Technical Project Lead (TPL) Review of PMTA

New Product Subject to this Review1

STN2 PM0004691.PD1 

Common Attributes

Submission date May 25, 2021

Receipt date May 25, 2021

Applicant Philip Morris Products S.A.

Product manufacturer Philip Morris Products S.A.

Application type Supplemental

Product category Heated Tobacco Product (HTP)

Product subcategory HTP Consumable

Cross-Referenced Submissions

All STNs PM0000424, PM0000479, MR0000059 

Supporting FDA Memoranda Relied Upon in this Review

All STNs None

Recommendation

Issue marketing granted order for the new tobacco product subject to this review.

Technical Project Lead (TPL): /S/

Todd L. Cecil, Ph.D.

Deputy Director for Regulatory Management

Office of Science

Signatory Decision: Concur with TPL recommendation and basis of recommendation

/S/

Benjamin Apelberg, Ph.D.

Director (Acting)

Office of Science

1 Product details, amendments, and dates provided in the Appendix. PMTA means premarket tobacco application(s). 2 Submission tracking numbers
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TABLE OF CONTENTS

1. EXECUTIVE SUMMARY ..................................................................................................................... 4

2. BACKGROUND.................................................................................................................................. 5

2.1. NEW PRODUCTS .............................................................................................................................. 5

2.2. REGULATORY ACTIVITY.................................................................................................................... 5 

2.3. SCOPE OF REVIEW ........................................................................................................................... 5 

3. SCIENTIFIC REVIEW .......................................................................................................................... 5

3.1. COMPARISON PRODUCTS................................................................................................................ 5 

Discipline key findings..................................................................................................... 5 

 Synthesis .......................................................................................................................... 6

3.2. PRODUCT CHARACTERIZATION ....................................................................................................... 6

Discipline key findings..................................................................................................... 6

 Synthesis .......................................................................................................................... 7

3.3. TOXICANT EXPOSURE ...................................................................................................................... 7

Discipline key findings..................................................................................................... 7

 Synthesis .......................................................................................................................... 7

3.4. ABUSE LIABILITY............................................................................................................................... 7

Discipline key findings..................................................................................................... 7

 Synthesis .......................................................................................................................... 7 

3.5. USER POPULATIONS ........................................................................................................................ 8 

Discipline key findings..................................................................................................... 8

 Synthesis .......................................................................................................................... 8 

3.6. HEALTH EFFECTS.............................................................................................................................. 9

Discipline key findings..................................................................................................... 9

 Synthesis .......................................................................................................................... 9 

3.7. POPULATION AND PUBLIC HEALTH................................................................................................. 9 

Discipline key findings..................................................................................................... 9 

 Synthesis .......................................................................................................................... 9 

3.8. STATUTORY REQUIREMENTS........................................................................................................... 9

Public health conclusion.................................................................................................. 9 

Tobacco product manufacturing practices.................................................................... 10

 Labeling ......................................................................................................................... 10

Product standards ......................................................................................................... 10

4. ENVIRONMENTAL DECISION........................................................................................................... 10

4.1. DISCIPLINE FINDINGS..................................................................................................................... 10

4.2. ENVIRONMENTAL CONCLUSION ................................................................................................... 10

5. CONCLUSION AND RECOMMENDATION......................................................................................... 10

6. APPENDIX ...................................................................................................................................... 11

6.1. MARKETING GRANTED ORDER APPENDICES................................................................................. 12

Appendix B: Postmarket Recordkeeping and Retention...............................................12

Appendix C: Postmarket Reporting ............................................................................... 16

Appendix D: Marketing Requirements.......................................................................... 22
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LIST OF TABLES

Table 1. Disciplines reviewed....................................................................................................................... 5

Table 2. Consultations.................................................................................................................................. 5

Table 3. Amendments received ................................................................................................................. 11
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1. EXECUTIVE SUMMARY

On December 14, 2020, FDA received a supplemental Premarket Tobacco Product Application (sPMTA) 

for Marlboro Amber HeatSticks (PM0004691.PD1). The applicant referenced the PMTAs for the 

Marlboro HeatSticks (PM0000424) and for the IQOS 2.4 Holder and Charger (PM0000479). The products 

subject to the previous PMTAs were granted marketing authorization April 30, 2019 (hereafter, referred 

to as “the authorized products”). 

Scientific review of the application found that the comparisons between the new product and the 

authorized products are appropriate. The applicant has provided adequate information on the 

manufacturing process and product quality controls that will help ensure that the new product is 

manufactured consistently and will meet the applicant’s specifications. The aerosols from the new 

product have been evaluated and found to be comparable to that from use of the authorized products. 

The new product is not marketed in the U.S.; however, the applicant has provided user information from 

the international marketing experience with the new product as well as consumer reports, complaint, 

published literature and product safety information. There were no new safety concerns or unexpected 

adverse experiences identified. Currently, there is no evidence the user population for the new product 

will be different from the population who use the authorized products. Although the marketing 

information provided is not U.S. data, current use patterns available for the authorized products within 

the U.S. have not raised concerns regarding product use in youth and young adults. Given the product 

similarities, there is currently no available evidence of increased risk for youth initiation and use for the 

new product as compared to the authorized products.

The similarities in the product designs of the new and authorized products make it unlikely there are 

new concerns related to health effects, product quality, human factors, or product misuse for the new 

product as compared to the authorized products. As the new and authorized products have similar 

operating procedures, use similar tobacco sources, and produce comparable aerosols, FDA currently has 

no reason to believe the new product will result in different nicotine exposure, use patterns, user 

populations, or abuse liability. 

The Agency determined that the environmental impacts of simultaneously marketing the authorized and 

the new products do not represent a significant environmental impact from the proposed and 

alternative actions. 

In conclusion, none of the grounds specified in Section 910(c)(2) of the FD&C Act apply. Specifically, I 

find the following:

1. Permitting the marketing of the product is appropriate for the protection of the public health

(APPH), as described in Section 910(c)(4) of the FD&C Act (subject to the labeling and advertising

changes described below);

2. The methods used in, and the facilities or controls used for, the manufacture, processing, and

packing of the product do not fail to conform to the requirements in Section 906(e) of the FD&C

Act;

3. Based on a fair evaluation of all material facts, the proposed labeling is not false or misleading in

any particular; and

4. The product does not fail to conform to a tobacco product standard in effect under Section 907

of the FD&C Act.

I recommend FDA grant marketing authorization for PM0004691.PD1. 
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FDA has examined the environmental effects of finding the new product APPH and made a Finding of No 

Significant Impact (FONSI). 

2. BACKGROUND

2.1. NEW PRODUCTS

The applicant submitted information for the new product listed on the cover page and with 

more detail in the Appendix. 

2.2. REGULATORY ACTIVITY 

On May 25, 2021, FDA received an sPMTA from Philip Morris Products S.A. FDA issued an 

Acceptance letter to the applicant on June 1, 2021. FDA issued a Filing letter to the applicant on

June 7, 2021. FDA issued a Deficiency letter to the applicant on August 19, 2021.

Refer to the Appendix, Table 3, for a complete list of amendments received by FDA. 

2.3. SCOPE OF REVIEW

This review captures all compliance and scientific reviews completed for the new product

subject of this review. 

Table 1. Disciplines reviewed 

Discipline 

Cycle 1 Cycle 2

Reviewer(s) Review 

Date Reviewer(s) Review Date

Regulatory Donna Cheung 6/1/2021 Not assigned N/A

Engineering Mary Searing 8/18/2021 Not assigned N/A

Chemistry Delauren McCauley 8/19/2021 Delauren 

McCauley 12/15/2021

Medical Lester (Jao) Lacorte 7/14/2021 Not assigned N/A

Environmental 

Science Bria Martin 8/18/2021 Bria Martin 4/25/2022

Table 2. Consultations 

Discipline or Office

Cycle 1 Cycle 2

Reviewer(s) Review 

Date Reviewer(s) Review Date

Medical Susan Rudy 6/22/2021 Susan Rudy 12/9/2021 Lester (Jao) Lacorte 7/14/2021

3. SCIENTIFIC REVIEW

3.1. COMPARISON PRODUCTS

Discipline key findings

The following discussion is based on key findings provided in the discipline reviews. 
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• Product Comparison

o The new product is a line extension of, and is being compared to, the

currently authorized tobacco product (PM0000424)

• Ingredient comparison

o The tobacco blend of the new product is identical to the authorized

products.

o The new product contains only minor ingredient modifications when

compared to the authorized products.

Synthesis

The applicant provided a complete description of the new tobacco product and provided a 

comparison of the product to the authorized tobacco product (PM0000424). The 

comparison product data are appropriate and sufficient to determine the relative risks 

associated with this new tobacco product with respect to the previously authorized tobacco 

product. The applicant has demonstrated that using the new product is comparable to use 

of the authorized product when used with the authorized device (PM0000479). 

3.2. PRODUCT CHARACTERIZATION 

Discipline key findings

The following discussion is based on key findings provided in the discipline reviews. 

3.2.1.1. Product design and composition

• The tobacco blend of the new product is identical to the authorized product.

• The applicant made minor ingredient modifications resulting in similar or lower total

ingredient quantities that are unlikely to result in changes to HPHCs in the aerosol.

• The packaging is identical in the new and authorized products with the exception of

the inner liner paper made from white paper in the new product compared to the

metalized/coated paper in the authorized product. Because the inner liner paper

does not contain ingredients that may effect the performance of the new product or

transfer any constituent that may increase the users exposure to HPHCs, the change

in inner liner paper is acceptable.

3.2.1.2. Manufacturing

• The applicant stated that the new product is manufactured in the same facilities

(i.e., PMP S.A. (Switzerland) and Philip Morris Manufacturing and Technology

Bologna S.p.A. (Italy)) as the authorized product.

• The manufacturing processing steps for the new product are identical to those of

the authorized product with the exception of the

The change in results in 

The manufacturing information submitted by the applicant is adequate. 

3.2.1.3. Product stability

The applicant stated that they maintained the same principles of process controls and 

quality assurance in the new product as the authorized product. The new product has an

identical tobacco blend and similar design, formulation, and container closure system as 

the authorized product.

(b)(4)

(b)(4)

(b)(4)

(b)(4)
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3.2.1.4. Product test data 

• The applicant provided minor ingredient component changes in the new product

which are expected to generate lower mainstream aerosol yields (e.g., tar, nicotine,

carbon monoxide, PAHs, phenols, aldehydes, and ketones) compared to the

authorized product. The data were considered acceptable.

Synthesis

As TPL, I agree with the reviewers’ conclusions that this sPMTA contains sufficient 

information to characterize the product design and adequate processes and controls to help 

ensure that the new products meet the manufacturer’s specifications.

3.3. TOXICANT EXPOSURE

Discipline key findings

There were no specific data related to product toxicity included in the applications. Because 

the tobacco blend and materials that come into contact with the emitted aerosol in the new 

product are identical to the authorized product, and the new product is a line extension of 

an authorized product it is reasonable for the toxicant exposure to translate to the new 

product.

Synthesis

The changes to the new products are limited to components that are not affected by the 

development and filtering of the aerosol. HPHCs in the aerosol of the new product, as

reported in the environmental assessment, are comparable to that of the authorized 

product and the changes described by the applicant do not demonstrate a different 

exposure risk than the authorized product.

3.4. ABUSE LIABILITY

Discipline key findings

There were no specific data related to nicotine pharmacokinetics, withdrawal, craving, or 

subjective effects included in this application. Because the tobacco blend and materials that 

come into contact with the emitted aerosol of the new product are identical to the 

authorized product, and the new product is a line extension of an authorized product it is 

reasonable for the nicotine exposure, use patterns, user populations, or abuse liability to 

translate to the new product.

Synthesis

There are no new data specifically related to abuse liability in this sPMTA. The new product

operates in a similar manner and uses the same IQOS device as the previously authorized

products. The ingredient difference in the new product has been evaluated and found to be 

comparable to that of the authorized product. As the new product has a similar flavor 

profile, operating procedures, use similar tobacco sources, and produce comparable 

aerosols, FDA has no reason to believe the new product will result in different nicotine 

exposure, use patterns, user populations, or abuse liability.
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3.5. USER POPULATIONS

Discipline key findings

There were no specific data related to current tobacco users, tobacco non-users, vulnerable 

populations, mitigation strategies or labeling and advertising included in this application. 

Because the new product is a line extension of an authorized product it is reasonable for the 

current tobacco users, tobacco non-users, vulnerable populations, mitigation strategies or 

labeling and advertising to translate to the new product.

3.5.1.1. Labeling and advertising 

The application included full copies of all the proposed product labeling, including 

color variations.

Synthesis

While the applicant did not provide specific data related to current tobacco users, tobacco 

non-users, vulnerable populations, mitigation strategies or labeling and advertising for the 

new products, they did provide user information from the international marketing 

experience with the new product as well as consumer reports, complaint, published 

literature and product safety information. There were no new safety concerns or 

unexpected adverse experiences identified. Currently, there is no evidence the user 

population for the new product will be different from the population who use the 

authorized products. Although the marketing information provided is not U.S. data, current 

use patterns available for the authorized products within the U.S. have not raised concerns 

regarding product use in youth and young adults. Given the product similarities, there is 

currently no available evidence of increased risk for youth initiation and use for the new 

product as compared to the authorized products. FDA has no reason to believe that the 

marketing and use patterns for the new products will be significantly different from the 

authorized product. I recommend that the postmarket restrictions imposed on the 

authorized products would also be imposed on the new products; these restrictions will 

reduce the likelihood of acquisition of the new products by consumers below legal age. 

Additionally, I recommend that any MGO letter encourage the applicant to take additional 

steps to limit youth exposure to print and point-of-sale advertising, including, for example, 

limiting advertising to print publications where 85% or more of the readership is 21 years of 

age or older and/or selecting publications that do not over-index for youth, requiring 

advertising to be placed inside the store, and placing product displays near other agerestricted products and away from toys and candy.

Similar to the authorized products, I recommend that any MGO letter state the removal of 

the warning “SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon 

Monoxide.” from the required warnings to be displayed on the product package labels and 

advertisements under FCLAA. Based on a fair evaluation of all material facts, the warning is 

misleading with respect to these products which, although categorized as cigarettes, do not 

produce carbon monoxide above environmental levels and do not increase CO-related 

health risks. 
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3.6. HEALTH EFFECTS

Discipline key findings

The applicant references the clinical and observational studies provided in the application 

for the authorized HeatSticks product (PM0000424). There were no specific data related to 

addiction, short- and long-term health effects, or likelihood and effects of product misuse

included in the application. Because the new product is a line extension of an authorized 

product it is reasonable for the addiction, short- and long-term health effects and likelihood 

of product misuse to translate to these new products.

3.6.1.1. BIMO inspection findings 

No inspections were conducted. 

3.6.1.2. Adverse experiences 

The applicant did not report any adverse experiences over what was previously 

reported under the post market experience for PM0000424 and PM0000479. FDA 

also performed a search for any reported adverse experiences and found none

directly related to the authorized product.

Synthesis

The similarities in the product designs of the new and authorized products make it unlikely 

that there are new concerns related to health effects, product quality, human factors, or 

product misuse for the new product. To that point, similar to the authorized product, the 

new products do not present signals of cytotoxicity . 

3.7. POPULATION AND PUBLIC HEALTH 

Discipline key findings

There were no specific data related to population or public health studies included in this 

sPMTA. Because the new product is a line extension of an authorized product it is 

reasonable for the specific data related to population or public health studies to translate to

the new product.

Synthesis

As the product design, characteristics, and tobacco source are similar, and the aerosol 

produced from the new product is comparable to that produced from the authorized 

product, there is no reason to believe the impact on population health will be different for 

the new product compared to the authorized product. Similarly, there is no evidence the 

user population for the new product will be different from the population who use the 

authorized product. Given the product similarities, there is currently no evidence of 

increased risk for youth initiation and use for the new product as compared to the 

authorized product.

3.8. STATUTORY REQUIREMENTS 

Public health conclusion 

Based on the findings and evaluations discussed in Sections 3.1-3.7, permitting marketing of 

the Marlboro Amber HeatSticks (PM0004691.PD1) as described by the applicant for use with 
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the authorized IQOS device is determined to be appropriate for the protection of the public 

health. 

Tobacco product manufacturing practices 

The methods used in, and the facilities or controls used for, the manufacture, processing, 

and packing of these products do not fail to conform to the requirements in Section 906(e) 

of the FD&C Act. The sPMTA contains sufficient information to characterize the product 

design and adequate processes and controls to help ensure that the product meets the 

manufacturer’s specifications.

Labeling

The proposed product labeling is not false or misleading.

Product standards

There are no applicable product standards for this sPMTA.

4. ENVIRONMENTAL DECISION

4.1. DISCIPLINE FINDINGS

The environmental science review concluded that the provided information is adequate. 

4.2. ENVIRONMENTAL CONCLUSION

A finding of no significant impact (FONSI) was signed by Luis G. Valerio, Jr., Ph.D., ATS on 

October 24, 2022. The FONSI was supported by an environmental assessment prepared by FDA

on October 19, 2022. 

5. CONCLUSION AND RECOMMENDATION

Based on our review of the sPMTA, I find that permitting the marketing of the new product is

appropriate for the protection of the public health. Periodic reporting is required on an annual

basis. Due to the similarity between the new product and the authorized products, the marketing 

restrictions applied to PM0000424 will also be applied to this product, with an update in 

frequency to annual reporting (see Appendix D).

FDA has examined the environmental effects of finding the new product APPH and made a Finding 

of No Significant Impact (FONSI). 

Marketing granted orders should be issued for the new product subject of this review, as identified 

on the cover page of this review. 
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6. APPENDIX

Appendix A. New products

Common Attributes 

Submission date May 25, 2021

Receipt date May 25, 2021

Applicant Philip Morris Products S.A.

Product manufacturer Philip Morris Products S.A.

Product category Heated Tobacco Product3

Product subcategory HTP Consumable

Attributes4,5 New Product

STN PM0004691

Static Product ID PD1

Product name Marlboro Amber HeatSticks6

Package type Box

Package quantity 20 HeatSticks

Characterizing flavor Tobacco7

Nicotine Source Tobacco

Diameter 7.42 mm

Length 45 mm

Ventilation Not Applicable

Additional property Source of energy: Electric (rechargeable battery)

Table 3. Amendments received

Submission 

Date

Receipt Date Amendment Applications 

being 

amended

Reviewed Brief Description

Oct 13, 2021 Oct 13, 2021 PM0005103 All8 Yes Response to Aug 19, 

2021 Deficiency 

Letter

Feb 25, 2022 Feb 25, 2022 PM0005188 All8 No. 

Amendment 

withdrawn

Additional 

information to 

original submission

Apr 20, 2022 Apr 20, 2022 PM0005255 All8 Yes Withdrawal of 

amendment 

PM0005188

3 The IQOS products meet the definition of cigarette in section 900(3) of the FD&C Act and components and parts in 21 CFR 

1100.3 and 1141.3. Cigarettes and their components and parts must comply with the applicable provisions of the FD&C Act and 

regulations. For purposes of scientific review, the product category and subcategory have been revised.

4 We interpret package type to mean container closure system and package quantity to mean product quantity within the 

container closure system, unless otherwise identified. 5 Effective April 14, 2022, FDA’s authority to regulate tobacco products was extended to include tobacco products containing 

nicotine from any source. As such, nicotine source is considered a required property for unique identification. 

https://www.congress.gov/bill/117th-congress/house-bill/2471 6 Brand/sub-brand or other commercial name used in commercial distribution. 7 The characterizing flavor previously identified as “None” has been updated in FDA records to “Tobacco” to accurately reflect 

that the product provides a tobacco characterizing flavor from the filler. As such, this product does not have any change in 

characterizing flavor.

8 This amendment applies to all STNs subject of this review.
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6.1. MARKETING GRANTED ORDER APPENDICES

Based on experience gained to date on postmarket review of PMTAs, as well as review of 

postmarket reports for the IQOS brand, I recommend updates to requirements under sections 

910(c)(1)(B) and 910(f) of the FD&C Act. As such, the following appendices should be attached 

and applied to all IQOS products that have received marketing authorization.

Appendix B: Postmarket Recordkeeping and Retention

Under section 910(f) of the FD&C Act, this order requires that you establish and maintain 

the records listed below. At any time during the retention period described in this order, 

FDA may request that you provide any of the documents described below. In addition, 

under section 704 of the FD&C Act, FDA may inspect your establishment(s) and request to 

inspect any record(s) described below. 

The following records must be retained according to the retention periods described below. 

These records must be legible, in English, and available for inspection and copying by 

officers or employees duly designated by the Secretary, upon request. 
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Record Description Retention Period

Prior PMTAs Each PMTA submitted prior to marketing orders 4 years from the date 

that FDA issues the 

marketing order

Postmarket reports Postmarket reports, including periodic and adverse 

experience reports as described in this order

4 years from the date the 

report was submitted to 

FDA or until FDA inspects 

the records, whichever 

occurs sooner

Correspondence with FDA Correspondence with FDA pertaining to each 

authorized product

4 years from the date of 

distribution of the last 

batch of each product 

subject to this order

Study data Nonclinical or clinical study documentation including: 

• Source data;

• Study protocols (including statistical analysis

plan) and amendments showing the dates

and reasons for each protocol revision;

• Institutional Review Board (IRB) or

Independent Ethics Committee (IEC)

approvals;

• Informed consent forms;

• Correspondence with study

monitors/investigators/contract research

organizations/sponsors/IRB/IEC;

• Investigator financial disclosure statements;

• Progress reports;

• Monitoring reports;

• Adverse experience reports;

• Case report forms/subject diaries/medical

records/laboratory reports;

• Subject data line listings/observations

records;

• Test article accountability records;

• Study results/protocol summaries/study

reports; and

• Certifications and amendments to

certifications

4 years from the date of 

the order or 4 years 

from the conclusion of 

the study, whichever 

occurs later

Manufacturing records Records pertaining to the manufacture, in process 

and release testing, production process (including any 

changes to the process, facility, or controls), 

packaging, storage, and stability monitoring and 

testing (including protocol and results) 

Records and reports of all manufacturing deviations, 

investigations, and corrective and preventive actions 

including, but not limited to, those deviations 

associated with processing, testing, packing, labeling, 

storage, holding and distribution; and any deviation 

that may affect the characteristics of each final 

product

4 years from the date of 

distribution of each 

batch of each product 

subject to this order
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Record Description Retention Period

Sales and/or distribution 

records 

A list of distributors and retailers of the products, 

including brick-and-mortar and digital9 (including 

internet/online and mobile)

Any available information (not to include personally 

identifiable information) about product purchasers, 

such as purchasers’ demographics (e.g., age, gender, 

race/ethnicity, geographic region) and previous or 

current use of other tobacco products (i.e., dual use) 

With respect to individuals under the federal 

minimum age of sale of tobacco products, policies 

and procedures regarding restrictions on access to 

the products, including purchaser age and identity 

verification processes 

4 years from the date of 

distribution of each 

batch of each product 

subject to this order

Complaints Records pertaining to any and all complaints 

associated with the tobacco product that is the 

subject of this order; such records may also include 

your analysis of those complaints 

4 years from the date of 

distribution of each 

batch of each product 

subject to this order

Health hazard analysis Health hazard analyses, if performed voluntarily or 

directed by FDA

4 years from the date of 

distribution of each 

batch of each product 

subject to this order

Labeling Specimens of all labeling (including all labeling 

variations, such as those reflecting different required 

warnings), labels, inserts/onserts, instructions, and 

other accompanying information 

4 years from the date of 

initial dissemination to 

the public

Advertising, marketing and 

promotional materials and 

plans

Copies of all advertising, marketing, and/or 

promotional materials published, disseminated to 

consumers, or for use in engaging or communicating 

with consumers

Copies of all advertising and marketing plans 

including strategic creative briefs and paid media 

plans, by channel and by product, and the details, 

dollar amount(s) and flighting of such plans, by 

channel and by product, including any: 

• Use of competent and reliable data sources, 

methodologies, and technologies to 

establish, maintain, and monitor highly 

targeted advertising and marketing plans 

and media buys, including a list of all data 

sources used to target advertising and 

marketing plans and media buys; 

• Targeting of specific group(s) by agerange(s), including young adults, ages 21-24, 

and other demographic or psychographic 

4 years from the date of 

initial dissemination to 

the public or 

implementation

9 For the purposes of this order, here and throughout the document, “digital” includes internet/online and mobile.
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Record Description Retention Period

characteristics that reflect your intended 

audience(s), including the source(s) of such 

data; 

• With respect to individuals under the federal 

minimum age of sale of tobacco products, 

actions taken to restrict access to the 

products and limit exposure to the products’ 

labeling, advertising, marketing, and/or 

promotion; 

• Use of owned, earned, shared, or paid media 

to create labeling for, advertise, market, 

and/or promote the products; 

• Use of partners, influencers, bloggers, or 

brand ambassadors to create labeling for, 

advertise, market, and/or promote the 

products; 

• Consumer engagements – whether 

conducted by you, on your behalf, or at your 

direction -including events at which the 

products will be demonstrated and how 

access will be restricted to individuals at or 

above the federal minimum age of sale of 

tobacco products; or 

• Use of public relations or other 

communications outreach to create labeling 

for, advertise, market, and/or promote the 

products

Copies of all records pertaining to media tracking and 

optimization, by channel, by product, and by 

audience demographics (e.g., age, gender, 

race/ethnicity, geographic region), and all postlaunch delivery-verification reports submitted to you 

from an accredited source, by channel, by product, 

and by audience demographics

Policies and procedures for real-time digital media 

monitoring to identify, correct, and prevent delivery 

of advertising impressions to individuals under the 

federal minimum age of sale of tobacco products, 

including documentation of such monitoring activities 

and implementation of corrective and preventive 

measures

Formative consumer 

research

Copies of any formative research studies conducted 

among any audiences, in the formation of the 

labeling, advertising, marketing, and/or promotional 

materials, including qualitative and quantitative 

research studies used to determine message 

4 years after the studies 

are completed
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Record Description Retention Period

effectiveness, consumer knowledge, attitudes, 

beliefs, intentions, and behaviors toward using the 

products, and including copies of the stimuli used in 

testing

Consumer evaluation 

research

Copies of any consumer evaluation research studies 

conducted among any audiences to determine the 

effectiveness of the labeling, advertising, marketing, 

and/or promotional materials and any shifts in 

consumer knowledge, attitudes, beliefs, intentions, 

and behaviors toward using the products, and 

including copies of the stimuli used in testing 

4 years after the studies 

are completed 

Contractual agreements Copies of any contractual agreements regarding the 

creation or dissemination of the products’ labeling, 

advertising, marketing, and/or promotional materials, 

including, for example, in print media, online or 

through digital platforms (e.g., social media and 

mobile applications), such as influencers, bloggers, 

and ambassadors, on your behalf, or at your direction 

4 years from the date of 

the contract or until the 

contract expires, 

whichever is later

Appendix C: Postmarket Reporting 

I. Annual Reporting

Under section 910(f) of the FD&C Act, these orders require that you submit the following 

postmarket reports to FDA on an annual basis, beginning twelve months from the date of 

the order to help FDA determine whether continued marketing of each new tobacco 

products are appropriate for the protection of public health or whether there is or may be 

other grounds for withdrawing or temporarily suspending such order. For each 12-month 

reporting period, the report must include:

1. A single submission with a cover letter that includes the following subject line: 

ANNUAL REPORT for PM0004691.PD1 . The cover letter should include the STN(s) 

and corresponding tobacco product name(s), applicant name, date of report, 

reporting period, and marketing status outside the United States; 

2. All final printed labeling (including all variations, such as those reflecting different 

required warnings) not previously submitted (e.g., if previously submitted under 

section 905(i) or previously submitted at the last reporting period and no changes 

were made, please list the date and manner of submission), including the date the 

labeling was first disseminated and the date when the labeling was discontinued, 

and a description of all changes to the labeling. The labeling must include all the 

panels and be presented in the actual size and color with legible text. The labeling 

must include labels, inserts/onserts, instructions, and any other accompanying 

information or materials for the products;

3. All final full-color advertising, marketing, and/or promotional materials, published, 

disseminated to consumers, or for use in engaging or communicating with 
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consumers not previously submitted (e.g., if previously submitted under 905(i) or 

previously submitted at the last reporting period and no changes were made, please 

list the date and manner of submission), along with the original date such materials 

were first disseminated and the date they were discontinued, and a description of 

all changes to the materials. The materials must be legible, include all panels where 

applicable (e.g., print ads, point of sale signs) and reflect the actual size and colors 

used. For any materials that would not fit on an 8.5” x 11” piece of paper, you may 

resize and submit electronic versions of such materials in a format that FDA can 

review and with sufficient resolution to allow FDA to read lettering clearly. If resizing 

the advertisement does not allow for text to be read easily, the complete text must 

be provided separately and clearly referenced. Digital media, such as videos and 

animations must be submitted in a format that FDA is able to open and review;

4. A description of each change made to the manufacturing, facilities, or

controls during the reporting period, including:

a. A comparison of each change to what was described in the PMTAs;

b. The rationale for making each change and, if any, a listing of any associated

changes; and

c. The basis for concluding that each change does not result in a new tobacco

product that is outside the scope of the marketing granted order.

5. A summary of any stability monitoring, and testing of the products, including the

monitoring and testing protocol(s) (including batch/lot sampling) and results;

6. A complete list of ongoing and completed studies about the tobacco products

conducted by, or on your behalf, that have not been previously reported;

7. Full reports of information published or known to you, or which should be

reasonably known to you, concerning scientific investigations and literature about

the tobacco products that have not been previously reported, as well as significant

findings from publications not previously reported;

8. A summary and analysis of all serious and unexpected adverse experiences

associated with the tobacco products that have been reported to you or that you

are aware of, accompanied by a statement of any changes to the overall risk

associated with the tobacco products, and a summary of any changes in the health

risks, including the nature and frequency of the adverse experience, and potential

risk factors;

9. A summary of sales and distribution of the tobacco products for the reporting

period, to the extent that you collect or receive such data, including:

a. Total U.S. sales reported in dollars, units, and volume with breakdowns by

U.S. census region, major retail markets, and channels in which the products

are sold;

b. The Universal Product Code that corresponds to the products identified in

the PMTA; and

c. Demographic characteristics of products purchasers, such as age, gender,

race/ethnicity, geographic region, and tobacco use status;
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10. A summary of the implementation and effectiveness of your policies and 

procedures regarding verification of the age and identity of purchasers of 

the products; 

11. A summary of the implementation and effectiveness of your policies and 

procedures regarding restrictions on access to the products for individuals 

under the federal minimum age of sale of tobacco products;

12. A summary of all formative consumer research studies conducted– whether by you, 

on your behalf, or at your direction -among any audiences, in the formation of new 

labeling, advertising, marketing, and/or promotional materials, not previously 

submitted, including qualitative and quantitative research studies used to 

determine message effectiveness, consumer knowledge, attitudes, beliefs, 

intentions and behaviors toward using the products, and including the findings or 

these studies and copies of the stimuli used in testing;

13. A summary of all consumer evaluation research studies conducted – whether by 

you, on your behalf, or at your direction - among any audiences, not previously 

submitted, to determine the effectiveness of labeling, advertising, marketing, 

and/or promotional materials and shifts in consumer knowledge, attitudes, beliefs, 

intentions, and behaviors toward using the products, and including the findings of 

these studies and copies of the stimuli used in testing; 

14. A summary of the creation and dissemination of the products’ labeling, advertising, 

marketing, and/or promotional materials – whether conducted by you, on your 

behalf, or at your direction – including a list of all entities involved and a description 

of their involvement, including a description of contractual agreements with such 

entities; 

15. A description of the implementation of all advertising and marketing plans – 

whether conducted by you, on your behalf, or at your direction - not previously 

submitted, including strategic creative briefs and paid media plans by channel and 

by product, and the details, dollar amount(s) and flighting of such plans, by channel 

and by product, including a description of any: 

a. Use of competent and reliable data sources, methodologies, and 

technologies to establish, maintain, and monitor highly targeted advertising 

and marketing plans and media buys, including a list of all data sources used 

to target advertising and marketing plans and media buys;

b. Targeting of specific group(s) by age-range(s), including young adults,

ages 21-24, and other demographic or psychographic characteristics that 

reflect the intended audience(s), including the source(s) of such data;

c. With respect to individuals under the federal minimum age of sale of 

tobacco products, actions taken to restrict access to the products and limit 
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exposure to the products’ labeling, advertising, marketing, and/or 

promotion;

d. Use of owned, earned, shared, or paid media to create labeling for, 

advertise, market, and/or promote the products; 

e. Use of partners, influencers, bloggers, and/or brand ambassadors to create 

labeling for, advertise, market, and/or promote the products; 

f. Consumer engagements – whether conducted by you, on your behalf, or at 

your direction – including events at which the products were demonstrated 

and how access was restricted to individuals at or above the federal 

minimum age of sale of tobacco products; or

g. Use of public-relations or other communications outreach to create labeling 

for, advertise, market, and/or promote the products; including the original 

date such plans were first used and the date they were discontinued, and a 

description of all changes to such plans since the last periodic report, by 

channel and by product;

16. A summary of media tracking and optimization, by channel, by product, and by 

audience demographics (e.g., age, gender, race/ethnicity, geographic region), 

including a summary of real-time digital media monitoring to identify, correct, and 

prevent delivery of advertising impressions to individuals under the federal 

minimum age of sale of tobacco products, and including a summary of 

implementation of any corrective and preventive measures, not previously 

submitted;

17. An analysis of the actual delivery of advertising impressions, by channel, by product, 

and by audience demographics (e.g., age, gender, race/ethnicity, geographic 

location), including a breakout by age-group (i.e., adults, ages 25+; young adults, 

ages 18-24; and youth, ages 12-17 and ages 11 and under), not previously 

submitted. This analysis must be verified against post-launch delivery-verification 

reports submitted to you from an accredited source; and

18. An overall assessment of how the marketing of the tobacco products continues to 

be appropriate for the protection of public health.

The products subject to these marketing granted orders are subject to withdrawal or 

temporary suspension as described in section 910(d) of the FD&C Act. Grounds that FDA will 

consider for withdrawal under section 910(d) of the FD&C Act include scenarios in which 

FDA finds that the continued marketing of the product is no longer APPH. These scenarios 

may include, but are not limited to, certain changes in product use behaviors that were not 

expected in FDA’s assessment of the PMTA (e.g., increases in the percentage or number of 

youth and young adults who report use of your products, fewer users of potentially more 

harmful products switching to your products than anticipated), changes in FDA’s 

understanding of the net effects of your products on the population as a whole, or new 

scientific evidence that demonstrates that the products present a greater risk to health than 

FDA understood during the review process. 
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II. Serious and Unexpected Adverse Experiences Reporting and Reporting of Certain

Manufacturing Deviations

Under section 910(f) of the FD&C Act, these orders require that you report to the FDA all 

adverse experiences that are both serious and unexpected and your analysis of the 

association between the adverse experience and each new tobacco product within 15 

calendar days after the report is received by you. These experiences may become known to 

you through any source including a customer complaint, request, or suggestion made as a 

result of an adverse experience, a manufacturing deviation analysis, tobacco product defect,

or failure reported to you; or identified in the literature or media. Your information should 

be submitted with a cover letter that includes the following subject line: SERIOUS 

UNEXPECTED ADVERSE EXPERIENCE REPORT for PM0004691.PD1. 

For purposes of reporting under these orders, serious adverse experience means an 

adverse experience that results in any of the following outcomes:

• Death;

• A life-threatening condition or illness;

• Inpatient hospitalization or prolongation of existing hospitalization;

• A persistent or significant incapacity or substantial disruption in the ability to

conduct normal life functions;

• A congenital anomaly/birth defect; or

• Any other adverse experience that, based upon appropriate medical judgment, may

jeopardize the health of a person and may require medical or surgical intervention

to prevent one of the other outcomes listed in this definition.

For purposes of reporting under these orders, unexpected adverse experience means an 

adverse experience occurring in one or more persons in which the nature, severity, or 

frequency of the experience is not consistent with:

• The known or foreseeable risks of adverse experiences associated with the use or

exposure to each tobacco product as described in the PMTA and other relevant

sources of information, such as postmarket reports and studies;

• The expected natural progression of any underlying disease, disorder, or condition

of the persons(s) experiencing the adverse experience and the person’s

predisposing risk factor profile for the adverse experience; or

• The results of nonclinical laboratory studies.

For products that have been distributed, if a manufacturing deviation occurs that you 

determine presents a reasonable probability that the tobacco product contains a 

manufacturing or other defect not ordinarily contained in tobacco products on the market 

that would cause serious, adverse health consequences or death you are required to report 

the deviation to FDA within 15 calendar days of identification.

III. Notifications

Under sections 910(c)(1)(B) and 910(f) of the FD&C Act, these orders also require that, as of 

the authorization date of your marketing granted orders, you submit the following 

notifications of your marketing plans and materials to FDA. This requirement to submit the 
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product’s labeling, advertising, marketing, and promotional materials and plans in advance 

of their use is not for pre-approval – that is, FDA is not requiring that it review and approve 

such materials or plans before they may be used. Rather, such advance notification will 

provide FDA timely access to such materials and plans and, if needed, allow FDA to provide 

advisory comments, including any concerns about their possible impact on youth appeal and 

tobacco use initiation. You may begin disseminating the materials 30 days after providing 

notification to FDA. 

This notification must be received by FDA at least 30 days prior to dissemination, which 

includes but is not limited to the publication, dissemination to consumers, or use in 

engaging or communicating with consumers of such materials. The duration of these

notification requirements is as follows:

• For a period of six months starting with the initial dissemination of the materials, 

provide notification of all labeling, advertising, marketing, and promotion. 

Each 30-day notification must include:

1. A single submission with a cover letter that includes the following subject line: 30-

DAY NOTIFICATION for PM0004691.PD1. The cover letter should include the STN(s) 

and corresponding tobacco product name(s), applicant name, date of notification, 

and planned dissemination date;

2. Full-color copies of all such labeling, advertising, marketing, and promotional 

materials for the products. The materials must be legible, include all panels where 

applicable (e.g., print ads, point of sale signs) and reflect the actual size and colors 

used. For any materials that would not fit on an 8.5” x 11” piece of paper, you may 

resize and submit electronic versions of such materials in a format that FDA can 

review and with sufficient resolution to allow FDA to read all lettering clearly. If 

resizing the advertisement does not allow for text to be read easily, the complete 

text must be provided separately and clearly referenced; and 

3. All advertising and marketing plans, including strategic creative briefs and paid 

media plans, by channel and by product, and the details, dollar amount(s) and 

flighting of such plans, by channel and by product, including any plans to:

a. Use competent and reliable data sources, methodologies, and technologies 

to establish, maintain, and monitor highly targeted advertising and 

marketing plans and media buys, including a list of all data sources used to 

target advertising and marketing plans and media buys; 

b. Targeting specific group(s) by age-range(s), including young adults, ages 21-

24, and other demographic or psychographic characteristics that reflect 

your intended audience, including the source(s) of such data;

c. With respect to individuals below the federal minimum age of sale of 

tobacco products, actions taken to restrict access and exposure to the 

products’ labeling, advertising, marketing, and/or promotion;

d. Use owned, earned, shared, or paid media to create labeling for, advertise, 

market, and/or promote the products; 

e. Use partners, influencers, bloggers, or brand ambassadors to create labeling 

for, advertise, market, and/or promote the products; 
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f. Conduct consumer engagements – whether by you, on your behalf, or at

your direction – including events at which the products will be

demonstrated and how access will be restricted to individuals at or above

the federal minimum age of sale of tobacco products; or

g. Use public-relations or other communications outreach to create labeling

for, advertise, market, and/or promote the products.

Appendix D: Marketing Requirements10

Under section 910(c)(1)(B) of the FD&C Act, these orders require you to: 

• Include the warning statement: “WARNING: This product contains nicotine. Nicotine

is an addictive chemical.” on the package labels of all HeatSticks packs and of all kits

containing HeatSticks packs as well as in all advertisements for such products and

kits11. Specifically, the warning statement must appear directly on the package and

must be clearly visible underneath any cellophane or other clear wrapping as

follows:

o Be located in a conspicuous and prominent place on the two principal

display panels of the package and the warning area must comprise at least

30 percent of each of the principal display panels;

o Be printed in at least 12-point font size and the warning statement must

occupy the greatest possible proportion of the warning area set aside for

the required text;

o Be printed in conspicuous and legible Helvetic bold or Arial bold type (or

other sans serif fonts) and in black text on a white background or white text

on a black background in a manner that contrasts by typography, layout, or

color, with all other printed material on the package;

o Be capitalized and punctuated as indicated in this order; and

o Be centered in the warning area in which the text is required to be printed

and positioned such that the text of the warning statement and the other

information on the principal display panel have the same orientation.

• For print advertisements and other advertisements with a visual component

(including, for example, advertisements on signs, shelf-talkers, websites, mobile

applications, and e-mail), the warning statement must appear in the upper portion

of the area of the advertisement within the trim area as follows:

o Occupy at least 20 percent of the area of the advertisement;

10 When the final rule for cigarette health warnings goes into effect, FDA will reevaluate the conditions of marketing with 

respect to warnings for the products subject to this order 11 This warning must appear on each package and each advertisement, in addition to the rotating Surgeon General warnings 

required under FCLAA (except the carbon monoxide warning, which is to be removed from the rotation of the Surgeon General 

warnings as described in this order).
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o Appear in at least 12-point font size and the warning statement must 

occupy the greatest possible proportion of the warning area set aside for 

the required text; 

o Appear in conspicuous and legible Helvetica bold or Arial bold type (or other 

similar sans serif fonts) and in black text on a white background or white 

text on a black background in a manner that contrasts by typography, 

layout, or color, with all other material on the advertisement; 

o Be capitalized and punctuated as indicated in this order; 

o Be centered in the warning area in which the text is required to appear and 

positioned such that the text of the warning statement and the other 

textual information in the advertisement have the same orientation; and 

o Be surrounded by a rectangular border that is the same color as the text of 

the warning statement and that is not less than 3 millimeters (mm) or more 

than 4 mm. 

• Removal of the warning: “SURGEON GENERAL’S WARNING: Cigarette Smoke 

Contains Carbon Monoxide.” from the required warnings to be displayed on the 

product package labels and advertisements under the Federal Cigarette, Labeling 

and Advertising Act (FCLAA). 

• As a reminder, under section 4 of FCLAA (15 U.S.C. 1333), you must submit a 

warning plan to the United States Federal Trade Commission (FTC).

Under section 910(c)(1)(B) of the FD&C Act, this order also requires you to:

• For any digital sales – whether conducted by you, on your behalf, or at your 

direction – establish, maintain, and monitor use of independent age- and identityverification service(s) that compare customer information against independent, 

competent, and reliable data sources, such as public records, to prevent the sale of 

the products to individuals who are under the federal minimum age of sale of 

tobacco products. 

• For any of the products’ labeling, advertising, marketing, and/or promotion 

appearing in your owned digital properties (e.g., your company-owned, consumerdirected, product-branded website(s) and/or mobile applications) – whether 

conducted by you, on your behalf, or at your direction – establish, maintain, and 

monitor use of independent age- and identity-verification service(s) that compare 

customer information against independent, competent, and reliable data sources, 

such as public records, at the first point of access to such properties, to restrict 

access to such labeling, advertising, marketing, and/or promotion to only individuals 

who are at or above the federal minimum age of sale of tobacco products. 

• For any of the products’ labeling, advertising, marketing, and/or promotion 

appearing in any shared digital properties (e.g., your product-branded social media 

accounts, pages and associated content; content promoting your products on your 

behalf disseminated through another entity’s social media accounts) – whether 

conducted by you, on your behalf, or at your direction – establish, maintain, and 
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monitor use of the available site-, platform- and content- (e.g., post, video) specific 

age-restriction controls (e.g., age-restrict an entire product-branded account and all 

associated content disseminated through such account; ensure age-restriction of a 

specific video disseminated by an influencer promoting the products on your behalf 

through the influencer’s account), at the first point of access to such properties, to 

restrict access to such labeling, advertising, marketing, and/or such promotion to 

only individuals who are at or above the federal minimum age of sale of tobacco 

products. 

• For any of the products’ labeling, advertising, marketing, and/or promotion

appearing in paid digital media (e.g., paid digital banner advertisements for the

products running on another company’s website; paid advertising for the products

running in social media; paid distribution of influencer content; paid advertising in

streaming/Over-The-Top video programming; paid advertising in streaming/internet

radio content) – whether conducted by you, on your behalf, or at your direction:

o Establish, maintain, and monitor use of competent and reliable data sources,

methodologies, and technologies to precisely target delivery of such labeling,

advertising, marketing, and/or promotion to only individuals who are or above

the federal minimum age of sale of tobacco products. Such targeting must use

only first- and/or second-party age-verified data, where:

 “First-party” age-verified data is data owned by you (e.g., your customer

registration data collected via site traffic to your company-owned website;

data you use in direct marketing to your adult smoking customers) that you

have age-verified through independent, competent, and reliable data

sources; and

 “Second-party” age-verified data is first-party data owned and age-verified

by another competent and reliable entity (e.g., another company’s firstparty user registration data) to which you have access. Such data must be

age-verified by the second party.

 “First-party” and “second-party” data does not include data obtained from

data aggregators who categorize consumers based on trackable activities

and inferred interests (e.g., internet search terms, video interactions,

browsing history, purchasing behaviors) to create demographic and

psychographic profiles marketers may use to enhance audience targeting.

Such data is not considered age-verified and can only be used in

combination with first- and/or second-party age-verified data.

• Establish, maintain, and monitor use of competent and reliable data sources,

methodologies, and technologies (e.g., using an embedded tracking pixel in all

digital advertising) – whether conducted by you, on your behalf, or at your direction

– to track and measure actual delivery of all advertising impressions, by channel,

by product, and by audience demographics (e.g., age, gender, race/ethnicity,

geographic region). Such monitoring requires real-time digital media tracking, and

identifying, correcting, and preventing delivery of advertising impressions to

individuals under the federal minimum age of sale of tobacco products. Such
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monitoring also requires post-launch delivery verification reports for other paid 

media be submitted to you or entities working on your behalf or at your direction 

from an accredited source. 

• For any use of partners, influencers, bloggers, and/or brand ambassadors to create

labeling for, advertise, market, and/or promote the products – whether conducted

by you, on your behalf, or at your direction – disclose to consumers or viewers, via

the use of statements such as “sponsored by [firm name]” in such labeling,

advertising, marketing, and/or promotional materials, any relationships between

you and entities that create labeling for, advertise, market, and/or promote the

products, on your behalf, or at your direction.