(Ref. 67). If the ENDS manufacturer determines that this risk is
reasonably likely to occur and that it may cause serious illness,
injury, or death not normally associated with the use of the tobacco
product, it would then be required to take appropriate treatment
measures to significantly minimize or prevent the risk, such as use of
overcharging protection circuits, thermal power cutoffs, and internal
overpressure relief mechanisms that can help prevent and mitigate
thermal runaway. The proposed provision would then require
manufacturers to verify and validate the design of the product taking
into account these risk treatment measures.
    FDA believes that engaging in a risk management process is the most
effective and efficient way to proactively ensure that risks associated
with finished and bulk tobacco products, their package, and their
production process, packing, and storage, are adequately assessed and
treated. FDA believes such an approach is more effective than
identifying and controlling risks through finished product testing or
sanitation controls alone (Ref. 95). Additionally, other TPMP
requirements such as product complaints, acceptance activities,
nonconforming product, and returned product may not be sufficient to
address all risks.
    The requirement to maintain records of required design and
development activities could help FDA understand how a tobacco product
manufacturer has established the specifications in the MMR for the
finished or bulk tobacco product and their impact on public health. In
addition, in the event of a recall, FDA could use these records to
learn information that may be related to the recall and ascertain the
appropriate way to address the issue. For example, FDA is aware of
instances where contamination of cigarettes with a suspected chemical
hazard resulted in a recall. One cigarette manufacturer announced a
voluntary recall of approximately 8 billion cigarettes because the
company detected unusual tastes and peculiar odors in 36 product lines
(Ref. 82). Consumers who smoked the affected cigarettes reportedly
suffered from pneumonia, exacerbation of asthma, bronchitis, chronic
obstructive pulmonary disease, eosinophilic pneumonitis, and laryngitis
(Ref. 82). The manufacturer detected methyl isothiocyanate (MITC) in
the cigarette filters (Ref. 82). Adverse health effects from MITC
exposure (e.g., mucosal irritation of the respiratory and
gastrointestinal tracts, conjunctival irritation, and neurologic
symptoms) have been documented, although it was not established in this
recall event that the reported illnesses were associated with users
smoking contaminated cigarettes (Ref. 82). In such a scenario, if MITC
was not previously an identified risk but was subsequently determined
to pose a risk because it was used in the production of cigarette
filters by the filter supplier, this provision would have required the
manufacturer to reassess the risk and to take appropriate risk
treatment steps. The risk assessment and risk treatment steps could
include notifying the filter supplier to cease the use of this
substance to minimize or prevent this risk if the manufacturer
determined the level of risk to be unacceptable. Alternatively, the
manufacturer could use the updated risk assessment to choose an
alternate filter supplier who does not use MITC in the manufacture of
filters.
    The proposed design and development activities requirements also
would help assure that the finished or bulk tobacco product is in
compliance with the requirements of chapter IX of the FD&C Act. For
example, finished or bulk tobacco products that pose risks such as
physical, chemical, and/or biological hazards may be adulterated under
section 902 of the FD&C Act. While some finished and bulk tobacco
product manufacturers may already have similar controls in place, FDA
believes that manufacturers should be required to engage in a risk
management process and perform design validation and verification to
help protect against the manufacture and distribution of nonconforming
and/or contaminated product.
3. Master Manufacturing Record
    Proposed Sec.  1120.44(a) would require finished and bulk tobacco
product manufacturers to establish and maintain an MMR for each
finished and bulk tobacco product they manufacture for distribution.
These proposed requirements are similar to those in other FDA-regulated
industry manufacturing regulations (e.g., Sec.  820.181). An MMR is a
document or a 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.
    Under proposed Sec.  1120.44(a)(1), the MMR must include the
tobacco product specifications and acceptance criteria for those
specifications. A tobacco product specification is any requirement
established by the manufacturer (including specifications necessary to
ensure that the tobacco product meets any applicable product standard)
with which a product must conform. 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.
    Tobacco product specifications in the MMR could include
specifications for the finished or bulk tobacco products as well as
specifications for incoming components and in-process tobacco products.
For example, a tobacco product manufacturer may establish
specifications for the cut size of incoming tobacco cut filler or the
length, diameter, and tow of incoming filters. Tobacco product
manufacturers may also establish specifications for in-process tobacco
products, for example, a specification for the pH of fermented tobacco
before it is packaged as a finished smokeless tobacco product or a
specification for the length, circumference, and pressure drop of
cigarette filter rods before they are packaged as finished cigarettes.
In addition, tobacco product manufacturers may establish specifications
for finished tobacco products, for example, specifications for the
length, circumference, and pressure drop for cigarettes, or cut size
and weight for smokeless tobacco products.
    Proposed Sec.  1120.44(a)(1) also would require that the MMR
include acceptance criteria for the tobacco product specifications. The
acceptance criteria should indicate if there is a particular value,
range, minimum or maximum value, and/or standard deviation associated
with a specification for an incoming component, in-process product, or
finished or bulk tobacco product. For example, if a smokeless

tobacco product manufacturer establishes a pH and a weight
specification for a finished smokeless tobacco product, proposed Sec.
1120.44(a)(1) would require that the MMR for the product indicate the
specific pH and weight acceptance criteria, for example, 7.2 0.5 pH and 3g 0.2 gram (g), respectively. Similarly,
if an ENDS manufacturer establishes a voltage specification for an
adjustable, variable voltage product, the MMR would have to indicate
the voltage acceptance criteria, for example, a range of 3-6 V. While
this proposed rule would require acceptance criteria, the tobacco
product manufacturer would determine the specific acceptance criteria
that are appropriate for each established specification.
    Under the proposed requirement, it would generally be up to
manufacturers to determine what specifications to include in the MMR
for each particular product they manufacture. However, proposed Sec.
1120.44(a)(1)(i) through (iv) would require that, at a minimum, tobacco
product specifications in the MMR include certain specifications
related to product content, design, any applicable product standards
established by FDA under section 907 of the FD&C Act, and pesticide
chemical residues for raw tobacco.
    Proposed Sec.  1120.44(a)(1)(i) would require the product
specifications in the MMR to include the identity and amount of any
components or parts, ingredients, additives, and materials in the
finished or bulk tobacco product. This information could be presented,
for example, in a bill of materials that describes the identity and
amount of the ingredients, additives, and materials in a finished
tobacco product. The identity of all components or parts, ingredients,
additives, and materials in the finished or bulk tobacco product should
include a uniquely identifying name and/or number information. The
proposed approach for uniquely identifying information is intended to
be consistent with FDA's current thinking on listing of ingredients
under section 904 of the FD&C Act as articulated in FDA's guidance
entitled ``Listing of Ingredients in Tobacco Products.'' For example,
for ingredients that are single chemical substances, uniquely
identifying information should be a unique scientific name or code,
such as the FDA Unique Ingredient Identifier code, Chemical Abstracts
Service number, or International Union of Pure and Applied Chemistry
name. Leaf tobacco (i.e., whole leaf or parts) that has been prepared
solely by mechanical processing that involves no chemical, additive, or
substance other than potable water should be uniquely identified by, if
known: the type (e.g., burley, bright, oriental); the variety; the cure
method (e.g., flue, fire, sun, steam, air) and heat source (e.g.,
propane, wood); and a description of any recombinant DNA technology
used to engineer the tobacco. Complex purchased ingredients, as
described in FDA's revised guidance, ``Listing of Ingredients in
Tobacco Products,'' should be identified by: the complete name of the
manufacturer of the complex purchased ingredient and the uniquely
identifying item name and/or number (e.g., catalog number or Universal
Product Code (UPC)) used by that manufacturer. Complex ingredients made
by the tobacco product manufacturer or made to the tobacco product
manufacturer's specifications should be included in the MMR in a manner
that uniquely identifies each individual ingredient.
    We recognize that some tobacco product manufacturers obtain certain
components or parts for their products from other manufacturers or
suppliers and may not be in a position to know every individual
ingredient in those components or parts. This is especially true if the
component or part is, for example, a proprietary blend. In these
instances, the tobacco product manufacturer could comply with proposed
Sec.  1120.44(a)(1)(i) by including the complete name of the
manufacturer of the component or part and a uniquely identifying item
name and/or number (e.g., catalog number or UPC) used by that
manufacturer. The tobacco product manufacturer, however, would have to
comply with additional requirements intended to ensure awareness of any
changes to purchased components or parts that may affect the tobacco
product (see proposed Sec.  1120.62(c), Purchasing controls).
    Proposed Sec.  1120.44(a)(1)(ii) would require the MMR to include
the finished or bulk tobacco product design, meaning the form and
structure concerning and the manner in which components or parts,
ingredients, additives, and materials are integrated to produce a
tobacco product. For example, a cigarette's design could include design
features such as ventilation, paper porosity, tobacco cut width, and
filter efficiency and the manner in which the tobacco cut filler,
filter, cigarette paper, tipping paper, and plug wrap are assembled to
produce a finished cigarette.
    Under proposed Sec.  1120.44(a)(1)(ii), a manufacturer must also
include an identification of the product's heating source, if any
(e.g., burning coal, electric, chemical reaction, carbon tip), a
discussion of the intended user operation (how the tobacco product will
be used or operated by a user), and any relevant product drawings or
schematics. For example, a discussion of the intended user operation of
an ENDS product could include the appropriate and intended methods to
charge the ENDS battery or how to handle, refill, and store the e-
liquids for the ENDS product.
    Proposed Sec.  1120.44(a)(1)(iii) would require the MMR to include
any specification necessary to ensure that the tobacco product meets
any applicable product standard established under section 907 of the
FD&C Act. For example, under section 907 of the FD&C Act, FDA could
establish a product standard requiring the reduction of an additive or
constituent in a tobacco product. In this case, the tobacco product
manufacturer would be required to include any specification necessary
to ensure that the product meets the established standard for that
additive or constituent. Finally, proposed Sec.  1120.44(a)(1)(iv)
would require the MMR to include specifications for pesticide chemical
residues for raw tobacco.
    Proposed Sec.  1120.44(a)(2) would require the MMR to include all
relevant manufacturing methods and production process procedures. This
requirement is intended to capture all the manufacturing steps involved
in making the tobacco product, from receipt of incoming materials to
distribution of the finished or bulk product. Under this requirement,
the tobacco product manufacturer would be required to include any
process controls, production process specifications with relevant
acceptance criteria, and monitoring and acceptance activities
(inspections, testing, evaluation, and other verification activities).
For example, a smokeless tobacco product manufacturer may control its
fermentation process by using a specific amount of a biological agent,
controlling temperature and humidity, and setting turn cycle
specifications. Under the proposed requirements, the manufacturer must
include these production process specifications and activities in the
MMR for the finished or bulk tobacco product. The manufacturer would
also be required to include any established acceptance criteria
associated with these activities and process specifications, for
example, acceptable temperature and humidity ranges for the
fermentation process.
    The manufacturing methods and production process procedures in the
MMR would also be required to include any monitoring and acceptance

activities. These are the activities the manufacturer performs to
ensure that the production process meets the established process
specifications. Acceptance and monitoring activities may include
inspections, tests, evaluation, and other verification activities.
Under proposed Sec.  1120.44(a)(2), the manufacturer would be required
to document all these activities in the MMR.
    Specific aspects of the requirement in proposed Sec.  1120.44(a)(2)
and related requirements are further discussed in the proposed sections
that follow, including proposed Sec. Sec.  1120.64 (Acceptance
activities), 1120.66 (Production processes and controls), and 1120.68
(Laboratory controls).
    Proposed Sec.  1120.44(a)(3) would require the MMR to include all
packaging, labeling, and labels approved by the manufacturer for use
with the finished or bulk tobacco product. To satisfy this requirement,
a tobacco product manufacturer could maintain actual copies of the
packaging, labeling, and labels approved for use with the finished and
bulk tobacco products. Alternatively, a manufacturer could maintain
artwork files that describe the design, layout, and content of the
packaging, labeling, and labels approved for use with the products. For
example, a finished tobacco product manufacturer may have packaging and
labeling materials with different warning statements or different
product package inserts or onserts. Under the proposed requirement, the
MMR for the finished tobacco product would have to include or reference
the location of these materials so that they can be readily accessible
to FDA during inspections.
    The MMR could 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.
For example, if a specific manufacturing procedure is relevant to
multiple tobacco products, the manufacturer would not need to reproduce
that procedure in the MMR file for each product; instead the MMR file
for each product could simply list and cross-reference the procedure
(e.g., identify it by a name and/or number) and indicate where the
procedure can be found. Similarly, MMR files for multiple products
could be included in one single document, as long as it is clear from
the document what information pertains to each specific finished or
bulk tobacco product.
    Proposed Sec.  1120.44(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
review and approval of the MMR, including any changes made to the MMR
after initial approval. Under these procedures, a designated, qualified
individual would be required to review and approve all MMR information
before it is implemented in the manufacture of finished or bulk tobacco
products for distribution. The designated, qualified individual's
approval of the MMR would be required to be documented by date of
approval and name and signature of the individual(s) approving the
document.
    When reviewing and approving the MMR for a tobacco product, the
designated, qualified individual would be required to confirm that any
design activities conducted to support the tobacco product
specifications have been completed in accordance with the product
design and development procedures established by the manufacturer under
Sec.  1120.42 and that the resulting production specifications are
correctly transferred into the established MMR. These proposed
requirements are intended to ensure that the tobacco product
manufacturer has adequate control over the MMR, including changes to
the MMR, and therefore over the product, prior to its release for
distribution.
    Proposed Sec.  1120.44(c) would require that the MMR describe which
methods and procedures established under Sec.  1120.44(a)(2) and
related sections, including Sec. Sec.  1120.62 (Purchasing controls),
1120.64 (Acceptance activities), 1120.66 (Production processes and
controls), and 1120.68 (Laboratory controls), are used to ensure that
the tobacco product is manufactured in conformance with each tobacco
product specification established under Sec.  1120.44(a)(1). Thus,
under proposed Sec.  1120.44(a)(1), the MMR would include all
established product specifications; under proposed Sec.  1120.44(a)(2),
the MMR would include all relevant manufacturing methods and production
process procedures; and under proposed Sec.  1120.44(c), the MMR would
link the methods and procedures with the specifications by indicating
which method or procedure would be used to ensure that each particular
specification is met.
    For example, under proposed Sec.  1120.44(a)(1) a finished
cigarette manufacturer may establish specifications for the porosity,
ink type and color, and burn properties of a cigarette paper. If the
manufacturer receives the paper from a qualified cigarette paper
supplier (consistent with the purchasing controls in proposed Sec.
1120.62) and ensures that the paper meets its specifications by relying
on a Certificate of Analysis (CoA) from the supplier that addresses
these specifications, under proposed Sec.  1120.44(c), the manufacturer
would be required to indicate in the MMR that a supplier's CoA is used
to ensure that the cigarette paper meets specifications for porosity,
ink type and color, and burn properties. Similarly, a smokeless tobacco
product manufacturer may use a laboratory test as its acceptance
activity (consistent with the acceptance activity requirements in
proposed Sec.  1120.64) to ensure that a smokeless product meets its pH
specification, or a cigarette manufacturer may use a validated cutting
process (consistent with the production processes and controls in
proposed Sec.  1120.66 and laboratory controls in proposed Sec.
1120.68) to demonstrate that the tobacco cut filler meets its cut size
specification. Under proposed Sec.  1120.44(c), the manufacturers would
be required to indicate the link between these activities and controls
and the tobacco product specifications in the MMR.
    The Agency believes that the proposed requirements would help
assure that the public health is protected and that tobacco products
are in compliance with the requirements of chapter IX of the FD&C Act.
The proposed requirements would accomplish this by requiring
manufacturers to establish specifications for each finished or bulk
tobacco product and follow manufacturing methods and procedures that
ensure that those specifications are met and, therefore, that products
are manufactured in a controlled and consistent manner. The proposed
MMR requirements provide a foundation for several of the requirements
in part 1120. Building on the specifications established in the MMR,
the purchasing controls, acceptance activities, process controls, and
production record requirements would help ensure that each batch of
tobacco product is manufactured in conformance with its established
specifications. A manufacturer that fails to maintain control over its
production process could manufacture and distribute nonconforming
tobacco products, which could adversely affect public health. Because
the MMR forms the foundation for the process controls that ensure that
the production process operates as intended, the proposed MMR
requirements would help ensure that nonconforming tobacco products are
not manufactured and released for distribution.
    Under the proposed MMR requirements, manufacturers would be
required to establish specifications

related to the content and design of their finished and bulk tobacco
products. Content and design are two critical parameters of finished
and bulk tobacco products that can have a direct effect on public
health. The physical design specifications of a tobacco product
interact with its chemical composition to influence its function and
effect on consumers. Thus, the content and design of finished and bulk
tobacco products can impact the health consequences and addictiveness
of the product. For example, the design of a cigarette filter's
ventilation impacts the level of tar, nicotine, and carbon monoxide
produced in the cigarette's smoke (Ref. 96). If a cigarette deviates
from this ventilation design, the amount of tar, nicotine, and carbon
monoxide delivered to the user may vary, affecting the tobacco
product's toxicity and addictiveness. Because the content and design of
a tobacco product can directly (e.g., by increasing harmful emissions)
or indirectly (e.g., by increasing the addictiveness and the amount of
use) contribute to the harm of a product, tobacco products that are
manufactured inconsistently with established specifications may cause
increased harm to the public health beyond what is normally associated
with the product (Ref. 6). Requiring manufacturers to establish product
specifications and manufacture products that meet those specifications
helps minimize harm to public health associated with nonconforming
products.
    In addition, the Agency believes that the proposed MMR requirements
would help assure that tobacco products are in compliance with the
requirements of chapter IX of the FD&C Act. For example, the proposed
requirements would enable the Agency to monitor and confirm that
tobacco products are not manufactured in a manner that causes them to
become adulterated or misbranded in violation of section 902(1) through
(3) or 903 of the FD&C Act.
    By requiring manufacturers to establish product specifications and
manufacturing methods and procedures, the proposed requirements would
reduce the chances of adulteration during the production process. For
example, maintaining a state of control would help decrease the
likelihood that products contain filthy, putrid, or decomposed
substances, or are otherwise contaminated by added poisonous or
deleterious substances that may render the product injurious to health.
A controlled production process would also help ensure that products
are not prepared, packed, or held under insanitary conditions.
    The proposed MMR requirements, in particular proposed Sec.
1120.44(a)(3), would also help ensure that the packaging, labeling, or
labels of finished tobacco products comply with applicable statutory
and regulatory requirements. For example, the packaging and labeling
information maintained in the MMR would help FDA ascertain whether
manufacturers are adulterating or misbranding products by approving and
using packaging or labeling that is false or misleading, lacks required
health warnings, or contains unauthorized modified risk claims.
    The proposed MMR requirements, together with the proposed process
controls, also would enable tobacco product manufacturers to ensure,
and FDA to verify, that tobacco products are manufactured in compliance
with the applicable premarket requirements under sections 905 and 910
of the FD&C Act. Specifically, the proposed requirements would enable
FDA to verify that the established specifications for new or MRTPs are
consistent with the tobacco product specifications provided by the
manufacturer to FDA in the relevant tobacco product applications (i.e.,
SE Report, request for SE exemption, PMTA, MRTPA) and that the
specifications for pre-existing tobacco products are consistent with
their original characteristics. The proposed MMR requirements would
also help manufacturers to ensure, and FDA to verify, that
manufacturers are not making changes to tobacco products that may
render the products new and adulterated under section 902(6) of the
FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
    The MMR requirements would also help ensure that tobacco products
are manufactured in compliance with any tobacco product standards
established under section 907 of the FD&C Act. Under section 907, the
Agency can adopt a tobacco product standard if it finds that the
standard is appropriate for the protection of the public health.
Proposed Sec.  1120.44(a)(1)(iii) would require the manufacturer to
establish in the MMR any specifications necessary to ensure that the
tobacco product meets any applicable product standard. For example,
under section 907, FDA could require a reduction or elimination of an
additive or constituent. In such an instance, proposed Sec.
1120.44(a)(1)(iii) would require manufacturers to establish
specifications in the MMR to ensure that the additive or constituent is
reduced or eliminated in accordance with the standard.

E. Process Controls

1. Purchasing Controls
    Proposed Sec.  1120.62 would require manufacturers to ensure that
purchased or otherwise received products and services from suppliers
conform to established specifications and that suppliers are qualified.
Specifically, proposed Sec.  1120.62(a) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures to
ensure that each purchased or otherwise received product or service
related to the manufacture of a finished or bulk tobacco product is
from a qualified supplier and conforms to established specifications.
In this context, ``products or services related to the manufacture of a
finished or bulk tobacco product'' means products or services that are
used in the manufacture of the product or that could impact the
performance, composition, constituents or characteristics of the
product.
    A purchased or otherwise received product related to the
manufacture of a finished or bulk tobacco product would include a
component or part, ingredient, additive, or other material purchased or
received for use in the manufacture of a finished or bulk tobacco
product. It also would include manufacturing materials as well as other
materials purchased or received for use in the manufacture, packing,
and storage of tobacco products, on tobacco product contact surfaces,
or for the manufacturing operation, including cleaning and sanitation,
of buildings, facilities, and grounds.
    A supplier of such product may be internal (from an establishment
within the manufacturer's organization; e.g., a sister facility) or
external (from an entity outside of the manufacturer; e.g., an external
third-party entity that supplies tobacco blends or flavorings). For
example, a cigarette manufacturer may establish filter specifications
for circumference, length, and pressure drop in the MMR in accordance
with proposed Sec.  1120.44(a)(1) and purchase filters from an external
supplier. The proposed purchasing controls provision would require that
the cigarette manufacturer establish and maintain procedures to ensure
that the filter supplier is qualified and that the filters purchased
and received from the external filter supplier conform to the
established specifications. Such purchasing control procedures would be
required whether payment for the products or services occurs or not.
Thus, for example, a cigarette manufacturer would be required to comply
with these requirements even when it receives

filters from an internal supplier, such as a ``sister facility'' or
another corporate or financial affiliate.
    A ``purchased or otherwise received service related to the
manufacture of a finished or bulk tobacco product'' would include any
activity associated with a manufacturing method or production process
procedure established in Sec.  1120.44(a)(2) as well as any activity
regulated under proposed part 1120. Such services would include
manufacturing or other activities (e.g., specification development,
laboratory testing, packaging and labeling) that are contracted to
others. For example, a tobacco product manufacturer may contract with a
third-party laboratory to perform laboratory tests, or contract with
others to perform certain activities required under proposed part 1120,
such as complaint handling, facility cleaning, or pest control.
Purchasing controls for such outsourcing services would be an
additional requirement to help ensure that any service purchased or
otherwise received from a supplier complies with the relevant
requirements in proposed part 1120 (e.g., Sec. Sec.  1120.44(a)(2),
1120.68, 1120.14, 1120.34) and meets specified requirements. In such
cases, the finished or bulk tobacco product manufacturer would still be
responsible for complying with all applicable requirements under
proposed part 1120, even though it has chosen to outsource certain
activities.
    Proposed Sec.  1120.62(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
qualifying their suppliers. It is important that suppliers be qualified
to demonstrate their ability to provide products and services to
tobacco product manufacturers that meet established specifications.
Proposed Sec.  1120.62(b)(1) would require the qualification procedures
to include evaluating and selecting potential suppliers based on their
ability to meet requirements set by the manufacturer in writing (on
paper or electronically). Supplier evaluation and selection may be
based, in part, on a supplier's past performance (i.e., a supplier's
historical ability to meet a manufacturer's specifications or
requirements consistently). Qualification could also include onsite
visits, audits of the supplier's practices or records, or periodic
testing or sampling of the supplier's products or services to determine
if they conform to established specifications and if the supplier
complies with applicable requirements under proposed part 1120. It
would be the finished and bulk tobacco product manufacturer's
responsibility to establish the appropriate supplier evaluation and
selection process to ensure that purchased or otherwise received
products and services related to the manufacture of a finished or bulk
tobacco product meet established requirements.
    Proposed Sec.  1120.62(b)(2) would require the qualification
procedures to include provisions that define the type and extent of
control to be exercised over selected suppliers and their product or
service, based on evaluation results. Manufacturers should determine
the degree of control necessary based on the specific product or
service purchased or otherwise received. When determining the type and
extent of control to be exercised over qualified suppliers,
manufacturers should use an appropriate mix of evaluations, which can
include audits and acceptance activities, to ensure that products and
services conform to established specifications. Factors such as the
tobacco product manufacturer's knowledge or control of the supplier's
manufacturing practices, the supplier's history of providing acceptable
products or services, history or trends of delivering products or
services that do not meet specifications, and the impact of the product
or service on the finished or bulk tobacco product meeting its
established specifications, can inform the type and extent of control
needed for a particular supplied product or service. For example, if a
tobacco product manufacturer determines that a component supplier has a
history of providing acceptable product that meets established
specifications, it may determine that a CoA is an adequate control.
However, if the tobacco product manufacturer observes a trend that a
supplier has been providing nonconforming products that have been
rejected and returned, it may determine that increased audits or
incoming product acceptance activities such as testing may be needed to
comply with these proposed requirements. FDA has observed on
inspections that manufacturers may implement more rigorous control over
those suppliers that are determined to have a ``critical'' impact on
product specifications and controls (Ref. 97).
    Proposed Sec.  1120.62(b)(3) would require the qualification
procedures to include developing a list of qualified suppliers and
their product(s) or service(s) and updating this information
periodically. This list of qualified suppliers is intended to help
provide assurance to the manufacturer and FDA that each supplier has
been evaluated and selected based on its ability to meet established
requirements.
    Proposed Sec.  1120.62(b)(4) would require that, as part of the
qualification procedures, finished and bulk tobacco product
manufacturers monitor qualified suppliers to ensure they meet specified
requirements and perform reevaluation as needed. This requirement could
be met by periodic testing or sampling, or through periodic
reevaluation of the types of information considered for initial
evaluation and selection of a supplier (e.g., records of nonconforming
product, onsite audits, independent test results) under proposed Sec.
1120.62(b)(1). Thus, the same kinds of information or records could be
used for both initial qualification and ongoing monitoring of
suppliers. For example, a manufacturer may use records of a supplier's
performance (e.g., records showing that a product meets established
specifications) to initially qualify suppliers as well as to monitor
their continued ability to meet specified requirements and determine
whether any adjustments to the type and extent of control over
qualified suppliers are necessary (see proposed Sec.  1120.62(b)(2)). A
manufacturer may determine that a supplier with a history of deficient
auditing results or that repeatedly fails to meet established
requirements should no longer be a qualified supplier.
    FDA notes that this proposed rule would allow for different
approaches to monitoring suppliers. While some suppliers might warrant
onsite visits depending on the products at issue, some products could
be monitored through acceptance activities. For example, if a supplier
supplies a manufacturer with labels bearing the required warnings for
its finished tobacco product and the historical rejection rate of the
labels at receipt is 1 percent, but that rate has recently risen to 25
percent, the manufacturer may consider that supplier no longer
qualified. Given that manufacturers are required to establish and
maintain records of acceptance activities under proposed Sec.
1120.64(e), reviewing trend lines across these activities would be an
acceptable way to comply with this provision.
    Proposed Sec.  1120.62(c) would require finished and bulk tobacco
product manufacturers to maintain records of all activities conducted
under proposed Sec.  1120.62. Records must include the date and time,
individual performing the activity, type of activity performed, any
information that demonstrates the requirement was met, and any data or
calculations necessary to reconstruct the results.

    The records described in this proposed provision would include all
types of purchasing records. Purchasing records are those records
associated with any supplier contract, the established specifications
for the product or service being provided, and any activities
undertaken to qualify, requalify, and monitor suppliers. Purchasing
records contain information on the specifications or requirements for a
specific product or service. They could include a purchasing contract
between a manufacturer and supplier, documents and records that set
forth the quality requirements (i.e., procedures and controls) that the
supplier must comply with, documents and records that reflect the
activities that the manufacturer uses to control and monitor the
supplier (e.g., audits), and documents and records provided by the
supplier that indicate the established specifications for the product
or service (e.g., certificate of analysis (CoA), drawings,
specifications sheets, catalogue numbers, engineering change order).
Some types of purchasing records also may demonstrate compliance with
other provisions of this proposed rule. For example, a CoA that
documents the specified requirements for filters purchased from a
supplier may constitute a purchasing record for purposes of this
section, but it could also be used as an acceptance activity record to
verify that a received batch of filters meets established
specifications. Similarly, a finished tobacco product manufacturer
using a contract pest control service to comply with the proposed
animal and pest control requirement in Sec.  1120.34(e) would be
required to maintain the invoice documenting purchase of this service
to satisfy the recordkeeping requirements under proposed Sec.
1120.62(c) as well as the recordkeeping requirements under proposed
Sec.  1120.34(f).
    Proposed Sec.  1120.62(c) would also require that records
maintained under this section include a written agreement (e.g.,
purchase order, contractual agreement) that the supplier will notify
the manufacturer of any change in the product or service so that the
manufacturer can determine whether the change may affect the
specifications of the finished or bulk tobacco product established in
accordance with Sec.  1120.44(a)(1). This provision is necessary to
ensure that a supplier does not make any changes to the product or
service without the knowledge of the finished or bulk tobacco product
manufacturer that would result in a change to a finished or bulk
tobacco product's specifications, rendering it a nonconforming product.
    If a tobacco product manufacturer conducts audits to address the
supplier qualification requirements at proposed Sec.  1120.62(b), FDA,
as a matter of policy, generally would not request to review or copy
such audit records during routine inspections. Instead, FDA would
consider a written certification by the manufacturer's management with
executive responsibility stating that the audits have been performed
and documented, the dates on which they were performed, and that any
action taken in response to the audit results has been completed, as
sufficient to meet the recordkeeping requirement under proposed Sec.
1120.62(c). Nevertheless, this provision would not limit the Agency's
ability to request for review or copy any procedures created to meet
the requirement at proposed Sec.  1120.62(b).
    A tobacco product manufacturer could contract out certain
activities required under proposed part 1120. To ensure purchased or
otherwise received products or services conform to specified
requirements, each tobacco product manufacturer would need to establish
and maintain procedures to ensure that purchasing is carried out
subject to adequate controls, including the evaluation and selection of
suppliers, and the clear and unambiguous specification of requirements
for such suppliers. In addition, the manufacturer would be required to
have acceptance activities in accordance with proposed Sec.  1120.64.
These controls would help ensure that only suppliers that meet the
specified requirements are used.
    The finished or bulk tobacco product manufacturer would have the
ultimate responsibility for ensuring that all applicable requirements
under proposed part 1120 are met. For example, if a finished or bulk
tobacco product manufacturer outsources laboratory testing services
performed as part of an acceptance activity to a contractor, the
manufacturer would be required to use purchasing controls to help
ensure that the contract laboratory's procedures, processes, and
records comply with the proposed laboratory controls requirements. The
finished or bulk tobacco product manufacturer would be responsible if
the contract laboratory does not adequately implement laboratory
control processes. Additionally, the finished or bulk tobacco product
manufacturer would be responsible for ensuring it receives all the
documents and records needed to comply with proposed Sec.  1120.122,
including all relevant metadata. A supplier (including a contractor or
consultant) would be directly responsible for complying with part 1120
to the extent that it is a finished or bulk tobacco product
manufacturer under this proposed rule. For example, if a finished
tobacco product manufacturer sends ENDS products to a contract packager
to package and label the products for consumer use, the finished
tobacco product manufacturer would be required to use purchasing
controls to help ensure that the contract packager's packaging and
labeling activities meet specified requirements; additionally, the
contract packager would be covered under the proposed rule as a
finished tobacco product manufacturer and would be directly responsible
for the packaging and labeling requirements under the proposed rule
(see the discussion of proposed subpart F in section IV.F).
    The proposed regulation is intended to allow flexibility in the way
finished and bulk tobacco product manufacturers ensure the
acceptability of products and services. Under the proposed purchasing
control requirements, manufacturers would be required to establish and
maintain procedures that clearly define the type and extent of control
they intend to apply to suppliers and their products and services. A
finished or bulk tobacco product manufacturer may choose to provide
greater in-house controls such as additional acceptance activities (see
discussion of proposed Sec.  1120.64 in section IV.F.2) to ensure that
products and services meet specified requirements, or the manufacturer
may require that the supplier adopt measures necessary to ensure
acceptability, as appropriate, for example, batch testing. FDA believes
that a mix of purchasing controls and in-house manufacturing controls
will generally be necessary to ensure acceptability of received
products and services. A manufacturer could review and approve the
supplier's procedures or perform supplier audits to assess the
supplier's continued capability to provide acceptable product. The
manufacturer could also review historical data, monitor and look for
trends in data such as acceptance and nonconforming product records,
and perform inspection and testing of received products.
    FDA has observed that tobacco product manufacturers use a variety
of different purchasing controls to ensure that received products and
services conform to established specifications. For example, a
manufacturer may use different purchasing controls based on the degree
of impact that the supplied product or service may have on the

finished or bulk tobacco product. A manufacturer may determine that a
supplier of liquid nicotine would need to provide a certificate of
analysis of the nicotine concentration for each batch, undergo a yearly
audit, and send every fifth batch for an independent laboratory
analysis to confirm a nonconformance rate of less than 1 percent. In
contrast, the manufacturer may determine that a supplier of outer
packaging for shipping (that does not come into contact with the
tobacco product) only needs to be initially qualified and to maintain
production records for review by the manufacturer as requested. In
addition, these proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001.
    The proposed purchasing controls requirements would help assure
that the public health is protected by ensuring that suppliers are
capable of providing products and services that conform to established
specifications and other specified requirements set by the
manufacturer. A change in a received product may impact one or more of
the established specifications of the finished or bulk tobacco product,
rendering it nonconforming. For example, a menthol supplier may change
its menthol formulation by using a different chemical compound, such as
L-menthol instead of D-menthol stereoisomer. This change in formulation
may affect the specification for this ingredient and cause the finished
tobacco product not to meet the specifications for menthol established
in the MMR. This change is formulation may also impact public health as
the change from D-menthol to L-menthol may promote smoking initiation
and nicotine addiction (Ref. 98).
    A change in service also may impact an established specification.
For example, if a contract laboratory changes the sampling plan for
product acceptance, the test results may no longer be representative of
the product, which may result in a nonconforming product. Use of
components or parts, ingredients, additives, and materials that do not
meet specifications may result in the manufacture of a nonconforming
tobacco product. In addition, use of an unqualified laboratory to
perform testing and sampling may result in a failure to conduct
adequate product acceptance activities and in the manufacture of a
nonconforming tobacco product.
    The proposed purchasing controls requirements would also help
assure that tobacco products are in compliance with chapter IX of the
FD&C Act. For example, purchasing controls would help ensure that
products meet relevant requirements under sections 905 and 910 of the
FD&C Act and that such products are not adulterated under section
902(6) or misbranded under section 903(a)(6) of the FD&C Act. The
proposed requirements would enable the tobacco product manufacturer to
be aware of any change to supplied products so that it may determine
whether the change may affect the established specifications of the
finished or bulk tobacco product in the MMR. A change in an established
tobacco product specification can result in a modification and the
creation of a new tobacco product under section 910(a)(1)(B) of the
FD&C Act for which premarket review is required. For example, a change
in the denier per filament specification of the acetate tow material of
a cigarette filter would change the filter's pressure drop, rendering
it a new tobacco product (Ref. 99). Therefore, this section would help
manufacturers to ensure, and FDA to verify, that manufacturers are not
making changes to their tobacco products that may render the products
adulterated under section 902(6) or misbranded under section 903(a)(6)
of the FD&C Act. In addition, if a tobacco product standard establishes
requirements respecting a component of a tobacco product, the proposed
purchasing controls requirement would help a finished tobacco product
manufacturer that obtains such component from a supplier to ensure that
the purchased or received component conforms to the standard. Likewise,
if a tobacco product standard establishes requirements for testing of a
tobacco product and the testing is performed by a contract laboratory,
the proposed requirement would help ensure that the purchased or
received service results in a product that conforms to the tobacco
product standard.
    The proposed purchasing controls requirements would also help
ensure that tobacco products are not adulterated under section 902 of
the FD&C Act by ensuring that purchased or received products are not
contaminated or held under insanitary conditions. For example, a bulk
manufacturer may require through purchasing controls that leaf
producers follow a Good Agricultural Practice program, including the
use of approved pesticides. This would help ensure that purchased leaf
tobacco is not treated with unapproved pesticides that may contain
``any added poisonous or added deleterious substance that may render
the product injurious to health'' and, therefore, adulterated under
section 902(1) of the FD&C Act.
2. Acceptance Activities
    Proposed Sec.  1120.64(a) would require tobacco product
manufacturers to establish and maintain procedures for acceptance
activities, including acceptance criteria. Acceptance activities can be
used throughout the production process--incoming, during the receipt of
incoming materials; in-process, during the manufacturing process; and
final, prior to the release of the finished or bulk product for
distribution. These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001.
    Acceptance activities could include inspections, tests,
evaluations, and other verification activities. Inspections could
include visual inspection of incoming, finished, or bulk tobacco
products (Refs. 100 and 101). Testing could include laboratory testing,
such as testing the resistance to draw of a cigarette (Ref. 102). Other
verification activities could include, for example, review of a
supplier's CoA to ensure that an ingredient meets its specification for
purity (e.g., Ref. 103), or use of worksheets or programs to determine
that the correct amount or weight of materials, ingredients, and
additives has been used. In addition, tobacco product acceptance
activities could include use of a validated production process with
appropriate continued process verification under proposed Sec.
1120.66(b).
    Although a manufacturer could rely on the review of purchasing
records during incoming acceptance such as a CoA, there may be
circumstances where testing or inspection may be necessary for
accepting incoming product. For example, if a manufacturer determines
that a supplier's product is close to the outer parameters of
acceptability, the manufacturer could establish a testing requirement
to audit the supplier under Sec.  1120.62(b)(2) to confirm the
information that is supplied in the CoA. Manufacturers would have the
flexibility to choose which acceptance activity method(s) is most
suitable to their needs, products, and manufacturing process.
    Proposed Sec.  1120.64(a) also would require that procedures for
all acceptance activities include acceptance criteria. Acceptance
criteria could be expressed as values, ranges, or tolerances or may
include criteria such as appearance, color, or specific gravity (e.g.,
Ref. 104). For example, under these proposed requirements, an e-liquid
manufacturer who uses liquid

nicotine to make e-liquids could perform laboratory testing as an
acceptance activity to verify that a specification for the
concentration of incoming liquid nicotine is met. If the manufacturer's
MMR establishes the specification at 90 percent nicotine and the
specification's acceptance criteria is designated with a tolerance of
0.40 percent, the laboratory testing results would need to
show that the concentration of nicotine is between 89.6 percent and
90.4 percent to meet the established specification. Under the proposed
requirements, if the incoming liquid nicotine has a nicotine
concentration of less than 89.6 percent or greater than 90.4 percent,
the manufacturer would need to treat the incoming liquid nicotine as a
nonconforming product in accordance with proposed Sec.  1120.74.
    In addition, acceptance activities that involve sampling would be
required to use representative sampling under proposed Sec.  1120.72.
Representative samples are frequently used to determine whether a batch
of tobacco product meets specifications. While FDA is aware that some
tobacco product manufacturers use sampling plans for acceptance
activities, the Agency believes that this requirement is needed to
ensure that all manufacturers who perform sampling in their acceptance
activities use representative samples to demonstrate that a batch meets
established specifications. CORESTA has also developed recommended
methods for sampling plans for the preparation of samples of different
types of tobacco products, such as cigarettes, smokeless tobacco, fine-
cut tobacco, and cigars (Refs. 105, 107, 108).
    Proposed Sec.  1120.64(b)(1) would require that the acceptance
activity procedures address acceptance activities for all incoming
products to ensure that any specifications established under Sec.
1120.44 or through purchasing controls under Sec.  1120.62 are met and
that such products are not contaminated or deteriorated. The term
``incoming products'' would include not only incoming tobacco products,
but also any incoming equipment that is used in the manufacturing of
tobacco products, such as cigarette makers, as well as any other
materials that may be used, such as cleaning agents that may be used to
clean the tobacco contacting equipment and may leave residues that
might contaminate the tobacco. Some tobacco product manufacturers
already use acceptance activities to verify that incoming products meet
established specifications. For example, organic solvents such as
toluene often are used for the printing of cigarette packages. A
tobacco product manufacturer could evaluate a CoA for incoming
cigarette packages that indicates an upper limit for the acceptance
criteria of each organic solvent. The tobacco product manufacturer
could review the analysis results in the CoA showing the actual
measurement of the organic solvent to determine whether these incoming
materials are acceptable for use in manufacturing (e.g., Ref. 109). A
tobacco product manufacturer could also conduct its own laboratory
testing of incoming material to determine that it meets established
specifications (e.g., Ref. 110).
    Proposed Sec.  1120.64(b)(1) also states that each accepted
incoming tobacco product would need to be designated by a unique
identifier, which must be maintained throughout manufacturing and
documented in accordance with Sec.  1120.70(b)(5). Incoming acceptance
would apply to all incoming products, but the unique identifier
requirement would be limited to those products that meet the definition
of a tobacco product. Once the tobacco product manufacturer accepts an
incoming tobacco product for use in the manufacturing process, a unique
identifier would be assigned. A unique identifier is information, such
as a code or number that is maintained for each accepted incoming
tobacco product, that would enable the tobacco product manufacturer and
FDA to identify the supplier and unique shipment (e.g., purchase order)
of the incoming tobacco product. The proposed unique identifier
requirement would establish traceability for all components or parts,
ingredients, additives, and materials in a finished or bulk tobacco
product and would aid in investigations related to tobacco product
complaints, CAPAs, and nonconforming products. For example, during an
investigation of a nonconforming product, the unique identifiers of all
components or parts, ingredients, additives, and materials in a
finished or bulk tobacco product would enable the manufacturer to
determine the scope and cause of the nonconformance. If a nonconformity
is attributed to a nonconforming component or part, ingredient,
additive, or material, the manufacturer could take appropriate
corrective action with respect to any other affected finished or bulk
tobacco product that uses the affected tobacco product. For an incoming
finished or bulk tobacco product, the unique identifier would be
required to include, or be traceable to, the manufacturing code on the
packaging or label of the incoming finished or bulk tobacco product.
This could be a separate unique identifier or it could incorporate the
manufacturing code of the incoming finished or bulk tobacco product.
This requirement would be important for tobacco product manufacturers
who perform only packaging and labeling, including repackaging and
relabeling, as the unique identifier would establish traceability to
the specific batch of the incoming finished or bulk tobacco product.
    FDA is not proposing to prescribe the format or mechanism (e.g.,
affixing a batch or control number to the immediate container or
product label) of the unique identifier requirement. Rather,
manufacturers would have the flexibility to determine the method that
they would use to track and identify the received and accepted incoming
tobacco products that are used in the manufacture of finished and bulk
tobacco products. On inspections, FDA has observed manufacturers using
various means of implementing unique identifiers, including
programmable and scannable bar codes and tags affixed to the immediate
container.
    FDA is proposing that the unique identifier for each accepted
incoming component or part, ingredient, additive, and material used in
the manufacture of finished and bulk tobacco products would need to be
documented in the production record in accordance with proposed Sec.
1120.70(b)(5). Although not required by this proposed rule, as
components and parts undergo further manufacturing and become a new
component or part, ingredient, additive, or material, a manufacturer
may choose to assign a new unique identifier to the combined product,
subassembly, or batch of tobacco product. The new unique identifier
would establish more accurate traceability to account for all
components or parts, ingredients, additives, and materials in a
finished or bulk tobacco product and would aid in investigations
related to tobacco product complaints, CAPAs, and nonconforming
products. However, any original unique identifier would need to be
maintained in the production record, even if a subsequent unique
identifier is assigned to the product after further manufacturing. For
example, if an e-liquid manufacturer assigns a unique identifier for
banana and vanilla flavor ingredients under Sec.  1120.64(b)(1) and
further processes these ingredients to make a batch of banana
cr[egrave]me flavor, it may assign a new identifier for the new flavor.
If this approach is used, traceability to the unique identifiers of the
new, as well as the original, individual components and parts,
ingredients, additives, and materials would need to be maintained in

accordance with proposed Sec.  1120.70(b)(5).
    This provision also would require that the results of incoming
acceptance activities be reviewed and approved to ensure that the
incoming tobacco product specifications established under proposed
Sec.  1120.44 or through purchasing controls under proposed Sec.
1120.62 are met and that the product is not contaminated or
deteriorated. Therefore, prior to using incoming product in the
manufacturing process, a designated qualified individual would be
required to review the results of the incoming tobacco product
acceptance activities, determine that the specifications established in
the MMR and through purchasing controls are met and that the product is
not contaminated or deteriorated, and approve the release of the
product for manufacturing. The acceptance status of the released
tobacco product would be maintained under proposed Sec.  1120.64(d).
FDA has observed on inspections that the number of personnel or the
complexity of the manufacturing process may determine whether the
review and approval of incoming acceptance activities is performed by
the individual who conducted the acceptance activity or a designated
quality assurance employee who reviews and approves acceptance activity
results conducted by others. The proposed rule would afford the
manufacturer flexibility to determine how it would perform this
activity, as long as it occurs prior to the release of incoming product
for manufacturing.
    Proposed Sec.  1120.64(b)(2) would require that acceptance
activities procedures address the testing and acceptance of raw tobacco
to ensure that raw tobacco from suppliers (internal and external to the
organization) complies with established specifications for pesticide
chemical residue(s). The specifications for pesticide chemical
residue(s) would need to be established by the manufacturer and comply
with any applicable tolerance(s) established under Federal law.\5\ FDA
considers raw tobacco to include tobacco leaf and tobacco cut rag that
is received from importers, wholesalers, and distributors.
---------------------------------------------------------------------------

    \5\ Under 907(a)(1)(B) of the FD&C Act, a tobacco product
manufacturer cannot use tobacco, including foreign grown tobacco,
that contains a pesticide chemical residue that is at a level
greater than is specified by any tolerance applicable under Federal
law to domestically grown tobacco. As of publication of this
proposed rule, such a tolerance level has not been established by
Federal statute or regulation.
---------------------------------------------------------------------------

    Manufacturers would be required to comply with this requirement for
all tobacco products containing raw tobacco. A tobacco product
manufacturer could comply with this proposed requirement by performing
its own testing or accepting a CoA from the supplier of the raw tobacco
showing that relevant specifications for pesticide chemical residue(s)
are met (e.g., Refs. 111 and 112). On inspections, FDA has observed
that several tobacco product manufacturers have established
specifications for pesticide chemical residues for raw tobacco, taking
into account recommendations in CORESTA's Guide No. 1--The Concept and
Implementation of CPA (crop protection agent) Guidance Residue Levels
(Ref. 86), and voluntary U.S. Department of Agriculture pesticide
residue standards at 7 CFR 29.427.
    Proposed Sec.  1120.64(b)(3) would require that all incoming
tobacco products, i.e., components or parts, ingredients, additives,
and materials, be evaluated during incoming acceptance activities to
ensure that they are not contaminated or deteriorated. FDA is aware
that tobacco product manufacturers have considered and used different
methods to evaluate products for physical and some biological
contamination including metal detectors, x-rays, and optical sorters
(e.g., Refs. 113 and 114). Tobacco product manufacturers could
establish procedures to visually inspect incoming product for
contamination or sources of potential contamination (e.g., Refs. 115
and 116). Any of these methods could be suitable for compliance with
this proposed section, depending on the product being inspected.
Deterioration of components or parts, ingredients, additives, and
materials could result in nonconforming product or otherwise render the
product adulterated or misbranded. Examples of possible deterioration
include discoloration, spotting, and staining of components (such as
packaging, labels, filters) or flavors or additives that have passed
their expiration date.
    Proposed Sec.  1120.64(c) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for in
process and/or final acceptance activities to ensure that each finished
or bulk tobacco product meets the specifications established under
proposed Sec.  1120.44. Tobacco product manufacturers could comply with
proposed Sec.  1120.64(c) in process or after manufacturing a finished
or bulk tobacco product. A manufacturer could comply with this
provision by performing batch testing on finished or bulk product. Any
acceptance activities that involve sampling would be required to comply
with proposed Sec.  1120.72. On inspections, FDA has observed that
tobacco product manufacturers may perform acceptance activities at
discrete points in the production process or use a stage-gate approach
to accept tobacco product and release it to the next stage of
processing (e.g., Ref. 117). For example, acceptance activities could
be performed on tobacco blends after primary processing, on smokeless
tobacco blends after fermentation, and on cigarettes or smokeless
tobacco product after making. Acceptance activities could also be
performed after the tobacco product is packaged; for example, testing
the finished tobacco product to ensure that it meets established
specifications (e.g., Ref. 118) and inspecting the product packaging to
determine it meets all packaging and labeling requirements.
    This provision also would require that the results of in-process
and final acceptance activities be reviewed and approved to ensure that
the finished and bulk tobacco product specifications established under
Sec.  1120.44 are met. Therefore, a designated qualified individual
would need to review the results of the tobacco product acceptance
activities to determine that the specifications established in the MMR
are met, and approve the release of the finished or bulk tobacco
product for distribution. As discussed previously regarding proposed
Sec.  1120.64, the proposed rule would afford the manufacturer
flexibility to determine how it would perform this activity, as long as
it occurs prior to distribution.
    Proposed Sec.  1120.64(d) would require tobacco product
manufacturers to identify, by suitable means, the acceptance status of
a tobacco product throughout the different stages of the manufacturing
process, indicating whether the tobacco product is a conforming or
nonconforming tobacco product. The identification of the acceptance
status would need to be maintained from receipt of incoming products
throughout manufacturing and until the finished or bulk tobacco product
passes required acceptance activities and is released for distribution.
FDA considers ``suitable means'' to mean that the acceptance status of
a tobacco product can be readily determined. For example, tobacco
product manufacturers could use various methods to identify the
acceptance status of tobacco products, including scannable barcodes,
labels, markings and other methods (e.g., Refs. 119 and 120). This
requirement is intended to ensure that manufacturers can effectively
identify the acceptance status of tobacco products and prevent mixups.

    This provision seeks to ensure that the acceptance status of all
tobacco products, including incoming tobacco products, in-process
tobacco products, and finished and bulk tobacco products is properly
identified throughout manufacturing to ensure that only tobacco
products that pass required acceptance activities are incorporated into
the finished or bulk tobacco product and ultimately released for
distribution. This requirement is intended to prevent nonconforming
tobacco product from being used in the manufacture of a finished or
bulk tobacco product. For example, if a smokeless tobacco blend does
not conform to a fermentation specification during a tobacco product
acceptance activity, its nonconforming acceptance status would need to
be identified so that it would not be used in the manufacture of a
finished smokeless tobacco product.
    Proposed Sec.  1120.64(e) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. This provision would require records to include the
date and time, individual performing the activity, type of activity
performed, acceptance criteria, any information that demonstrates the
requirement was met, equipment used if applicable, and any data or
calculations necessary to reconstruct the results. This provision is
necessary to help ensure that acceptance activities are performed
according to established procedures and that the tobacco product meets
the specifications established in proposed Sec.  1120.44. The date and
time when the acceptance activities were conducted and the name of the
individual who performed the activities could help manufacturers and
FDA identify the scope of any nonconformity.
    The proposed acceptance activities requirements would help assure
that the public health is protected. Tobacco product specifications
could impact the toxicity and addictiveness of the product, and
acceptance activities would help ensure that tobacco products do not
exceed established specifications that affect these parameters. For
example, if a tobacco product manufacturer establishes a nicotine
concentration level for an ENDS product, acceptance activities would
help ensure that the tobacco product meets that specification. This
would be important because a finished ENDS that contains a nicotine
concentration higher than the established specification could be more
addictive (Refs. 4 and 5).
    In addition, the physical design specifications of a tobacco
product interact with its chemical composition to influence its
function and effect on consumers, which can impact the toxicity and
addictiveness of the product (Ref. 6). For example, the design of a
cigarette filter's ventilation impacts the level of nicotine in the
cigarette's smoke (Ref. 96). If a cigarette's filter deviates from its
established ventilation design specification, the amount of nicotine
delivered to the user may be affected, which can increase
addictiveness. A tobacco product's operating and design specifications
and features can affect the toxicity and addictiveness of the product.
For example, a variable voltage ENDS product can enable a user to
control the power input. The electrical power input--which is
proportional to the square of the voltage and inversely proportional to
the heater resistance--influences the temperature at which the aerosol
is produced, which may influence nicotine and other toxicant emissions
(Ref. 121). Acceptance activities would verify that the tobacco product
conforms to its established design specification and, therefore, help
to minimize additional harm associated with nonconforming products.
    The proposed acceptance activities requirements also would help
assure that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. Acceptance activities would help tobacco
product manufacturers to verify, and enable FDA to confirm, that
finished and bulk tobacco products conform to established
specifications. These provisions would help ensure that new tobacco
products and MRTPs are manufactured consistent with the specifications
provided in their applications (i.e., SE Report, request for SE
exemption, PMTA, MRTPA) and that pre-existing products are manufactured
consistent with their original characteristics. The acceptance
activities requirements also would help ensure that the packaging,
labeling, and labels of finished tobacco products comply with
applicable statutory and regulatory requirements. For example, by
ensuring that correct packaging, labeling, and labels are used with
each product, the acceptance activities and associated records would
help ensure that labeling does not contain false or misleading
statements, that packages and labels bear required health warnings or
statements, and that the labeling or labels do not contain unauthorized
modified risk claims. Additionally, the acceptance activities
requirements and associated records would help ensure that a product is
compliant with any product standards established by FDA under section
907 of the FD&C Act. For example, under section 907, FDA could require
a reduction or elimination of an additive or constituent. The
acceptance activity records would help enable FDA to verify that the
amount of the additive or constituent in the manufacturers' products
meets the product standard.
    The proposed requirements also would help ensure that tobacco
products do not contain a contaminant or hazard that may cause the
product to be adulterated under section 902(1)-(3) of the FD&C Act. For
example, visual inspection of incoming tobacco leaf for mold or NTRM
(including glass or metal fragments) or use of metal detectors, x-rays,
optical sorters, and other methods would help minimize the likelihood
that tobacco products contain such substances.
3. Production Processes and Controls
    Proposed Sec.  1120.66(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for their
production processes, including process controls, to ensure that
tobacco products conform to requirements established in the MMR in
accordance with proposed Sec.  1120.44. Production processes include
the methods, activities, or steps that a tobacco product manufacturer
uses to manufacture a tobacco product. Production processes may include
primary processing such as blending, casing, and cutting tobacco;
fermenting tobacco; mixing flavors and liquid nicotine; and assembling
components or parts.
    Under proposed Sec.  1120.66(a)(1), production process procedures
would be required to address production process specifications with
relevant acceptance criteria. For example, a manufacturer could
establish production specifications for moisture with relevant
acceptance criteria at different points in the production process to
ensure that the tobacco product moisture specification is met at the
point of each acceptance activity. Similarly, a manufacturer could
establish time, temperature, and humidity production process
specifications with relevant acceptance criteria to ensure that the
tobacco product pH specification is met.
    Proposed Sec.  1120.66(a)(2) would also require that the production
process procedures include relevant process controls such as monitoring
and acceptance activities (inspection, testing, evaluation, and other
verification activities). For example, if a

manufacturer established production process specifications with
acceptance criteria, such as time, temperature, and humidity, the
manufacturer would be required to implement relevant process controls
such as monitoring or testing tobacco product to verify that such
production process specifications are met. Under proposed Sec.
1120.66(a)(2), such process controls would be included in the
production process procedures. The proposed requirements are intended
to provide tobacco product manufacturers with the flexibility to
establish the production process procedures that are appropriate for
their particular manufacturing operations and type of tobacco products
to ensure that manufactured tobacco products conform to the
requirements established in the MMR in accordance with proposed Sec.
1120.44.
    Proposed Sec.  1120.66(a)(1) and (2) are intended to help ensure
that the production process is controlled so that tobacco products meet
their product specifications at the appropriate acceptance activity
stage. For example, the fermentation of smokeless tobacco must occur
under specific environmental conditions to assure that at the end of
fermentation desired specifications, such as pH and oven volatiles are
met. The production process procedures required by this proposed
provision would, therefore, specify that fermentation occur in an
environmentally-controlled room. The manufacturer would need to
establish time, temperature, and humidity ranges for the room to ensure
that the room is maintained within the environmental ranges required to
meet product specifications. In this example, the production process
specifications would be the upper and lower temperature and humidity
limits for specified durations. The manufacturer would also use
relevant process controls such as monitoring activities to confirm that
the process occurred within the required time, temperature, and
humidity ranges and to alert staff if these conditions are not met, for
example, if the room temperature is drifting towards a temperature that
does not meet the established production process specification.
    Proposed Sec.  1120.66(a)(3) would require that the production
process procedures include a requirement for investigating any
deviations from the production process specifications and established
acceptance criteria, or from relevant process controls, to determine if
the deviation results in a nonconforming product. Process deviations
can be identified from process and product sources, such as process
monitoring, acceptance activities, production records, and records of
nonconforming products. For example, if the fermentation of a tobacco
blend deviates from established production processes and controls for
fermentation, such as maintaining temperature and humidity through
specified turn cycles necessary to meet a pH specification, the tobacco
product manufacturer would be required to perform an investigation to
determine if the deviation results in a nonconforming product. Proposed
Sec.  1120.66(a)(3) would also require that the manufacturer document
the disposition of any product affected by the deviation. A product
manufactured under conditions that deviate from the process
specifications could be released for further processing or distribution
if the investigation determines that the product conforms to product
specifications, for example, if data from process validation activities
demonstrates that product produced within those process specifications
still conforms to product specifications. Product found to be
nonconforming would need to be handled in accordance with proposed
Sec.  1120.74.
    If a manufacturer finds that its originally established process
specifications are difficult to maintain (i.e., result in many process
deviations), the manufacturer may decide to use a wider range of
process specifications for future production where it is supported by
the original process validation activities, rather than investigating
each time a product is produced outside the narrower range. In such a
case, the proposed rule would require that the updated process
specifications be documented in the MMR in accordance with the
procedures established under Sec.  1120.44. If the manufacturer decides
to adopt new ranges beyond the originally validated process
specifications, the manufacturer would need to evaluate the change
under proposed Sec.  1120.66(a)(4) and revalidate the process, where
appropriate.
    Proposed Sec.  1120.66(a)(4) would require that the production
process procedures include a requirement for evaluating all changes to
production processes, including process controls, to determine their
impact on the tobacco product specifications in the MMR. If any
production process changes result in a change to the tobacco product
specifications, the proposed rule would require that the manufacturer
ensure that procedures applicable to the changes in tobacco product
specifications are followed in accordance with Sec. Sec.  1120.42 and
1120.44 and update the tobacco product specifications in the MMR as
needed. This requirement is intended to ensure that the manufacturer
identifies changes to a production process that may affect a tobacco
product specification and, therefore, lead to a nonconforming product.
For example, if a manufacturer uses a 3-turn fermentation process to
manufacture a smokeless tobacco product with an established pH
specification, and the tobacco product manufacturer changes the
fermentation process to a 2-turn process, under this proposed
provision, the manufacturer would need to evaluate the production
process change to determine if it results in a change to the pH (or any
other specifications) of the smokeless tobacco product. If it does,
then the manufacturer could decide against making the process change or
could change the tobacco product specifications in accordance with
proposed Sec. Sec.  1120.42 and 1120.44.
    Proposed Sec.  1120.66(a)(4) would also require that any changes to
validated processes be revalidated before implementation, where
appropriate. For example, if a tobacco product manufacturer makes a
change to the validated forming and drying process for reconstituted
leaf tobacco by adjusting the thickness and pressure of the size press,
these changes would need to be evaluated and revalidated, where
appropriate, before being implemented.
    In addition to the requirements in proposed Sec.  1120.66(a),
proposed Sec.  1120.66(b) would require that the production process
procedures include requirements for process validation, if applicable.
Specifically, if the results of a process cannot be fully verified
(including any automated processes), this provision would require
finished and bulk tobacco product manufacturers to validate the process
to demonstrate that the process will produce a tobacco product that
conforms to the tobacco product specifications established under Sec.
1120.44(a)(1). The results of a process cannot be fully verified, for
example, where the manufacturer cannot demonstrate that the tobacco
product meets established specifications through acceptance activities
using representative samples (e.g., automated cigarettes manufactured
with millions or tens of millions of cigarettes in a batch, because the
size of the batch is too large) or where acceptance activities cannot
fully determine whether the product meets established specifications
(e.g., laser welding of an ENDS atomizer to a tolerance of 0.0002 inches)). Although this provision would not require
processes to be validated where the results can be fully verified, the

Agency encourages manufacturers to validate all processes.
    Process validation includes activities to establish scientific
evidence that a process is capable of consistently producing product
that conforms to established specifications. FDA is aware that some
tobacco product manufacturers use validation master plans to validate
the processes and equipment for the manufacturing and packaging of
tobacco products; these plans cover the criteria for review and
approval of the processes, specific methods and procedures to qualify
the process, methods for continued process verification through
monitoring and measurement of the processes, and revalidation.
    This proposal would require process validation to use appropriate
objective measures and valid scientific tools and analyses to maintain
the process in a state of control. Examples of valid scientific tools
and analyses used in process validation would include a capability
study to measure the ability of the process to consistently meet
specifications, challenge tests to demonstrate where nonconformities
are due to variation and off-target processes under worst-case
conditions, and acceptance sampling plans to determine the number of
samples to be tested to provide a gross check for defect rate increase
with respect to a predetermined acceptable quality level (e.g., Ref.
122). Acceptance sampling can be based on standards (e.g., ISO
28590:2017, ISO 3951:2013, ANSI Z1.4, ANSI Z1.9) (Refs. 123-126).
    Proposed Sec.  1120.66(b)(1) would require finished and bulk
tobacco product manufacturers, as part of process validation, to design
a production process for manufacturing a tobacco product. The process
design would need to address the capability and functionality of the
production process. The process design also would establish a strategy
for process control to develop operational limits and monitoring of the
production process that should take into account the building,
facility, and equipment and possible sources of variability posed by
personnel and environmental conditions. This provision is intended to
help ensure that products conform to established specifications.
    For example, a cigarette maker can operate at speeds up to 20,000
cigarettes per minute and manufacture cigarettes to specifications of
weight, length, and diameter. In this case, proposed Sec.
1120.66(b)(1) would require a manufacturer to address the capability
and functionality of its production process at various operational
speeds and establish a strategy for process control. The tobacco
product manufacturer may determine that the cigarette maker operates at
an optimal speed of 16,000 cigarettes per minute and the process
control could consist of samples being taken every 30 minutes to
monitor the production process. However, if the maker operates at its
maximum 20,000 cigarettes per minute speed, a process control could
consist of samples being taken more frequently (e.g., every 15 minutes)
to assure that the tobacco product remains conforming at the increased
production speed.
    Alternatively, in a case where the product attribute is not readily
measurable due to limitations of sampling or detectability, operational
limits and in-process monitoring parameters could be established for
process control. For example, a manufacturer may establish process
specifications for manufacturing cigarette filter rods. The
manufacturer would have to validate the process used by the automated
filter rod maker to ensure that filters meet product specifications.
For this process, the manufacturer could establish a target
specification for parameters such as the pressure drop. The lower
specification and upper specification limits or tolerances would also
need to be developed around the target specification. The manufacturer
would then be required to determine lower and upper process control
limits for parameters such as the speed of cellulose acetate fiber that
is fed into the rod maker. These process control limits would be at
values between the target and lower and upper specification limits.
Based on the results obtained by a predetermined sampling plan, the
values would be used to adjust the machine to ensure that filters are
manufactured in accordance with the product specifications.
    For any required process validation activities, proposed Sec.
1120.66(b)(2)(i) would require finished and bulk tobacco product
manufacturers to perform process qualification to determine if the
process is capable of reproducible manufacturing. Manufacturers would
need to demonstrate that the design of the facility is appropriate and
qualify the equipment to confirm that it is suitable for its intended
purposes and will perform properly. This could involve qualifying that
the equipment is appropriate for its specific use, verifying that
equipment is built and installed in conformance with its design
specifications, and verifying that equipment operates properly in all
anticipated operating ranges. Proposed Sec.  1120.66(b)(2)(ii) would
require manufacturers to perform process performance qualification to
confirm the process design and to demonstrate that the manufacturing
process performs as expected in accordance with established criteria,
which would need to be documented in a written protocol. This could
involve utilizing the qualified equipment with trained personnel and
production process procedures, including process controls, to confirm
the process design and demonstrate that the commercial manufacturing
process performs as expected.
    Proposed Sec.  1120.66(b)(3) would require finished and bulk
tobacco product manufacturers to monitor the production process using
data collected from records required under proposed part 1120 and valid
scientific tools to detect variability and ensure that the process
remains in a state of control. This proposed requirement is intended to
help prevent process deviations. A manufacturer could accomplish this
by monitoring for undesired process variability and determining the
appropriate actions to correct, anticipate, and prevent problems.
Relevant process and product data must be collected from records
covered under proposed part 1120, and would include data regarding
acceptance activities (proposed Sec.  1120.64) and reviews of
nonconforming product (proposed Sec.  1120.74).
    Valid scientific tools can include statistical process control
techniques, control charts, recognized standards such as American
Society for Testing and Materials (ASTM) E2281-03 ``Standard Practice
for Process and Measurement Capability Indices'' and ASTM E2709-09
``Standard Practice for Demonstrating Capability to Comply with a Lot
Acceptance Procedure'' (e.g., Refs. 127-130). The collection and
analysis of data and use of valid scientific tools can detect trends
caused by process deviations.
    If continued process verification under proposed Sec.
1120.66(b)(3) reveals that the process is no longer operating in a
state of control and requires a change to the existing validated
production process, such as to its method, procedure, or process
control, revalidation under proposed Sec.  1120.66(a)(4) would be
required.
    Proposed Sec.  1120.66(c) would require that the production process
procedures include certain additional requirements, if applicable.
Under proposed Sec.  1120.66(c)(1), if a production process includes a
manual method or process, the production process procedures would be
required to describe the manual method or process in sufficient detail
to ensure that the tobacco product

meets established specifications and include, if applicable, the
criteria for workmanship using a standard or approved model sample. An
actual or diagrammatic representation of a model sample could show the
design and construction of a tobacco product. For example, a hand-
rolled cigar could be represented by a model sample that defines the
type and size of tobacco leaf to be used for the wrapper, the type and
amount of filler tobacco to be used, the brand label to be applied, and
the size/shape/length/diameter of the finished, rolled cigar.
Similarly, a documented standard could establish specific length, gauge
width, and shapes of certain types of standardized cigars (e.g.,
Corona, Churchill, and Panetela) (Ref. 131).
    Proposed Sec.  1120.66(c)(2) would require that the production
process procedures address the use and removal of manufacturing
material if such material could reasonably be expected to contaminate a
tobacco product or otherwise result in a nonconforming tobacco product.
For example, if a tobacco product manufacturer uses a mold release
agent for an injection molding process for smokeless tobacco
containers, and that agent contains volatile solvents that can
contaminate the tobacco product and be toxic to users, the production
process procedures would need to address how to clean and remove the
manufacturing material (e.g., Refs. 132-134).
    Proposed Sec.  1120.66(d) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. Under this proposed provision, records must include
the date and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
These records could include drawings of the process validation process,
a general outline of steps for process validation, or meeting agendas
and notes regarding the validation process (e.g., Refs. 135-137).
    The proposed production processes and controls requirements would
help assure that the public health is protected because they can
prevent, monitor, and detect variability in the manufacturing process.
Variability in the manufacturing process may result in the manufacture
of tobacco product that does not conform to established specifications.
For example, many tobacco product manufacturers establish moisture
specifications for finished and bulk tobacco products. The regulation
of moisture throughout the production process is important because of
the influence of moisture on tobacco and other components and parts,
their processing properties, and on the finished tobacco product itself
(Ref. 138). Moisture also can affect the properties of tobacco and
other components and parts (e.g., paper, filters), such as the level of
micro-organisms and mass, hardness, circumference, pressure drop, and
filter ventilation (id.). In addition, the moisture content of a
finished cigarette is one of the physical variables that can affect the
level of total particulate matter and the chemical composition of
particulate phase smoke, such as during the initial puffs (Ref. 139).
Similarly, many tobacco product manufacturers establish a pH
specification for smokeless tobacco products using production processes
such as curing, fermentation, or pasteurization. An increase in pH can
result in an increase in the speed of nicotine absorption, which is
associated with the development of tolerance and physical dependence to
nicotine (Ref. 19). Inadequate production processes and controls may
also contribute to substantial variability in actual nicotine
concentration as compared to labeled nicotine concentration in e-
liquids intended to be used with ENDS (Ref. 1). This variability could
be particularly problematic for users seeking to limit or cease tobacco
product use. Therefore, these proposed provisions are needed to prevent
the manufacture and distribution of nonconforming products that may
have an adverse effect on public health.
    In addition, the proposed requirements for production processes and
controls would help assure that tobacco products are in compliance with
the requirements of chapter IX of the FD&C Act. If tobacco products are
not consistently manufactured to conform to established specifications,
new tobacco products and MRTPs may not conform to the specifications
that are described in their applications (i.e., SE Report, request for
SE exemption, PMTA, MRTPA) and pre-existing tobacco products may not be
manufactured consistent with their original characteristics. Relatedly,
the proposed requirements would help manufacturers to ensure, and FDA
to verify, that manufacturers are not making changes to tobacco
products that may render them new and adulterated under section 902(6)
of the FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
Further, a finished or bulk tobacco product whose contents, such as
nicotine concentration, are not consistent with its labels or labeling
also may be deemed misbranded and subject to regulatory action.
4. Laboratory Controls
    Proposed Sec.  1120.68 establishes requirements for laboratory
controls. Under proposed Sec.  1120.68(a), finished and bulk tobacco
product manufacturers would be required to demonstrate laboratory
competence when using a laboratory (either in-house or contract
laboratory) to conduct activities under proposed part 1120. Under
proposed Sec.  1120.68(b), finished and bulk tobacco product
manufacturers would also be required to establish and maintain
laboratory control procedures for any laboratory activities that are
conducted under proposed part 1120. Laboratory activities conducted
under proposed part 1120 may include, for example, those used for
design and development activities, acceptance activities, and process
controls, and for the calibration of testing, monitoring, and measuring
equipment. The requirements under proposed Sec.  1120.68(a) are
intended to ensure that the facilities and personnel of in-house
laboratories, as well as those of contract laboratories, are competent
to perform the laboratory testing conducted under proposed part 1120.
The requirements under proposed Sec.  1120.68(b) establish the specific
requirements that the laboratory control procedures would be required
to address in order to ensure that the laboratory testing is adequately
performed.
    Proposed Sec.  1120.68(a) would require finished and bulk tobacco
product manufacturers, when using a laboratory (either in-house or
contract) to conduct activities under proposed part 1120, to
demonstrate the laboratory's competence to perform laboratory
activities associated with the manufacture of finished and bulk tobacco
products. This proposed requirement is intended to ensure that tobacco
product manufacturers confirm that laboratories are technically
competent and able to produce precise and accurate data to comply with
proposed part 1120. While manufacturers would have the flexibility to
determine how they would demonstrate a laboratory's competency, they
would be required to have appropriate documentation. Tobacco product
manufacturers could utilize various means to show their laboratory's
competency to carry out its activities such as a standard
accreditation, such as ISO 17025:2005 (Ref. 140), or otherwise
documenting a laboratory QMS (i.e., standard operating procedures for
test methods, equipment maintenance and calibration logs, quality
control

sampling protocols, and personnel training).
    Proposed Sec.  1120.68(b) would require finished and bulk tobacco
product manufacturers to establish and maintain laboratory control
procedures for any laboratory activities that are conducted under
proposed part 1120. The laboratory control procedure requirements in
proposed Sec.  1120.68(b)(1) through (3) are inter-related and intended
to ensure that manufacturers utilize appropriate laboratory facilities
and equipment, and that laboratory activities associated with the
manufacture of tobacco products are performed with controls sufficient
to ensure accurate and reliable results. For example, a manufacturer
may use a laboratory to test pH levels of smokeless tobacco products to
ensure that the pH levels meet the product specifications (Ref. 141).
The laboratory control requirements in this section would help ensure
that the data from such laboratory testing are accurate and precise,
for example, by helping ensure that the laboratory uses properly
calibrated pH meters, nonexpired pH check solutions, and a valid test
method (Ref. 141).
    If a tobacco product manufacturer contracts its laboratory
activities to an outside entity, the manufacturer would remain
responsible for complying with the proposed laboratory control
requirements. However, we note that these proposed requirements would
not apply to laboratory activities outside the scope of manufacturing
activities. For example, the proposed requirements would not apply to
testing for harmful and potentially harmful constituents performed
solely to comply with section 904(a)(3) of the FD&C Act.
    Proposed Sec.  1120.68(b) would require the laboratory control
procedures to include several specific laboratory control requirements.
First, proposed Sec.  1120.68(b)(1) would require the laboratory
controls to include the use of scientifically valid laboratory methods
that are accurate, precise, and appropriate for their intended purpose.
A laboratory method can be scientifically valid if it is based on
scientific data or results published in, for example, scientific
journals, references, or text books.
    Second, proposed Sec.  1120.68(b)(2) would require laboratory
controls to include the use of representative samples based on valid
scientific rationale, in accordance with proposed Sec.  1120.72. As
further described in proposed Sec.  1120.72, samples for laboratory
control activities required under Sec.  1120.68(b)(2) would need to
follow an established sampling plan to ensure that samples being tested
or evaluated are representative of the material being sampled (i.e.,
the batch or part of the batch).
    Third, proposed Sec.  1120.68(b)(3) would require laboratory
controls to include demonstration of analytical control, which means a
laboratory must be able to show that its laboratory method and
instrumentation reliably generate accurate and valid results.
Demonstration of analytical control can be shown using a variety of
quality control activities including but not limited to the use of
certified reference materials, positive and negative controls,
replicate testing, and/or internal standards. Quality control
activities should be appropriate for the type and frequency of testing,
suitable to monitor the analytical performance of the method and
instrumentation used by the laboratory, and enable the laboratory to
determine if the test yielded the expected result or response. One way
to demonstrate compliance with this requirement would be to generate
and maintain a quality control chart, which tracks and assesses results
of quality control sample analysis with known amounts, to demonstrate
analytical control of the equipment and test method. Demonstration of
analytical control allows a tobacco product manufacturer to have
confidence in the test sample measurements and investigate any
anomalies early in the production process (e.g., Refs. 142 and 143).
    Under this proposed provision, for example, if a tobacco product
manufacturer uses a laboratory to test or measure the moisture content
of a cigarette as part of its acceptance activities to ensure that the
product meets established specifications, a scientifically valid
laboratory method would have to be used, such as the Weighing-Drying-
Method with Oven and Balance, described in the Tobacco Moisture, Water
and Oven Volatiles CORESTA Technical Report (Ref. 138). In addition, a
sampling plan would have to be used to collect representative samples
based on a valid scientific rationale, such as ISO 8243:2013 (e.g.,
Ref. 144).
    Proposed Sec.  1120.68(c) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under proposed Sec.  1120.68. Under this paragraph, records would be
required to include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculation necessary to
reconstruct the results. As stated elsewhere in this preamble, for
purposes of proposed part 1120, FDA interprets ``reconstruct'' to mean
the ability to re-create the results by analyzing all data, including
source and metadata data, and records, including calculations. Whether
the laboratory control activities are conducted by the tobacco product
manufacturer or contracted out to another facility, the manufacturer
would be responsible for ensuring laboratory records, including
results, are maintained in compliance with proposed Sec. Sec.
1120.68(c) and 1120.122. These records could be included directly in
the relevant production record or cross-referenced in another record
that is readily accessible for inspection.
    This proposed provision would help assure that the public health is
protected. Laboratory controls, such as those used for acceptance
activities, are important analytical tools for evaluating and testing a
tobacco product to determine if it conforms to specifications
established in the MMR, which could help to minimize the harm to public
health associated with nonconforming products. For example, a smokeless
tobacco product that does not conform to established pH specifications
could adversely affect public health because it may have a more rapid
rate of nicotine delivery and absorption, which can lead to increased
dependence (Refs. 6 and 19).
    This proposed provision also would require tobacco product
manufacturers to control the laboratory activities that are part of the
production process, which would further help to protect against the
manufacture of a nonconforming product. For example, a tobacco product
manufacturer may determine that monitoring the water content by
measuring oven volatiles in the production process is necessary to
control the level of microorganisms. Laboratory controls would ensure
that the laboratory method used to monitor and control the moisture
content in the production process is maintained within production
process specifications, minimizing the chance for development of
potentially harmful microorganisms.
    In addition, the Agency believes that the proposed laboratory
controls requirements would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act. These
proposed requirements would enable the Agency to monitor and confirm
that tobacco products are not manufactured in a manner that causes them
to become adulterated under section 902(1) through (3) of the FD&C Act,
that

tobacco products conform to specifications established in their MMRs,
that new tobacco products and MRTPs are manufactured consistent with
the specifications provided in their applications (i.e., SE Report,
request for exemption from SE, PMTA, MRTPA), and that pre-existing
products are manufactured consistent with their original
characteristics.
5. Production Record
    Proposed Sec.  1120.70(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to ensure
that a production record is prepared for each batch of finished or bulk
tobacco products to demonstrate conformity with the requirements
established in the MMR in accordance with Sec.  1120.44. These proposed
requirements are generally consistent with the practices of
manufacturing establishments that follow ISO 9001. The production
record could consist of a single record or compilation of records that
represent the complete production history of the finished or bulk
tobacco product by batch, including identification of all of its
components or parts, ingredients, additives, and materials (e.g., Ref.
145).
    Proposed Sec.  1120.70(a) also would require that designated
personnel review and approve the production record for release of each
batch of finished and bulk tobacco products into distribution. This
requirement is intended to ensure that each batch is acceptable for
release into distribution (e.g., that the products conform to MMR
specifications; there were no unaddressed nonconformities as a result
of deviations from process specifications or process controls; and the
manufacturer has completed all acceptance activities and the results
demonstrate that the acceptance criteria were met). The review and
approval could take place at the end of manufacturing or at the end of
stages of the production process such as, for example, primary, making,
and packing stages in cigarette production.
    Proposed Sec.  1120.70(b)(1) through (7) would require that the
production record include, or refer to the location of, certain
information. Proposed Sec.  1120.70(b)(1) would require the production
record to include the manufacturing code of the finished or bulk
tobacco product, which is defined in proposed Sec.  1120.3 to include
the manufacture date and batch number (see also proposed Sec.
1120.96). This information is needed to identify affected tobacco
product, for example, during a tobacco product complaint and/or
nonconforming product investigation. A tobacco product manufacturer
could also choose to include manufacturing time in the production
record to further narrow the scope of any nonconforming product
investigation. In this context, ``manufacturing time'' generally refers
to the time that the finished or bulk tobacco product was packaged
(e.g., designated by year/month/date/hour/minute).
    Proposed Sec.  1120.70(b)(2) would require the production record to
include the quantity of finished or bulk tobacco product manufactured
in the batch. This information would be helpful for conducting tobacco
product complaint and nonconforming product investigations because it
would help determine how many tobacco products may be affected and,
therefore, the scope of the investigation.
    Proposed Sec.  1120.70(b)(3) would require the production record to
identify the major equipment and processing lines used in manufacturing
the batch of finished or bulk tobacco product. If a tobacco product
manufacturer has more than one piece of major equipment and/or
processing line, this provision would require the manufacturer to
document the specific major equipment and/or processing line that was
used in the manufacture of the batch. This information would help to
determine whether a nonconforming product is attributable to an issue
with a particular piece of equipment or processing line and help
determine the scope of product that might be affected.
    Proposed Sec.  1120.70(b)(4) would require that the production
record also include records of any activities performed under proposed
part 1120 necessary to demonstrate that the batch of finished or bulk
tobacco product was manufactured to conform with the MMR requirements
established under proposed Sec.  1120.44. The records to be maintained
in a production record under paragraph (b)(4) include purchasing
records, acceptance activity records, continued process verification
records, laboratory testing records, reprocessing and rework records,
and packaging and labeling records. To the extent that these records
may overlap with other records required under proposed part 1120, the
manufacturer need not maintain duplicate copies in the production
record but may instead simply cross-reference the location of the
relevant records. We note, relatedly, that the records would not have
to be physically located in the same place but the location of all
relevant records must be included in the production record, and the
records must comply with the requirements in proposed Sec.  1120.122
(e.g., the records must be readily accessible to responsible officials
of the tobacco product manufacturer and to FDA).
    Proposed Sec.  1120.70(b)(5) would require the production record to
include all unique identifiers of all accepted incoming tobacco
products, including components or parts, ingredients, additives, and
materials, used in the manufacture of the batch of finished or bulk
tobacco product. This information could help a tobacco product
manufacturer or FDA to determine if there is a problem with a
particular component or part, ingredient, additive, or material and to
establish traceability to identify other affected tobacco products.
    Proposed Sec.  1120.70(b)(6) would require that, if any finished or
bulk tobacco product was used in the manufacture of the batch, the
manufacturing code for that finished or bulk tobacco product must be
included in the production record. For example, if a finished tobacco
product manufacturer uses bulk tobacco product from a supplier, under
Sec.  1120.70(b)(6), the production record for the batch of finished
tobacco product must include the manufacturing code for the bulk
tobacco product (as received from the supplier and provided on the
label of the bulk product). Similarly, if returned and reworked
finished product is used in the subsequent manufacture of another
finished product, under Sec.  1120.70(b)(6), the production record for
the subsequent finished product must include the manufacturing code of
the incorporated returned and reworked product. We note that the
requirement in proposed Sec.  1120.70(b)(6) is distinct from and in
addition to the requirement in proposed Sec.  1120.70(b)(1) that the
production record for each batch of finished or bulk tobacco product
include the manufacturing code assigned by the manufacturer for that
finished or bulk tobacco product. This information is needed to
establish traceability and help identify affected tobacco products
during a tobacco product complaint and/or nonconforming product
investigation.
    Proposed Sec.  1120.70(b)(7) would require actual or copies of the
packaging, labeling, and labels (as defined in proposed Sec.  1120.3)
used with the finished and bulk tobacco product, including inserts and
onserts that accompany the product.
    Finally, proposed Sec.  1120.70(b)(8) would require the name(s) and
signature(s) of the designated individual(s) reviewing and approving
the production record for release of the batch of finished or bulk
tobacco

product into distribution. The designated individual can perform the
function of a gatekeeper by conducting a final review and approval of
the production record for the batch for release into distribution.
Alternatively, review and approval of the relevant portions of the
production record can be conducted in stages. If review and approval is
performed in stages throughout the production process, the manufacturer
could also perform a final review and approval of the production record
to verify that approvals of all production process stages had been made
and documented.
    The proposed production record requirements would help assure that
the public health is protected. The proposed requirements would ensure
that tobacco product manufacturers review and approve the production
record prior to the release of each batch of finished and bulk tobacco
product. The manufacturer would ensure that all records required to be
included in the production record (e.g., records from acceptance
activities) have been included, or their location referenced, and that
the production record demonstrates that the batch of finished or bulk
tobacco product conforms to the MMR. These requirements would help
prevent the distribution of nonconforming product.
    In addition, the proposed production record contents are essential
to the conduct of adequate tobacco product complaint and nonconforming
product investigations to identify the scope and cause of an issue and
ensure traceability to determine affected tobacco products. For
example, if there are complaints that report a particular problem,
review of the relevant production records (e.g., manufacturing code,
identification of major equipment and processing lines) can help
determine the scope of the problem (e.g., whether it is limited to a
specific piece of equipment or processing line or certain production
batches, or whether it includes all products from the establishment),
the cause, and the quantity of affected tobacco product manufactured.
If a manufacturer has to initiate a corrective action such as a recall,
the manufacturing code included in the production record could also be
used to identify the corresponding distribution records to help
determine where the affected products were distributed.
    The proposed production record requirements would also help assure
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. For example, information regarding the
identity and amount of all components or parts, ingredients, additives,
and materials used in the manufacture of a finished or bulk tobacco
product could be used to confirm ingredient listings submitted to FDA
under section 904(a)(1) of the FD&C Act. Documenting in the production
record the packaging, labeling, and labels used with finished tobacco
products also would help enable FDA to determine if the tobacco
products display required warning statements and are in compliance with
the MRTP provisions in section 911 of the FD&C Act (21 U.S.C. 387k) and
relevant requirements of section 903(a)(2) of the FD&C Act.
6. Sampling
    For any sampling performed under proposed part 1120, proposed Sec.
1120.72 would require finished and bulk tobacco product manufacturers
to establish and maintain an adequate sampling plan using
representative samples. These proposed requirements are similar to
those in other FDA-regulated industry manufacturing regulations. To
comply with this requirement, each manufacturer would be required to
create a written sampling plan using representative samples, implement
and follow the sampling plan, and update the sampling plan as needed.
The proposed sampling requirements in proposed Sec.  1120.72 would
apply to all sampling performed under proposed part 1120, including
sampling used for acceptance activities, process control monitoring,
and continued process verification. Acceptance sampling is performed to
determine the disposition of products tested (e.g., accept, reject)
whereas statistical process control and the sampling associated with
monitoring a process are used to distinguish between variation that is
inherent in the process and variation induced by some external factor
that would result in nonconforming product.
    A sampling plan is a written, detailed document that describes: (1)
the purpose of the sampling, (2) the scientific technique or method
used to establish the number of samples, including an explanation of
how the sample size is representative of the material being sampled,
and (3) the method of sampling. A sampling plan is essential to ensure
that sampling is reliable, consistent, replicable, and suitable for its
intended purpose. Under the proposed rule, manufacturers could tailor
their sampling plans to specific activities and purposes. For example,
a sampling plan for an acceptance activity could be different than one
for monitoring whether a production process remains in a state of
control or for continued process verification to detect sources of
variability.
    The basic principles of an adequate sampling plan include the
following: the samples are representative of the batch or quantity
being sampled, the number of samples is based on a valid scientific
rationale, and the number of samples is sufficient for the intended
purpose. ``Valid scientific rationale'' refers to scientific techniques
or methods used to establish the number of representative samples and
should take into account tolerance for variability, confidence levels,
and the degree of precision required (Refs. 105, 107, 108). FDA
believes that requiring the number of samples to be based on a ``valid
scientific rationale'' would provide manufacturers with the flexibility
to determine the appropriate number of representative samples for any
sampling plan. While FDA is proposing this flexibility, this provision
would require that manufacturers have support for the scientific
technique or methods used to establish the number of representative
samples used and to show that the sampling size is representative of
the material being sampled.
    Proposed Sec.  1120.72(a) through (c) specifies the required
elements of a sampling plan. First, proposed Sec.  1120.72(a) would
require the sampling plan to describe the intended purpose of the
sampling (e.g., product acceptance, monitor a production process, or
detect sources of variability). Second, proposed Sec.  1120.72(b) would
require the plan to describe the scientific technique or method used to
establish the sample size, including an explanation of how the sample
size is representative of the material being sampled. Examples of
scientific techniques or methods for sampling can include the ``ISO
2859 series of standards for sampling procedures for inspection by
attributes,'' as well as ANSI/American Society for Quality (ASQ) Z1.4
(Refs. 146 and 125). Information regarding the scientific techniques
and methods used would be required to include an explanation of the
sample size (i.e., the quantity or amount of product to be sampled) and
how the sample size is representative of the material being sampled.
The sample size would need to be sufficient for the intended purpose of
the sampling plan and analysis to be performed. Third, proposed Sec.
1120.72(c) would require the plan to describe the method of sampling.
This refers to when and how samples are collected. For example, CORESTA
Recommended Method No 24--Cigarettes--Sampling, A.3 states that samples
should be drawn from one or more cartons of cigarettes at random from
each sampling point to form the necessary gross and there should be at

least 10 sampling points distributed between factories where the
cigarettes are made (Ref. 105).
    The proposed representative sample requirements would help assure
that the public health is protected by ensuring that any sampling
performed under proposed part 1120 is scientifically sound and
appropriate for its intended purpose and does not erroneously support
the release of a batch containing tobacco products that do not conform
to established specifications. If a sampling plan is not adequate, the
results of an acceptance activity may not accurately demonstrate
whether the batch meets established specifications, the established
production process may not be properly controlled, and a validated
process may not be adequately monitored to detect sources of
variability, all of which could result in the manufacture and
distribution of nonconforming product.
    The proposed sampling requirements would also help assure that
tobacco products are in compliance with the requirements of chapter IX
of the FD&C Act. Appropriate sampling methods would help manufacturers
ensure that the new tobacco products and MRTPs they manufacture meet
the specifications described in their applications (i.e., SE report,
request for exemption from SE, PMTA, MRTPA) and that the specifications
for pre-existing tobacco products continue to be consistent with their
original characteristics.
7. Nonconforming Tobacco Product
    Proposed Sec.  1120.74 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
control and disposition of nonconforming tobacco product. A
nonconforming tobacco product is defined as any tobacco product that
does not meet a product specification as set by 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. These procedures are necessary to help
prevent the distribution of nonconforming tobacco products, which could
pose risks not normally associated with tobacco products, by ensuring
that all potential nonconforming products are identified, segregated,
and investigated, and that appropriate disposition and followup is
taken for products determined to be nonconforming. These provisions are
also intended to help manufacturers determine the extent of any
nonconformity and, in cases in which nonconforming product has already
been released for distribution, determine where it was distributed.
These proposed requirements are generally consistent with the practices
of manufacturing establishments that follow ISO 9001 and the industry
recommendations.
    These proposed requirements would be applicable throughout the
manufacturing process. For example, if an ENDS manufacturer determines
through its in-process product acceptance activities that the liquid
nicotine contains contaminants such as metal or silicate particles
(known to cause respiratory disease and distress), the liquid nicotine
would be a nonconforming product and would have to be handled according
to the procedures outlined in proposed Sec.  1120.74 (Ref. 2).
Similarly, if an ENDS manufacturer determines through its process
controls that the liquid nicotine concentration does not meet the
concentration specification established in its MMR, the liquid nicotine
would be a nonconforming product and the manufacturer would have to
identify, segregate, investigate, and determine its disposition (e.g.,
rework as appropriate or discard) in accordance with proposed Sec.
1120.74(c) (Ref. 5). As another example, if a smokeless tobacco product
manufacturer determines through its tobacco product acceptance
activities that its chewing tobacco is contaminated with aflatoxins
(Ref. 17), the manufacturer would be required to follow its
nonconforming product procedures in accordance with this provision.
    Proposed Sec.  1120.74(a) would require finished and bulk tobacco
product manufacturers to identify and segregate potential nonconforming
product in a manner that prevents mixups and use of potential
nonconforming product prior to investigation and disposition. This
requirement would be triggered upon discovery of a potential
nonconforming product. For example, if a manufacturer establishes
acceptance activities to visually inspect incoming tobacco for the
presence of mold, and a product appears to be discolored or blighted,
the manufacturer would determine that the tobacco may be nonconforming
and therefore subject to this provision. If an ENDS manufacturer
performs laboratory testing on the nicotine concentration of an e-
liquid as part of acceptance activities and the testing results do not
conform to the established specification and acceptance criteria, the
manufacturer would determine that the e-liquid is a potential
nonconforming product that must be identified and segregated. If a
tobacco product was manufactured under conditions outside of an
established production process specification where failure to meet the
process specification is reasonably likely to cause the tobacco product
to fail to meet a product specification, the product should be treated
as a potential nonconforming product.
    Identification of potential nonconforming product can be
accomplished in many ways (e.g., applying a label with the relevant
information directly to the product container; or, if an electronic
system is utilized, associating the nonconforming product information
with the relevant barcode). Identification is a critical first step to
preventing further processing, production, or distribution of potential
nonconforming tobacco product.
    Proposed Sec.  1120.74(a) would also require finished and bulk
tobacco product manufacturers to segregate potential nonconforming
product in a manner that prevents mixups and use of potential
nonconforming product prior to investigation and disposition. This
provision would require potential nonconforming product to remain
segregated pending an investigation until it is determined to be