[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 15174-15263]
[FR Doc No: 2023-04591]

Vol. 88

Friday,

No. 47

March 10, 2023

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1120

Requirements for Tobacco Product Manufacturing Practice; Proposed Rule

Federal Register / Vol. 88 , No. 47 / Friday, March 10, 2023 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1120

[Docket No. FDA-2013-N-0227]
RIN 0910-AH91

Requirements for Tobacco Product Manufacturing Practice

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
proposing to establish tobacco product manufacturing practice
requirements for manufacturers of finished and bulk tobacco products.
This proposed rule, if finalized, would set forth the requirements with
which finished and bulk tobacco product manufacturers must comply in
the manufacture, preproduction design validation, packing, and storage
of finished and bulk tobacco products, to assure that the public health
is protected and that tobacco products are in compliance with chapter
IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Either electronic or written comments on the proposed rule must
be submitted by September 6, 2023. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by April 10, 2023 (see section ``VI.
Paperwork Reduction Act of 1995'' of this document). See section V of
this document for the proposed effective date of a final rule based on
this proposed rule.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2013-N-0227 for ``Requirements for Tobacco Product Manufacturing
Practice.'' 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,<PHONE_NUMBER>.
     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 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    Submit comments on information collection issues to the Office of
Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
[email protected]. All comments should be identified with the
title, ``Requirements for Tobacco Product Manufacturing Practice.''

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Office of
Regulations, or Rear Admiral Emil Wang, Office of Compliance and
Enforcement, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Legal Authority
    B. Rationale for the Proposed Regulation
    C. Development of the Proposed Regulation
IV. Description of the Proposed Regulation
    A. General Provisions
    B. Management System Requirements
    C. Buildings, Facilities, and Equipment
    D. Design and Development Controls
    E. Process Controls

    F. Packaging and Labeling Controls
    G. Handling, Storage, and Distribution
    H. Recordkeeping and Document Controls
    I. Small Tobacco Product Manufacturers
    J. Exemptions and Variances
V. Proposed Effective and Compliance Dates
VI. Preliminary Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed regulation--proposed part 1120 (21 CFR part 1120)--
sets forth requirements for tobacco product manufacturing practice
(TPMP) and provides a framework for manufacturers of finished or bulk
tobacco products to follow that would include: (1) establishing tobacco
product design and development controls to prevent or minimize certain
risks; (2) ensuring that finished and bulk tobacco products are
manufactured in conformance with established specifications; (3)
minimizing the likelihood of the manufacture and distribution of
nonconforming tobacco products; (4) requiring investigation and
identification of nonconforming products, including those that have
been distributed in order to institute appropriate corrective actions,
such as conducting a recall as needed; (5) requiring manufacturers to
take appropriate measures to prevent contamination of tobacco products;
and (6) establishing traceability to account for all components or
parts, ingredients, additives, and materials, as well as each batch of
finished or bulk tobacco product, to aid in investigations of
nonconforming tobacco products. Therefore, this proposed regulation
would establish requirements for the control of tobacco product
manufacturing activities and the treatment of contaminated or otherwise
nonconforming tobacco products, including the investigation,
evaluation, and corrective and preventive actions (CAPA) necessary to
protect the public health.
    These provisions are generally similar to many existing industry
practices and are drafted to provide tobacco product manufacturers with
flexibility in the manner they comply with the proposed requirements
while assuring the protection of public health. This proposal is
intended to ensure that tobacco products conform to established
specifications and to help prevent the manufacture and distribution of
contaminated or otherwise nonconforming products, thereby assuring that
the public health is protected and that tobacco products comply with
the requirements in chapter IX of the FD&C Act.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed regulation is divided into 10 subparts. This proposed
regulation is intended to provide a framework that requires all
finished and bulk tobacco product manufacturers subject to the rule
(including specification developers, contract manufacturers, and
repackagers/relabelers) to establish and maintain procedures for
various aspects of the manufacturing, preproduction design validation,
packing, and storage processes, while allowing flexibility to establish
procedures that are unique to the manufacturer's facilities and
activities, and appropriate for a given tobacco product. The proposed
requirements are written in general terms to allow manufacturers to
establish procedures appropriate for their specific products and
operations. The extent of the procedures necessary to meet the
regulation requirements may vary with the size and complexity of the
design and manufacturing operations. Tobacco product manufacturers who
have a complex manufacturing process would likely need to establish
more detailed procedures to comply with the rule, while tobacco product
manufacturers who have a less complex manufacturing process may need
less extensive procedures.
1. Subpart A--General Provisions
    Subpart A contains two proposed sections: scope and definitions.
The scope section describes the purpose of this proposed regulation and
the products and activities to which it applies. This proposed
regulation would apply to manufacturers (foreign and domestic) of
finished and bulk tobacco products. The definitions section defines the
terminology applicable to the proposed requirements laid out in this
notice of proposed rulemaking (NPRM). The proposed rule would define
``tobacco product manufacturer'' to mean ``any person(s), including a
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product, or imports a finished or bulk
tobacco product for sale or distribution in the United States. The
manufacture of a tobacco product includes establishing the
specifications of or the requirements for a tobacco product.''
2. Subpart B--Management System Requirements
    Subpart B contains three proposed sections: organization and
personnel; tobacco product complaints; and CAPA. The organization and
personnel section would require finished and bulk tobacco product
manufacturers to establish and maintain an organizational structure;
have sufficient personnel; designate personnel with appropriate
responsibility, including management with executive responsibility;
train personnel; and maintain certain records of these activities. The
tobacco product complaints section would require finished and bulk
tobacco product manufacturers to establish and maintain complaint
handling procedures for the receipt, evaluation, investigation, and
documentation of all complaints. The CAPA section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for implementing CAPA and to maintain records of
the activities required under this subpart.
3. Subpart C--Buildings, Facilities, and Equipment
    Subpart C contains four proposed sections: personnel practices;
buildings, facilities, and grounds; equipment; and environmental
controls. The personnel practices section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
related to personnel practices to reduce the risk of contamination with
filth biological materials, chemical hazards, or other deleterious
substances, including rocks or metal shavings. The buildings,
facilities, and grounds section would require such manufacturers to
ensure that buildings and facilities are of suitable construction,
design, and location to facilitate cleaning and sanitation,
maintenance, and proper operations. In addition, manufacturers would be
required to ensure that facility grounds are maintained in a condition
to prevent contamination and to control the water used in the
manufacturing process. The proposed requirements would also require
such manufacturers to establish and maintain procedures for proper
cleaning and sanitation and animal and pest control, and maintain
records of these activities to demonstrate compliance with this
proposed rule. The equipment section would provide requirements for
design, construction, and maintenance of equipment as well as certain
additional requirements (e.g., calibration) for testing, monitoring,
and measuring equipment used in the tobacco product manufacturing
processes and for major

equipment and processing line identification. Lastly, the environmental
controls section would require that environmental control systems be
maintained and monitored to verify that environmental controls,
including necessary equipment, are adequate and functioning properly.
This subpart would also require manufacturers to maintain certain
records to demonstrate compliance with this proposed rule.
4. Subpart D--Design and Development Controls
    Subpart D contains two proposed sections: design and development
activities and master manufacturing record (MMR). The design and
development activities section would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
the design and development of tobacco products, including the control
of risks associated with the product, production process, packing, and
storage, as well as procedures for design verification and validation.
These requirements would include developing a process for
identification, analysis, and evaluation of known and reasonably
foreseeable risks associated with the tobacco product and its packaging
as well as taking appropriate measures to reduce or eliminate risks
using recognized tools for risk management. Manufacturers would also be
required to maintain records of all activities required under this
section.
    The proposed MMR section would require manufacturers to establish
and maintain an MMR for each finished and bulk tobacco product they
manufacture for distribution. The proposed section would require each
MMR to include tobacco product specifications, the manufacturing
methods and production process procedures, and all packaging, labeling,
and labels approved for use with the product. Additionally, the
proposed MMR section includes requirements for the review and approval
of the MMR, including any changes after initial approval.
5. Subpart E--Process Controls
    Subpart E contains nine proposed sections: purchasing controls;
acceptance activities; production processes and controls; laboratory
controls; production record; sampling; nonconforming tobacco product;
returned tobacco product; and reprocessing and rework. The purchasing
controls section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for ensuring that
purchased or otherwise received products and services related to the
manufacture of a finished or bulk tobacco product are from qualified
suppliers and conform to established specifications. The acceptance
activities section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for incoming and for
in-process and/or final acceptance activities, including acceptance
criteria, to ensure that products meet established specifications. The
production processes and controls section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
for production processes, including process specifications and process
controls, process validation, and manual methods and manufacturing
material. The laboratory controls section would require finished and
bulk tobacco product manufacturers to demonstrate laboratory competency
to perform laboratory activities associated with the manufacture of
finished and bulk tobacco products and to establish and maintain
laboratory control procedures for any laboratory activities conducted
under proposed part 1120. The production record section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that a production record is prepared
for each batch of finished or bulk product to demonstrate conformity
with the requirements established under the MMR. The sampling section
would require finished and bulk tobacco product manufacturers to
establish and maintain an adequate sampling plan that uses
representative samples based on a valid scientific rationale for any
sampling performed under proposed part 1120. The nonconforming tobacco
product section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for control and
disposition of nonconforming tobacco product, including specific
requirements for identification and segregation, investigation, and
disposition and followup. The proposed returned tobacco product section
would require procedures for the control and disposition of returned
tobacco product, including specific requirements for identification,
segregation, evaluation, and disposition. The reprocessing and rework
section would require procedures for reprocessing and reworking tobacco
products, including specific requirements for evaluation of the tobacco
product to determine that it is appropriate for reprocessing or rework,
authorization of the reprocessing or rework, and production processes,
including process controls, to ensure that reprocessed and reworked
tobacco product conforms to MMR specifications. Manufacturers also
would be required to maintain records of all activities required under
this subpart.
6. Subpart F--Packaging and Labeling Controls
    Subpart F contains four proposed sections: packaging and labeling
controls; repackaging and relabeling; manufacturing code; and warning
plans. The packaging and labeling controls section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that the correct packaging and
labeling is used to prevent mixups and that all packaging and labeling
is approved for use by the manufacturer and complies with all
requirements of the MMR as well as other applicable requirements of the
FD&C Act, the Comprehensive Smokeless Tobacco Health Education Act
(CSTHEA), and the Federal Cigarette Labeling and Advertising Act
(FCLAA) and their implementing regulations. The section would also
require the packaging and labeling control procedures to ensure that
labels are indelibly printed on or permanently affixed to finished and
bulk tobacco product packages; and that the packaging, labeling,
storage, and shipping cases do not contaminate or otherwise render the
tobacco product adulterated or misbranded. The repackaging and
relabeling requirements would require finished tobacco product
manufacturers to establish and maintain procedures for repackaging and
relabeling operations. The manufacturing code section would require
finished and bulk tobacco product manufacturers to apply a
manufacturing code that contains the manufacturing date and batch
number to the packaging or label of all finished and bulk tobacco
products. The warning plans section would require manufacturers of
finished tobacco products that are required to comply with a warning
plan for tobacco product packaging, to establish and maintain
procedures for implementing the requirements of such plan.
Manufacturers would also be required to maintain records of all
activities required under this subpart.
7. Subpart G--Handling, Storage and Distribution
    Subpart G contains two proposed sections: handling and storage and
distribution. The handling and storage

section would require finished and bulk tobacco product manufactures to
establish and maintain procedures to ensure that tobacco products are
handled and stored under appropriate conditions to prevent
nonconforming products as well as mixups, deterioration, contamination,
adulteration, and misbranding of tobacco products. The distribution
section would require finished and bulk tobacco product manufacturers
to establish and maintain procedures to ensure that tobacco products
are distributed to the initial consignee under appropriate conditions
and that only those finished and bulk tobacco products approved for
release are distributed. The distribution section would also require
finished and bulk tobacco product manufacturers to maintain
distribution records and a list of direct accounts.
8. Subpart H--Recordkeeping and Document Controls
    The recordkeeping and document control requirements section
establishes certain requirements for documents and records required by
this rule. This section would require that all documents and records be
maintained at the manufacturing establishment or another location that
is readily accessible to responsible individuals of the manufacturer
and to FDA and that they be written in English or an English
translation be made available upon request. Documents and records
required under this section that are associated with a batch of
finished or bulk tobacco product must be retained for a period of not
less than 4 years from the date of distribution of the batch or until
the product reaches its expiration date if one exists, whichever is
later. Documents and records required under this section that are not
associated with a batch of finished or bulk tobacco product must be
retained for a period of not less than 4 years from the date they were
last in effect. FDA is soliciting comment on whether the timeframe for
manufacturers to retain the documents and records under this section is
sufficient for FDA's inspections and compliance activities or if it
should be extended for an additional 1 or 2 years after the tobacco
product reaches its expiration date if one exists. They also must be
made readily accessible to FDA during the retention period for
inspection and photocopying or other means of reproduction. This
section also would require finished and bulk tobacco product
manufacturers to ensure that all records are attributable to a
responsible individual, legible, contemporaneously recorded, original,
and accurate and to establish and maintain procedures for the approval
and distribution of documents and for making changes to documents.
9. Subpart I--Small Tobacco Product Manufacturers
    Subpart I explains that small tobacco product manufacturers of
finished and bulk tobacco products would not have to comply with the
TPMP regulation until 4 years after the effective date of the final
rule.
10. Subpart J--Exemptions and Variances
    Subpart J consists of five sections, and it sets forth the proposed
procedures and requirements for petitioning for an exemption or
variance from a TPMP requirement. Pursuant to section 906(e)(2)(B) of
the FD&C Act (21 U.S.C. 387f), this subpart also would establish that a
petition for an exemption or variance may be referred to the Tobacco
Products Scientific Advisory Committee (TPSAC) and describe how FDA
would make a determination on a petition for an exemption or variance.
Finally, pursuant to section 906(e)(2)(E) of the FD&C Act, this subpart
would provide that the petitioner has an opportunity for a hearing
after the issuance of an order denying or approving a petition for an
exemption or variance.

C. Legal Authority

    Section 906(e) of the FD&C Act (21 U.S.C. 387f) states that in
applying manufacturing restrictions to tobacco, FDA shall prescribe
regulations requiring that the methods used in, and the facilities and
controls used for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco product),
packing, and storage of a tobacco product conform to current good
manufacturing practice (cGMP) or hazard analysis and critical control
point (HACCP) methodology as prescribed in such regulations to assure
that the public health is protected and that the tobacco product is in
compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through
387u). The proposed requirements flow from this authority and serve
these goals of protecting public health and assuring compliance with
chapter IX of the FD&C Act.
    The proposed rule is also being issued based upon: FDA's
authorities related to adulterated and misbranded tobacco products
under sections 902 and 903 (21 U.S.C. 387c); FDA's authorities related
to records and reports under section 909 (21 U.S.C. 387i); and FDA's
rulemaking and inspection authorities under sections 701 (21 U.S.C.
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the FD&C
Act.

D. Costs and Benefits

    The proposed rule, if finalized, would establish requirements for
manufacturers of finished and bulk tobacco products on the methods used
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products.
The TPMP requirements described in the proposed rule are expected to
ensure that tobacco product manufacturers control the design and
specifications of finished and bulk tobacco products, providing a level
of assurance of conformity in the production of tobacco products to
established and required specifications that does not occur in the
existing market for tobacco products, to prevent the adulteration and
misbranding of finished and bulk tobacco products, and establish
controls for traceability purposes.
    Estimated quantified benefits of the proposed rule arise from the
value of reduced adverse events due to nonconforming finished and bulk
tobacco products and from the reduction of costs associated with
reduced product recalls and market withdrawals. We estimate the mean
present value of benefits annualized over ten years using a seven and
three percent discount rate to be $27.2 million and $29.9 million.
    There are other potential benefits associated with the proposed
rule which we have not quantified. First, the proposed recordkeeping
provisions would support FDA's regulatory compliance activities and
help FDA implement and enforce other provisions of the FD&C Act which
will likely generate government cost savings. Second, the proposed
rule, if finalized, may further reduce losses to health and property
for users and nonusers associated with nonconforming tobacco products,
beyond those estimated in the quantified benefits. Third, the proposed
rule's risk assessment, CAPA, tobacco product complaints, and related
provisions will facilitate investigation and identification of causes
and root causes of consumer complaints and other reports of adverse
events. Other benefits include avoided spillover costs to capital
markets.\1\
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    \1\ Estimated quantified benefits of avoided recalls include
reduced external costs in the supply chain of the recalled or
withdrawn products (or they exclude reduced recall costs to
manufacturers). Estimated external costs of conducting a recall or
market withdrawal include lost sales to retailers and wholesalers,
expenses associated with notifying tobacco retailers (for
wholesalers) and consumers, removal and storage of inventory costs
collection and shipping costs, disposal costs, and legal costs,
among others. Estimated quantified benefits do not include avoided
spillover costs to capital markets.

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    Initial and recurring costs from this proposed rule arise from
conducting tasks associated with establishing and maintaining
procedures for various aspects of the manufacturing, preproduction
design validation, packing and storage processes. We estimate the mean
present value of costs annualized over ten years using a seven and
three percent discount rate to be $27.0 million and $28.2 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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     Abbreviation/acronym                    What it means
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AAMI.........................  Advancement of Medical Instrumentation.
ALCOA........................  Attributable, Legible, Contemporaneously
                                Recorded, Original, and Accurate.
ANSI.........................  American National Standards Institute.
ASTM.........................  American Society for Testing and
                                Materials.
ASQ..........................  American Society for Quality.
CAPA.........................  Corrective and Preventive Actions.
CDC..........................  Centers for Disease Control and
                                Prevention.
cGMP.........................  Current Good Manufacturing Practice.
CoA..........................  Certificate of Analysis.
CORESTA......................  Cooperation Centre for Scientific
                                Research Relative to Tobacco.
CSTHEA.......................  Comprehensive Smokeless Tobacco Health
                                Education Act.
Deeming Rule.................  Deeming Tobacco Products To Be Subject to
                                the Food, Drug, and Cosmetic Act, as
                                Amended by the Family Smoking Prevention
                                and Tobacco Control Act; Regulations
                                Restricting the Sale and Distribution of
                                Tobacco Products and Required Warning
                                Statements for Tobacco Product Packages
                                and Advertisements.
EA...........................  Environmental Assessment.
E. coli......................  Escherichia coli.
EIS..........................  Environmental Impact Statement.
ENDS.........................  Electronic Nicotine Delivery Systems.
E.O..........................  Executive Order.
FCLAA........................  Federal Cigarette Labeling and
                                Advertising Act.
FCTC.........................  Framework Convention on Tobacco Control.
FDA or Agency................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FR...........................  Federal Register.
HACCP........................  Hazard Analysis and Critical Control
                                Point.
HHS..........................  Health and Human Services.
HVAC.........................  Heating, Ventilation, and Cooling.
IARC.........................  International Agency for Research on
                                Cancer.
IEC..........................  International Electrotechnical
                                Commission.
ISO..........................  International Organization for
                                Standardization.
MITC.........................  Manufacturer Detected Methyl
                                Isothiocyanate.
MMR..........................  Master Manufacturing Record.
MRTPs........................  Modified Risk Tobacco Products.
MRTPA........................  Modified Risk Tobacco Product
                                Application.
NNK..........................  4-(methylnitrosamino)-1-(3-pyridyl)-1-
                                butanone.
NNN..........................  N-nitrosonornicotine.
NPRM.........................  Notice of Proposed Rulemaking.
NTRMs........................  Nontobacco Related Materials.
OMB..........................  Office of Management and Budget.
OOS..........................  Out-Of-Specification.
SE...........................  Substantial Equivalence.
PMTA.........................  Premarket Tobacco Product Application.
PRA..........................  Paperwork Reduction Act of 1995.
PRIA.........................  Proposed Regulatory Impact Analysis.
QMS..........................  Quality Management System.
QSR..........................  Quality System Regulation.
RYO..........................  Roll-Your-Own.
Tobacco Control Act..........  Family Smoking Prevention and Tobacco
                                Control Act.
TPMP.........................  Tobacco Product Manufacturing Practice.
TPSAC........................  Tobacco Products Scientific Advisory
                                Committee.
TSNAs........................  Tobacco-Specific Nitrosamines.
UPC..........................  Universal Product Code.
USB..........................  Universal Serial Bus.
U.S.C........................  United States Code.
WHO..........................  World Health Organization.
------------------------------------------------------------------------

III. Background

A. Legal Authority

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) was enacted on June 22, 2009, amending the FD&C Act and
providing FDA with the authority to regulate tobacco products (Pub. L.
111-31). Specifically, section 101(b) of the Tobacco Control Act
amended the FD&C Act by adding chapter IX, which provides FDA with the
authority to regulate tobacco products and imposes certain obligations
on tobacco product

manufacturers (including importers), distributors, and retailers.
    Section 901(b) of the FD&C Act establishes FDA's immediate
authority over cigarettes, cigarette tobacco, roll-your-own (RYO)
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco,\2\ and permits FDA, by
regulation, to deem additional tobacco products subject to chapter IX
of the FD&C Act. In the Federal Register of May 10, 2016 (81 FR 28973),
FDA published a final rule entitled ``Deeming Tobacco Products To Be
Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Regulations Restricting the
Sale and Distribution of Tobacco Products and Required Warning
Statements for Tobacco Product Packages and Advertisements'' (Deeming
Rule) deeming all tobacco products meeting the statutory definition of
``tobacco product,'' except accessories of deemed tobacco products, to
be subject to chapter IX of the FD&C Act. FDA intends for this proposed
rule to apply to manufacturers of all finished and bulk tobacco
products that are subject to chapter IX of the FD&C Act, except
finished and bulk accessories of cigarettes, cigarette tobacco, RYO
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco.
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    \2\ See Consolidated Appropriations Act, 2022, Public Law 117-
103, div. P, tit. I, subtit. A, sec. 111(b) (March 15, 2022).
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    Section 906(e) of the FD&C Act provides that in applying
manufacturing restrictions to tobacco, FDA shall prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a tobacco product), packing, and
storage of a tobacco product conform to cGMP or HACCP methodology, as
prescribed in such regulations to assure that the public health is
protected and that the tobacco product is in compliance with chapter IX
of the FD&C Act. The requirements in proposed part 1120, including
management system requirements; buildings, facilities, and equipment
requirements; design and development controls; process controls;
packaging and labeling controls; handling, storage, and distribution
requirements; and recordkeeping and document controls, are derived from
this authority. Section 902(7) of the FD&C Act provides that a tobacco
product shall be deemed to be adulterated if the methods used in, or
the facilities or controls used for, its manufacture, packing, or
storage are not in conformity with applicable requirements under
section 906(e)(1) of the FD&C Act or an applicable condition prescribed
by an order under section 906(e)(2) of the FD&C Act. As a result, a
product will be adulterated if a manufacturer fails to comply with the
requirements prescribed in this proposed regulation. Violations
relating to section 906(e) of the FD&C Act are subject to regulatory
action by FDA, including seizure and injunction.
    In addition, section 909 of the FD&C Act authorizes FDA, by
regulation, to require manufacturers and importers of tobacco products
to establish and maintain records, make reports, and provide
information to assure that such tobacco products are not adulterated or
misbranded, and to otherwise protect public health. Section 909 thus
provides additional legal authority for the proposed rule's
recordkeeping, reporting, and related requirements. In addition, under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has the
authority to issue regulations for the efficient enforcement of the
FD&C Act. The proposed rule will help assure that tobacco products are
not adulterated or misbranded under other provisions of the FD&C Act
and will assist in the efficient enforcement of those other provisions.
For example, section 902 of the FD&C Act provides that a tobacco
product is adulterated in several circumstances including: (1) if a
tobacco product consists in whole or in part of any filthy, putrid, or
decomposed substance, or is otherwise contaminated by any added
poisonous or added deleterious substance that may render the product
injurious to health; (2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated with filth,
or whereby it may have been rendered injurious to health; or (3) its
package is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to
health. (Section 902(1)-(3) of the FD&C Act.) The proposed rule will
help ensure that tobacco products are not adulterated in these ways,
and that appropriate records, reports, and information will be
available to enforce section 902's adulteration provisions. To similar
effect, section 903 provides that a tobacco product is misbranded if,
for example, its labeling is false or misleading in any particular or
if the product does not bear labeling that is required by an applicable
tobacco product standard established under section 907 (section
903(a)(1) and (a)(9) of the FD&C Act). The proposed rule's labeling
requirements will help prevent tobacco products from being misbranded
in violation of section 903.
    Further, section 801(a) of the FD&C Act gives FDA authority to
refuse admission of tobacco products imported or offered for import
into the United States in situations where it appears such products:
(1) have been manufactured, processed, or packed under insanitary
conditions; (2) are forbidden or restricted in sale in the country in
which they were produced or from which they were exported; or (3) are
adulterated or misbranded. As noted earlier, section 701(a) of the FD&C
Act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the
efficient enforcement of the FD&C Act. The proposed rule will assist in
the efficient enforcement of the FD&C Act's import requirements under
section 801(a) by requiring manufacturers of finished and bulk tobacco
products to implement certain controls over their product
manufacturing, preproduction design validation, packing, and storage
activities, including recordkeeping, to prevent the import of tobacco
products that appear to be adulterated or misbranded.
    Finally, the proposed rule will assist in the performance of FDA
inspections under section 704 (21 U.S.C. 374) and 905(g) (21 U.S.C.
387e(g)) of the FD&C Act.

B. Rationale for the Proposed Regulation

    While all tobacco products have inherent risks to the public
health, FDA is proposing TPMP requirements to minimize or prevent
product problems, as well as health issues not normally associated with
use of a tobacco product. For example, these requirements would help
minimize or prevent the manufacture and distribution of tobacco
products contaminated with foreign substances (e.g., nontobacco related
materials (NTRMs) such as metal, glass, nails, pins, wood, dirt, sand,
stones, rocks, fabric, cloth, and plastics) which have been found in
finished tobacco products as will be discussed further below. These
requirements also would help minimize or prevent the manufacture and
distribution of nonconforming electronic nicotine delivery systems
(ENDS) e-liquids that contain nicotine concentration levels that vary
from the labeled amount and vary from one ENDS product to another
within the same brand (Ref. 1, Ref. 178). As explained elsewhere in
this document, this potential variability in nicotine concentration, in
which an e-liquid product contains significantly higher

levels of nicotine than what is stated on the label, could be
misleading to consumers concerned about nicotine delivery levels,
potentially intensifying or prolonging their addiction and potentially
exposing users to increased toxins (Refs. 4 and 5). Tobacco products
may introduce preventable harms not normally associated with use of
tobacco products due to inadequate design or manufacturing controls;
for example, defective solder joints from an ENDS cartomizer (atomizer
plus replaceable fluid-filled cartridge) may cause respiratory distress
due to metallic particles in the aerosol (Ref. 2). This proposed
regulation would help to assure that the public health is protected
from these, and other, types of hazards and that tobacco products
comply with chapter IX of the FD&C Act.
    FDA is proposing a TPMP regulation under section 906(e) of the FD&C
Act that employs a Quality Management System (QMS) approach. QMS
approaches are well established and have been required (e.g., 21 CFR
part 820) or utilized by FDA (e.g., ``FDA Guidance for Industry--
Quality Systems Approach to Pharmaceutical CGMP Regulations'') in other
product categories. A QMS can protect the public health in several
ways. First, a QMS can enable the manufacturer to demonstrate its
ability to consistently produce products that meet applicable statutory
and regulatory requirements. Second, a QMS can enable a manufacturer to
establish and maintain a robust design and development process for its
product and to adequately identify and control nonconforming products
to prevent their distribution and related potential harm. Finally, if
nonconforming products are discovered, a QMS can provide the
manufacturer with a recognized framework to effectively investigate and
identify the nonconforming products in order to institute appropriate
corrective actions such as conducting a recall as needed. If a firm is
manufacturing a tobacco product that is contaminated or inconsistent
with the specifications identified in an application under which it has
received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Thus, the proposed
regulation based on a QMS approach, if finalized, would help assure
that the public health is protected and that tobacco products are in
compliance with chapter IX of the FD&C Act.
1. Assuring That the Public Health Is Protected
    The proposed regulation would help assure that the public health is
protected by, among other things, minimizing the likelihood of the
manufacture and distribution of nonconforming tobacco products. A
``nonconforming tobacco product'' is proposed to be defined as any
tobacco product that: (1) does not meet a product specification as set
by the MMR (see proposed Sec.  1120.44(a)(1)); (2) has packaging,
labeling, or labels other than those included in the MMR (see proposed
Sec.  1120.44(a)(3)); or (3) is a contaminated tobacco product
(proposed Sec.  1120.3). Nonconforming products occur for many
different reasons, including inadequate sanitation practices, design
issues, failures of or problems with purchasing controls, inadequate
process controls, improper facilities or equipment, inadequate
personnel training, inadequate manufacturing methods and procedures,
the introduction or presence of hazards, or improper handling or
storage of the tobacco product. A tobacco product that does not conform
to established specifications, has incorrect packaging, labeling, or
labels, or is contaminated could increase the product's risk compared
to what would normally be associated with use of the product.
    Tobacco products with contaminants that could have been prevented
with the implementation of this proposed TPMP rule have been
identified. For example, consumer complaints of foreign metal material,
including sharp metal objects, in a manufacturer's smokeless tobacco
(e.g., chewing) products ultimately led the manufacturer to issue a
voluntary recall of certain products on January 31, 2017 (Ref. 3). In
other instances, smokeless tobacco products have contained rocks or
metal shavings as well as other NTRMs (e.g., glass, nails, pins, wood,
dirt, sand, fabric, cloth, and plastics) in finished tobacco products.
These NTRMs can cause cuts or lacerations to the lips and gums or
result in broken teeth. This proposed regulation includes measures that
will help avoid such contamination, in addition to provisions for how
manufacturers would be required to handle complaints in similar
situations, as well as the subsequent investigation, evaluation, and
CAPA they would need to take to address such issues.
    Consumers have reported additional substances not ordinarily
contained in tobacco products such as biological materials (e.g., mold,
mildew, hair, fingernails) and chemical hazards (e.g., ammonia,
cleaning agents, and kerosene). Caustic cleaning chemicals may cause
vomiting, nausea, allergic reactions, dizziness, numbness, or
headaches.
    Even when nonconforming tobacco products are not contaminated with
foreign objects or substances, they may contain higher levels of a
constituent than the consumer is expecting, which can have negative
health effects not normally associated with the tobacco product. For
example, researchers have reported on the variability of nicotine in
certain ENDS e-liquids and that the labeling of these products did not
accurately reflect the actual nicotine levels. For example, there have
been reports of wide variability in e-cigarette manufacturing,
including nicotine concentrations in e-liquid, that were inconsistent
with the information contained on the product label (Ref. 178). In one
study, researchers found that actual nicotine amounts differed from
label amounts by more than 20 percent in 9 out of 20 original e-
cigarette cartridges tested, and in 3 out of 15 refill cartridges
tested (Ref. 1). In a second study, 9 of 21 samples had nicotine levels
that deviated from the labeled value by more than 10%, with
inconsistencies ranging from -21 percent to +22.1 percent (Ref. 4).
Nicotine delivery varies not only across brands, but also within brands
(Refs. 178-180). A finished ENDS that contains a nicotine concentration
higher than the established specification can be more addictive.
Similarly, a cigarette that does not conform to its pH specification
can affect the amount of nicotine that is delivered to the user and its
rate of absorption that can increase the tobacco product's toxicity and
addictiveness (Ref. 6).
    Nonconforming products may also occur because of design issues,
which can cause the tobacco product to be more harmful. For example, an
ENDS product, as designed, may have a design feature that contributes
to an increased risk of fire and/or explosion. The ENDS product, during
use or foreseeable misuse, can expose consumers to increased harm if
the product catches fire or explodes resulting in serious burns that
would not be expected from use of the product (e.g., Ref. 7).
    Given the dangers associated with contaminated and otherwise
nonconforming tobacco products, FDA is proposing this regulation to
help assure that the public health is protected by requiring that
finished and bulk tobacco product manufacturers establish and maintain
certain controls to prevent the manufacture and distribution of
nonconforming products

that may have an adverse effect on public health.
2. Ensuring Compliance With Chapter IX of the FD&C Act
    The proposed regulation would help assure that tobacco products are
in compliance with the requirements of chapter IX of the FD&C Act
pursuant to section 906(e) of the FD&C Act. In particular, by requiring
controls over the manufacturing process, the proposed regulation would
help assure that tobacco products are manufactured in accordance with
the specifications provided in their applications authorized by FDA.
Specifications generally are included in four types of applications:
     Substantial equivalence (SE) report--To request marketing
authorization for a new tobacco product, manufacturers may submit a
report pursuant to section 905(j) of the FD&C Act (21 U.S.C. 387e) to
demonstrate that the new tobacco product has the same characteristics
as a predicate tobacco product, or has different characteristics than
the predicate tobacco product but the information submitted
demonstrates that it is not appropriate to regulate the product under
section 910 because the product does not raise different questions of
public health.
     Exemption from SE--To request marketing authorization for
a new tobacco product that is modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive, manufacturers may request an exemption from
demonstrating SE under certain circumstances (see 21 CFR 1107.1 and
section 905(j) of the FD&C Act).
     Premarket tobacco product application (PMTA)--To request
marketing authorization for a new tobacco product, manufacturers may
submit a PMTA, which must include, among other things, a full statement
of the components, ingredients, additives, and properties of the
product as well as a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and when
relevant, packing and installation of the product. This pathway
requires the applicant to demonstrate that marketing the new tobacco
product is appropriate for the protection of public health pursuant to
section 910 of the FD&C Act.
     Modified risk tobacco product application (MRTPA)--To
request that a product be sold or distributed for use to reduce harm or
the risk of tobacco-related diseases associated with commercially
marketed tobacco products, manufacturers may submit an MRTPA, which
must include, among other things, a description of the product and the
formulation of the product. Applicants must demonstrate that, among
other things, the product will or is expected to benefit the health of
the population as a whole.
    If a firm is manufacturing a tobacco product that is inconsistent
with the specifications identified in the application under which it
has received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Such a product could have
negative effects on public health. For example, a cigarette that does
not meet its specifications for ventilation such that ventilation is
reduced can pose public health risk through the resulting higher
delivery of harmful and potentially harmful constituents (HPHCs)
including nicotine (Refs. 8-9, 106, 173, and 183). FDA believes that
the proposed TPMP rule (if finalized) would help ensure that tobacco
products conform to the specifications in their authorized marketing
applications and do not provide a more addictive or toxic product to
consumers.
    Pursuant to section 910(a)(1) of the FD&C Act, tobacco products
that were commercially marketed (other than exclusively in test
markets) in the United States as of February 15, 2007 (``pre-existing
products''), are not considered ``new tobacco products'' and thus are
not subject to the premarket requirements of the FD&C Act. These
products are subject to other provisions of the FD&C Act, including
proposed TPMP requirements. The proposed rule would help manufacturers
ensure that pre-existing tobacco products are manufactured to their
original specifications, and thus do not undergo any modification that
would render them ``new'' and in violation of the requirements of
chapter IX of the FD&C Act because they lack proper marketing
authorization. It would also help FDA identify and determine if any
changes to established specifications or manufacturing methods and
procedures result in a modification that would render the tobacco
product ``new.''
    Manufacturers must also ensure that their tobacco products are in
compliance with tobacco product standards under section 907 of the FD&C
Act. Tobacco product standards may reduce the death and disease caused
by tobacco use, encourage cessation, decrease initiation, or reduce the
harms not normally associated with tobacco use, such as nicotine
poisoning. The proposed requirements would help a finished or bulk
tobacco product manufacturer to ensure that, and FDA to review whether,
the tobacco products conform to applicable tobacco product standards.
    In addition to helping assure that tobacco products are
manufactured in accordance with the specifications provided in their
marketing applications authorized by FDA and that products are
manufactured in accordance with applicable product standards, the
proposed TPMP rule would help tobacco product manufacturers assure
compliance with other requirements in chapter IX of the FD&C Act. For
example, tobacco product manufacturers must submit a listing of
ingredients, additives, and harmful and potentially harmful
constituents to FDA under section 904 and applicable regulations under
section 915 of the FD&C Act. The proposed TPMP recordkeeping
requirements, including the MMR and production record requirements,
could help FDA verify that the ingredients of these products are
consistent with the listing of ingredients reported to FDA under
section 904(a)(1) of the FD&C Act.
    Similarly, under section 905(i) of the FD&C Act, copies of all
labeling, and section 910(b)(1)(F) of the FD&C Act, specimens of
labeling, must be submitted by tobacco product manufacturers to FDA.
This helps the Agency determine if a manufacturer has included
unauthorized modified risk claims on product labels or labeling or if
product labeling is false or misleading or otherwise renders the
product misbranded under section 903 of the FD&C Act. The recordkeeping
requirements in the proposed regulation related to packaging and
labeling would help the Agency make similar assessments, as well as
identify variations between the submitted labeling and actual packaging
and labeling.
    Finally, the proposed contamination and risk management controls
would help prevent products from becoming contaminated. Finished or
bulk tobacco products that contain substances such as physical,
chemical, and/or biological hazards may be adulterated under sections
902(1) to (3) of the FD&C Act. The proposed requirements for facilities
and controls covering the manufacture, packing, and storage of tobacco
products would help minimize the occurrence of these kinds of hazards
and would therefore help ensure that products are in compliance with
the requirements of chapter IX of the FD&C Act.

C. Development of the Proposed Regulation

    FDA's development of this proposed regulation reflects its
experience in regulating tobacco products, including the inspections
and facility visits of tobacco manufacturing facilities it has
conducted, recommendations for good manufacturing practice requirements
for ENDS submitted by tobacco product manufacturers, and public
comments filed in response to these recommendations (Docket No. FDA-
2013-N-0227). FDA is also drawing on its experience with cGMP and HACCP
regulations for other regulated products, such as foods, medical
devices, drugs, and dietary supplements.
    FDA's experience with biennial inspections of tobacco products has
informed this proposal. Pursuant to section 905(g) of the FD&C Act, FDA
has conducted hundreds of inspections of establishments engaged in the
manufacture of regulated tobacco products, including cigarettes,
cigarette tobacco, RYO tobacco, and smokeless tobacco since October 1,
2011. FDA believes that this experience is also relevant to
establishments that manufacture deemed products, which engage in many
similar activities and processes. Beginning in 2017, the Agency also
began inspecting manufacturing establishments of deemed tobacco
products, including ENDS products.
    In August 2012, FDA issued a notice in the Federal Register
announcing an invitation to participate in its Tobacco Product
Manufacturing Facility Visits program (77 FR 48992, August 15, 2012).
The purpose of the program was to provide an opportunity for tobacco
product manufacturing facilities, including facilities related to
laboratory testing, to invite FDA staff to visit these facilities and
observe their manufacturing operations. As part of this program, FDA
staff visited tobacco product manufacturers, including small tobacco
product manufacturers, of cigarettes, smokeless tobacco products, and
cigarette papers, as well as facilities that conduct laboratory testing
services for the tobacco industry. In response to a similar notice
issued in 2016 (81 FR 39053, June 15, 2016), FDA staff also visited
manufacturing facilities of domestic and foreign manufacturers,
including small tobacco product manufacturers, of deemed tobacco
products including cigars, ENDS, and e-liquids. FDA's experiences
during these visits have helped to inform this proposal.
    In addition, on January 10, 2012, 13 tobacco companies and a trade
association of tobacco product manufacturers submitted to FDA their
recommendations for regulations on cGMP. This group of industry
stakeholders included manufacturers of a variety of tobacco products
including cigarettes, smokeless tobacco, and snus. On May 2, 2012,
representatives of the tobacco companies met with the Agency to present
an overview of the recommendations and their approach to developing
them. FDA established a public docket requesting public comment on
these industry recommendations (78 FR 16824, March 19, 2013). These
industry GMP recommendations included proposed requirements for an
extensive range of manufacturing practices including: qualification of
personnel; complaints and recordkeeping; procedures for nonconforming
product; contamination prevention; buildings, facilities, and
equipment; MMR; acceptance activities; supplier evaluation;
manufacturing records; packaging and labeling; handling and storage;
and general recordkeeping and document control procedures. We received
comments on the industry recommendations from a variety of stakeholders
including manufacturers of cigarettes, cigars, smokeless tobacco, and
snus, as well as from public health advocates.
    Further, on June 7, 2017, a group of 13 tobacco companies, a trade
coalition representing small tobacco product manufacturers, and a
standards organization representing vaping manufacturers and retailers
submitted updated supplemental industry recommendations in order to
provide additional cGMP recommendations for ENDS products. The
supplemental industry GMP recommendations were generally similar to
industry manufacturing practices that the Agency has observed through
its biennial inspections. Among the cGMP requirements that industry
recommended for ENDS products were specific ENDS design process and
procedures, process qualification requirements to ensure that products
consistently meet specifications, procedures to validate and approve
test methods, and requirements for stability testing, reserve samples,
and sampling plans.
    FDA established a public docket requesting comment on these updated
industry recommendations for good manufacturing practice requirements
for ENDS (82 FR 55613, November 22, 2017). FDA received additional
comments from manufacturers of a variety of tobacco products, public
health advocates, and individuals sharing their experiences with ENDS.
In developing this regulation, FDA reviewed and considered the
recommendations from both industry proposals, as well as the comments
submitted to the public docket.
    FDA is proposing many requirements similar to those included in the
industry GMP recommendations, particularly in the areas of personnel;
contamination prevention; requirements for buildings, facilities, and
equipment; development of an MMR; purchasing controls; process
controls; production records; procedures for nonconforming tobacco
product; complaints; packaging and labeling; distribution; and document
control procedures.
    However, FDA's proposal deviates from the industry GMP
recommendations in several ways. First, the proposed TPMP regulation
generally includes more robust provisions for procedures and records
than provisions in the industry GMP recommendations. For example, the
industry recommendations do not propose requirements for design and
development activities generally, returned tobacco product, and warning
plans, as discussed throughout this preamble. Such provisions are
critical for the efficient enforcement of the FD&C Act.
    Second, FDA's proposal includes additional provisions that are
necessary to assure that the public health is protected and that
manufacturers' tobacco products are in compliance with chapter IX of
the FD&C Act. As noted, the industry GMP recommendations do not propose
requirements for returned tobacco product and warning plans (see
sections IV.E and IV.F.3 for a discussion of these FDA proposals and
why FDA believes they will help assure the protection of the public
health). In addition, to ensure that tobacco product manufacturers can
demonstrate that their tobacco products consistently conform to
established specifications, an important public health objective, the
proposed rule includes additional requirements for environmental
controls, process validation, laboratory controls, and sampling.
Moreover, this document includes proposed requirements for design and
development activities, as well as complaint, CAPA, and nonconforming
product investigations. To address risks not normally associated with
use of tobacco products, FDA is also proposing manufacturing code and
distribution record requirements to facilitate the traceability of
nonconforming products and enable tobacco product manufacturers and FDA
to take appropriate corrective actions to protect the public health.

    FDA also has chosen not to propose certain requirements in the
industry cGMP recommendations which, in some cases, would have been
more burdensome than FDA's proposed requirements. For example, FDA
considered industry recommendations stating that TPMP requirements
should be modified for ENDS given that they are different from other
tobacco products. FDA's proposed rule, instead, utilizes an
``umbrella'' approach with flexible requirements, similar to other cGMP
regulations, that would apply to the wide variety of tobacco products
offered for sale or distribution. For example, the scope of covered
tobacco products in the 2017 supplemental industry cGMP recommendations
covers manufacturers and suppliers of ENDS components and parts and
included an additional requirement for stability tests to determine
appropriate storage conditions and expiration dates for finished ENDS
products. However, FDA believes that such requirements are unnecessary
and that the FDA proposal to cover bulk tobacco product manufacturers
and the proposed requirements for design and development controls,
process controls, and handling and storage requirements are sufficient
to address the design, manufacture, and storage of ENDS products.
    Further, the industry GMP recommendations include a requirement for
a HACCP analysis for ENDS and e-liquids. While the Agency considered
requiring HACCP plans in this proposal, as discussed in section IV.D.1,
FDA determined that use of a risk management process would be more
flexible for manufacturers while still assuring that the public health
was protected.
    FDA also did not include the industry's proposed GMP recommendation
to require reserve samples of the e-liquid-containing component/product
from each lot or batch of finished ENDS products, similar to the
reserve samples that are required for medical products. While reserve
samples could be useful for determining a root cause for any
nonconforming products or addressing any customer complaints, we
believe that the proposed documentation and recordkeeping requirements
are sufficient to address any investigation required under the proposed
rule. For example, for a released product found to be nonconforming
because of its nicotine concentration, under the proposed rule, the
manufacturer and/or FDA could review the MMR and the purchasing,
acceptance activities, and production records to determine the nicotine
concentration of the released product as well as who conducted the
testing and signed off on the release of the product. FDA's request for
comments includes comments both on industry GMP recommendations that
FDA is proposing in these requirements, and industry GMP
recommendations that FDA is not proposing.
    In addition to the industry GMP recommendation, FDA considered its
existing cGMP regulations for other regulated products and evaluated
them for their suitability and applicability to tobacco products.
Specifically, FDA considered the medical device quality system
regulation (QSR) (part 820), and the food, dietary supplement, and drug
cGMP regulations (21 CFR parts 110, 111, 210, and 211, respectively).
In addition, FDA examined its regulations on HACCP systems, such as
preventive controls for human foods, juice HACCP regulations, and fish
and fishery products HACCP regulations (21 CFR parts 117, 120, and 123,
respectively).
    FDA also considered voluntary industry cGMP and quality system
standards in developing this proposal. For example, FDA evaluated the
American E-Liquid Manufacturing Standards Association's voluntary E-
Liquid Manufacturing Standards (Ref. 10). The Agency also considered
the International Organization for Standardization (ISO) ISO
9001:2015--Quality management systems--Requirements (Ref. 11); ISO
31000: 2018--Risk Management--Principles and Guidelines (Ref. 12).
    FDA considered the quality systems and QMS requirements in FDA's
medical device QSR and pharmaceutical cGMP for the 21st century (Ref.
13) in designing the proposed rule. The Agency believes certain aspects
of those regulations are informative but not wholly applicable to
tobacco products because of certain key differences between tobacco
products and medical products regulated by FDA. For example, marketing
applications for medical products are evaluated to determine whether
they are ``safe and effective.'' Unlike medical products, tobacco
products cannot be ``safe and effective'' even if used as intended and,
therefore, the FD&C Act requires that marketing applications for
tobacco products be evaluated under different standards (see, e.g., the
``appropriate for the protection of the public health'' standard under
section 910 of the FD&C Act). FDA has taken these differences into
account in developing the proposed rule. For example, while the Agency
has included requirements for CAPA, it has decided not to propose
continuous process improvement requirements as part of this rule.
    The Agency's proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Because this
regulation would apply to many different types of tobacco products, the
proposal does not prescribe in detail how a manufacturer must produce a
specific tobacco product. Rather, the proposed regulation provides the
framework that all manufacturers would follow by requiring that
manufacturers establish and maintain procedures and fill in the details
that are appropriate to a given tobacco product.

V. Description of the Proposed Regulation

A. General Provisions

1. Scope
    The Tobacco Control Act gave FDA immediate authority over
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco. In
addition, the Tobacco Control Act gave FDA the authority to promulgate
regulations deeming other tobacco products subject to its authorities
in chapter IX of the FD&C Act. In the Federal Register of May 10, 2016,
FDA issued the Deeming Rule deeming all other products meeting the
statutory definition of tobacco product to be subject to FDA's
regulatory authority under chapter IX of the FD&C Act, except
accessories of deemed products. 81 FR 28974. That rule became effective
on August 8, 2016.
    As discussed in proposed Sec.  1120.1(a), FDA is proposing TPMP
requirements that would apply to manufacturers of all finished and bulk
tobacco products that are subject to chapter IX of the FD&C Act (e.g.,
cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, ENDS, e-
liquids, pipe tobacco, cigars, hookah tobacco, nicotine gels, and
dissolvable tobacco products) but not their related accessories.
    FDA proposes to define a ''finished tobacco product'' as a tobacco
product, including any component or part, sealed in final packaging
(e.g., a pack of cigarettes, a can of moist snuff). For the purposes of
the ``finished tobacco product'' definition, a ``package'' is a pack,
box, carton, or container of any kind or, if no other container, any
wrapping, including cellophane, in which a finished tobacco product is
offered for sale, sold, or otherwise distributed to consumers. As
discussed in more detail below, the proposed

definition of finished tobacco product also includes components or
parts of tobacco products sealed in final packaging (e.g., rolling
papers, filters, filter tubes, or e-liquids sold separately to
consumers or as part of kits). FDA intends for this TPMP rule to cover
manufacturers of finished tobacco products to help assure that the
public health is protected and that those products are in compliance
with chapter IX of the FD&C Act.
    FDA proposes to define a ``bulk tobacco product'' as any tobacco
product that is not sealed in final packaging but is otherwise suitable
for consumer use as a tobacco product (e.g., bulk cigarettes, bulk RYO
tobacco, bulk pipe tobacco). As discussed in more detail below, the
proposed definition of bulk tobacco product also includes components or
parts of tobacco products that are not sealed in final packaging but
are otherwise suitable for consumer use as tobacco products (e.g., bulk
filters, bulk e-liquids). Products that are suitable for consumer use
as tobacco products are those products that do not require further
processing by a tobacco product manufacturer, such as mixing, cutting,
curing, blending, or adding components or parts, ingredients, additives
and materials, before they can be used by a consumer. For example, an
e-liquid not sealed in final packaging is suitable for consumer use as
a tobacco product because it requires no additional processing by a
tobacco product manufacturer before it can be used by a consumer in an
ENDS device; it requires only final packaging and labeling to be a
finished tobacco product. A product can be suitable for consumer use as
a tobacco product even if it could undergo additional processing by a
manufacturer, such as blending, as long as it does not require further
processing by a manufacturer before use by a consumer. For example,
coconut and pineapple e-liquids not sealed in final packaging would be
considered bulk tobacco products because they are suitable for consumer
use as tobacco products, even if they might later be blended together
by a manufacturer to make pi[ntilde]a colada e-liquid.
    FDA is including bulk manufacturers within the scope of this
proposed rule in order to cover critical regulatory gaps that would
occur if the rule were to only cover manufacturers of finished tobacco
products. Bulk manufacturers provide bulk tobacco products, such as
bulk cigarettes, bulk RYO or pipe tobacco, and bulk e-liquids, to
finished tobacco product manufacturers who merely package and/or label
the products for consumer use. Bulk tobacco products are suitable for
consumer use as tobacco products with no additional processing by a
tobacco product manufacturer and, therefore, should be regulated in the
same manner as finished tobacco products. If the scope of the rule were
limited to finished tobacco product manufacturers, then entities that
perform key manufacturing steps other than final packaging and labeling
for consumer use, such as design and development, blending, mixing,
cutting, processing, assembling, and compounding, might not be subject
to any TPMP requirements. Inadequate controls in earlier stages of
manufacturing could result in contaminated or otherwise nonconforming
bulk tobacco products that would not be detected by a finished tobacco
product manufacturer during packaging and labeling operations. In
addition, a finished tobacco product manufacturer that packages or
labels a bulk tobacco product may not be able to conduct adequate
investigations of product complaints and implementing CAPA for issues
related to product design or production processes.
    As noted above, the proposed definitions of finished and bulk
tobacco products would include finished and bulk components or parts of
tobacco products. FDA proposes to define ``component or part'' for
purposes of proposed part 1120 consistent with the definition of
``component or part'' in the Deeming Rule, codified at 21 CFR 1143.1.
Accordingly, a component or part would mean any software or assembly of
materials intended or reasonably expected: (1) to alter or affect the
tobacco product's performance, composition, constituents, or
characteristics, or (2) to be used with or for the human consumption of
a tobacco product; but would exclude anything that is an accessory of a
tobacco product. The requirements of proposed part 1120 would apply to
manufacturers of finished and bulk components or parts of tobacco
products. This would include manufacturers of finished or bulk RYO
tobacco, papers, and filters, ENDS e-liquids, atomizers, batteries
(with or without variable voltage), and cartomizers (atomizer plus
replaceable fluid-filled cartridge).
    In determining whether software or an assembly of materials might
be ``intended or reasonably expected'' to alter or affect a tobacco
product's performance, composition, constituents, or characteristics,
or to be used with or for the human consumption of a tobacco product
(and, therefore, whether the software or assembly of materials is a
``component or part''), the manufacturer's subjective claims of intent
are not controlling. Rather, FDA considers all relevant evidence,
including direct and circumstantial objective evidence, which
encompasses a variety of factors, such as circumstances surrounding the
distribution of the product or the context in which it is sold, sales
data, and how the product is used by consumers.
    The requirements of proposed part 1120 would also apply to
manufacturers of finished or bulk products for general consumer use
(i.e., products not specifically designed for use with tobacco
products) that meet the definition of finished or bulk tobacco products
(including finished or bulk components or parts). For example, the
requirements of proposed part 1120 would apply to manufacturers of
finished or bulk batteries who intend them to be used in an ENDS
device, for example by labeling or co-packaging the batteries with an
ENDS device. Similarly, the rule would apply to manufacturers of
finished or bulk food grade flavors who intend the flavors to be used
with e-liquids. Likewise, the rule would apply to the manufacturer of a
screen sold at a hardware store for a variety of general uses if that
manufacturer labels the screen for use with a tobacco product, such as
an ENDS, or co-packages the screen with a tobacco product.
    The proposed rule would not apply to manufacturers of accessories
of finished or bulk tobacco products. FDA proposes to define an
``accessory'' as any product that is intended or reasonably expected to
be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following: (1) is not intended or reasonably expected to
affect or alter the performance, composition, constituents, or
characteristics of a tobacco product or (2) is intended or reasonably
expected to affect or maintain the performance, composition,
constituents, or characteristics of a tobacco product but (i) solely
controls moisture and/or temperature of a stored tobacco product; or
(ii) solely provides an external heat source to initiate but not
maintain combustion of a tobacco product. This proposed definition is
the same as the definition of ``accessory'' under 21 CFR 1100.3 and
under 21 CFR 1143.1. Examples of accessories of finished and bulk
tobacco products include ashtrays, spittoons, hookah tongs, cigar clips
and stands, and pipe pouches, because they do not contain tobacco, are
not derived from tobacco, and do not affect or alter the performance,
composition, constituents, or characteristics of a

tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is
maintaining the combustion of the tobacco. Accessories of deemed
products are not currently subject to chapter IX of the FD&C Act. At
this time, FDA believes that the proposed requirements of this rule
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act without applying the
requirements to manufacturers of accessories of cigarettes, cigarette
tobacco, RYO tobacco, smokeless tobacco, and deemed tobacco products.
2. Umbrella Approach
    This proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Thus, the
proposed regulation provides the framework that requires all finished
and bulk tobacco product manufacturers subject to the rule (including
specification developers, contract manufacturers, and repackagers/
relabelers) to establish and maintain procedures that are unique to the
manufacturer's facilities and activities, and appropriate for a given
tobacco product. The proposed requirements are written in general terms
to allow manufacturers to establish procedures appropriate for their
specific products and operations. The extent of the procedures
necessary to meet the regulation requirements may vary with the size
and complexity of the design and manufacturing operations. Tobacco
product manufacturers who have a complex manufacturing process would
likely need to establish more detailed procedures to comply with the
rule, while tobacco product manufacturers who have a less complex
manufacturing process may need less extensive procedures.
3. Specification Developers
    As discussed in proposed Sec.  1120.1(a), manufacturers of finished
and bulk tobacco products include specification developers, contract
manufacturers, and repackagers and relabelers. If a specification
developer designs and establishes tobacco product specifications of a
finished or bulk tobacco product and provides the specifications to a
contract manufacturer to physically manufacture the product, both the
specification developer and the contract manufacturer would be engaged
in the manufacture and/or preproduction design validation of finished
or bulk tobacco products for purposes of this rule and would be
required to comply with this proposed rule. This approach is similar to
other cGMP and HACCP regulations that have been applied to other FDA-
regulated products, such as part 820, QSR for medical devices, and part
211, cGMP for finished pharmaceuticals.
    A specification developer is a person who controls the design and
development of a tobacco product and/or initiates or creates the
specifications for the product. Such activities are important steps in
the manufacture and preproduction design validation of a tobacco
product. A specification developer is, in concept, like an architect
who creates a ``blueprint'' of a tobacco product. A specification
developer may be the same party that physically manufactures the
tobacco product or a separate entity that only provides specification
development services to another manufacturer, who then physically
manufactures the tobacco product. FDA is aware that some tobacco
product manufacturers have established an organizational structure that
places the specification development functions in an entity separate
from the entity in charge of physically manufacturing the finished or
bulk tobacco product; these entities develop and usually control
changes to the specifications of the tobacco product. Such entities are
specification developers under the proposed rule.
    A tobacco product manufacturer may utilize a specification
developer to initiate or create the specifications of a finished or
bulk tobacco product when the manufacturer lacks knowledge or expertise
in product design and development. Specifically, a manufacturer may
want to produce a tobacco product with certain features but lack the
knowledge needed to design such a product and translate the desired
features into particular product specifications. For example, a
cigarette manufacturer who wants to manufacture a cigarette with
certain constituent yields and consumer sensory qualities may use a
specification developer to create appropriate specifications for the
product, such as the specific tobacco blend, paper type and grade,
filter ventilation, additives, and other features. A tobacco product
manufacturer who intends to manufacture a dissolvable lozenge, orb, or
strip smokeless tobacco product may similarly involve a specification
developer to create appropriate product specifications such as tobacco
mixtures, pH, additives, colorants, size and shape, and packaging
materials. A tobacco product manufacturer who wants to commercially
market an e-cigarette with certain performance features such as
particular power levels, aerosol particle size, pressure drop, airflow,
and puff count may similarly use a specification developer who can
design a product with such features and translate them into appropriate
specifications, including cartridge, atomizer, heating element,
battery, and circuit board/software specifications.
    FDA proposes to regulate specification developers under this rule
because product design and the development of product specifications
are integral parts of the manufacturing and preproduction design
validation process. Product design and specification development are
important because these can affect the level of risk or harm (e.g.,
toxicity, addictiveness) a tobacco product consumer may be exposed to
when using tobacco products, and, in the absence of proper controls,
can also result in harm not normally associated with the use of a
tobacco product.
    FDA has authority to include requirements about product design in
its TPMP regulation. Specifically, section 906(e) of the FD&C Act
provides, in part, that FDA shall prescribe regulations requiring that
the methods used in and the facilities and controls used for tobacco-
product manufacture and preproduction design validation (including a
process to assess the performance of a tobacco product) conform to
current good manufacturing practice, or HACCP methodology. Requiring
specification developers to comply with TPMP provisions is consistent
with that authority.
    FDA believes that it is necessary to apply the proposed TPMP
regulation to specification developers because of their key role in the
manufacture and preproduction design validation of finished and bulk
tobacco products and because, under certain circumstances, a
specification developer may be the most appropriate party or even the
only capable party, to adequately perform certain activities required
under the proposed regulation. Design and development frequently
involve knowledge of trade secrets and/or other confidential commercial
information, and a specification developer may not

share such information with the entity that physically manufactures the
finished or bulk tobacco product.
    Such activities include, for example, conducting adequate
investigations of product complaints and implementing CAPA for issues
related to product design. For example, if complaints are received that
users are experiencing respiratory distress from the aerosol of an ENDS
product, only a specification developer may be able to conduct an
adequate investigation to determine the cause of problems and implement
the necessary actions to correct and prevent the problems. The finished
or bulk ENDS manufacturer who physically manufactures the product may
be able to rule out a manufacturing problem (e.g., defectively
manufactured solder joints), but it may not be able to determine the
cause of the problem if the issue relates to design (e.g., metallic
particles that result from improper material selection for the
cartomizer wires). In that case, only the specification developer may
have the unique knowledge regarding the product's design and history of
specification development necessary to determine the cause of the
problem and how to address it.
    Similarly, if complaints are received that the software of an ENDS
product that controls the heat and temperature functions is being
altered or hacked by users and causing malfunctions that result in
overheating, fires, or explosions, the specification developer--not the
manufacturer who physically manufactures the product--would have the
expertise to conduct a thorough investigation and initiate a CAPA to
redesign the software to prevent this user misuse.
    Specification developers are also the only party capable of
adequately performing certain activities included in the proposed
product development control requirements, such as identifying known or
reasonably foreseeable risks associated with the design of the tobacco
product and/or package as well as design verification and validation
activities. With product design and development knowledge, the
specification developer would be in the best position to identify and
take appropriate measures to treat risks associated with the design of
the tobacco product and package that are not normally associated with
the use of the tobacco product and package, or that it determines
constitute an unacceptable level of risk. For example, a specification
developer of a dissolvable tobacco product (e.g., a tobacco lozenge)
would have the knowledge to address possible misuse of the product by a
child that could cause choking or inadvertent exposure and to take
appropriate measures to redesign the size and shape of the tobacco
product or redesign the packaging. As another example, a specification
developer of a heat-not-burn tobacco product would have the knowledge
to assess whether the product could reach temperatures that could cause
burns and to take appropriate measures to reduce this risk.
    Accordingly, FDA believes that requiring specification developers
to comply with the proposed TPMP requirements is essential to ensure
that the proposed TPMP regulation operates as intended.
4. Foreign Manufacturers
    Further, FDA is proposing that foreign manufacturers of finished or
bulk tobacco products that are imported or offered for import into the
United States be covered under this TPMP rule. In accordance with
section 906(e) of the FD&C Act, FDA believes that covering foreign
manufacturers is necessary to assure the protection of the public
health. The risks associated with the tobacco product, production
process, packaging, and storage are the same for all tobacco products
covered by this proposed rule, regardless of where they are
manufactured, and all can be addressed by the same types of controls.
For example, the proposed design and development controls (proposed
subpart D) would address these risks, including risks associated with
the design of ENDS products that are primarily designed and
manufactured in China and for which there have been numerous reports of
battery fires and explosions (e.g., Ref. 7).
    In addition, having the proposed rule apply to foreign
manufacturers of finished or bulk tobacco products would be necessary
to ensure that imported tobacco products comply with chapter IX of the
FD&C Act. For example, the proposed controls (e.g., design and
development controls, MMR, acceptance activities, and production record
requirements) would help to ensure that imported tobacco products meet
all applicable tobacco product standards, and thus avoid being
adulterated or misbranded. A tobacco product which is subject to a
tobacco product standard is adulterated under section 902(5) of the
FD&C Act unless the product is in all respects in conformity with the
standard. Similarly, a tobacco product subject to a tobacco product
standard is misbranded under section 903(a)(9) of the FD&C Act unless
it bears such labeling as may be prescribed in the standard.
5. Vape Shops Engaged in the Manufacture of Tobacco Products
    Vape shops are establishments that generally, among other things,
sell a variety of products including ENDS, replacement pieces,
hardware, custom mixed e-liquids, and other related accessories. Sales
of such products, standing alone, would not constitute finished or bulk
tobacco product manufacturing. However, some vape shops are also
tobacco product manufacturers under the Deeming Rule, 81 FR at 29044,
because they also (for example) mix or prepare e-liquids or create or
modify aerosolizing apparatuses for direct sale to consumers for use in
ENDS. Under the proposed regulation, vape shops engaged in these
additional activities would be manufacturers of finished or bulk
tobacco products. When such vape shops are engaged in the manufacture,
preproduction design validation, packing, and storage of finished or
bulk tobacco products within the meaning of the proposed rule, they
would be subject to the requirements in this proposed TPMP rule.
Requiring such manufacturers to comply with TPMP requirements, as
proposed, is important for protecting the public health because
products manufactured at the retail level pose many of the same public
health risks as those manufactured upstream, and possibly additional
risks related to the lack of standard manufacturing practices and
controls. A vape shop that does not engage in the activities described
above would not be a finished or bulk tobacco product manufacturer
subject to the requirements of this proposed part 1120. In addition, as
set out immediately below, proposed Sec.  1120.1(b) would require a
finished and bulk tobacco product manufacturer to comply only with
requirements applicable to its finished and bulk tobacco product
manufacturing operations. Therefore, smaller tobacco product
manufacturers (such as vape shops that engage in some but not all of
the activities described above) would be able to tailor their
procedures to suit their smaller operations while still complying with
the proposed TPMP requirements.
6. Compliance With Requirements Applicable to Operations
    Proposed Sec.  1120.1(b) clarifies that if a tobacco product
manufacturer engages in some operations subject to the requirements of
proposed part 1120, but not others, the manufacturer need only comply
with those requirements applicable to the operations in which it is
engaged. This is the same approach

used in the drug cGMP regulation at Sec.  210.2(b) and the device QSR
at Sec.  820.1(a)(1).
    For example, a manufacturer of finished e-liquids would not need to
comply with the warning plan requirements in proposed Sec.  1120.98
because e-liquids are only required to bear a single warning.
Similarly, a finished cigarette manufacturer who does not engage in
repackaging or relabeling operations would not need to comply with the
repackaging and relabeling requirements in proposed Sec.  1120.94.
Likewise, a specification developer who only designs/creates the MMR
for another manufacturer's tobacco product and does not engage in any
physical manufacturing would not be subject to, for example, the
proposed requirements in subparts C (Buildings, Facilities, and
Equipment), E (Production Processes and Controls), and G (Handling,
Storage, and Distribution). If manufacturers believe a requirement is
not appropriate or necessary to ensure that the public health is
protected and that the tobacco product will be in compliance with this
chapter, they may petition for an exemption or variance from all or
part of the regulation pursuant to proposed Sec.  1120.142.
    Proposed Sec.  1120.1(c) clarifies the term ``where appropriate,''
which appears several times in proposed part 1120. As discussed in
proposed Sec.  1120.1(c), when a requirement is qualified with ``where
appropriate,'' it is deemed to be appropriate unless the tobacco
product manufacturer documents in writing (on paper or electronically)
an adequate justification prior to abstaining from implementing the
requirement. An adequate justification would address why abstaining
from the requirement would not result in a nonconforming tobacco
product or in the manufacturer not being able to carry out necessary
corrective actions. In this circumstance, the manufacturer need not
petition for or receive an exemption or variance under Sec.  1120.140.
Proposed Sec.  1120.1(d) notes that requirements in proposed part 1120
are intended to protect the public health and assure that tobacco
products are in compliance with the relevant provisions of the FD&C Act
and explains that the failure to comply with any applicable provision
in proposed part 1120 would render the tobacco product adulterated
under section 902(7) of the FD&C Act.
7. Other Manufacturers and Request for Comment
    At this time, FDA is not proposing to apply these proposed TPMP
requirements to manufacturers of tobacco products other than finished
and bulk tobacco products. In particular, the proposed regulation will
not reach manufacturers of components or parts that are not offered for
sale, sold, or otherwise distributed to consumers, i.e., components or
parts for further manufacture. For example, the rule would not apply to
manufacturers of filter tow material and cigarette tipping paper that
are intended or reasonably expected to be used to manufacture a
cigarette, because those products are not sold to consumers. The
proposed rule's current scope does not reach such components or parts
directly, but rather requires incoming tobacco product components or
parts, ingredients, additives, and materials to be subject to
purchasing controls and acceptance activities implemented by finished
and bulk tobacco product manufacturers to ensure that they meet
established specifications. In addition, FDA is not currently proposing
to apply these proposed requirements to manufacturers of accessories.
    FDA is soliciting comment on the scope of the proposed rule, as
well as whether the scope of this regulation should be expanded to
reach more than finished and bulk tobacco products. If you believe that
FDA should expand the scope of this proposed rule to reach additional
tobacco products, please explain why you believe FDA should take that
approach; which proposed requirements, if any, should apply to other
manufacturers; whether the regulation should cover manufacturers of all
regulated tobacco products, including all components or parts, or only
manufacturers of certain products; as well as any public health data
and information that would support what you believe would be the
appropriate scope of this rule. Alternatively, if you believe that FDA
should limit the scope of the proposed regulation, please explain why
you believe the scope of the rule should be more limited than finished
and bulk tobacco product manufacturers and provide any data or
information that would support that such a limited scope would still
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act.
8. Definitions
    Proposed Sec.  1120.3 sets forth the meaning of terms used in
proposed part 1120.
     Accessory. We propose to define ``accessory'' as any
product that is intended or reasonably expected to be used with or for
the human consumption of a tobacco product; does not contain tobacco
and is not made or derived from tobacco; and meets either of the
following: (1) is not intended or reasonably expected to affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product or (2) is intended or reasonably expected to affect
or maintain the performance, composition, constituents, or
characteristics of a tobacco product but (i) solely controls moisture
and/or temperature of a stored tobacco product; or (ii) solely provides
an external heat source to initiate but not maintain combustion of a
tobacco product. Examples of accessories are ashtrays, spittoons,
hookah tongs, cigar clips and stands and pipe pouches, because they do
not contain tobacco, are not derived from tobacco, and do not affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is used to
maintain the combustion of the tobacco.
     Additive. We propose to define ``additive'' as any
substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or coloring
or in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except that such term
does not include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical. An additive can be a type of
ingredient in a tobacco product; an example is methyl salicylate in
smokeless tobacco, which can serve as an absorption enhancer and affect
the characteristics of the tobacco product by changing the rate of
absorption into the body.
     Batch. We propose to define ``batch'' as a specific
identified amount of tobacco product produced in a unit of time or
quantity and that is intended to have the same specifications. FDA
proposes to give tobacco product manufacturers flexibility to determine
what unit of time or quantity is appropriate for their product, and how
batches would be designated. For example, manufacturers likely would
define a batch for cigarette production, which is almost continuous,
differently

than a batch for smokeless tobacco, which likely would be defined based
on the amount processed in a vat through the fermentation process.
     Brand. We propose to define ``brand'' as a variety of
tobacco product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, packaging, logo,
registered trademark, brand name, identifiable pattern of colors, or
any combination of such attributes.
     Bulk tobacco product. We proposed to define ``bulk tobacco
product'' as a tobacco product not sealed in final packaging but
otherwise suitable for consumer use as a tobacco product. Products that
are suitable for consumer use as a tobacco product are those products
that do not require further processing by a tobacco product
manufacturer before they can be used by a consumer, such as mixing,
cutting, curing, blending, and adding components or parts, ingredients,
additives and materials. A tobacco product can be suitable for use even
if it could undergo additional processing by a manufacturer as long as
it does not require further processing by a manufacturer before use by
a consumer. Examples of bulk tobacco products include bulk RYO tobacco,
bulk pipe tobacco, bulk RYO filters, and bulk e-liquids. However,
cigarette paper that is supplied on a bobbin roll would not be
considered a bulk tobacco product because it would need to be cut into
rolling paper sizes or combined/glued with filters to make cigarette
tubes. The terms ``bulk tobacco product'' and ``finished tobacco
product'' are distinguishable because bulk tobacco products are not
sealed in final packaging, whereas finished tobacco products are sealed
in final packaging.
     Characteristic. We propose to define ``characteristic'' as
the materials, ingredients, design, composition, heating source, or
other features of a tobacco product.
     Component or Part. We propose to define ``component or
part'' as any software or assembly of materials intended or reasonably
expected: (1) to alter or affect the tobacco product's performance,
composition, constituents, or characteristics or (2) to be used with or
for the human consumption of a tobacco product. Component or part
excludes anything that is an accessory of a tobacco product.
     Contaminated tobacco product. We propose to define
``contaminated tobacco product'' as a tobacco product that contains a
substance not ordinarily contained in that tobacco product. ``Not
ordinarily contained'' refers to a substance that is not intended or
expected to be in that tobacco product. As stated in proposed Sec.
1120.3, an example of a contaminated tobacco product is a smokeless
tobacco product with metal fragments in the tobacco filler.
     Design. We propose to define ``design'' as the form and
structure concerning and the manner in which components or parts,
ingredients, additives, and materials are integrated to produce a
tobacco product.
     Direct accounts. We propose to define ``direct accounts''
as all persons who are customers of the tobacco product manufacturer
that receive finished or bulk tobacco products directly from the
manufacturer or from any person under control of the manufacturer.
Direct accounts may include wholesalers, distributors, and retailers.
Direct accounts do not include individual purchasers of tobacco
products for personal consumption.
     Establish and maintain. We propose to define ``establish
and maintain'' as to define, document in writing (on paper or
electronically), implement, follow, and update. Multiple requirements
in the proposed regulation direct manufacturers to ``establish and
maintain'' certain procedures. For example, proposed Sec.
1120.12(e)(1) would require tobacco product manufacturers to establish
and maintain procedures for identifying training needs and establishing
training frequency for personnel based on the work the employee
performs. Therefore, to comply with proposed Sec.  1120.12(e)(1), a
manufacturer would be required to create written procedures for
identifying and meeting training needs, implement and follow the
written procedures, and update the procedures as needed.
     Equipment. We propose to define ``equipment'' as any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment used during testing
and laboratory activities conducted as part of the manufacturing
process would be covered under this proposed definition.
     Finished tobacco product. We propose to define ``finished
tobacco product'' as a tobacco product, including any component or
part, sealed in final packaging. Additional examples of finished
tobacco products include a pack of cigarettes, a can of moist snuff,
and rolling papers, filters, filter tubes, or e-liquids sold to
consumers. One finished tobacco product may contain others. For
example, a carton of cigarette packs (which are finished tobacco
products) is also a finished tobacco product, because, like a cigarette
pack, a carton is a tobacco product sealed in final packaging. As noted
below, final packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a finished tobacco product is offered for sale, sold, or
otherwise distributed to consumers. (See definition of packaging).
     Ingredient. We propose to define ``ingredient'' as
tobacco, substances, compounds, or additives contained within or added
to the tobacco, paper, filter, or any other component or part of a
tobacco product, including substances and compounds reasonably expected
to be formed through chemical action during tobacco product
manufacturing.
    For example, an ingredient may be a single chemical substance, leaf
tobacco, or the product of a reaction, such as a chemical reaction, in
manufacturing. Examples of substances and compounds (ingredients)
reasonably expected to be formed through a chemical reaction during
tobacco product manufacturing include the following:

--The reaction of sugars with amines to form families of compounds with
new carbon-nitrogen bonds, including Maillard reaction products and
Amadori compounds;
--the reaction of sodium hydroxide with citric acid to form sodium
citrate;
--the production of ethyl alcohol, a residual solvent, from ethyl
acetate during production of tipping paper adhesive;
--products of thermolytic reactions,
--such as the production of carboxylic acids from sugar esters;
--products of enzymatically or nonenzymatically catalyzed reactions,
such as the hydrolytic production of flavor or aroma precursors from
nonvolatile glucosides; and
--products of acid-base reactions, such as removal of a proton from
protonated nicotine to generate the basic form of nicotine (``free''
nicotine). 86 FR 55300 at 55313 (Oct. 5, 2021).

     Label. We propose to define ``label'' as a display of
written, printed, or graphic matter upon the immediate container of any
article. For finished tobacco products, the term label means a display
of written, printed, or graphic matter upon the immediate container of
any finished tobacco product. Likewise, for a bulk tobacco product, the
term label means a display of written, printed, or graphic matter upon
the immediate container of any bulk tobacco product.
     Labeling. We propose to define ``labeling'' as all labels
and other

written, printed, or graphic matter: (1) upon any article or any of its
containers or wrappers or (2) accompanying such article.
     Management with executive responsibility. We propose to
define ``management with executive responsibility'' as one or more
designated personnel who have the authority and responsibility to
ensure compliance with TPMP requirements, including allocating
resources and making changes to the organizational structure,
buildings, facilities, equipment or the manufacture, preproduction
design validation, packing, and storage of a tobacco product. These
employees are typically senior employees with the authority to
establish or make changes to tobacco product manufacturing policies.
Such person(s) also would be responsible for ensuring that TPMP
requirements are communicated, understood, implemented, and followed at
all levels of the organization.
     Manual method, process, or procedure. We propose to define
``manual method, process, or procedure'' as any nonautomated method,
process, or procedure, including processes performed by hand with or
without the use of equipment.
     Manufacturing. We propose to define ``manufacturing'' as
the manufacturing, fabricating, assembling, processing, or labeling,
including the repackaging or relabeling, of a tobacco product. The term
``manufacturing'' includes establishing the specifications of a
finished or bulk tobacco product. Examples of manufacturing activities
include expanding (a process used with the tobacco leaf, typically dry
ice expanded tobacco), homogenizing, mixing, and formulating a tobacco
product.
     Manufacturing code. We propose to define ``manufacturing
code'' as any distinctive sequence or combination of letters, numbers,
or symbols that begins with the manufacturing date followed by the
batch number. The purpose of the manufacturing code is to allow
manufacturers and FDA to identify the production batch of a particular
finished or bulk product that has been released for distribution. This
information is intended to help determine the product's history (e.g.,
batch production records) and assist manufacturers and FDA in the event
of a nonconforming product investigation and any corrective actions to
be taken as a result of the investigation.
     Manufacturing date. We propose to define ``manufacturing
date'' as the month, day, and year in 2-digit numerical values in the
format (MMDDYY) that a finished or bulk tobacco product is packaged for
distribution. The manufacturing date is included in the manufacturing
code.
     Manufacturing material. We propose to define
``manufacturing material'' as material used in or used to facilitate
the manufacturing process that is not equipment and is not intended to
be part of the product. Such material would have to contact the tobacco
product or tobacco product-contact surface. An example of manufacturing
material would be a mold release agent used to facilitate the release
of a tobacco product from a mold.
     Master manufacturing record (MMR). We propose to define
``master manufacturing record'' as a document or designated compilation
of documents containing the established specifications for a tobacco
product including acceptance criteria for those specifications, all
relevant manufacturing methods and production process procedures for
the tobacco product, and all approved packaging, labeling, and labels
for the tobacco product. Tobacco product specifications, as used in
this definition, may be established by the manufacturer or required by
FDA. The MMR may be prepared either as a single document (or single
file of documents) or as a product-specific index system that
references and includes the location of all the required information.
     Nonconforming tobacco product. We propose to define
``nonconforming tobacco product'' as any tobacco product that does not
meet a product specification in the MMR (see proposed Sec.
1120.44(a)(1)); has packaging, labeling, or labels other than those
included in the MMR (see proposed Sec.  1120.44(a)(3)); or is a
contaminated tobacco product.
     Not normally associated. We propose to define ``not
normally associated'' as not an inherent risk of using the tobacco
product. In this context, the inherent risk would be associated with
using the specific category of tobacco product. For example, inherent
risks of using cigarettes include cancers of the mouth, throat, larynx,
esophagus, trachea, lung, stomach, liver, pancreas, kidney, bladder,
cervix, and colon/rectum, as well as one form of leukemia (Ref. 14).
Other examples of inherent risks of using cigarettes include stroke,
heart disease, peripheral vascular disease, COPD, tuberculosis, asthma,
pneumonia and other respiratory diseases (id.). Examples of inherent
risks of cigars include oral, laryngeal, pharyngeal, and esophageal
cancers, as well as lung cancer and heart disease (Ref. 15). Examples
of inherent risks of smokeless tobacco include oral and pancreatic
cancers (Ref. 16).
    Examples of risks not normally associated with tobacco products
include lacerations of the gums or lips due to metal fragments found in
chewing tobacco; broken teeth caused by rocks found in chewing tobacco;
bodily injury caused by an exploding battery of an ENDS product;
vomiting, nausea, allergic reactions, dizziness, numbness, or headaches
caused by toxic chemical compounds found in nonconforming products; a
serious illness caused by a tobacco product contaminated by aflatoxin
from a fungus; and acute breathing difficulties associated with an
allergic reaction to a contaminated tobacco product (e.g., Ref. 17).
     Package or packaging. We propose to define ``package'' or
``packaging'' as a pack, box, carton, or container of any kind or, if
no other container, any wrapping (including cellophane), in which a
finished tobacco product is offered for sale, sold, or otherwise
distributed to consumers (this is also referred to as final package or
final packaging), or in which a bulk tobacco product is offered for
sale, sold, or otherwise distributed (including commercial distribution
and interplant transfers). For example, under the proposed definition,
a carton offered for sale to consumers, which holds individual
cigarette packages, would be considered a ``package'' or ``packaging.''
However, a shipping crate that holds multiple cartons of cigarettes, or
other multiple quantities of finished tobacco products, for
distribution to retailers would not be considered ``packages'' or
``packaging,'' because such shipping crates for distribution to
retailers are not containers or wrapping in which a finished tobacco
product is offered for sale, sold, or otherwise distributed to
consumers. We use the terms ``package'' and ``packaging''
interchangeably throughout this proposed rule.
     Personnel. We propose to define ``personnel'' as all
persons, including managers, staff, consultants, contractors, and
third-party entities, performing services for the manufacturer subject
to proposed part 1120. The term ``personnel'' includes independent
contractors performing services for the manufacturer.
     Relabeling. We propose to define ``relabeling'' as
operations in which the labeling of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally labeled the product. For example, if a finished
tobacco product fails an acceptance activity because it bears the wrong
label, the manufacturer

may relabel the product with the correct label.
     Repackaging. We propose to define ``repackaging'' as
operations in which the packaging of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally packaged the product. For example, if the package
of a finished tobacco product is damaged during storage, the
manufacturer may repackage the finished product in a new package.
     Representative sample. We propose to define
``representative sample'' as a sample that consists of a number of
units that are drawn based on a valid scientific rationale (such as
random sampling) and intended to ensure that the sample accurately
reflects the material being sampled.
     Reprocessing. We propose to define ``reprocessing'' as
using tobacco product that has been previously recovered from
manufacturing in the subsequent manufacture of a finished or bulk
tobacco product. FDA has observed that reprocessing is a routine
manufacturing process. An example of reprocessing would be using
tobacco recovered through a ripper short process for cigarettes (where
tobacco is removed from rejected cigarettes using equipment such as
feeders, shakers, and separators) to make other cigarettes. Similar
reprocessing occurs for smokeless tobacco, where the tobacco is
recovered from rejected finished or bulk tobacco products, for example,
due to incorrect weight or defective packaging/labels, and then used to
make other smokeless tobacco products.
     Returned tobacco product. We propose to define ``returned
tobacco product'' as commercially distributed finished or bulk tobacco
product returned to the tobacco product manufacturer by any person not
under the control of the tobacco product manufacturer, including a
wholesaler/distributor, retailer, consumer, or member of the public.
Individuals may return tobacco products to the manufacturer for a
number of reasons, including improper weight or taste.
     Rework. We propose to define ``rework'' as action taken on
a nonconforming or returned tobacco product to ensure that the product
meets the specifications and other requirements in the MMR of a
subsequently manufactured tobacco product before it is released for
further manufacturing or distribution. For example, a smokeless tobacco
product that fails an acceptance activity for pH level can be reworked
by further fermentation.
     Small tobacco product manufacturer. We propose to define
``small tobacco product manufacturer'' as a tobacco product
manufacturer that employs fewer than 350 employees. For purposes of
this definition, the number of employees of a manufacturer includes
those employees and personnel of each entity that controls, is
controlled by, or is under common control with such manufacturer.
     Specification. We propose to define ``specification'' as
any requirement with which a product, process, service, or other
activity must conform. A tobacco product specification is a requirement
established by the manufacturer (including specification developer,
contract manufacturer, or repackager/relabeler), including a
requirement established to ensure that the tobacco product meets any
applicable product standard under section 907 of the FD&C Act. Tobacco
product specifications can include physical, chemical, and biological
specifications. Examples of physical specifications include length,
circumference, and pressure drop for cigarettes, and cut size and
weight for smokeless tobacco products. An example of a chemical
specification is a pH level for smokeless tobacco products, and an
example of a biological specification is a specification related to the
use of a biological fermentation agent used during the manufacturing
process for smokeless tobacco products. Examples of a production
process specification are the upper and lower temperature and humidity
limits for specified durations, as part of the fermentation process for
a smokeless tobacco product. An example of a service specification is a
requirement with which a pest control service must conform.
    This proposed rule would require that the tobacco product
specifications and acceptance criteria for those specifications be
included in the MMR for each finished and bulk tobacco product. For
example, if an ENDS manufacturer establishes a voltage specification
for an adjustable, variable voltage product with a range of 3-6V, the
MMR would have to indicate the voltage acceptance criteria that reflect
the tolerance that is established around the upper and lower
specifications.
     Tobacco product. The term ``tobacco product'' means any
product made or derived from tobacco, or containing nicotine from any
source, that is intended for human consumption, including any
component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product). The term ``tobacco product'' does
not mean an article that is a drug under section 201(g)(1) (21 U.S.C.
321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a
combination product described in section 503(g) of the FD&C Act (21
U.S.C. 353(g)). The term ``tobacco product'' does not mean an article
that is a food under section 201(f) (21 U.S.C. 321(f)), if such article
contains no nicotine, or no more than trace amounts of naturally
occurring nicotine.
     Tobacco product-contact surface. We propose to define
``tobacco product-contact surface'' to mean a surface that comes into
contact with a tobacco product or a surface from which drainage (or
other transfer) ordinarily occurs onto the tobacco product or onto
surfaces that come into contact with the tobacco product during the
normal course of operations. This definition would include surfaces of
equipment that come into contact with the tobacco product.
     Tobacco product manufacturer. We propose to define the
term ``tobacco product manufacturer'' as any person(s), including any
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product; or imports a finished tobacco
product for sale or distribution in the United States. Tobacco product
manufacturer includes any person(s) who establishes the specifications
for a tobacco product.
    FDA does not propose to define ``tobacco product manufacturer'' to
include third-party laboratories. A finished or bulk tobacco product
manufacturer who uses a third-party laboratory is responsible for
ensuring that the laboratory is qualified to provide services under
proposed Sec.  1120.62 and is competent to perform laboratory
activities associated with the manufacture of a finished or bulk
tobacco product under proposed Sec.  1120.68. A finished or bulk
tobacco product manufacturer who uses a third-party laboratory is also
responsible for ensuring that it receives from the third-party
laboratory all the documents and records (including all metadata)
needed to comply with the proposed TPMP requirements, including, for
example, proposed Sec. Sec.  1120.68(c) and 1120.122. It is the
finished or bulk tobacco product manufacturer, not the laboratory, that
is required to comply with the laboratory control requirements in
proposed Sec.  1120.68.
     Unique identifier. We propose to define ``unique
identifier'' as information, such as a code or number, that is
maintained for each accepted incoming product that would enable the

tobacco product manufacturer and FDA to identify the supplier and
unique shipment of the incoming product.
     Validation. We propose to define ``validation'' as
confirmation by examination and objective evidence that the particular
requirements can be consistently fulfilled. An example of a validation
activity would be the validation of the smokeless tobacco fermentation
process, which would demonstrate that when key parameters (e.g.,
temperature, pH, oven volatiles, and number of turns) are met,
conforming product will be produced in that batch. The relevant
parameters would be monitored to confirm that the batch was produced
within the validated ranges for the fermentation process.
     Verification. We propose to define ``verification'' as
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or approved model to confirm the proper shape
and dimensions of that finished cigar.

B. Management System Requirements

1. Organization and Personnel
    Proposed Sec.  1120.12 describes the proposed requirements for
finished and bulk tobacco product manufacturers' organization and
personnel. This section forms the foundation for manufacturers to
adequately perform and comply with the proposed requirements under
proposed part 1120. These proposed requirements are generally similar
to the organization and personnel requirements in the industry
recommendations, and similar practices that FDA has observed during
establishment inspections.
    Specifically, proposed Sec.  1120.12(a) would require finished and
bulk tobacco product manufacturers to establish and maintain an