Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability, 4893-4894 [2017-00773]
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373,
AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Compliance Policy for Required
Warning Statements on Small-Packaged
Cigars.’’
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act granted FDA
the authority to regulate the
manufacture, marketing, and
distribution of cigarettes, cigarette
tobacco, roll-your-own tobacco, and
smokeless tobacco products to protect
the public health and to reduce tobacco
use by minors.
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to Chapter IX of the FD&C
Act (section 901(b) of the FD&C Act). On
May 10, 2016, FDA issued that rule,
extending FDA’s tobacco product
authority to cigars, among other
products (81 FR 28974). Among the
requirements that now apply to cigars
are health warning statements
prescribed under section 906(d) of the
FD&C Act, which permits restrictions on
the sale and distribution of tobacco
products that are ‘‘appropriate for the
protection of the public health.’’ The
rule specifies the health warning
statements that must be displayed on
cigar packaging and where those
statements must be placed, among other
requirements.
The draft guidance discusses FDA’s
compliance policy for cigars with
packaging too small or otherwise unable
to accommodate the warning statements
and specifications required under the
regulation.
sradovich on DSK3GMQ082PROD with NOTICES
II. Significance of Draft Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on its compliance policy for cigars in
small packaging. It does not 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.
VerDate Sep<11>2014
18:21 Jan 13, 2017
Jkt 241001
III. Paperwork Reduction Act of 1995
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 1143 have been approved
under 0910–0768.
IV. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00855 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0120]
Interpretation of and Compliance
Policy for Certain Label Requirement;
Applicability of Certain Federal Food,
Drug, and Cosmetic Act Requirements
to Vape Shops; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Interpretation of and Compliance
Policy for Certain Label Requirement;
Applicability of Certain Federal Food,
Drug, and Cosmetic Act Requirements to
Vape Shops.’’ This draft guidance
provides FDA’s interpretation of, and a
compliance policy for, the requirement
that the label of tobacco products
contain an accurate statement of the
percentage of foreign and domestic
grown tobacco under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act).
This draft guidance document is also
intended to assist retailers who sell
newly deemed products by explaining
whether engaging in certain activities
subjects such establishments to
additional requirements of the FD&C
Act and the limited circumstances
under which FDA does not intend to
enforce compliance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
4893
considers your comment of 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 February 16,
2017.
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2017–D–0120 for ‘‘Interpretation of and
Compliance Policy for Certain Label
Requirement; Applicability of Certain
Federal Food, Drug, and Cosmetic Act
Requirements to Vape Shops.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
E:\FR\FM\17JAN1.SGM
17JAN1
sradovich on DSK3GMQ082PROD with NOTICES
4894
Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
or at the Division of Dockets
Management 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 Division of Dockets
Management. 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 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. 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
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Katherine Collins, Center for Tobacco
Products, Food and Drug
VerDate Sep<11>2014
18:21 Jan 13, 2017
Jkt 241001
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 1–877–287–1373, email:
AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Interpretation of and Compliance
Policy for Certain Label Requirement;
Applicability of Certain Federal Food,
Drug, and Cosmetic Act Requirements to
Vape Shops.’’
This draft guidance document, when
finalized, will provide FDA’s
interpretation of, and a compliance
policy for, the label requirement under
section 903(a)(2)(C) of the FD&C Act (21
U.S.C. 387c(a)(2)(C)). This draft
guidance document, when finalized, is
also intended to assist retailers who sell
newly deemed products by explaining
whether engaging in certain activities
subjects such establishments to
additional requirements of the FD&C
Act and the limited circumstances
under which FDA does not intend to
enforce compliance.
The Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31)
(Tobacco Control Act), enacted on June
22, 2009, amends section 904 of the
FD&C Act (21 U.S.C. 387d) and provides
FDA with the authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Cigarettes, cigarette tobacco, roll-yourown tobacco, and smokeless tobacco
were immediately covered by FDA’s
tobacco product authorities in chapter
IX of the FD&C Act, when the Tobacco
Control Act went into effect. As for
other types of tobacco products, section
901(b) of the FD&C Act (21 U.S.C.
387a(b)) grants FDA authority to deem
those products subject to chapter IX of
the FD&C Act. Under that authority,
FDA issued a rule deeming all other
products that meet the statutory
definition of ‘‘tobacco product,’’ set
forth in section 201(rr) of the FD&C Act
(21 U.S.C. 321(rr)), except for
accessories of those products, as subject
to chapter IX of the FD&C Act (81 FR
28974). FDA published the final rule on
May 10, 2016, and it became effective
on August 8, 2016.
Section 903(a)(2)(C) of the FD&C Act
provides that a tobacco product in
package form is misbranded unless its
label contains ‘‘an accurate statement of
the percentage of tobacco used in the
product that is domestically grown
tobacco and the percentage that is
foreign grown tobacco.’’ The draft
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
guidance provides FDA’s interpretation
of, and a compliance policy for, this
label requirement.
Retail establishments, such as vape
shops, which engage in certain activities
may also be subject to certain
requirements of the FD&C Act that
apply to tobacco product manufacturers
and to establishments that engage in the
manufacture, preparation,
compounding, or processing of tobacco
product. These activities may also
include modifying a product so that it
is a new tobacco product requiring
compliance with the premarket
authorization requirements. This draft
guidance explains which activities
subject vape shops to these FD&C Act
requirements and the limited
circumstances under which FDA does
not intend to enforce compliance.
II. Significance of Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA.
It does not 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. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00773 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0114]
Referencing Approved Drug Products
in Abbreviated New Drug Application
Submissions; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
E:\FR\FM\17JAN1.SGM
17JAN1
Agencies
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4893-4894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00773]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-0120]
Interpretation of and Compliance Policy for Certain Label
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic
Act Requirements to Vape Shops; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Interpretation
of and Compliance Policy for Certain Label Requirement; Applicability
of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape
Shops.'' This draft guidance provides FDA's interpretation of, and a
compliance policy for, the requirement that the label of tobacco
products contain an accurate statement of the percentage of foreign and
domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act). This draft guidance document is also intended to assist
retailers who sell newly deemed products by explaining whether engaging
in certain activities subjects such establishments to additional
requirements of the FD&C Act and the limited circumstances under which
FDA does not intend to enforce compliance.
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 of 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 February 16, 2017.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2017-D-0120 for ``Interpretation of and Compliance Policy for
Certain Label Requirement; Applicability of Certain Federal Food, Drug,
and Cosmetic Act Requirements to Vape Shops.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov
[[Page 4894]]
or at the Division of Dockets Management 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 Division of Dockets Management. 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 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.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. 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 electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email: AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``Interpretation of and Compliance Policy for Certain Label
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic
Act Requirements to Vape Shops.''
This draft guidance document, when finalized, will provide FDA's
interpretation of, and a compliance policy for, the label requirement
under section 903(a)(2)(C) of the FD&C Act (21 U.S.C. 387c(a)(2)(C)).
This draft guidance document, when finalized, is also intended to
assist retailers who sell newly deemed products by explaining whether
engaging in certain activities subjects such establishments to
additional requirements of the FD&C Act and the limited circumstances
under which FDA does not intend to enforce compliance.
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amends section 904
of the FD&C Act (21 U.S.C. 387d) and provides FDA with the authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco were immediately covered by FDA's tobacco product authorities
in chapter IX of the FD&C Act, when the Tobacco Control Act went into
effect. As for other types of tobacco products, section 901(b) of the
FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those
products subject to chapter IX of the FD&C Act. Under that authority,
FDA issued a rule deeming all other products that meet the statutory
definition of ``tobacco product,'' set forth in section 201(rr) of the
FD&C Act (21 U.S.C. 321(rr)), except for accessories of those products,
as subject to chapter IX of the FD&C Act (81 FR 28974). FDA published
the final rule on May 10, 2016, and it became effective on August 8,
2016.
Section 903(a)(2)(C) of the FD&C Act provides that a tobacco
product in package form is misbranded unless its label contains ``an
accurate statement of the percentage of tobacco used in the product
that is domestically grown tobacco and the percentage that is foreign
grown tobacco.'' The draft guidance provides FDA's interpretation of,
and a compliance policy for, this label requirement.
Retail establishments, such as vape shops, which engage in certain
activities may also be subject to certain requirements of the FD&C Act
that apply to tobacco product manufacturers and to establishments that
engage in the manufacture, preparation, compounding, or processing of
tobacco product. These activities may also include modifying a product
so that it is a new tobacco product requiring compliance with the
premarket authorization requirements. This draft guidance explains
which activities subject vape shops to these FD&C Act requirements and
the limited circumstances under which FDA does not intend to enforce
compliance.
II. Significance of Guidance
FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA. It does not
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. Electronic Access
Persons with access to the Internet may obtain an electronic
version of the draft guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.
Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00773 Filed 1-13-17; 8:45 am]
BILLING CODE 4164-01-P