for at least 30 
calendar days from the date the NSE order issues for those products 
that are in the retailer's current inventory at a specific retail 
location on the date FDA issues the NSE order.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on 
``Enforcement Policy for Certain (Provisional) Tobacco Products That 
FDA Finds Not Substantially Equivalent.'' It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

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 draft guidance 
at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03978 Filed 2-24-14; 8:45 am]
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