82 FR 4893 - 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Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 10 (January 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 10 (January 17, 2017)
| Page Range | 4893-4894 | |
| FR Document | 2017-00773 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Notices] [Pages 4893-4894] From the Federal Register Online [www.thefederalregister.org] [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Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act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 This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the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 This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017.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: http://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: [email protected]. 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 http://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
![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices 4893
Products, Food and Drug III. Paperwork Reduction Act of 1995 considers your comment of this draft
Administration, Document Control This draft guidance also refers to guidance before it begins work on the
Center, Bldg. 71, Rm. G335, 10903 New previously approved collections of final version of the guidance, submit
Hampshire Ave., Silver Spring, MD information found in FDA regulations. either electronic or written comments
20993–0002, 1–877–287–1373, The collections of information in 21 on the draft guidance by February 16,
AskCTP@fda.hhs.gov. CFR part 1143 have been approved 2017.
SUPPLEMENTARY INFORMATION: under 0910–0768. ADDRESSES: You may submit comments
I. Background IV. Electronic Access as follows:
FDA is announcing the availability of Persons with access to the Internet Electronic Submissions
a draft guidance for industry entitled may obtain an electronic version of the Submit electronic comments in the
‘‘Compliance Policy for Required guidance at either http:// following way:
Warning Statements on Small-Packaged www.regulations.gov or http:// • Federal eRulemaking Portal:
Cigars.’’ www.fda.gov/TobaccoProducts/ https://www.regulations.gov. Follow the
On June 22, 2009, the President Labeling/RulesRegulationsGuidance/ instructions for submitting comments.
signed the Family Smoking Prevention default.htm. Comments submitted electronically,
and Tobacco Control Act (Tobacco Dated: January 11, 2017. including attachments, to https://
Control Act) (Pub. L. 111–31) into law. Leslie Kux, www.regulations.gov will be posted to
The Tobacco Control Act granted FDA the docket unchanged. Because your
Associate Commissioner for Policy.
the authority to regulate the comment will be made public, you are
[FR Doc. 2017–00855 Filed 1–13–17; 8:45 am]
manufacture, marketing, and solely responsible for ensuring that your
BILLING CODE 4164–01–P
distribution of cigarettes, cigarette comment does not include any
tobacco, roll-your-own tobacco, and confidential information that you or a
smokeless tobacco products to protect third party may not wish to be posted,
DEPARTMENT OF HEALTH AND
the public health and to reduce tobacco such as medical information, your or
HUMAN SERVICES
use by minors. anyone else’s Social Security number, or
The Tobacco Control Act also gave Food and Drug Administration confidential business information, such
FDA the authority to issue a regulation as a manufacturing process. Please note
deeming all other products that meet the [Docket No. FDA–2017–D–0120] that if you include your name, contact
statutory definition of a tobacco product information, or other information that
Interpretation of and Compliance
to be subject to Chapter IX of the FD&C identifies you in the body of your
Policy for Certain Label Requirement;
Act (section 901(b) of the FD&C Act). On comments, that information will be
Applicability of Certain Federal Food,
May 10, 2016, FDA issued that rule, posted on https://www.regulations.gov.
Drug, and Cosmetic Act Requirements
extending FDA’s tobacco product
to Vape Shops; Draft Guidance for • If you want to submit a comment
authority to cigars, among other with confidential information that you
Industry; Availability
products (81 FR 28974). Among the do not wish to be made available to the
requirements that now apply to cigars AGENCY: Food and Drug Administration, public, submit the comment as a
are health warning statements HHS. written/paper submission and in the
prescribed under section 906(d) of the ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper
FD&C Act, which permits restrictions on Submissions’’ and ‘‘Instructions’’).
the sale and distribution of tobacco SUMMARY: The Food and Drug
products that are ‘‘appropriate for the Administration (FDA or we) is Written/Paper Submissions
protection of the public health.’’ The announcing the availability of a draft Submit written/paper submissions as
rule specifies the health warning guidance for industry entitled follows:
statements that must be displayed on ‘‘Interpretation of and Compliance • Mail/Hand delivery/Courier (for
cigar packaging and where those Policy for Certain Label Requirement; written/paper submissions): Division of
statements must be placed, among other Applicability of Certain Federal Food, Dockets Management (HFA–305), Food
requirements. Drug, and Cosmetic Act Requirements to and Drug Administration, 5630 Fishers
The draft guidance discusses FDA’s Vape Shops.’’ This draft guidance Lane, Rm. 1061, Rockville, MD 20852.
compliance policy for cigars with provides FDA’s interpretation of, and a • For written/paper comments
packaging too small or otherwise unable compliance policy for, the requirement submitted to the Division of Dockets
to accommodate the warning statements that the label of tobacco products Management, FDA will post your
and specifications required under the contain an accurate statement of the comment, as well as any attachments,
regulation. percentage of foreign and domestic except for information submitted,
grown tobacco under the Federal Food, marked and identified, as confidential,
II. Significance of Draft Guidance Drug, and Cosmetic Act (the FD&C Act). if submitted as detailed in
FDA is issuing this draft guidance This draft guidance document is also ‘‘Instructions.’’
consistent with FDA’s good guidance intended to assist retailers who sell Instructions: All submissions received
practices regulation (21 CFR 10.115). newly deemed products by explaining must include the Docket No. FDA–
The draft guidance, when finalized, will whether engaging in certain activities 2017–D–0120 for ‘‘Interpretation of and
represent the current thinking of FDA subjects such establishments to Compliance Policy for Certain Label
sradovich on DSK3GMQ082PROD with NOTICES
on its compliance policy for cigars in additional requirements of the FD&C Requirement; Applicability of Certain
small packaging. It does not establish Act and the limited circumstances Federal Food, Drug, and Cosmetic Act
any rights for any person and is not under which FDA does not intend to Requirements to Vape Shops.’’ Received
binding on FDA or the public. You can enforce compliance. comments will be placed in the docket
use an alternative approach if it satisfies DATES: Although you can comment on and, except for those submitted as
the requirements of the applicable any guidance at any time (see 21 CFR ‘‘Confidential Submissions,’’ publicly
statutes and regulations. 10.115(g)(5)), to ensure that the Agency viewable at https://www.regulations.gov
VerDate Sep<11>2014 18:21 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/82_FR_4903/page/1.svg)
![4894 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
or at the Division of Dockets Administration, Document Control guidance provides FDA’s interpretation
Management between 9 a.m. and 4 p.m., Center, 10903 New Hampshire Ave., of, and a compliance policy for, this
Monday through Friday. Bldg. 71, Rm. G335, Silver Spring, MD label requirement.
• Confidential Submissions—To 20993–0002, 1–877–287–1373, email: Retail establishments, such as vape
submit a comment with confidential AskCTP@fda.hhs.gov. shops, which engage in certain activities
information that you do not wish to be SUPPLEMENTARY INFORMATION: may also be subject to certain
made publicly available, submit your requirements of the FD&C Act that
comments only as a written/paper I. Background apply to tobacco product manufacturers
submission. You should submit two We are announcing the availability of and to establishments that engage in the
copies total. One copy will include the a draft guidance for industry entitled manufacture, preparation,
information you claim to be confidential ‘‘Interpretation of and Compliance compounding, or processing of tobacco
with a heading or cover note that states Policy for Certain Label Requirement; product. These activities may also
‘‘THIS DOCUMENT CONTAINS Applicability of Certain Federal Food, include modifying a product so that it
CONFIDENTIAL INFORMATION.’’ The Drug, and Cosmetic Act Requirements to is a new tobacco product requiring
Agency will review this copy, including Vape Shops.’’ compliance with the premarket
the claimed confidential information, in This draft guidance document, when authorization requirements. This draft
its consideration of comments. The finalized, will provide FDA’s guidance explains which activities
second copy, which will have the interpretation of, and a compliance subject vape shops to these FD&C Act
claimed confidential information policy for, the label requirement under requirements and the limited
redacted/blacked out, will be available section 903(a)(2)(C) of the FD&C Act (21 circumstances under which FDA does
for public viewing and posted on U.S.C. 387c(a)(2)(C)). This draft not intend to enforce compliance.
https://www.regulations.gov. Submit guidance document, when finalized, is
also intended to assist retailers who sell II. Significance of Guidance
both copies to the Division of Dockets
Management. If you do not wish your newly deemed products by explaining FDA is issuing this draft guidance
name and contact information to be whether engaging in certain activities consistent with FDA’s good guidance
made publicly available, you can subjects such establishments to practices regulation (21 CFR 10.115).
provide this information on the cover additional requirements of the FD&C The draft guidance, when finalized, will
sheet and not in the body of your Act and the limited circumstances represent the current thinking of FDA.
comments and you must identify this under which FDA does not intend to It does not establish any rights for any
information as ‘‘confidential.’’ Any enforce compliance. person and is not binding on FDA or the
information marked as ‘‘confidential’’ The Family Smoking Prevention and public. You can use an alternative
will not be disclosed except in Tobacco Control Act (Pub. L. 111–31) approach if it satisfies the requirements
accordance with 21 CFR 10.20 and other (Tobacco Control Act), enacted on June of the applicable statutes and
22, 2009, amends section 904 of the regulations.
applicable disclosure law. For more
FD&C Act (21 U.S.C. 387d) and provides
information about FDA’s posting of III. Electronic Access
FDA with the authority to regulate the
comments to public dockets, see 80 FR
manufacture, marketing, and Persons with access to the Internet
56469, September 18, 2015, or access
distribution of tobacco products to may obtain an electronic version of the
the information at: http://www.fda.gov/
protect the public health generally and draft guidance at either https://
regulatoryinformation/dockets/
to reduce tobacco use by minors. www.regulations.gov or http://
default.htm. Cigarettes, cigarette tobacco, roll-your-
Docket: For access to the docket to www.fda.gov/TobaccoProducts/
own tobacco, and smokeless tobacco Labeling/RulesRegulationsGuidance/
read background documents or the were immediately covered by FDA’s
electronic and written/paper comments default.htm.
tobacco product authorities in chapter
received, go to https:// Dated: January 9, 2017.
IX of the FD&C Act, when the Tobacco
www.regulations.gov and insert the Control Act went into effect. As for Leslie Kux,
docket number, found in brackets in the other types of tobacco products, section Associate Commissioner for Policy.
heading of this document, into the 901(b) of the FD&C Act (21 U.S.C. [FR Doc. 2017–00773 Filed 1–13–17; 8:45 am]
‘‘Search’’ box and follow the prompts 387a(b)) grants FDA authority to deem BILLING CODE 4164–01–P
and/or go to the Division of Dockets those products subject to chapter IX of
Management, 5630 Fishers Lane, Rm. the FD&C Act. Under that authority,
1061, Rockville, MD 20852. FDA issued a rule deeming all other DEPARTMENT OF HEALTH AND
Submit written requests for single products that meet the statutory HUMAN SERVICES
copies of the draft guidance to the definition of ‘‘tobacco product,’’ set
Center for Tobacco Products, Food and Food and Drug Administration
forth in section 201(rr) of the FD&C Act
Drug Administration, Document Control (21 U.S.C. 321(rr)), except for [Docket No. FDA–2017–D–0114]
Center, Bldg. 71, Rm. G335, 10903 New accessories of those products, as subject
Hampshire Ave., Silver Spring, MD to chapter IX of the FD&C Act (81 FR Referencing Approved Drug Products
20993–0002. Send one self-addressed 28974). FDA published the final rule on in Abbreviated New Drug Application
adhesive label to assist that office in May 10, 2016, and it became effective Submissions; Draft Guidance for
processing your request or include a fax on August 8, 2016. Industry; Availability
number to which the guidance Section 903(a)(2)(C) of the FD&C Act
sradovich on DSK3GMQ082PROD with NOTICES
document may be sent. See the AGENCY: Food and Drug Administration,
provides that a tobacco product in HHS.
SUPPLEMENTARY INFORMATION section for package form is misbranded unless its
electronic access to the guidance ACTION: Notice of availability.
label contains ‘‘an accurate statement of
document. the percentage of tobacco used in the SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: product that is domestically grown Administration (FDA or Agency) is
Katherine Collins, Center for Tobacco tobacco and the percentage that is announcing the availability of a draft
Products, Food and Drug foreign grown tobacco.’’ The draft guidance for industry entitled
VerDate Sep<11>2014 18:21 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/82_FR_4903/page/2.svg)
Document Created: 2017-01-14 01:44:38
Document Modified: 2017-01-14 01:44:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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: [email protected] | |
| FR Citation | 82 FR 4893 |
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