Requirements for Tobacco Product Manufacturing Practice

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1120

[Docket No. FDA-2013-N-0227]

RIN 0910-AH91

Requirements for Tobacco Product Manufacturing Practice

AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

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

DATES:

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

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The

https://www.regulations.gov

electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 6, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand Delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2013-N-0227 for “Requirements for Tobacco Product Manufacturing Practice.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Submit comments on information collection issues to the Office of Management and Budget (OMB) in the following ways:

• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to

oira_submission@omb.eop.gov.

All comments should be identified with the title, “Requirements for Tobacco Product Manufacturing Practice.”

FOR FURTHER INFORMATION CONTACT:

Matthew Brenner, Office of Regulations, or Rear Admiral Emil Wang, Office of Compliance and Enforcement, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877-287-1373,

AskCTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

A. Purpose of the Proposed Rule

B. Summary of the Major Provisions of the Proposed Rule

C. Legal Authority

D. Costs and Benefits

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

III. Background

A. Legal Authority

B. Rationale for the Proposed Regulation

C. Development of the Proposed Regulation

IV. Description of the Proposed Regulation

A. General Provisions

B. Management System Requirements

C. Buildings, Facilities, and Equipment

D. Design and Development Controls

E. Process Controls

F. Packaging and Labeling Controls

G. Handling, Storage, and Distribution

H. Recordkeeping and Document Controls

I. Small Tobacco Product Manufacturers

J. Exemptions and Variances

V. Proposed Effective and Compliance Dates

VI. Preliminary Economic Analysis of Impacts

VII. Paperwork Reduction Act of 1995

VIII. Analysis of Environmental Impact

IX. Federalism

X. Consultation and Coordination With Indian Tribal Governments

XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

This proposed regulation—proposed part 1120 (21 CFR part 1120)—sets forth requirements for tobacco product manufacturing practice (TPMP) and provides a framework for manufacturers of finished or bulk tobacco products to follow that would include: (1) establishing tobacco product design and development controls to prevent or minimize certain risks; (2) ensuring that finished and bulk tobacco products are manufactured in conformance with established specifications; (3) minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products; (4) requiring investigation and identification of nonconforming products, including those that have been distributed in order to institute appropriate corrective actions, such as conducting a recall as needed; (5) requiring manufacturers to take appropriate measures to prevent contamination of tobacco products; and (6) establishing traceability to account for all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of nonconforming tobacco products. Therefore, this proposed regulation would establish requirements for the control of tobacco product manufacturing activities and the treatment of contaminated or otherwise nonconforming tobacco products, including the investigation, evaluation, and corrective and preventive actions (CAPA) necessary to protect the public health.

These provisions are generally similar to many existing industry practices and are drafted to provide tobacco product manufacturers with flexibility in the manner they comply with the proposed requirements while assuring the protection of public health. This proposal is intended to ensure that tobacco products conform to established specifications and to help prevent the manufacture and distribution of contaminated or otherwise nonconforming products, thereby assuring that the public health is protected and that tobacco products comply with the requirements in chapter IX of the FD&C Act.

B. Summary of the Major Provisions of the Proposed Rule

The proposed regulation is divided into 10 subparts. This proposed regulation is intended to provide a framework that requires all finished and bulk tobacco product manufacturers subject to the rule (including specification developers, contract manufacturers, and repackagers/relabelers) to establish and maintain procedures for various aspects of the manufacturing, preproduction design validation, packing, and storage processes, while allowing flexibility to establish procedures that are unique to the manufacturer's facilities and activities, and appropriate for a given tobacco product. The proposed requirements are written in general terms to allow manufacturers to establish procedures appropriate for their specific products and operations. The extent of the procedures necessary to meet the regulation requirements may vary with the size and complexity of the design and manufacturing operations. Tobacco product manufacturers who have a complex manufacturing process would likely need to establish more detailed procedures to comply with the rule, while tobacco product manufacturers who have a less complex manufacturing process may need less extensive procedures.

1. Subpart A—General Provisions

Subpart A contains two proposed sections: scope and definitions. The scope section describes the purpose of this proposed regulation and the products and activities to which it applies. This proposed regulation would apply to manufacturers (foreign and domestic) of finished and bulk tobacco products. The definitions section defines the terminology applicable to the proposed requirements laid out in this notice of proposed rulemaking (NPRM). The proposed rule would define “tobacco product manufacturer” to mean “any person(s), including a repacker or relabeler, who: manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished or bulk tobacco product for sale or distribution in the United States. The manufacture of a tobacco product includes establishing the specifications of or the requirements for a tobacco product.”

2. Subpart B—Management System Requirements

Subpart B contains three proposed sections: organization and personnel; tobacco product complaints; and CAPA. The organization and personnel section would require finished and bulk tobacco product manufacturers to establish and maintain an organizational structure; have sufficient personnel; designate personnel with appropriate responsibility, including management with executive responsibility; train personnel; and maintain certain records of these activities. The tobacco product complaints section would require finished and bulk tobacco product manufacturers to establish and maintain complaint handling procedures for the receipt, evaluation, investigation, and documentation of all complaints. The CAPA section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for implementing CAPA and to maintain records of the activities required under this subpart.

3. Subpart C—Buildings, Facilities, and Equipment

Subpart C contains four proposed sections: personnel practices; buildings, facilities, and grounds; equipment; and environmental controls. The personnel practices section would require finished and bulk tobacco product manufacturers to establish and maintain procedures related to personnel practices to reduce the risk of contamination with filth biological materials, chemical hazards, or other deleterious substances, including rocks or metal shavings. The buildings, facilities, and grounds section would require such manufacturers to ensure that buildings and facilities are of suitable construction, design, and location to facilitate cleaning and sanitation, maintenance, and proper operations. In addition, manufacturers would be required to ensure that facility grounds are maintained in a condition to prevent contamination and to control the water used in the manufacturing process. The proposed requirements would also require such manufacturers to establish and maintain procedures for proper cleaning and sanitation and animal and pest control, and maintain records of these activities to demonstrate compliance with this proposed rule. The equipment section would provide requirements for design, construction, and maintenance of equipment as well as certain additional requirements (

e.g.,

calibration) for testing, monitoring, and measuring equipment used in the tobacco product manufacturing processes and for major

equipment and processing line identification. Lastly, the environmental controls section would require that environmental control systems be maintained and monitored to verify that environmental controls, including necessary equipment, are adequate and functioning properly. This subpart would also require manufacturers to maintain certain records to demonstrate compliance with this proposed rule.

4. Subpart D—Design and Development Controls

Subpart D contains two proposed sections: design and development activities and master manufacturing record (MMR). The design and development activities section would require finished and bulk tobacco product manufacturers to establish and maintain procedures to control the design and development of tobacco products, including the control of risks associated with the product, production process, packing, and storage, as well as procedures for design verification and validation. These requirements would include developing a process for identification, analysis, and evaluation of known and reasonably foreseeable risks associated with the tobacco product and its packaging as well as taking appropriate measures to reduce or eliminate risks using recognized tools for risk management. Manufacturers would also be required to maintain records of all activities required under this section.

The proposed MMR section would require manufacturers to establish and maintain an MMR for each finished and bulk tobacco product they manufacture for distribution. The proposed section would require each MMR to include tobacco product specifications, the manufacturing methods and production process procedures, and all packaging, labeling, and labels approved for use with the product. Additionally, the proposed MMR section includes requirements for the review and approval of the MMR, including any changes after initial approval.

5. Subpart E—Process Controls

Subpart E contains nine proposed sections: purchasing controls; acceptance activities; production processes and controls; laboratory controls; production record; sampling; nonconforming tobacco product; returned tobacco product; and reprocessing and rework. The purchasing controls section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for ensuring that purchased or otherwise received products and services related to the manufacture of a finished or bulk tobacco product are from qualified suppliers and conform to established specifications. The acceptance activities section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for incoming and for in-process and/or final acceptance activities, including acceptance criteria, to ensure that products meet established specifications. The production processes and controls section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for production processes, including process specifications and process controls, process validation, and manual methods and manufacturing material. The laboratory controls section would require finished and bulk tobacco product manufacturers to demonstrate laboratory competency to perform laboratory activities associated with the manufacture of finished and bulk tobacco products and to establish and maintain laboratory control procedures for any laboratory activities conducted under proposed part 1120. The production record section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for ensuring that a production record is prepared for each batch of finished or bulk product to demonstrate conformity with the requirements established under the MMR. The sampling section would require finished and bulk tobacco product manufacturers to establish and maintain an adequate sampling plan that uses representative samples based on a valid scientific rationale for any sampling performed under proposed part 1120. The nonconforming tobacco product section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for control and disposition of nonconforming tobacco product, including specific requirements for identification and segregation, investigation, and disposition and followup. The proposed returned tobacco product section would require procedures for the control and disposition of returned tobacco product, including specific requirements for identification, segregation, evaluation, and disposition. The reprocessing and rework section would require procedures for reprocessing and reworking tobacco products, including specific requirements for evaluation of the tobacco product to determine that it is appropriate for reprocessing or rework, authorization of the reprocessing or rework, and production processes, including process controls, to ensure that reprocessed and reworked tobacco product conforms to MMR specifications. Manufacturers also would be required to maintain records of all activities required under this subpart.

6. Subpart F—Packaging and Labeling Controls

Subpart F contains four proposed sections: packaging and labeling controls; repackaging and relabeling; manufacturing code; and warning plans. The packaging and labeling controls section would require finished and bulk tobacco product manufacturers to establish and maintain procedures for ensuring that the correct packaging and labeling is used to prevent mixups and that all packaging and labeling is approved for use by the manufacturer and complies with all requirements of the MMR as well as other applicable requirements of the FD&C Act, the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), and the Federal Cigarette Labeling and Advertising Act (FCLAA) and their implementing regulations. The section would also require the packaging and labeling control procedures to ensure that labels are indelibly printed on or permanently affixed to finished and bulk tobacco product packages; and that the packaging, labeling, storage, and shipping cases do not contaminate or otherwise render the tobacco product adulterated or misbranded. The repackaging and relabeling requirements would require finished tobacco product manufacturers to establish and maintain procedures for repackaging and relabeling operations. The manufacturing code section would require finished and bulk tobacco product manufacturers to apply a manufacturing code that contains the manufacturing date and batch number to the packaging or label of all finished and bulk tobacco products. The warning plans section would require manufacturers of finished tobacco products that are required to comply with a warning plan for tobacco product packaging, to establish and maintain procedures for implementing the requirements of such plan. Manufacturers would also be required to maintain records of all activities required under this subpart.

7. Subpart G—Handling, Storage and Distribution

Subpart G contains two proposed sections: handling and storage and distribution. The handling and storage

section would require finished and bulk tobacco product manufactures to establish and maintain procedures to ensure that tobacco products are handled and stored under appropriate conditions to prevent nonconforming products as well as mixups, deterioration, contamination, adulteration, and misbranding of tobacco products. The distribution section would require finished and bulk tobacco product manufacturers to establish and maintain procedures to ensure that tobacco products are distributed to the initial consignee under appropriate conditions and that only those finished and bulk tobacco products approved for release are distributed. The distribution section would also require finished and bulk tobacco product manufacturers to maintain distribution records and a list of direct accounts.

8. Subpart H—Recordkeeping and Document Controls

The recordkeeping and document control requirements section establishes certain requirements for documents and records required by this rule. This section would require that all documents and records be maintained at the manufacturing establishment or another location that is readily accessible to responsible individuals of the manufacturer and to FDA and that they be written in English or an English translation be made available upon request. Documents and records required under this section that are associated with a batch of finished or bulk tobacco product must be retained for a period of not less than 4 years from the date of distribution of the batch or until the product reaches its expiration date if one exists, whichever is later. Documents and records required under this section that are not associated with a batch of finished or bulk tobacco product must be retained for a period of not less than 4 years from the date they were last in effect. FDA is soliciting comment on whether the timeframe for manufacturers to retain the documents and records under this section is sufficient for FDA's inspections and compliance activities or if it should be extended for an additional 1 or 2 years after the tobacco product reaches its expiration date if one exists. They also must be made readily accessible to FDA during the retention period for inspection and photocopying or other means of reproduction. This section also would require finished and bulk tobacco product manufacturers to ensure that all records are attributable to a responsible individual, legible, contemporaneously recorded, original, and accurate and to establish and maintain procedures for the approval and distribution of documents and for making changes to documents.

9. Subpart I—Small Tobacco Product Manufacturers

Subpart I explains that small tobacco product manufacturers of finished and bulk tobacco products would not have to comply with the TPMP regulation until 4 years after the effective date of the final rule.

10. Subpart J—Exemptions and Variances

Subpart J consists of five sections, and it sets forth the proposed procedures and requirements for petitioning for an exemption or variance from a TPMP requirement. Pursuant to section 906(e)(2)(B) of the FD&C Act (21 U.S.C. 387f), this subpart also would establish that a petition for an exemption or variance may be referred to the Tobacco Products Scientific Advisory Committee (TPSAC) and describe how FDA would make a determination on a petition for an exemption or variance. Finally, pursuant to section 906(e)(2)(E) of the FD&C Act, this subpart would provide that the petitioner has an opportunity for a hearing after the issuance of an order denying or approving a petition for an exemption or variance.

C. Legal Authority

Section 906(e) of the FD&C Act (21 U.S.C. 387f) states that in applying manufacturing restrictions to tobacco, FDA shall prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice (cGMP) or hazard analysis and critical control point (HACCP) methodology as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through 387u). The proposed requirements flow from this authority and serve these goals of protecting public health and assuring compliance with chapter IX of the FD&C Act.

The proposed rule is also being issued based upon: FDA's authorities related to adulterated and misbranded tobacco products under sections 902 and 903 (21 U.S.C. 387c); FDA's authorities related to records and reports under section 909 (21 U.S.C. 387i); and FDA's rulemaking and inspection authorities under sections 701 (21 U.S.C. 371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the FD&C Act.

D. Costs and Benefits

The proposed rule, if finalized, would establish requirements for manufacturers of finished and bulk tobacco products on the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation, packing, and storage of tobacco products. The TPMP requirements described in the proposed rule are expected to ensure that tobacco product manufacturers control the design and specifications of finished and bulk tobacco products, providing a level of assurance of conformity in the production of tobacco products to established and required specifications that does not occur in the existing market for tobacco products, to prevent the adulteration and misbranding of finished and bulk tobacco products, and establish controls for traceability purposes.

Estimated quantified benefits of the proposed rule arise from the value of reduced adverse events due to nonconforming finished and bulk tobacco products and from the reduction of costs associated with reduced product recalls and market withdrawals. We estimate the mean present value of benefits annualized over ten years using a seven and three percent discount rate to be $27.2 million and $29.9 million.

There are other potential benefits associated with the proposed rule which we have not quantified. First, the proposed recordkeeping provisions would support FDA's regulatory compliance activities and help FDA implement and enforce other provisions of the FD&C Act which will likely generate government cost savings. Second, the proposed rule, if finalized, may further reduce losses to health and property for users and nonusers associated with nonconforming tobacco products, beyond those estimated in the quantified benefits. Third, the proposed rule's risk assessment, CAPA, tobacco product complaints, and related provisions will facilitate investigation and identification of causes and root causes of consumer complaints and other reports of adverse events. Other benefits include avoided spillover costs to capital markets.

1

1

Estimated quantified benefits of avoided recalls include reduced external costs in the supply chain of the recalled or withdrawn products (or they exclude reduced recall costs to manufacturers). Estimated external costs of conducting a recall or market withdrawal include lost sales to retailers

and wholesalers, expenses associated with notifying tobacco retailers (for wholesalers) and consumers, removal and storage of inventory costs collection and shipping costs, disposal costs, and legal costs, among others. Estimated quantified benefits do not include avoided spillover costs to capital markets.

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

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

Abbreviation/acronym

What it means

AAMI

Advancement of Medical Instrumentation.

ALCOA

Attributable, Legible, Contemporaneously Recorded, Original, and Accurate.

ANSI

American National Standards Institute.

ASTM

American Society for Testing and Materials.

ASQ

American Society for Quality.

CAPA

Corrective and Preventive Actions.

CDC

Centers for Disease Control and Prevention.

cGMP

Current Good Manufacturing Practice.

CoA

Certificate of Analysis.

CORESTA

Cooperation Centre for Scientific Research Relative to Tobacco.

CSTHEA

Comprehensive Smokeless Tobacco Health Education Act.

Deeming Rule

Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements.

EA

Environmental Assessment.

E. coli

Escherichia coli

.

EIS

Environmental Impact Statement.

ENDS

Electronic Nicotine Delivery Systems.

E.O.

Executive Order.

FCLAA

Federal Cigarette Labeling and Advertising Act.

FCTC

Framework Convention on Tobacco Control.

FDA or Agency

Food and Drug Administration.

FD&C Act

Federal Food, Drug, and Cosmetic Act.

FR

Federal Register

.

HACCP

Hazard Analysis and Critical Control Point.

HHS

Health and Human Services.

HVAC

Heating, Ventilation, and Cooling.

IARC

International Agency for Research on Cancer.

IEC

International Electrotechnical Commission.

ISO

International Organization for Standardization.

MITC

Manufacturer Detected Methyl Isothiocyanate.

MMR

Master Manufacturing Record.

MRTPs

Modified Risk Tobacco Products.

MRTPA

Modified Risk Tobacco Product Application.

NNK

4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone.

NNN

N-nitrosonornicotine.

NPRM

Notice of Proposed Rulemaking.

NTRMs

Nontobacco Related Materials.

OMB

Office of Management and Budget.

OOS

Out-Of-Specification.

SE

Substantial Equivalence.

PMTA

Premarket Tobacco Product Application.

PRA

Paperwork Reduction Act of 1995.

PRIA

Proposed Regulatory Impact Analysis.

QMS

Quality Management System.

QSR

Quality System Regulation.

RYO

Roll-Your-Own.

Tobacco Control Act

Family Smoking Prevention and Tobacco Control Act.

TPMP

Tobacco Product Manufacturing Practice.

TPSAC

Tobacco Products Scientific Advisory Committee.

TSNAs

Tobacco-Specific Nitrosamines.

UPC

Universal Product Code.

USB

Universal Serial Bus.

U.S.C

United States Code.

WHO

World Health Organization.

III. Background

A. Legal Authority

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

manufacturers (including importers), distributors, and retailers.

Section 901(b) of the FD&C Act establishes FDA's immediate authority over cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, smokeless tobacco, and tobacco products containing nicotine that is not made or derived from tobacco,

2

and permits FDA, by regulation, to deem additional tobacco products subject to chapter IX of the FD&C Act. In the

Federal Register

of May 10, 2016 (81 FR 28973), FDA published a final rule entitled “Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements” (Deeming Rule) deeming all tobacco products meeting the statutory definition of “tobacco product,” except accessories of deemed tobacco products, to be subject to chapter IX of the FD&C Act. FDA intends for this proposed rule to apply to manufacturers of all finished and bulk tobacco products that are subject to chapter IX of the FD&C Act, except finished and bulk accessories of cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, and tobacco products containing nicotine that is not made or derived from tobacco.

2

See

Consolidated Appropriations Act, 2022, Public Law 117-103, div. P, tit. I, subtit. A, sec. 111(b) (March 15, 2022).

Section 906(e) of the FD&C Act provides that in applying manufacturing restrictions to tobacco, FDA shall prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to cGMP or HACCP methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with chapter IX of the FD&C Act. The requirements in proposed part 1120, including management system requirements; buildings, facilities, and equipment requirements; design and development controls; process controls; packaging and labeling controls; handling, storage, and distribution requirements; and recordkeeping and document controls, are derived from this authority. Section 902(7) of the FD&C Act provides that a tobacco product shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 906(e)(1) of the FD&C Act or an applicable condition prescribed by an order under section 906(e)(2) of the FD&C Act. As a result, a product will be adulterated if a manufacturer fails to comply with the requirements prescribed in this proposed regulation. Violations relating to section 906(e) of the FD&C Act are subject to regulatory action by FDA, including seizure and injunction.

In addition, section 909 of the FD&C Act authorizes FDA, by regulation, to require manufacturers and importers of tobacco products to establish and maintain records, make reports, and provide information to assure that such tobacco products are not adulterated or misbranded, and to otherwise protect public health. Section 909 thus provides additional legal authority for the proposed rule's recordkeeping, reporting, and related requirements. In addition, under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has the authority to issue regulations for the efficient enforcement of the FD&C Act. The proposed rule will help assure that tobacco products are not adulterated or misbranded under other provisions of the FD&C Act and will assist in the efficient enforcement of those other provisions. For example, section 902 of the FD&C Act provides that a tobacco product is adulterated in several circumstances including: (1) if a tobacco product consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; (2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (Section 902(1)-(3) of the FD&C Act.) The proposed rule will help ensure that tobacco products are not adulterated in these ways, and that appropriate records, reports, and information will be available to enforce section 902's adulteration provisions. To similar effect, section 903 provides that a tobacco product is misbranded if, for example, its labeling is false or misleading in any particular or if the product does not bear labeling that is required by an applicable tobacco product standard established under section 907 (section 903(a)(1) and (a)(9) of the FD&C Act). The proposed rule's labeling requirements will help prevent tobacco products from being misbranded in violation of section 903.

Further, section 801(a) of the FD&C Act gives FDA authority to refuse admission of tobacco products imported or offered for import into the United States in situations where it appears such products: (1) have been manufactured, processed, or packed under insanitary conditions; (2) are forbidden or restricted in sale in the country in which they were produced or from which they were exported; or (3) are adulterated or misbranded. As noted earlier, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. The proposed rule will assist in the efficient enforcement of the FD&C Act's import requirements under section 801(a) by requiring manufacturers of finished and bulk tobacco products to implement certain controls over their product manufacturing, preproduction design validation, packing, and storage activities, including recordkeeping, to prevent the import of tobacco products that appear to be adulterated or misbranded.

Finally, the proposed rule will assist in the performance of FDA inspections under section 704 (21 U.S.C. 374) and 905(g) (21 U.S.C. 387e(g)) of the FD&C Act.

B. Rationale for the Proposed Regulation

While all tobacco products have inherent risks to the public health, FDA is proposing TPMP requirements to minimize or prevent product problems, as well as health issues not normally associated with use of a tobacco product. For example, these requirements would help minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances (

e.g.,

nontobacco related materials (NTRMs) such as metal, glass, nails, pins, wood, dirt, sand, stones, rocks, fabric, cloth, and plastics) which have been found in finished tobacco products as will be discussed further below. These requirements also would help minimize or prevent the manufacture and distribution of nonconforming electronic nicotine delivery systems (ENDS) e-liquids that contain nicotine concentration levels that vary from the labeled amount and vary from one ENDS product to another within the same brand (Ref. 1, Ref. 178). As explained elsewhere in this document, this potential variability in nicotine concentration, in which an e-liquid product contains significantly higher

levels of nicotine than what is stated on the label, could be misleading to consumers concerned about nicotine delivery levels, potentially intensifying or prolonging their addiction and potentially exposing users to increased toxins (Refs. 4 and 5). Tobacco products may introduce preventable harms not normally associated with use of tobacco products due to inadequate design or manufacturing controls; for example, defective solder joints from an ENDS cartomizer (atomizer plus replaceable fluid-filled cartridge) may cause respiratory distress due to metallic particles in the aerosol (Ref. 2). This proposed regulation would help to assure that the public health is protected from these, and other, types of hazards and that tobacco products comply with chapter IX of the FD&C Act.

FDA is proposing a TPMP regulation under section 906(e) of the FD&C Act that employs a Quality Management System (QMS) approach. QMS approaches are well established and have been required (

e.g.,

21 CFR part 820) or utilized by FDA (

e.g.,

“FDA Guidance for Industry—Quality Systems Approach to Pharmaceutical CGMP Regulations”) in other product categories. A QMS can protect the public health in several ways. First, a QMS can enable the manufacturer to demonstrate its ability to consistently produce products that meet applicable statutory and regulatory requirements. Second, a QMS can enable a manufacturer to establish and maintain a robust design and development process for its product and to adequately identify and control nonconforming products to prevent their distribution and related potential harm. Finally, if nonconforming products are discovered, a QMS can provide the manufacturer with a recognized framework to effectively investigate and identify the nonconforming products in order to institute appropriate corrective actions such as conducting a recall as needed. If a firm is manufacturing a tobacco product that is contaminated or inconsistent with the specifications identified in an application under which it has received marketing authorization, the tobacco product may be adulterated or misbranded pursuant to section 902 or section 903 of the FD&C Act and subject to regulatory action. Thus, the proposed regulation based on a QMS approach, if finalized, would help assure that the public health is protected and that tobacco products are in compliance with chapter IX of the FD&C Act.

1. Assuring That the Public Health Is Protected

The proposed regulation would help assure that the public health is protected by, among other things, minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products. A “nonconforming tobacco product” is proposed to be defined as any tobacco product that: (1) does not meet a product specification as set by the MMR (see proposed § 1120.44(a)(1)); (2) has packaging, labeling, or labels other than those included in the MMR (see proposed § 1120.44(a)(3)); or (3) is a contaminated tobacco product (proposed § 1120.3). Nonconforming products occur for many different reasons, including inadequate sanitation practices, design issues, failures of or problems with purchasing controls, inadequate process controls, improper facilities or equipment, inadequate personnel training, inadequate manufacturing methods and procedures, the introduction or presence of hazards, or improper handling or storage of the tobacco product. A tobacco product that does not conform to established specifications, has incorrect packaging, labeling, or labels, or is contaminated could increase the product's risk compared to what would normally be associated with use of the product.

Tobacco products with contaminants that could have been prevented with the implementation of this proposed TPMP rule have been identified. For example, consumer complaints of foreign metal material, including sharp metal objects, in a manufacturer's smokeless tobacco (

e.g.,

chewing) products ultimately led the manufacturer to issue a voluntary recall of certain products on January 31, 2017 (Ref. 3). In other instances, smokeless tobacco products have contained rocks or metal shavings as well as other NTRMs (

e.g.,

glass, nails, pins, wood, dirt, sand, fabric, cloth, and plastics) in finished tobacco products. These NTRMs can cause cuts or lacerations to the lips and gums or result in broken teeth. This proposed regulation includes measures that will help avoid such contamination, in addition to provisions for how manufacturers would be required to handle complaints in similar situations, as well as the subsequent investigation, evaluation, and CAPA they would need to take to address such issues.

Consumers have reported additional substances not ordinarily contained in tobacco products such as biological materials (

e.g.,

mold, mildew, hair, fingernails) and chemical hazards (

e.g.,

ammonia, cleaning agents, and kerosene). Caustic cleaning chemicals may cause vomiting, nausea, allergic reactions, dizziness, numbness, or headaches.

Even when nonconforming tobacco products are not contaminated with foreign objects or substances, they may contain higher levels of a constituent than the consumer is expecting, which can have negative health effects not normally associated with the tobacco product. For example, researchers have reported on the variability of nicotine in certain ENDS e-liquids and that the labeling of these products did not accurately reflect the actual nicotine levels. For example, there have been reports of wide variability in e-cigarette manufacturing, including nicotine concentrations in e-liquid, that were inconsistent with the information contained on the product label (Ref. 178). In one study, researchers found that actual nicotine amounts differed from label amounts by more than 20 percent in 9 out of 20 original e-cigarette cartridges tested, and in 3 out of 15 refill cartridges tested (Ref. 1). In a second study, 9 of 21 samples had nicotine levels that deviated from the labeled value by more than 10%, with inconsistencies ranging from −21 percent to +22.1 percent (Ref. 4). Nicotine delivery varies not only across brands, but also within brands (Refs. 178-180). A finished ENDS that contains a nicotine concentration higher than the established specification can be more addictive. Similarly, a cigarette that does not conform to its pH specification can affect the amount of nicotine that is delivered to the user and its rate of absorption that can increase the tobacco product's toxicity and addictiveness (Ref. 6).

Nonconforming products may also occur because of design issues, which can cause the tobacco product to be more harmful. For example, an ENDS product, as designed, may have a design feature that contributes to an increased risk of fire and/or explosion. The ENDS product, during use or foreseeable misuse, can expose consumers to increased harm if the product catches fire or explodes resulting in serious burns that would not be expected from use of the product (

e.g.,

Ref. 7).

Given the dangers associated with contaminated and otherwise nonconforming tobacco products, FDA is proposing this regulation to help assure that the public health is protected by requiring that finished and bulk tobacco product manufacturers establish and maintain certain controls to prevent the manufacture and distribution of nonconforming products

that may have an adverse effect on public health.

2. Ensuring Compliance With Chapter IX of the FD&C Act

The proposed regulation would help assure that tobacco products are in compliance with the requirements of chapter IX of the FD&C Act pursuant to section 906(e) of the FD&C Act. In particular, by requiring controls over the manufacturing process, the proposed regulation would help assure that tobacco products are manufactured in accordance with the specifications provided in their applications authorized by FDA. Specifications generally are included in four types of applications:

• Substantial equivalence (SE) report—To request marketing authorization for a new tobacco product, manufacturers may submit a report pursuant to section 905(j) of the FD&C Act (21 U.S.C. 387e) to demonstrate that the new tobacco product has the same characteristics as a predicate tobacco product, or has different characteristics than the predicate tobacco product but the information submitted demonstrates that it is not appropriate to regulate the product under section 910 because the product does not raise different questions of public health.

• Exemption from SE—To request marketing authorization for a new tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, manufacturers may request an exemption from demonstrating SE under certain circumstances (see 21 CFR 1107.1 and section 905(j) of the FD&C Act).

• Premarket tobacco product application (PMTA)—To request marketing authorization for a new tobacco product, manufacturers may submit a PMTA, which must include, among other things, a full statement of the components, ingredients, additives, and properties of the product as well as a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation of the product. This pathway requires the applicant to demonstrate that marketing the new tobacco product is appropriate for the protection of public health pursuant to section 910 of the FD&C Act.

• Modified risk tobacco product application (MRTPA)—To request that a product be sold or distributed for use to reduce harm or the risk of tobacco-related diseases associated with commercially marketed tobacco products, manufacturers may submit an MRTPA, which must include, among other things, a description of the product and the formulation of the product. Applicants must demonstrate that, among other things, the product will or is expected to benefit the health of the population as a whole.

If a firm is manufacturing a tobacco product that is inconsistent with the specifications identified in the application under which it has received marketing authorization, the tobacco product may be adulterated or misbranded pursuant to section 902 or section 903 of the FD&C Act and subject to regulatory action. Such a product could have negative effects on public health. For example, a cigarette that does not meet its specifications for ventilation such that ventilation is reduced can pose public health risk through the resulting higher delivery of harmful and potentially harmful constituents (HPHCs) including nicotine (Refs. 8-9, 106, 173, and 183). FDA believes that the proposed TPMP rule (if finalized) would help ensure that tobacco products conform to the specifications in their authorized marketing applications and do not provide a more addictive or toxic product to consumers.

Pursuant to section 910(a)(1) of the FD&C Act, tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007 (“pre-existing products”), are not considered “new tobacco products” and thus are not subject to the premarket requirements of the FD&C Act. These products are subject to other provisions of the FD&C Act, including proposed TPMP requirements. The proposed rule would help manufacturers ensure that pre-existing tobacco products are manufactured to their original specifications, and thus do not undergo any modification that would render them “new” and in violation of the requirements of chapter IX of the FD&C Act because they lack proper marketing authorization. It would also help FDA identify and determine if any changes to established specifications or manufacturing methods and procedures result in a modification that would render the tobacco product “new.”

Manufacturers must also ensure that their tobacco products are in compliance with tobacco product standards under section 907 of the FD&C Act. Tobacco product standards may reduce the death and disease caused by tobacco use, encourage cessation, decrease initiation, or reduce the harms not normally associated with tobacco use, such as nicotine poisoning. The proposed requirements would help a finished or bulk tobacco product manufacturer to ensure that, and FDA to review whether, the tobacco products conform to applicable tobacco product standards.

In addition to helping assure that tobacco products are manufactured in accordance with the specifications provided in their marketing applications authorized by FDA and that products are manufactured in accordance with applicable product standards, the proposed TPMP rule would help tobacco product manufacturers assure compliance with other requirements in chapter IX of the FD&C Act. For example, tobacco product manufacturers must submit a listing of ingredients, additives, and harmful and potentially harmful constituents to FDA under section 904 and applicable regulations under section 915 of the FD&C Act. The proposed TPMP recordkeeping requirements, including the MMR and production record requirements, could help FDA verify that the ingredients of these products are consistent with the listing of ingredients reported to FDA under section 904(a)(1) of the FD&C Act.

Similarly, under section 905(i) of the FD&C Act, copies of all labeling, and section 910(b)(1)(F) of the FD&C Act, specimens of labeling, must be submitted by tobacco product manufacturers to FDA. This helps the Agency determine if a manufacturer has included unauthorized modified risk claims on product labels or labeling or if product labeling is false or misleading or otherwise renders the product misbranded under section 903 of the FD&C Act. The recordkeeping requirements in the proposed regulation related to packaging and labeling would help the Agency make similar assessments, as well as identify variations between the submitted labeling and actual packaging and labeling.

Finally, the proposed contamination and risk management controls would help prevent products from becoming contaminated. Finished or bulk tobacco products that contain substances such as physical, chemical, and/or biological hazards may be adulterated under sections 902(1) to (3) of the FD&C Act. The proposed requirements for facilities and controls covering the manufacture, packing, and storage of tobacco products would help minimize the occurrence of these kinds of hazards and would therefore help ensure that products are in compliance with the requirements of chapter IX of the FD&C Act.

C. Development of the Proposed Regulation

FDA's development of this proposed regulation reflects its experience in regulating tobacco products, including the inspections and facility visits of tobacco manufacturing facilities it has conducted, recommendations for good manufacturing practice requirements for ENDS submitted by tobacco product manufacturers, and public comments filed in response to these recommendations (Docket No. FDA-2013-N-0227). FDA is also drawing on its experience with cGMP and HACCP regulations for other regulated products, such as foods, medical devices, drugs, and dietary supplements.

FDA's experience with biennial inspections of tobacco products has informed this proposal. Pursuant to section 905(g) of the FD&C Act, FDA has conducted hundreds of inspections of establishments engaged in the manufacture of regulated tobacco products, including cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco since October 1, 2011. FDA believes that this experience is also relevant to establishments that manufacture deemed products, which engage in many similar activities and processes. Beginning in 2017, the Agency also began inspecting manufacturing establishments of deemed tobacco products, including ENDS products.

In August 2012, FDA issued a notice in the

Federal Register

announcing an invitation to participate in its Tobacco Product Manufacturing Facility Visits program (77 FR 48992, August 15, 2012). The purpose of the program was to provide an opportunity for tobacco product manufacturing facilities, including facilities related to laboratory testing, to invite FDA staff to visit these facilities and observe their manufacturing operations. As part of this program, FDA staff visited tobacco product manufacturers, including small tobacco product manufacturers, of cigarettes, smokeless tobacco products, and cigarette papers, as well as facilities that conduct laboratory testing services for the tobacco industry. In response to a similar notice issued in 2016 (81 FR 39053, June 15, 2016), FDA staff also visited manufacturing facilities of domestic and foreign manufacturers, including small tobacco product manufacturers, of deemed tobacco products including cigars, ENDS, and e-liquids. FDA's experiences during these visits have helped to inform this proposal.

In addition, on January 10, 2012, 13 tobacco companies and a trade association of tobacco product manufacturers submitted to FDA their recommendations for regulations on cGMP. This group of industry stakeholders included manufacturers of a variety of tobacco products including cigarettes, smokeless tobacco, and snus. On May 2, 2012, representatives of the tobacco companies met with the Agency to present an overview of the recommendations and their approach to developing them. FDA established a public docket requesting public comment on these industry recommendations (78 FR 16824, March 19, 2013). These industry GMP recommendations included proposed requirements for an extensive range of manufacturing practices including: qualification of personnel; complaints and recordkeeping; procedures for nonconforming product; contamination prevention; buildings, facilities, and equipment; MMR; acceptance activities; supplier evaluation; manufacturing records; packaging and labeling; handling and storage; and general recordkeeping and document control procedures. We received comments on the industry recommendations from a variety of stakeholders including manufacturers of cigarettes, cigars, smokeless tobacco, and snus, as well as from public health advocates.

Further, on June 7, 2017, a group of 13 tobacco companies, a trade coalition representing small tobacco product manufacturers, and a standards organization representing vaping manufacturers and retailers submitted updated supplemental industry recommendations in order to provide additional cGMP recommendations for ENDS products. The supplemental industry GMP recommendations were generally similar to industry manufacturing practices that the Agency has observed through its biennial inspections. Among the cGMP requirements that industry recommended for ENDS products were specific ENDS design process and procedures, process qualification requirements to ensure that products consistently meet specifications, procedures to validate and approve test methods, and requirements for stability testing, reserve samples, and sampling plans.

FDA established a public docket requesting comment on these updated industry recommendations for good manufacturing practice requirements for ENDS (82 FR 55613, November 22, 2017). FDA received additional comments from manufacturers of a variety of tobacco products, public health advocates, and individuals sharing their experiences with ENDS. In developing this regulation, FDA reviewed and considered the recommendations from both industry proposals, as well as the comments submitted to the public docket.

FDA is proposing many requirements similar to those included in the industry GMP recommendations, particularly in the areas of personnel; contamination prevention; requirements for buildings, facilities, and equipment; development of an MMR; purchasing controls; process controls; production records; procedures for nonconforming tobacco product; complaints; packaging and labeling; distribution; and document control procedures.

However, FDA's proposal deviates from the industry GMP recommendations in several ways. First, the proposed TPMP regulation generally includes more robust provisions for procedures and records than provisions in the industry GMP recommendations. For example, the industry recommendations do not propose requirements for design and development activities generally, returned tobacco product, and warning plans, as discussed throughout this preamble. Such provisions are critical for the efficient enforcement of the FD&C Act.

Second, FDA's proposal includes additional provisions that are necessary to assure that the public health is protected and that manufacturers' tobacco products are in compliance with chapter IX of the FD&C Act. As noted, the industry GMP recommendations do not propose requirements for returned tobacco product and warning plans (see sections IV.E and IV.F.3 for a discussion of these FDA proposals and why FDA believes they will help assure the protection of the public health). In addition, to ensure that tobacco product manufacturers can demonstrate that their tobacco products consistently conform to established specifications, an important public health objective, the proposed rule includes additional requirements for environmental controls, process validation, laboratory controls, and sampling. Moreover, this document includes proposed requirements for design and development activities, as well as complaint, CAPA, and nonconforming product investigations. To address risks not normally associated with use of tobacco products, FDA is also proposing manufacturing code and distribution record requirements to facilitate the traceability of nonconforming products and enable tobacco product manufacturers and FDA to take appropriate corrective actions to protect the public health.

FDA also has chosen not to propose certain requirements in the industry cGMP recommendations which, in some cases, would have been more burdensome than FDA's proposed requirements. For example, FDA considered industry recommendations stating that TPMP requirements should be modified for ENDS given that they are different from other tobacco products. FDA's proposed rule, instead, utilizes an “umbrella” approach with flexible requirements, similar to other cGMP regulations, that would apply to the wide variety of tobacco products offered for sale or distribution. For example, the scope of covered tobacco products in the 2017 supplemental industry cGMP recommendations covers manufacturers and suppliers of ENDS components and parts and included an additional requirement for stability tests to determine appropriate storage conditions and expiration dates for finished ENDS products. However, FDA believes that such requirements are unnecessary and that the FDA proposal to cover bulk tobacco product manufacturers and the proposed requirements for design and development controls, process controls, and handling and storage requirements are sufficient to address the design, manufacture, and storage of ENDS products.

Further, the industry GMP recommendations include a requirement for a HACCP analysis for ENDS and e-liquids. While the Agency considered requiring HACCP plans in this proposal, as discussed in section IV.D.1, FDA determined that use of a risk management process would be more flexible for manufacturers while still assuring that the public health was protected.

FDA also did not include the industry's proposed GMP recommendation to require reserve samples of the e-liquid-containing component/product from each lot or batch of finished ENDS products, similar to the reserve samples that are required for medical products. While reserve samples could be useful for determining a root cause for any nonconforming products or addressing any customer complaints, we believe that the proposed documentation and recordkeeping requirements are sufficient to address any investigation required under the proposed rule. For example, for a released product found to be nonconforming because of its nicotine concentration, under the proposed rule, the manufacturer and/or FDA could review the MMR and the purchasing, acceptance activities, and production records to determine the nicotine concentration of the released product as well as who conducted the testing and signed off on the release of the product. FDA's request for comments includes comments both on industry GMP recommendations that FDA is proposing in these requirements, and industry GMP recommendations that FDA is not proposing.

In addition to the industry GMP recommendation, FDA considered its existing cGMP regulations for other regulated products and evaluated them for their suitability and applicability to tobacco products. Specifically, FDA considered the medical device quality system regulation (QSR) (part 820), and the food, dietary supplement, and drug cGMP regulations (21 CFR parts 110, 111, 210, and 211, respectively). In addition, FDA examined its regulations on HACCP systems, such as preventive controls for human foods, juice HACCP regulations, and fish and fishery products HACCP regulations (21 CFR parts 117, 120, and 123, respectively).

FDA also considered voluntary industry cGMP and quality system standards in developing this proposal. For example, FDA evaluated the American E-Liquid Manufacturing Standards Association's voluntary E-Liquid Manufacturing Standards (Ref. 10). The Agency also considered the International Organization for Standardization (ISO) ISO 9001:2015—Quality management systems—Requirements (Ref. 11); ISO 31000: 2018—Risk Management—Principles and Guidelines (Ref. 12).

FDA considered the quality systems and QMS requirements in FDA's medical device QSR and pharmaceutical cGMP for the 21st century (Ref. 13) in designing the proposed rule. The Agency believes certain aspects of those regulations are informative but not wholly applicable to tobacco products because of certain key differences between tobacco products and medical products regulated by FDA. For example, marketing applications for medical products are evaluated to determine whether they are “safe and effective.” Unlike medical products, tobacco products cannot be “safe and effective” even if used as intended and, therefore, the FD&C Act requires that marketing applications for tobacco products be evaluated under different standards (see,

e.g.,

the “appropriate for the protection of the public health” standard under section 910 of the FD&C Act). FDA has taken these differences into account in developing the proposed rule. For example, while the Agency has included requirements for CAPA, it has decided not to propose continuous process improvement requirements as part of this rule.

The Agency's proposed rule utilizes an “umbrella” approach to the regulation of all types of finished and bulk tobacco products, which is similar to the approach taken by the other cGMPs and voluntary standards considered in the development of this proposal. Because this regulation would apply to many different types of tobacco products, the proposal does not prescribe in detail how a manufacturer must produce a specific tobacco product. Rather, the proposed regulation provides the framework that all manufacturers would follow by requiring that manufacturers establish and maintain procedures and fill in the details that are appropriate to a given tobacco product.

V. Description of the Proposed Regulation

A. General Provisions

1. Scope

The Tobacco Control Act gave FDA immediate authority over cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco. In addition, the Tobacco Control Act gave FDA the authority to promulgate regulations deeming other tobacco products subject to its authorities in chapter IX of the FD&C Act. In the

Federal Register

of May 10, 2016, FDA issued the Deeming Rule deeming all other products meeting the statutory definition of tobacco product to be subject to FDA's regulatory authority under chapter IX of the FD&C Act, except accessories of deemed products. 81 FR 28974. That rule became effective on August 8, 2016.

As discussed in proposed § 1120.1(a), FDA is proposing TPMP requirements that would apply to manufacturers of all finished and bulk tobacco products that are subject to chapter IX of the FD&C Act (

e.g.,

cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, ENDS, e-liquids, pipe tobacco, cigars, hookah tobacco, nicotine gels, and dissolvable tobacco products) but not their related accessories.

FDA proposes to define a ”finished tobacco product” as a tobacco product, including any component or part, sealed in final packaging (

e.g.,

a pack of cigarettes, a can of moist snuff). For the purposes of the “finished tobacco product” definition, a “package” is a pack, box, carton, or container of any kind or, if no other container, any wrapping, including cellophane, in which a finished tobacco product is offered for sale, sold, or otherwise distributed to consumers. As discussed in more detail below, the proposed

definition of finished tobacco product also includes components or parts of tobacco products sealed in final packaging (

e.g.,

rolling papers, filters, filter tubes, or e-liquids sold separately to consumers or as part of kits). FDA intends for this TPMP rule to cover manufacturers of finished tobacco products to help assure that the public health is protected and that those products are in compliance with chapter IX of the FD&C Act.

FDA proposes to define a “bulk tobacco product” as any tobacco product that is not sealed in final packaging but is otherwise suitable for consumer use as a tobacco product (

e.g.,

bulk cigarettes, bulk RYO tobacco, bulk pipe tobacco). As discussed in more detail below, the proposed definition of bulk tobacco product also includes components or parts of tobacco products that are not sealed in final packaging but are otherwise suitable for consumer use as tobacco products (

e.g.,

bulk filters, bulk e-liquids). Products that are suitable for consumer use as tobacco products are those products that do not require further processing by a tobacco product manufacturer, such as mixing, cutting, curing, blending, or adding components or parts, ingredients, additives and materials, before they can be used by a consumer. For example, an e-liquid not sealed in final packaging is suitable for consumer use as a tobacco product because it requires no additional processing by a tobacco product manufacturer before it can be used by a consumer in an ENDS device; it requires only final packaging and labeling to be a finished tobacco product. A product can be suitable for consumer use as a tobacco product even if it

could

undergo additional processing by a manufacturer, such as blending, as long as it does not

require

further processing by a manufacturer before use by a consumer. For example, coconut and pineapple e-liquids not sealed in final packaging would be considered bulk tobacco products because they are suitable for consumer use as tobacco products, even if they might later be blended together by a manufacturer to make piña colada e-liquid.

FDA is including bulk manufacturers within the scope of this proposed rule in order to cover critical regulatory gaps that would occur if the rule were to only cover manufacturers of finished tobacco products. Bulk manufacturers provide bulk tobacco products, such as bulk cigarettes, bulk RYO or pipe tobacco, and bulk e-liquids, to finished tobacco product manufacturers who merely package and/or label the products for consumer use. Bulk tobacco products are suitable for consumer use as tobacco products with no additional processing by a tobacco product manufacturer and, therefore, should be regulated in the same manner as finished tobacco products. If the scope of the rule were limited to finished tobacco product manufacturers, then entities that perform key manufacturing steps other than final packaging and labeling for consumer use, such as design and development, blending, mixing, cutting, processing, assembling, and compounding, might not be subject to any TPMP requirements. Inadequate controls in earlier stages of manufacturing could result in contaminated or otherwise nonconforming bulk tobacco products that would not be detected by a finished tobacco product manufacturer during packaging and labeling operations. In addition, a finished tobacco product manufacturer that packages or labels a bulk tobacco product may not be able to conduct adequate investigations of product complaints and implementing CAPA for issues related to product design or production processes.

As noted above, the proposed definitions of finished and bulk tobacco products would include finished and bulk components or parts of tobacco products. FDA proposes to define “component or part” for purposes of proposed part 1120 consistent with the definition of “component or part” in the Deeming Rule, codified at 21 CFR 1143.1. Accordingly, a component or part would mean any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product's performance, composition, constituents, or characteristics, or (2) to be used with or for the human consumption of a tobacco product; but would exclude anything that is an accessory of a tobacco product. The requirements of proposed part 1120 would apply to manufacturers of finished and bulk components or parts of tobacco products. This would include manufacturers of finished or bulk RYO tobacco, papers, and filters, ENDS e-liquids, atomizers, batteries (with or without variable voltage), and cartomizers (atomizer plus replaceable fluid-filled cartridge).

In determining whether software or an assembly of materials might be “intended or reasonably expected” to alter or affect a tobacco product's performance, composition, constituents, or characteristics, or to be used with or for the human consumption of a tobacco product (and, therefore, whether the software or assembly of materials is a “component or part”), the manufacturer's subjective claims of intent are not controlling. Rather, FDA considers all relevant evidence, including direct and circumstantial objective evidence, which encompasses a variety of factors, such as circumstances surrounding the distribution of the product or the context in which it is sold, sales data, and how the product is used by consumers.

The requirements of proposed part 1120 would also apply to manufacturers of finished or bulk products for general consumer use (

i.e.,

products not specifically designed for use with tobacco products) that meet the definition of finished or bulk tobacco products (including finished or bulk components or parts). For example, the requirements of proposed part 1120 would apply to manufacturers of finished or bulk batteries who intend them to be used in an ENDS device, for example by labeling or co-packaging the batteries with an ENDS device. Similarly, the rule would apply to manufacturers of finished or bulk food grade flavors who intend the flavors to be used with e-liquids. Likewise, the rule would apply to the manufacturer of a screen sold at a hardware store for a variety of general uses if that manufacturer labels the screen for use with a tobacco product, such as an ENDS, or co-packages the screen with a tobacco product.

The proposed rule would not apply to manufacturers of accessories of finished or bulk tobacco products. FDA proposes to define an “accessory” as any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored tobacco product; or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product. This proposed definition is the same as the definition of “accessory” under 21 CFR 1100.3 and under 21 CFR 1143.1. Examples of accessories of finished and bulk tobacco products include ashtrays, spittoons, hookah tongs, cigar clips and stands, and pipe pouches, because they do not contain tobacco, are not derived from tobacco, and do not affect or alter the performance, composition, constituents, or characteristics of a

tobacco product. Examples of accessories also include humidors or refrigerators that solely control the moisture and/or temperature of a stored product and conventional matches and lighters that solely provide an external heat source to initiate but not maintain combustion of a tobacco product. An electric heater or charcoal used for prolonged heating of waterpipe tobacco is not an accessory because it is maintaining the combustion of the tobacco. Accessories of deemed products are not currently subject to chapter IX of the FD&C Act. At this time, FDA believes that the proposed requirements of this rule assure that the public health is protected and that tobacco products are in compliance with chapter IX of the FD&C Act without applying the requirements to manufacturers of accessories of cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, and deemed tobacco products.

2. Umbrella Approach

This proposed rule utilizes an “umbrella” approach to the regulation of all types of finished and bulk tobacco products, which is similar to the approach taken by the other cGMPs and voluntary standards considered in the development of this proposal. Thus, the proposed regulation provides the framework that requires all finished and bulk tobacco product manufacturers subject to the rule (including specification developers, contract manufacturers, and repackagers/relabelers) to establish and maintain procedures that are unique to the manufacturer's facilities and activities, and appropriate for a given tobacco product. The proposed requirements are written in general terms to allow manufacturers to establish procedures appropriate for their specific products and operations. The extent of the procedures necessary to meet the regulation requirements may vary with the size and complexity of the design and manufacturing operations. Tobacco product manufacturers who have a complex manufacturing process would likely need to establish more detailed procedures to comply with the rule, while tobacco product manufacturers who have a less complex manufacturing process may need less extensive procedures.

3. Specification Developers

As discussed in proposed § 1120.1(a), manufacturers of finished and bulk tobacco products include specification developers, contract manufacturers, and repackagers and relabelers. If a specification developer designs and establishes tobacco product specifications of a finished or bulk tobacco product and provides the specifications to a contract manufacturer to physically manufacture the product, both the specification developer and the contract manufacturer would be engaged in the manufacture and/or preproduction design validation of finished or bulk tobacco products for purposes of this rule and would be required to comply with this proposed rule. This approach is similar to other cGMP and HACCP regulations that have been applied to other FDA-regulated products, such as part 820, QSR for medical devices, and part 211, cGMP for finished pharmaceuticals.

A specification developer is a person who controls the design and development of a tobacco product and/or initiates or creates the specifications for the product. Such activities are important steps in the manufacture and preproduction design validation of a tobacco product. A specification developer is, in concept, like an architect who creates a “blueprint” of a tobacco product. A specification developer may be the same party that physically manufactures the tobacco product or a separate entity that only provides specification development services to another manufacturer, who then physically manufactures the tobacco product. FDA is aware that some tobacco product manufacturers have established an organizational structure that places the specification development functions in an entity separate from the entity in charge of physically manufacturing the finished or bulk tobacco product; these entities develop and usually control changes to the specifications of the tobacco product. Such entities are specification developers under the proposed rule.

A tobacco product manufacturer may utilize a specification developer to initiate or create the specifications of a finished or bulk tobacco product when the manufacturer lacks knowledge or expertise in product design and development. Specifically, a manufacturer may want to produce a tobacco product with certain features but lack the knowledge needed to design such a product and translate the desired features into particular product specifications. For example, a cigarette manufacturer who wants to manufacture a cigarette with certain constituent yields and consumer sensory qualities may use a specification developer to create appropriate specifications for the product, such as the specific tobacco blend, paper type and grade, filter ventilation, additives, and other features. A tobacco product manufacturer who intends to manufacture a dissolvable lozenge, orb, or strip smokeless tobacco product may similarly involve a specification developer to create appropriate product specifications such as tobacco mixtures, pH, additives, colorants, size and shape, and packaging materials. A tobacco product manufacturer who wants to commercially market an e-cigarette with certain performance features such as particular power levels, aerosol particle size, pressure drop, airflow, and puff count may similarly use a specification developer who can design a product with such features and translate them into appropriate specifications, including cartridge, atomizer, heating element, battery, and circuit board/software specifications.

FDA proposes to regulate specification developers under this rule because product design and the development of product specifications are integral parts of the manufacturing and preproduction design validation process. Product design and specification development are important because these can affect the level of risk or harm (

e.g.,

toxicity, addictiveness) a tobacco product consumer may be exposed to when using tobacco products, and, in the absence of proper controls, can also result in harm not normally associated with the use of a tobacco product.

FDA has authority to include requirements about product design in its TPMP regulation. Specifically, section 906(e) of the FD&C Act provides, in part, that FDA shall prescribe regulations requiring that the methods used in and the facilities and controls used for tobacco-product manufacture and preproduction design validation (including a process to assess the performance of a tobacco product) conform to current good manufacturing practice, or HACCP methodology. Requiring specification developers to comply with TPMP provisions is consistent with that authority.

FDA believes that it is necessary to apply the proposed TPMP regulation to specification developers because of their key role in the manufacture and preproduction design validation of finished and bulk tobacco products and because, under certain circumstances, a specification developer may be the most appropriate party or even the only capable party, to adequately perform certain activities required under the proposed regulation. Design and development frequently involve knowledge of trade secrets and/or other confidential commercial information, and a specification developer may not

share such information with the entity that physically manufactures the finished or bulk tobacco product.

Such activities include, for example, conducting adequate investigations of product complaints and implementing CAPA for issues related to product design. For example, if complaints are received that users are experiencing respiratory distress from the aerosol of an ENDS product, only a specification developer may be able to conduct an adequate investigation to determine the cause of problems and implement the necessary actions to correct and prevent the problems. The finished or bulk ENDS manufacturer who physically manufactures the product may be able to rule out a manufacturing problem (

e.g.,

defectively manufactured solder joints), but it may not be able to determine the cause of the problem if the issue relates to design (

e.g.,

metallic particles that result from improper material selection for the cartomizer wires). In that case, only the specification developer may have the unique knowledge regarding the product's design and history of specification development necessary to determine the cause of the problem and how to address it.

Similarly, if complaints are received that the software of an ENDS product that controls the heat and temperature functions is being altered or hacked by users and causing malfunctions that result in overheating, fires, or explosions, the specification developer—not the manufacturer who physically manufactures the product—would have the expertise to conduct a thorough investigation and initiate a CAPA to redesign the software to prevent this user misuse.

Specification developers are also the only party capable of adequately performing certain activities included in the proposed product development control requirements, such as identifying known or reasonably foreseeable risks associated with the design of the tobacco product and/or package as well as design verification and validation activities. With product design and development knowledge, the specification developer would be in the best position to identify and take appropriate measures to treat risks associated with the design of the tobacco product and package that are not normally associated with the use of the tobacco product and package, or that it determines constitute an unacceptable level of risk. For example, a specification developer of a dissolvable tobacco product (

e.g.,

a tobacco lozenge) would have the knowledge to address possible misuse of the product by a child that could cause choking or inadvertent exposure and to take appropriate measures to redesign the size and shape of the tobacco product or redesign the packaging. As another example, a specification developer of a heat-not-burn tobacco product would have the knowledge to assess whether the product could reach temperatures that could cause burns and to take appropriate measures to reduce this risk.

Accordingly, FDA believes that requiring specification developers to comply with the proposed TPMP requirements is essential to ensure that the proposed TPMP regulation operates as intended.

4. Foreign Manufacturers

Further, FDA is proposing that foreign manufacturers of finished or bulk tobacco products that are imported or offered for import into the United States be covered under this TPMP rule. In accordance with section 906(e) of the FD&C Act, FDA believes that covering foreign manufacturers is necessary to assure the protection of the public health. The risks associated with the tobacco product, production process, packaging, and storage are the same for all tobacco products covered by this proposed rule, regardless of where they are manufactured, and all can be addressed by the same types of controls. For example, the proposed design and development controls (proposed subpart D) would address these risks, including risks associated with the design of ENDS products that are primarily designed and manufactured in China and for which there have been numerous reports of battery fires and explosions (

e.g.,

Ref. 7).

In addition, having the proposed rule apply to foreign manufacturers of finished or bulk tobacco products would be necessary to ensure that imported tobacco products comply with chapter IX of the FD&C Act. For example, the proposed controls (

e.g.,

design and development controls, MMR, acceptance activities, and production record requirements) would help to ensure that imported tobacco products meet all applicable tobacco product standards, and thus avoid being adulterated or misbranded. A tobacco product which is subject to a tobacco product standard is adulterated under section 902(5) of the FD&C Act unless the product is in all respects in conformity with the standard. Similarly, a tobacco product subject to a tobacco product standard is misbranded under section 903(a)(9) of the FD&C Act unless it bears such labeling as may be prescribed in the standard.

5. Vape Shops Engaged in the Manufacture of Tobacco Products

Vape shops are establishments that generally, among other things, sell a variety of products including ENDS, replacement pieces, hardware, custom mixed e-liquids, and other related accessories. Sales of such products, standing alone, would not constitute finished or bulk tobacco product manufacturing. However, some vape shops are also tobacco product manufacturers under the Deeming Rule, 81 FR at 29044, because they also (for example) mix or prepare e-liquids or create or modify aerosolizing apparatuses for direct sale to consumers for use in ENDS. Under the proposed regulation, vape shops engaged in these additional activities would be manufacturers of finished or bulk tobacco products. When such vape shops are engaged in the manufacture, preproduction design validation, packing, and storage of finished or bulk tobacco products within the meaning of the proposed rule, they would be subject to the requirements in this proposed TPMP rule. Requiring such manufacturers to comply with TPMP requirements, as proposed, is important for protecting the public health because products manufactured at the retail level pose many of the same public health risks as those manufactured upstream, and possibly additional risks related to the lack of standard manufacturing practices and controls. A vape shop that does not engage in the activities described above would not be a finished or bulk tobacco product manufacturer subject to the requirements of this proposed part 1120. In addition, as set out immediately below, proposed § 1120.1(b) would require a finished and bulk tobacco product manufacturer to comply only with requirements applicable to its finished and bulk tobacco product manufacturing operations. Therefore, smaller tobacco product manufacturers (such as vape shops that engage in some but not all of the activities described above) would be able to tailor their procedures to suit their smaller operations while still complying with the proposed TPMP requirements.

6. Compliance With Requirements Applicable to Operations

Proposed § 1120.1(b) clarifies that if a tobacco product manufacturer engages in some operations subject to the requirements of proposed part 1120, but not others, the manufacturer need only comply with those requirements applicable to the operations in which it is engaged. This is the same approach

used in the drug cGMP regulation at § 210.2(b) and the device QSR at § 820.1(a)(1).

For example, a manufacturer of finished e-liquids would not need to comply with the warning plan requirements in proposed § 1120.98 because e-liquids are only required to bear a single warning. Similarly, a finished cigarette manufacturer who does not engage in repackaging or relabeling operations would not need to comply with the repackaging and relabeling requirements in proposed § 1120.94. Likewise, a specification developer who only designs/creates the MMR for another manufacturer's tobacco product and does not engage in any physical manufacturing would not be subject to, for example, the proposed requirements in subparts C (Buildings, Facilities, and Equipment), E (Production Processes and Controls), and G (Handling, Storage, and Distribution). If manufacturers believe a requirement is not appropriate or necessary to ensure that the public health is protected and that the tobacco product will be in compliance with this chapter, they may petition for an exemption or variance from all or part of the regulation pursuant to proposed § 1120.142.

Proposed § 1120.1(c) clarifies the term “where appropriate,” which appears several times in proposed part 1120. As discussed in proposed § 1120.1(c), when a requirement is qualified with “where appropriate,” it is deemed to be appropriate unless the tobacco product manufacturer documents in writing (on paper or electronically) an adequate justification prior to abstaining from implementing the requirement. An adequate justification would address why abstaining from the requirement would not result in a nonconforming tobacco product or in the manufacturer not being able to carry out necessary corrective actions. In this circumstance, the manufacturer need not petition for or receive an exemption or variance under § 1120.140. Proposed § 1120.1(d) notes that requirements in proposed part 1120 are intended to protect the public health and assure that tobacco products are in compliance with the relevant provisions of the FD&C Act and explains that the failure to comply with any applicable provision in proposed part 1120 would render the tobacco product adulterated under section 902(7) of the FD&C Act.

7. Other Manufacturers and Request for Comment

At this time, FDA is not proposing to apply these proposed TPMP requirements to manufacturers of tobacco products other than finished and bulk tobacco products. In particular, the proposed regulation will not reach manufacturers of components or parts that are not offered for sale, sold, or otherwise distributed to consumers,

i.e.,

components or parts for further manufacture. For example, the rule would not apply to manufacturers of filter tow material and cigarette tipping paper that are intended or reasonably expected to be used to manufacture a cigarette, because those products are not sold to consumers. The proposed rule's current scope does not reach such components or parts directly, but rather requires incoming tobacco product components or parts, ingredients, additives, and materials to be subject to purchasing controls and acceptance activities implemented by finished and bulk tobacco product manufacturers to ensure that they meet established specifications. In addition, FDA is not currently proposing to apply these proposed requirements to manufacturers of accessories.

FDA is soliciting comment on the scope of the proposed rule, as well as whether the scope of this regulation should be expanded to reach more than finished and bulk tobacco products. If you believe that FDA should expand the scope of this proposed rule to reach additional tobacco products, please explain why you believe FDA should take that approach; which proposed requirements, if any, should apply to other manufacturers; whether the regulation should cover manufacturers of all regulated tobacco products, including all components or parts, or only manufacturers of certain products; as well as any public health data and information that would support what you believe would be the appropriate scope of this rule. Alternatively, if you believe that FDA should limit the scope of the proposed regulation, please explain why you believe the scope of the rule should be more limited than finished and bulk tobacco product manufacturers and provide any data or information that would support that such a limited scope would still assure that the public health is protected and that tobacco products are in compliance with chapter IX of the FD&C Act.

8. Definitions

Proposed § 1120.3 sets forth the meaning of terms used in proposed part 1120.

•

Accessory.

We propose to define “accessory” as any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored tobacco product; or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Examples of accessories are ashtrays, spittoons, hookah tongs, cigar clips and stands and pipe pouches, because they do not contain tobacco, are not derived from tobacco, and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product. Examples of accessories also include humidors or refrigerators that solely control the moisture and/or temperature of a stored product and conventional matches and lighters that solely provide an external heat source to initiate but not maintain combustion of a tobacco product. An electric heater or charcoal used for prolonged heating of waterpipe tobacco is not an accessory because it is used to maintain the combustion of the tobacco.

•

Additive.

We propose to define “additive” as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical. An additive can be a type of ingredient in a tobacco product; an example is methyl salicylate in smokeless tobacco, which can serve as an absorption enhancer and affect the characteristics of the tobacco product by changing the rate of absorption into the body.

•

Batch.

We propose to define “batch” as a specific identified amount of tobacco product produced in a unit of time or quantity and that is intended to have the same specifications. FDA proposes to give tobacco product manufacturers flexibility to determine what unit of time or quantity is appropriate for their product, and how batches would be designated. For example, manufacturers likely would define a batch for cigarette production, which is almost continuous, differently

than a batch for smokeless tobacco, which likely would be defined based on the amount processed in a vat through the fermentation process.

•

Brand.

We propose to define “brand” as a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of such attributes.

•

Bulk tobacco product.

We proposed to define “bulk tobacco product” as a tobacco product not sealed in final packaging but otherwise suitable for consumer use as a tobacco product. Products that are suitable for consumer use as a tobacco product are those products that do not require further processing by a tobacco product manufacturer before they can be used by a consumer, such as mixing, cutting, curing, blending, and adding components or parts, ingredients, additives and materials. A tobacco product can be suitable for use even if it

could

undergo additional processing by a manufacturer as long as it does not

require

further processing by a manufacturer before use by a consumer. Examples of bulk tobacco products include bulk RYO tobacco, bulk pipe tobacco, bulk RYO filters, and bulk e-liquids. However, cigarette paper that is supplied on a bobbin roll would not be considered a bulk tobacco product because it would need to be cut into rolling paper sizes or combined/glued with filters to make cigarette tubes. The terms “bulk tobacco product” and “finished tobacco product” are distinguishable because bulk tobacco products are not sealed in final packaging, whereas finished tobacco products are sealed in final packaging.

•

Characteristic.

We propose to define “characteristic” as the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

•

Component or Part.

We propose to define “component or part” as any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product's performance, composition, constituents, or characteristics or (2) to be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.

•

Contaminated tobacco product.

We propose to define “contaminated tobacco product” as a tobacco product that contains a substance not ordinarily contained in that tobacco product. “Not ordinarily contained” refers to a substance that is not intended or expected to be in that tobacco product. As stated in proposed § 1120.3, an example of a contaminated tobacco product is a smokeless tobacco product with metal fragments in the tobacco filler.

•

Design.

We propose to define “design” as the form and structure concerning and the manner in which components or parts, ingredients, additives, and materials are integrated to produce a tobacco product.

•

Direct accounts.

We propose to define “direct accounts” as all persons who are customers of the tobacco product manufacturer that receive finished or bulk tobacco products directly from the manufacturer or from any person under control of the manufacturer. Direct accounts may include wholesalers, distributors, and retailers. Direct accounts do not include individual purchasers of tobacco products for personal consumption.

•

Establish and maintain.

We propose to define “establish and maintain” as to define, document in writing (on paper or electronically), implement, follow, and update. Multiple requirements in the proposed regulation direct manufacturers to “establish and maintain” certain procedures. For example, proposed § 1120.12(e)(1) would require tobacco product manufacturers to establish and maintain procedures for identifying training needs and establishing training frequency for personnel based on the work the employee performs. Therefore, to comply with proposed § 1120.12(e)(1), a manufacturer would be required to create written procedures for identifying and meeting training needs, implement and follow the written procedures, and update the procedures as needed.

•

Equipment.

We propose to define “equipment” as any machinery, tool, instrument, utensil, or other similar or related article, used in the manufacture, preproduction design validation, packing, or storage of a tobacco product. Equipment used during testing and laboratory activities conducted as part of the manufacturing process would be covered under this proposed definition.

•

Finished tobacco product.

We propose to define “finished tobacco product” as a tobacco product, including any component or part, sealed in final packaging. Additional examples of finished tobacco products include a pack of cigarettes, a can of moist snuff, and rolling papers, filters, filter tubes, or e-liquids sold to consumers. One finished tobacco product may contain others. For example, a carton of cigarette packs (which are finished tobacco products) is also a finished tobacco product, because, like a cigarette pack, a carton is a tobacco product sealed in final packaging. As noted below, final packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a finished tobacco product is offered for sale, sold, or otherwise distributed to consumers. (See definition of packaging).

•

Ingredient.

We propose to define “ingredient” as tobacco, substances, compounds, or additives contained within or added to the tobacco, paper, filter, or any other component or part of a tobacco product, including substances and compounds reasonably expected to be formed through chemical action during tobacco product manufacturing.

For example, an ingredient may be a single chemical substance, leaf tobacco, or the product of a reaction, such as a chemical reaction, in manufacturing. Examples of substances and compounds (ingredients) reasonably expected to be formed through a chemical reaction during tobacco product manufacturing include the following:

—The reaction of sugars with amines to form families of compounds with new carbon-nitrogen bonds, including Maillard reaction products and Amadori compounds;

—the reaction of sodium hydroxide with citric acid to form sodium citrate;

—the production of ethyl alcohol, a residual solvent, from ethyl acetate during production of tipping paper adhesive;

—products of thermolytic reactions,

—such as the production of carboxylic acids from sugar esters;

—products of enzymatically or nonenzymatically catalyzed reactions, such as the hydrolytic production of flavor or aroma precursors from nonvolatile glucosides; and

—products of acid-base reactions, such as removal of a proton from protonated nicotine to generate the basic form of nicotine (“free” nicotine). 86 FR 55300 at 55313 (Oct. 5, 2021).

•

Label.

We propose to define “label” as a display of written, printed, or graphic matter upon the immediate container of any article. For finished tobacco products, the term label means a display of written, printed, or graphic matter upon the immediate container of any finished tobacco product. Likewise, for a bulk tobacco product, the term label means a display of written, printed, or graphic matter upon the immediate container of any bulk tobacco product.

•

Labeling.

We propose to define “labeling” as all labels and other

written, printed, or graphic matter: (1) upon any article or any of its containers or wrappers or (2) accompanying such article.

•

Management with executive responsibility.

We propose to define “management with executive responsibility” as one or more designated personnel who have the authority and responsibility to ensure compliance with TPMP requirements, including allocating resources and making changes to the organizational structure, buildings, facilities, equipment or the manufacture, preproduction design validation, packing, and storage of a tobacco product. These employees are typically senior employees with the authority to establish or make changes to tobacco product manufacturing policies. Such person(s) also would be responsible for ensuring that TPMP requirements are communicated, understood, implemented, and followed at all levels of the organization.

•

Manual method, process, or procedure.

We propose to define “manual method, process, or procedure” as any nonautomated method, process, or procedure, including processes performed by hand with or without the use of equipment.

•

Manufacturing.

We propose to define “manufacturing” as the manufacturing, fabricating, assembling, processing, or labeling, including the repackaging or relabeling, of a tobacco product. The term “manufacturing” includes establishing the specifications of a finished or bulk tobacco product. Examples of manufacturing activities include expanding (a process used with the tobacco leaf, typically dry ice expanded tobacco), homogenizing, mixing, and formulating a tobacco product.

•

Manufacturing code.

We propose to define “manufacturing code” as any distinctive sequence or combination of letters, numbers, or symbols that begins with the manufacturing date followed by the batch number. The purpose of the manufacturing code is to allow manufacturers and FDA to identify the production batch of a particular finished or bulk product that has been released for distribution. This information is intended to help determine the product's history (

e.g.,

batch production records) and assist manufacturers and FDA in the event of a nonconforming product investigation and any corrective actions to be taken as a result of the investigation.

•

Manufacturing date.

We propose to define “manufacturing date” as the month, day, and year in 2-digit numerical values in the format (MMDDYY) that a finished or bulk tobacco product is packaged for distribution. The manufacturing date is included in the manufacturing code.

•

Manufacturing material.

We propose to define “manufacturing material” as material used in or used to facilitate the manufacturing process that is not equipment and is not intended to be part of the product. Such material would have to contact the tobacco product or tobacco product-contact surface. An example of manufacturing material would be a mold release agent used to facilitate the release of a tobacco product from a mold.

•

Master manufacturing record (MMR).

We propose to define “master manufacturing record” as a document or designated compilation of documents containing the established specifications for a tobacco product including acceptance criteria for those specifications, all relevant manufacturing methods and production process procedures for the tobacco product, and all approved packaging, labeling, and labels for the tobacco product. Tobacco product specifications, as used in this definition, may be established by the manufacturer or required by FDA. The MMR may be prepared either as a single document (or single file of documents) or as a product-specific index system that references and includes the location of all the required information.

•

Nonconforming tobacco product.

We propose to define “nonconforming tobacco product” as any tobacco product that does not meet a product specification in the MMR (see proposed § 1120.44(a)(1)); has packaging, labeling, or labels other than those included in the MMR (see proposed § 1120.44(a)(3)); or is a contaminated tobacco product.

•

Not normally associated.

We propose to define “not normally associated” as not an inherent risk of using the tobacco product. In this context, the inherent risk would be associated with using the specific category of tobacco product. For example, inherent risks of using cigarettes include cancers of the mouth, throat, larynx, esophagus, trachea, lung, stomach, liver, pancreas, kidney, bladder, cervix, and colon/rectum, as well as one form of leukemia (Ref. 14). Other examples of inherent risks of using cigarettes include stroke, heart disease, peripheral vascular disease, COPD, tuberculosis, asthma, pneumonia and other respiratory diseases (id.). Examples of inherent risks of cigars include oral, laryngeal, pharyngeal, and esophageal cancers, as well as lung cancer and heart disease (Ref. 15). Examples of inherent risks of smokeless tobacco include oral and pancreatic cancers (Ref. 16).

Examples of risks not normally associated with tobacco products include lacerations of the gums or lips due to metal fragments found in chewing tobacco; broken teeth caused by rocks found in chewing tobacco; bodily injury caused by an exploding battery of an ENDS product; vomiting, nausea, allergic reactions, dizziness, numbness, or headaches caused by toxic chemical compounds found in nonconforming products; a serious illness caused by a tobacco product contaminated by aflatoxin from a fungus; and acute breathing difficulties associated with an allergic reaction to a contaminated tobacco product (

e.g.,

Ref. 17).

•

Package

or

packaging.

We propose to define “package” or “packaging” as a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a finished tobacco product is offered for sale, sold, or otherwise distributed to consumers (this is also referred to as final package or final packaging), or in which a bulk tobacco product is offered for sale, sold, or otherwise distributed (including commercial distribution and interplant transfers). For example, under the proposed definition, a carton offered for sale to consumers, which holds individual cigarette packages, would be considered a “package” or “packaging.” However, a shipping crate that holds multiple cartons of cigarettes, or other multiple quantities of finished tobacco products, for distribution to retailers would not be considered “packages” or “packaging,” because such shipping crates for distribution to retailers are not containers or wrapping in which a finished tobacco product is offered for sale, sold, or otherwise distributed to consumers. We use the terms “package” and “packaging” interchangeably throughout this proposed rule.

•

Personnel.

We propose to define “personnel” as all persons, including managers, staff, consultants, contractors, and third-party entities, performing services for the manufacturer subject to proposed part 1120. The term “personnel” includes independent contractors performing services for the manufacturer.

•

Relabeling.

We propose to define “relabeling” as operations in which the labeling of a finished tobacco product is subsequently changed or replaced. This may be performed by the same person who originally labeled the product. For example, if a finished tobacco product fails an acceptance activity because it bears the wrong label, the manufacturer

may relabel the product with the correct label.

•

Repackaging.

We propose to define “repackaging” as operations in which the packaging of a finished tobacco product is subsequently changed or replaced. This may be performed by the same person who originally packaged the product. For example, if the package of a finished tobacco product is damaged during storage, the manufacturer may repackage the finished product in a new package.

•

Representative sample.

We propose to define “representative sample” as a sample that consists of a number of units that are drawn based on a valid scientific rationale (such as random sampling) and intended to ensure that the sample accurately reflects the material being sampled.

•

Reprocessing.

We propose to define “reprocessing” as using tobacco product that has been previously recovered from manufacturing in the subsequent manufacture of a finished or bulk tobacco product. FDA has observed that reprocessing is a routine manufacturing process. An example of reprocessing would be using tobacco recovered through a ripper short process for cigarettes (where tobacco is removed from rejected cigarettes using equipment such as feeders, shakers, and separators) to make other cigarettes. Similar reprocessing occurs for smokeless tobacco, where the tobacco is recovered from rejected finished or bulk tobacco products, for example, due to incorrect weight or defective packaging/labels, and then used to make other smokeless tobacco products.

•

Returned tobacco product.

We propose to define “returned tobacco product” as commercially distributed finished or bulk tobacco product returned to the tobacco product manufacturer by any person not under the control of the tobacco product manufacturer, including a wholesaler/distributor, retailer, consumer, or member of the public. Individuals may return tobacco products to the manufacturer for a number of reasons, including improper weight or taste.

•

Rework.

We propose to define “rework” as action taken on a nonconforming or returned tobacco product to ensure that the product meets the specifications and other requirements in the MMR of a subsequently manufactured tobacco product before it is released for further manufacturing or distribution. For example, a smokeless tobacco product that fails an acceptance activity for pH level can be reworked by further fermentation.

•

Small tobacco product manufacturer.

We propose to define “small tobacco product manufacturer” as a tobacco product manufacturer that employs fewer than 350 employees. For purposes of this definition, the number of employees of a manufacturer includes those employees and personnel of each entity that controls, is controlled by, or is under common control with such manufacturer.

•

Specification.

We propose to define “specification” as any requirement with which a product, process, service, or other activity must conform. A tobacco product specification is a requirement established by the manufacturer (including specification developer, contract manufacturer, or repackager/relabeler), including a requirement established to ensure that the tobacco product meets any applicable product standard under section 907 of the FD&C Act. Tobacco product specifications can include physical, chemical, and biological specifications. Examples of physical specifications include length, circumference, and pressure drop for cigarettes, and cut size and weight for smokeless tobacco products. An example of a chemical specification is a pH level for smokeless tobacco products, and an example of a biological specification is a specification related to the use of a biological fermentation agent used during the manufacturing process for smokeless tobacco products. Examples of a production process specification are the upper and lower temperature and humidity limits for specified durations, as part of the fermentation process for a smokeless tobacco product. An example of a service specification is a requirement with which a pest control service must conform.

This proposed rule would require that the tobacco product specifications and acceptance criteria for those specifications be included in the MMR for each finished and bulk tobacco product. For example, if an ENDS manufacturer establishes a voltage specification for an adjustable, variable voltage product with a range of 3-6V, the MMR would have to indicate the voltage acceptance criteria that reflect the tolerance that is established around the upper and lower specifications.

•

Tobacco product.

The term “tobacco product” means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term “tobacco product” does not mean an article that is a drug under section 201(g)(1) (21 U.S.C. 321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The term “tobacco product” does not mean an article that is a food under section 201(f) (21 U.S.C. 321(f)), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.

•

Tobacco product-contact surface.

We propose to define “tobacco product-contact surface” to mean a surface that comes into contact with a tobacco product or a surface from which drainage (or other transfer) ordinarily occurs onto the tobacco product or onto surfaces that come into contact with the tobacco product during the normal course of operations. This definition would include surfaces of equipment that come into contact with the tobacco product.

•

Tobacco product manufacturer.

We propose to define the term “tobacco product manufacturer” as any person(s), including any repacker or relabeler, who: manufactures, fabricates, assembles, processes, or labels a tobacco product; or imports a finished tobacco product for sale or distribution in the United States. Tobacco product manufacturer includes any person(s) who establishes the specifications for a tobacco product.

FDA does not propose to define “tobacco product manufacturer” to include third-party laboratories. A finished or bulk tobacco product manufacturer who uses a third-party laboratory is responsible for ensuring that the laboratory is qualified to provide services under proposed § 1120.62 and is competent to perform laboratory activities associated with the manufacture of a finished or bulk tobacco product under proposed § 1120.68. A finished or bulk tobacco product manufacturer who uses a third-party laboratory is also responsible for ensuring that it receives from the third-party laboratory all the documents and records (including all metadata) needed to comply with the proposed TPMP requirements, including, for example, proposed §§ 1120.68(c) and 1120.122. It is the finished or bulk tobacco product manufacturer, not the laboratory, that is required to comply with the laboratory control requirements in proposed § 1120.68.

•

Unique identifier.

We propose to define “unique identifier” as information, such as a code or number, that is maintained for each accepted incoming product that would enable the

tobacco product manufacturer and FDA to identify the supplier and unique shipment of the incoming product.

•

Validation.

We propose to define “validation” as confirmation by examination and objective evidence that the particular requirements can be consistently fulfilled. An example of a validation activity would be the validation of the smokeless tobacco fermentation process, which would demonstrate that when key parameters (

e.g.,

temperature, pH, oven volatiles, and number of turns) are met, conforming product will be produced in that batch. The relevant parameters would be monitored to confirm that the batch was produced within the validated ranges for the fermentation process.

•

Verification.

We propose to define “verification” as confirmation by examination and objective evidence that specified requirements have been fulfilled. Examples of verification activities would include measuring a dimension such as the length or circumference of a cigarette or cigar to confirm it meets a specified requirement, conducting a laboratory analysis of a pH level to confirm it is within a specified range, and performing a visual comparison of a hand-rolled cigar against a standard or approved model to confirm the proper shape and dimensions of that finished cigar.

B. Management System Requirements

1. Organization and Personnel

Proposed § 1120.12 describes the proposed requirements for finished and bulk tobacco product manufacturers' organization and personnel. This section forms the foundation for manufacturers to adequately perform and comply with the proposed requirements under proposed part 1120. These proposed requirements are generally similar to the organization and personnel requirements in the industry recommendations, and similar practices that FDA has observed during establishment inspections.

Specifically, proposed § 1120.12(a) would require finished and bulk tobacco product manufacturers to establish and maintain an organizational structure that will ensure that their manufacturing operations meet the requirements of part 1120. The organizational structure should clearly delineate the parts of the organization and personnel responsible for complying with the proposed requirements. FDA has observed that it is standard industry practice to maintain an organizational structure, position descriptions, and employee training programs.

Proposed § 1120.12(b) would require finished and bulk tobacco product manufacturers to employ sufficient personnel to carry out the requirements of proposed part 1120. Personnel must have the background, education, training, and experience, or any combination thereof, needed to carry out the requirements of proposed part 1120. Each manufacturer should determine the appropriate background and necessary education for personnel to carry out these requirements. A manufacturer may determine that appropriate certifications and job-related trainings are necessary for a particular job function. For example, employees responsible for quality assurance could take classes or coursework relevant to their role auditing the production process and evaluating the final product for conformance to tobacco product specifications and other requirements established in the MMR. FDA recommends that such training be updated on a regular basis so that responsible employees are aware of current procedures and controls to ensure that they can consistently meet the requirements of proposed part 1120. Proposed § 1120.12(b) would also require manufacturers to maintain appropriate written records of the background, education, training, and experience of its personnel in the format described in proposed § 1120.12(f) and discussed in more detail below.

Proposed § 1120.12(c) would require each finished and bulk tobacco product manufacturer to designate, in writing (on paper or electronically), the appropriate responsibility and authority for all personnel who perform an activity subject to proposed part 1120. Therefore, while proposed § 1120.12(a) would require manufacturers to establish an organizational structure, this provision would require manufacturers to specifically designate the responsibilities and authority for those personnel who would be responsible for performing the activities required under proposed part 1120. This provision would help manufacturers to ensure that their tobacco products conform to their established specifications and reduce the likelihood that nonconforming products would be distributed to consumers.

Proposed § 1120.12(d) would require finished and bulk tobacco product manufacturers to designate, in writing (on paper or electronically), management with executive responsibility that has the duty, power, and responsibility to implement the proposed requirements under proposed part 1120. Management with executive responsibility refers to those individual(s) who are ultimately responsible for ensuring compliance with proposed part 1120. This responsibility would include the allocation of resources, including facilities, equipment, materials, controls, and personnel used for the manufacture, preproduction design validation, packing, and storage of a tobacco product. These employees are typically senior employees with the authority to establish or make changes to tobacco product manufacturing policies and ensure that they are effectively communicated throughout the organization. Management with executive responsibility would be required to establish and maintain required processes and procedures to ensure compliance with requirements under proposed part 1120. Such person(s) also would be required to ensure that TPMP requirements are communicated, understood, implemented, and followed at all levels of the organization. FDA believes that this proposed requirement is generally similar to existing industry practice.

Proposed § 1120.12(e) would require finished and bulk tobacco product manufacturers to establish and maintain training procedures. This provision would require that training procedures identify training needs and establish training frequency for personnel based on the work the employee performs. Under this provision, manufacturers should assess whether employees need periodic or refresher training. FDA is not proposing to prescribe the extent and frequency of training or type of training, but rather the Agency believes that manufacturers should have the flexibility to determine how to adequately train their personnel to perform their assigned responsibilities in accordance with proposed part 1120. For example, some tobacco manufacturing facilities are only open for portions of the year and staffed with seasonal personnel. In this case, a manufacturer may opt to train its personnel at the start of each new manufacturing season.

Proposed § 1120.12(e) would also require finished and bulk tobacco product manufacturers to train personnel on their assigned responsibility and on the TPMP requirements relevant to their responsibility. Under this provision, manufacturers would not be required to train personnel on all the requirements of the proposed regulation, but rather on the provisions of the regulation that are relevant to their assigned responsibility,

including their understanding of the relevant procedures and how to maintain applicable records. Training should also cover the consequences of improper performance so that personnel will be apprised of nonconformities that can result if they do not adequately perform their assigned responsibility and implement the tobacco product manufacturing requirements relevant to their responsibility.

Proposed § 1120.12(f) establishes the format for training records required by § 1120.12(b). These training records would be required to include the type and description of the training, the training date, the names of the parties performing and taking the training, and documentation supporting completion. Training records should demonstrate which personnel were trained, identify the training completed, and illustrate whether that personnel received the proper training for their job functions. Documentation supporting completion may include the results of an assessment or examination given to personnel upon completion of the training.

The Agency believes that the proposed organization and personnel requirements would assure that the public health is protected by requiring that the responsible individuals at all levels of the organization have the knowledge, experience, and training to ensure that the establishment manufactures and distributes tobacco products that conform to established specifications and are not contaminated during the manufacturing process. Deficiencies in personnel qualification and training could increase the likelihood that a company manufactures and distributes nonconforming tobacco products. For example, one company found that spotting and staining of nonconforming finished cigarettes was due to improper training, when personnel used plasticizer instead of casing in the manufacturing process (Ref. 18). In addition, if an employee responsible for analyzing samples in the lab is not properly trained on the techniques for sample preparation and extraction to measure for pH in smokeless tobacco, the results may be unreliable and could lead to products that do not conform to the established specifications for distribution. The pH can influence the availability of nicotine and increase the risk to consumers beyond those normally associated with the product (Ref. 19).

In addition, the Agency believes that the proposed personnel requirements would help assure that tobacco products are in compliance with the requirements of chapter IX of the FD&C Act. In particular, the proposed requirements would help ensure that personnel with proper background and expertise are participating in and monitoring the production process, thus ensuring that the tobacco product does not become adulterated or misbranded under section 902 or section 903 of the FD&C Act. The proposed requirements also would help ensure that new and modified risk tobacco products (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. For example, for an SE product, qualified personnel are needed to ensure that tobacco products are manufactured to the specifications described in the SE report. Similarly, these proposed personnel requirements would help ensure that tobacco products that were commercially marketed in the United States as of February 15, 2007 (pre-existing products), continue to be manufactured consistently with their original characteristics.

Qualified and trained personnel are vital to a controlled production process. Requiring manufacturers to have qualified personnel with designated roles and who are appropriately trained would help ensure that personnel are competent in their assigned roles. This, in turn, would help ensure that manufacturing operations are performed correctly and would reduce the chances of adulteration during the manufacturing process. For example, qualified personnel with specific responsibilities to clean tobacco product-contact surfaces 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. This would also help ensure that products are not prepared or held under insanitary conditions.

2. Tobacco Product Complaints

Proposed § 1120.14 sets forth the requirements for the receipt, evaluation, investigation, and documentation of all complaints. FDA considers a “complaint,” in this context, to be any communication (including written, electronic, and oral communication) that the tobacco product does not meet expectations, is unsatisfactory or unacceptable, or appears to be a nonconforming product. Tobacco product complaints may come from any source, including healthcare professionals, consumers, the public, and businesses (

e.g.,

retailers, other tobacco product manufacturers).

The proposed requirements are generally similar to complaint handling processes that FDA has observed during establishment inspections. For example, FDA is aware that tobacco product manufacturers generally maintain complaint records containing information about nonconforming tobacco products, such as incorrectly packaged tobacco products, filters that fall off the filter rod of a cigarette, broken or torn cigarettes, filter plug problems, and irregular and improper burning of cigarettes. FDA is also aware of complaint records containing information about contaminants and hazards in finished tobacco products such as NTRMs (

e.g.,

metal, glass, nails, pins, wood, dirt, sand, stones, rocks, fabric, cloth, plastics), biological materials (

e.g.,

mold, mildew, hair, fingernails), oil or greasy spots on cigarettes, chemicals (

e.g.,

ammonia, cleaning agents, kerosene), and the presence or infestation of tobacco beetles or insects. Further, FDA is aware that manufacturers maintain reports of complaints such as exploding e-cigarettes, excessive heating during use and charging of ENDS, as well as cuts and lacerations, broken teeth, vomiting, nausea, burns, allergic reactions, dizziness, numbness, headaches, and other personal or property damage reported to tobacco product manufacturers. These experiences and records have informed the proposed complaint requirements.

Given the clear importance of tobacco product complaints in alerting manufacturers and FDA to product problems, proposed § 1120.14(a) would require finished and bulk tobacco product manufacturers to establish and maintain procedures for the receipt, evaluation, investigation, and documentation of all tobacco product complaints. FDA believes it is necessary for manufacturers to establish and maintain procedures to address all activities related to complaints (

i.e.,

receipt and processing; evaluation, investigation, and documentation) in order to ensure that manufacturers properly handle complaints.

Proposed § 1120.14(a)(1) through (3) would require that the tobacco product complaint procedures ensure that each complaint is: (1) processed upon receipt in a uniform and timely manner; (2) evaluated and, if necessary, investigated, in accordance with § 1120.14(b) and (c); and (3) documented in accordance with § 1120.14(e). All complaints would need to be processed upon receipt by the

manufacturer. Even complaints that may not appear to be directly related to illness or injury (such as failure to meet a specification, defective packaging, mixup of products, product bearing wrong labeling/warning, or incorrect quantity of product) may be important in identifying a nonconforming product or other manufacturing issue. Such complaints may indicate that the product is adulterated or misbranded and that a corrective action, such as a recall, is needed. Moreover, even a complaint regarding a side effect that appears to be normally associated with tobacco use may indicate a nonconforming product or a product design issue and, therefore, would be required to be investigated. For example, a complaint about respiratory distress could be determined to be attributed to a nonconforming product due to defective solder joints from an ENDS cartomizer that results in metallic particles in the aerosol (Ref. 2). Similarly, a complaint about dizziness or nausea could be due to the addition of too many ammonia compounds and other substances to reconstituted tobacco in a cigarette, which can affect free nicotine levels.

FDA is aware that some manufacturers have a corporate complaint department that handles complaints for all establishments and others have different complaint handling units for different product types and different establishments, which could result in multiple processes for handling complaints. Therefore, under proposed § 1120.14, manufacturers should designate in their procedures which individual(s) are responsible for coordinating and performing all complaint handling functions to ensure consistent handling, categorization, and evaluation/investigation of complaints across the corporation and establishments.

Proposed § 1120.14(b) elaborates on the evaluation requirement found in proposed § 1120.14(a)(2). Proposed § 1120.14(b) would require that personnel evaluate each complaint to determine whether it could be related to: (1) a nonconforming tobacco product; (2) a product design issue; or (3) any adverse experience that is required to be reported under a regulation issued under section 909(a) of the FD&C Act or implementing regulations.

3

3

We note that, currently, there are no adverse events required to be reported under section 909(a) of the FD&C Act; however, this provision would trigger automatically should FDA issue a regulation based on section 909(a).

Complaint information may need to be incorporated into the risk management process in proposed § 1120.42 to inform the manufacturer's risk assessment and risk treatment. For example, a manufacturer that previously determined in its risk assessment that a dissolvable tobacco product is unlikely to cause a safety hazard to users would be required to reassess its risks, pursuant to proposed § 1120.42(a)(1)(iii), if it receives complaints alleging choking adverse experiences that could change the previous risk assessment.

Proposed § 1120.14(c)(1) states that if the evaluation determines that the complaint could be related to the circumstances identified in proposed § 1120.14(b)(1) through (3), an investigation must be performed (unless it is subject to the exception as provided in proposed § 1120.14(d). For example, if a complaint evaluation indicates that an ENDS product explosion could be related to an issue with the product's design, the tobacco product manufacturer would be required to perform an investigation under § 1120.14(c). Records of previously received complaints may be relevant to this evaluation. The evaluation phase would not be required to include an analysis regarding the veracity of the complaint.

Accordingly, this proposed section would require that all complaints be processed and evaluated. However, only certain complaints would need to be investigated (

i.e.,

complaints that could be related to a nonconforming product, a product design issue, or reportable adverse experience). For example, a complaint regarding the price of the product or the size offerings distributed by the manufacturer (for example, customer complaints that the manufacturer should offer a larger package size) would need to be processed and evaluated but would not need to be investigated under the proposed rule. However, complaints regarding an exploding battery, metal or rocks found in the tobacco, or nicotine poisoning of the user (or nonuser) would need to be investigated.

As stated in proposed § 1120.14(c)(2), the complaint investigation would be required to identify the scope and cause of the issue and the risk of illness or injury it poses. If a manufacturer's investigation shows that the scope and cause of the issue cannot be determined without the involvement of another entity, such as a specification developer, contract manufacturer, or other entity or establishment that performs a manufacturing operation for the product, then the manufacturer should work together with the other entity to determine the scope and cause of the issue. This would include the timely reporting to other entities of all relevant information related to the complaint.

For example, if complaints are reported to a contract manufacturer and, after investigation, are determined to pertain to a possible product design issue, the contract manufacturer should report these complaints to the specification developer for further investigation. The specification developer has the specific knowledge of the design and development information of the finished tobacco product and would be required to conduct an investigation of the product complaints and implement CAPA, as needed pursuant to proposed § 1120.16, including potential redesign of the product. The contract manufacturer, in turn, should continue to work with the specification developer to ensure that the complaint is resolved in accordance with the proposed requirements in this section. Similarly, if a finished tobacco product manufacturer that only packages or labels bulk tobacco products receives complaints of nonconforming products that may be related to the design or manufacture of the incoming bulk tobacco product, it should report these complaints to the bulk manufacturer who must then also conduct an investigation into the scope and cause of the issue, the risk of illness or injury posed by the issue, and whether any followup action is necessary, and implement CAPA, as needed pursuant to proposed § 1120.16. The finished tobacco product manufacturer should follow up with the bulk manufacturer as needed to ensure that the product complaints have been resolved in accordance with these proposed requirements. This would include the finished tobacco product manufacturer documenting the evaluation, investigation, and any associated followup action regarding the complaint, including any information provided by the bulk manufacturer.

A complaint investigation also must determine whether any followup action is necessary, including whether a CAPA is necessary under proposed § 1120.16. Followup action could include, for example, updating a procedure, requiring refresher training, making a manufacturing process change, or other action to correct and prevent a nonconforming product or design problem; initiating a recall; reporting an adverse experience under a section 909(a) regulation; or beginning to monitor the issue to see if there is a trend that might require further action. This proposed requirement is necessary to ensure that finished and bulk tobacco product manufacturers adequately

investigate complaints that could relate to nonconforming tobacco products, issues related to product design, and reportable adverse experiences to protect consumers, correct the issue, and prevent the same or similar problems from occurring in the future.

A complaint investigation may lead the tobacco product manufacturer to initiate a corrective action, such as a recall or a change to the manufacturing process. For example, in one case, FDA received a consumer complaint that an ENDS product created thick and searing smoke that caused an unexpected health problem, specifically, sore, raw, and swollen throat that persisted for several days (Ref. 20). If, during the investigation, the manufacturer determined that the user's health problem was due to excess voltage causing the atomizer coil to burn, these proposed requirements would ensure that manufacturers investigate the scope of such an issue, the risk of illness or injury it poses, and whether any followup action, such as a CAPA, is necessary. A tobacco product manufacturer may initiate a CAPA under proposed § 1120.16, to implement a design change to control the maximum voltage output to prevent coil overheating. While some tobacco product manufacturers may initiate such actions on their own, FDA believes that these requirements are needed to ensure that all manufacturers take these steps to assure the public health is protected.

Complaints could also identify a reasonably foreseeable risk not previously known to the manufacturer, including risks that may occur with normal use and reasonably foreseeable misuse of the tobacco product, which could relate to a design issue. FDA acknowledges that a manufacturer cannot possibly foresee every single potential misuse during the design of a tobacco product, but should the manufacturer become aware through a complaint of information about risks posed by the product due to misuse, the corrective and preventive action requirements under proposed § 1120.16 and the risk management requirements under proposed § 1120.42 would be triggered, which would include reassessing and treating the risk pursuant to proposed § 1120.42(a)(1)(iii). For example, an ENDS manufacturer may receive complaints of respiratory distress for an ENDS product and determine in its investigation that users are modifying the heating element to increase voltage in order to produce greater clouds of vapor, resulting in higher aerosol temperatures than designed that generate harmful constituents such as formaldehyde, acetaldehyde, and acrolein (Ref. 21). Knowing that information, the manufacturer would reassess and treat the risk and initiate appropriate corrective action, which may include implementing design changes to prevent a user from disassembling and modifying the heating element.

When conducting investigations, tobacco product manufacturers should also review available records related to the complaint (

e.g.,

acceptance records, nonconforming product records, or CAPA records). For example, a tobacco product manufacturer may receive complaints about an ENDS overheating. Even if the product is not returned, the manufacturer may review other complaint files and determine that complaints related to other ENDS models have been received. An investigation and review of acceptance records (see proposed § 1120.64) may reveal an increase in the number of heating element components being rejected from a particular supplier. As a result of the investigation, the tobacco product manufacturer may initiate a CAPA to increase monitoring of the supplier and require additional testing to ensure that received components meet established specifications.

Proposed § 1120.14(d) provides an exception to the requirement to conduct an investigation under § 1120.14(c). This paragraph would provide that a tobacco product manufacturer is not required to complete an investigation if it has already conducted an investigation of a similar complaint and the tobacco product manufacturer determines and documents that the previous investigation results apply and another investigation is not necessary. FDA interprets a similar complaint to be one related to the same type of nonconformity or issue and likely to have the same cause or source. Therefore, a tobacco product manufacturer would not need to conduct an investigation if its documentation includes a reference to a previous investigation and a statement explaining why the complaints were sufficiently similar such that the previous investigation results apply and another investigation is not necessary. This analysis would be based on the particular facts and circumstances at issue. For example, a tobacco product manufacturer may determine and document that it need not investigate a complaint of an ENDS overheating, because it had previously investigated a complaint and found that a particular component caused the overheating and the production record shows that the product at issue used the same component from the same supplier, before the problem was corrected.

Proposed § 1120.14(e) would require a manufacturer of finished or bulk tobacco products to maintain complaint records containing the information required by § 1120.14(e)(1) through (14). Complaints requiring investigation that may result in a risk of illness, injury, or death not normally associated with tobacco product use must be clearly identified or separated. Additional discussion of the meaning of “not normally associated” can be found in section II.A.2. This proposed requirement would enable tobacco product manufacturers to recognize these types of complaints and prioritize appropriate followup action.

Proposed § 1120.14(e)(1) through (14) states that the complaint record must include the following information, if available: the name of the product, including brand and sub-brand; a description of the product; manufacturing code; date the complaint was received; format of complaint (

i.e.,

oral or written); name, address, and phone number of complainant; nature and details of the complaint, including how the product was used; identification of individual(s) receiving complaint; record of evaluation by the manufacturer, including the name of the individual(s) performing the evaluation; if no investigation is undertaken, the name of the individual(s) responsible for that decision and the rationale for the decision; investigation date(s); record of investigational activities performed and personnel who performed the activities; results of investigation; and any follow up action taken, including any reply to the complainant or any corrective and preventive action taken. Some of this information would be obtained during the evaluation stage while other information would be obtained during the investigation stage, if an investigation is required. The complaint record would also include activities performed by other entities that assist in the investigation. For example, if a manufacturer reports a complaint to another entity, such as a specification developer, or contract manufacturer, because the manufacturer's investigation shows that the scope and cause of the issue cannot be determined without the involvement the other entity, then the manufacturer should include in the complaint record information regarding the investigation performed by the other entity, if available.

The information in proposed § 1120.14(e) is basic information that is

essential to any complaint investigation and necessary to ensure a thorough complaint investigation and facilitate an appropriate followup. The manufacturer should make a reasonable effort to obtain the information listed in proposed § 1120.14(e)(1) through (14). For example, should some of the basic information in proposed § 1120.14(e)(1) through (14) be missing with respect to a particular complaint, a single unsuccessful attempt to reach the complainant would not be considered by FDA to be a reasonable effort to obtain information related to the complaint. If the information described in proposed § 1120.14(e)(1) through (14) cannot be obtained, this provision would require the manufacturer to document the attempts to obtain this information and explain why the information was not included, as described in proposed § 1120.14(f).

FDA believes that these proposed requirements would assure that the public health is protected by requiring tobacco product manufacturers to systematically handle the receipt, evaluation, investigation, and documentation of all complaints to determine if there is a problem with the tobacco product, a related tobacco product, or the manufacturing process, and take appropriate action. If a tobacco product manufacturer does not have a written complaint procedure, the manufacturer may not properly evaluate and if necessary, investigate the received complaint and may fail to identify a nonconforming tobacco product, a product design issue, or a reportable adverse experience. For example, if a customer reports to a manufacturer that there are metal objects in a can of smokeless tobacco (

e.g.,

Ref. 3), and the complaint procedures do not describe how to perform an investigation, the manufacturer may not conduct an adequate investigation and take an appropriate followup action, including a corrective and preventive action that would prevent consumer illness or injury from such contaminants.

Complaints from users and nonusers are an invaluable source of information for tobacco product manufacturers. The evaluation and investigation of complaints can help a tobacco product manufacturer identify problems with a tobacco product's design, established specifications, or production process. For example, if a manufacturer is receiving complaints alleging explosions of ENDS, this proposed rule would require the manufacturer to investigate the scope and cause of the issue to determine if, for example, it is due to a design problem or manufacturing problem. The investigation may determine that the problem is due to use of a non-Original Equipment Manufacturer battery charger that does not meet the manufacturer's established specification. The U.S. Fire Administration has found that nearly 25 percent of e-cigarette fires occurred when the battery was being charged (Ref. 22). Many e-cigarettes are charged using an ordinary universal serial bus (USB) port charging connection that allows users to connect the e-cigarette to power adapters that are not provided by the original manufacturer of the device. Because the voltage and current provided by USB ports can vary significantly between manufacturers, use of a USB port or power adapter not supplied by the original manufacturer may subject the battery to a higher current than is safe, leading to thermal runaway that results in an explosion and/or fire. As a result of this complaint information, the manufacturer may initiate a CAPA pursuant to proposed § 1120.16 (and further discussed in section IV.B.3) to redesign the battery to have a proprietary connection that could only be connected to a charging unit designed to be compatible or redesign the battery management system to detect an incompatible power adapter and prevent the battery from charging. New information on increased likelihood of occurrence or severity of harm obtained from tobacco product complaints should be incorporated into the manufacturer's ongoing risk management activities (

i.e.,

review of new information that could change the original risk assessment and risk treatment) under proposed § 1120.42.

In addition, FDA believes that the proposed tobacco product complaint requirements would help assure that tobacco products are in compliance with the requirements of chapter IX of the FD&C Act. Consumer complaints about adverse experiences or product problems may indicate nonconforming tobacco products that are not being manufactured to established specifications. Therefore, these proposed complaint requirements would help tobacco product manufacturers to 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. For example, if numerous complaints are received about a product, the manufacturer may investigate and learn that the product does not have the same characteristics it had as of the pre-existing date.

Complaints can also indicate that distributed tobacco products are adulterated or misbranded under section 902 or 903 of the FD&C Act. For example, complaints could indicate that products have been “prepared, packed, or held under insanitary conditions” (section 902(2) of the FD&C Act). In addition, as noted previously, complaints can uncover cross-contamination in a production process that resulted in an adverse experience to the user, necessitating a change in the manufacturing process to prevent the further production of cross-contaminated products. The proposed requirements in this rule that would require manufacturers to process, evaluate, investigate, and document complaints would help them to address and prevent recurrence of such adulteration.

These proposed complaint requirements also may help ensure that the packaging, labeling, or labels of finished and bulk tobacco products comply with applicable statutory and regulatory requirements. For example, a complaint may note that tobacco products are missing labels with required warning statements causing the products to be misbranded under section 903 of the FD&C Act. The investigation may determine that adequate acceptance activities are not being performed during the packaging and labeling operations. This provision would enable the manufacturer to ensure that required warning statements are applied to prevent misbranded products from being commercially marketed.

3. Corrective and Preventive Actions

Proposed § 1120.16 sets forth the requirements for CAPA. CAPA, for purposes of proposed § 1120.16, is a systematic assessment of nonconforming tobacco products and design problems to determine the cause and implement appropriate changes to the product specifications, relevant manufacturing methods and production process procedures, and/or packaging, labeling, and labels to correct and prevent the cause of the nonconformity or design problem. CAPA also helps prevent the distribution of identified nonconforming product and helps identify design problems. These proposed requirements are generally similar to the industry recommendations and to practices of tobacco product manufacturing establishments that follow ISO 9001-2015 (Ref. 11). Tobacco product manufacturers have utilized CAPA in

the past to take appropriate actions to correct and prevent identified causes of nonconformities and design problems (

e.g.,

Refs. 23-27). FDA believes that all tobacco product manufacturers should implement CAPA procedures.

Proposed § 1120.16(a) would require finished and bulk tobacco product manufacturers to establish and maintain procedures for implementing CAPAs. Specifically, proposed § 1120.16(a)(1) would require such manufacturers to review and analyze processes, process control records, complaints, production records, returned products, reprocessed products, reworked products, and other sources of data to identify existing and potential causes of nonconforming tobacco product and design problems. These sources would help manufacturers identify possible causes of nonconformities and design problems and may also help manufacturers identify previously undetected problems.

Under the proposed rule, FDA expects that manufacturers would periodically examine manufacturing processes to look for causes of nonconforming tobacco products or design problems, and take steps to prevent their occurrence. For example, under proposed § 1120.16(a)(1) (and the proposed production processes and controls provision discussed further below (see § 1120.66)), a finished or bulk e-liquid manufacturer would periodically review the mixing process for an e-liquid to determine if it has been trending towards the upper control limit for the nicotine concentration. Such an issue would require a corrective action to maintain the mixing operation within the control limits so as not to produce n

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