Ii 

Technical Project Lead (TPL) Review of PMTAs 

New Products Subject to this Review1 

STNs2 PM0004337.PD1 - PM0004337.PD2 

Common Attributes 

Submission date December 11, 2020 

Receipt date December 14, 2020 

Applicant Philip Morris Products S.A. 

Product manufacturer Philip Morris Products S.A. 

Application t ype Supplemental 

Product category Heated Tobacco Product (HTP) 

Product subcategory HTP Consumable 

Cross-Referenced Submissions 

All STNs PM0000424, PM0000479IDJ (4) I, MR0000059 

Supporting FDA Memoranda Relied Upon in this Review 

All STNs 

Addendum to February 24, 2017, Equivalence Testing for SE Evaluations 

Memo (April 16, 2019). 

Recommendation 

Issue marketing granted orders for t he new tobacco products subject to t his review. 

Technical Project Lead (TPL): 

Signatory Decision: 

Todd L. Ceci l, Ph.D. 

Deputy Director for Regulatory Management 

Office of Science 

Concur wit h TPL recommendation and basis of recommendation 

Benjamin Apelberg, Ph.D. 

Director (Acting) 

Office of Science 

1 Product details, amendments, and dat es provided in t he 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 .......................................................................................................................... 6 

3.1. COMPARISON PRODUCTS................................................................................................................ 6 

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

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

3.2. PRODUCT CHARACTERIZATION ....................................................................................................... 7 

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

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

3.3. TOXICANT EXPOSURE ...................................................................................................................... 9 

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

Synthesis........................................................................................................................ 10 

3.4. ABUSE LIABILITY............................................................................................................................. 10 

Discipline key findings ................................................................................................... 10 

Synthesis........................................................................................................................ 10 

3.5. USER POPULATIONS ...................................................................................................................... 11 

Discipline key findings ................................................................................................... 11 

Synthesis........................................................................................................................ 11 

3.6. HEALTH EFFECTS............................................................................................................................ 12 

Discipline key findings ................................................................................................... 12 

Synthesis........................................................................................................................ 12 

3.7. POPULATION AND PUBLIC HEALTH ............................................................................................... 13 

Discipline key findings ................................................................................................... 13 

Synthesis........................................................................................................................ 13 

3.8. STATUTORY REQUIREMENTS......................................................................................................... 13 

Public health conclusion................................................................................................ 13 

Tobacco product manufacturing practices.................................................................... 13 

Labeling ......................................................................................................................... 13 

Product standards ......................................................................................................... 13 

4. ENVIRONMENTAL DECISION........................................................................................................... 13 

4.1. DISCIPLINE FINDINGS..................................................................................................................... 13 

4.2. ENVIRONMENTAL CONCLUSION ................................................................................................... 14 

5. CONCLUSION AND RECOMMENDATION ......................................................................................... 14 

6. APPENDIX ...................................................................................................................................... 15 

6.1. MARKETING GRANTED ORDER APPENDICES................................................................................. 16 

Appendix B: Postmarket Recordkeeping and Retention ............................................... 16 

Appendix C: Postmarket Reporting ............................................................................... 20 

Appendix D: Marketing Requirements .......................................................................... 26 
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LIST OF TABLES 

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

Table 2. Consultations.................................................................................................................................. 6 

Table 3. Amendment received................................................................................................................... 16 
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1. EXECUTIVE SUMMARY 

On December 14, 2020, FDA received supplemental Premarket Tobaco Product Applications (sPMTAs) 

for Marlboro Sienna and Bronze HeatSticks (PM0004337.PD1 and PM0004337.PD2, respectively). The 

applicant referenced the PMTAs for the Marlboro HeatSticks (PM0000424) 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 applications found that the comparisons between the new products and the 

authorized products and combusted reference cigarettes are appropriate. The applicant has provided 

adequate information on the manufacturing process and product quality controls that will help ensure 

that the new products are manufactured consistently and will meet the applicant’s specifications. The 

aerosols from the new products have been evaluated and found to be comparable to that from use of 

the authorized products. Both the Marlboro Sienna and Bronze HeatSticks were additionally found to 

have substantially lower HPHC exposure potential than combusted cigarettes. 

The new products are not marketed in the U.S.; however, the applicant has provided user information 

from the international marketing experience with new products 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 

products 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 products 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 

products 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 products 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 products 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 
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4. The product s do 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 PM0004337.PD1 - PM0004337.PD2. 

FDA has examined t he environmental effects of finding the new products APPH and made a Finding of 

No Significant Impact (FONS!). 

2. BACKGROUND 

2.1. NEW PRODUCTS 

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

more detail in t he Appendix. 

2.2. REGULATORY ACTIVITY 

On December 14, 2020, FDA received two sPMTAs from Philip Morris Products S.A. FDA issued 

an Acceptance letter to t he applicant on May 25, 2021. FDA issued a Filing letter to the applicant 

on June 7, 2021. FDA issued a Deficiency letter to t he 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 products 

subject to t his review. 

Table 1. Disciplines reviewed 

Cycle 1 Cycle 2 

Discipline Reviewer(s) Review Reviewer(s) Review 

Date Date 

Regulatory Donna Cheung 5/ 25/ 2021 Not Assigned N/ A 

Engineering Mary Searing 8/ 18/ 2021 Mary Searing 12/ 15/ 2021 

Chemistry Delauren McCauley 8/ 19/ 2021 

Delauren 

12/ 15/ 2021 McCauley 

Toxicology Not assigned N/ A Chad Brocker 4/ 25/ 2022 

Behavioral and 

Clinica l Katie Hart ka 8/ 18/ 2021 Not assigned N/ A 

Pharmacology 

Apostolos 

Epidemiology Alexandridis & 8/ 18/ 2021 Not assigned N/ A 

Gabriella Anic 

Social science Samantha Stanley 8/ 18/ 2021 Not assigned N/ A 

Environmental 

Di lip Venugopal 8/ 18/ 2021 Di lip Venugopal 4/ 25/ 2022 science 
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Table 2. Consultations 

Cycle 1 Cycle 2 

Discipline or Office 

Reviewer(s) Review Reviewer(s) Review 

Date 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 

3.1.1. Discipline key findings 

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

• Design Comparison 

o The new products are line extensions of, and are being compared to, the 

currently authorized tobacco product (PM0000424). No other comparison 

products were provided with respect to the product design. 

• Ingredient comparison 

o The tobacco blends in the new products are comparable to the authorized 

product (PM0000424), 1'1% (1.9 mg/ HeatStick). 

o The applicant made minor ingredient modifications resulting in similar or 

lower total ingredient quantities. 

o 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 

products 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 products or transfer any constituent 

that may increase the users exposure to HPHCs, the change in inner liner 

paper is acceptable. 

• Analytical Comparison 

o The authorized product's nicotine content (0.98 - 1.50 mg/ HeatStick) is 

similar to Marlboro Sienna and Bronze HeatSticks nicotine content (1.11-

1. 73 mg/ HeatStick and 0.93 -1.73 mg/ HeatStick, respectively). 

o The applicant provided HPHC yields for analytes identified in the PMl-58 

study and FDA 18+6 study for the new and authorized products, and also 

provided Non-Targeted Differential Screening (NTDS) of aerosol yields 

generated in the new and authorized products. 

o Most aerosol yields for the new and authorized products are analyt ica lly 

equivalent, except for the following where yields in the new products were 

analyt ically nonequivalent and higher than the authorized products: 

acetone (1'20% -23%, 6.1-7.0 μg/ HeatStick), and mercury (1'48-64%, 0.66-

0.88 ng/ HeatStick). In addit ion, compared to the authorized products, there 

were analyt ically nonequivalent and higher yields in PM0004337.PD1: 

TSNAs (i.e., NAB, NAT, NNN) ( 1'22-33%, 0.51-3.3 ng/ HeatStick), acetamide 
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3.1.2. Synthesis 

(1'24%, 0.7 μg/ HeatStick), propylene oxide (1'47%, 4.2 ng/ HeatStick), 

isoprene ( 1'35%, 0.53 μg/ HeatStick), and pyrene ( 1'25%, 1.1 ng/ HeatStick). 

o The applicant measured mainstream smoke HPHCs of Kentucky reference 

cigarettes 3R4F and 1R6F. HPHC aerosol yields from the new products are 

greatly reduced compared to combusted cigarettes, and many of the know n 

HPHCs found in 3R4F cigarette smoke are very low or undetectable in the 

new products' aerosols. 

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

comparison of these products to the authorized tobacco product (PM0000424) and to 

reference cigarettes (3R4F and 1R6F). The application includes data demonstrating that the 

new products produce similar HPHCs and amounts to the authorized HeatSticks when 

measured using the same device. The applicant states that certain HPHCs are present in 

increased amounts in the new products relative to the authorized product. However, each 

of the increases result in HPHC exposure that is substantially lower than the HPHC exposure 

reported for the reference cigarettes. The reference cigarettes are neither intended to be 

used in clinical trials nor are they appropriate for market usage as they contain no flavorings 

typical in modern cigarette products. Nonetheless, these reference cigarettes were 

formulated to represent a t ypical American blend cigarette and are appropriate for 

comparison of the new products and combusted cigarette constituents. The comparison 

products data are appropriate and sufficient to determine the relative risks associated with 

these new tobacco products with respect to the previously authorized tobacco product and 

typica l cigarette products. The applicant has demonstrated that using the new products is 

comparable to use of the authorized product (PM0000424) when used with the authorized 

device (PM0000479). 

3.2. PRODUCT CHARACTERIZATION 

3.2.1. 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 t wo new products have a different..__..._."---------' and tobacco 

flavoring compared to the authorized product. In comparison to the authorized 

product, the formulation ____ of the new products had 

. The applicant stated that the change w as to 

The applicant claims that the changes to (4J .-,----,--

do not adversely affect the operation of the new products, and this was ---- supported with data comparing the performance, pH and nicotine. Further, the 

changes to the formu lation are small and are unlikely to result in a change to the 

content or amount of HPHCs in the aerosol. 

• The amount of the ___ __.in the mouthpiece fi lter is increased in the new 

products compared to the authorized product. The applicant claims that the change 

is made in order to.!I'-~...,."--":"-":"-------~ , ____ in the aerosol. 

This claim was verified through the measurement of t (4; in the new and 
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authorized products. The data provided indicates a 35-36% decrease in th ....... _._ .. content in the aerosol. Therefore, the change in the..._.L.a ...... _. in the mouthpiece is 

unlikely to result in an increase in HPHCs in the aerosol and may result in a 

decreased level of phenol. 

• The overall product weight of each of the two new products is reduced 

approximately 2% compared to the authorized product. This is primarily due to (1) 

and (2) J (4) 

• Aerosol droplet size distribution results indicate the upper bound average of the 

new products are within the respirable range. 

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

ingredient quantit ies. 

3.2.1.2. Manufacturing 

• The applicant demonstrates that the new products can be manufactured in a 

manner consistent with the authorized product. 

• The applicant states that the new products are manufactured in the same faci lit ies 

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

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

• The..,_,._...., _ ___. and ingredient differences result in a small change in potential 

nicotine content in the aerosol of the new products, however the average yields are 

still within the acceptance ranges of the authorized product. All batch release 

results obtained were within specifications and the product performance 

specifications are identical in the new and authorized products. 

3.2.1.3. Product stability 

• The applicant stated that product stability information is not included for the new 

products due to similar design, formulation and container closure system compared 

to the authorized product. The manufacturer proposes to set a Best Used Before 

Date (BUBO) of ____ after the production date for the new products, similar to 

the authorized product. 

3.2.1.4. Product test data 

• The batch release testing results provided by the applicant fall within the acceptable 

criteria for both new products. 

• The applicant provided two studies to characterize the contents and amount of 

chemical constituents in the aerosol of the new products, authorized products, and 

combusted cigarettes. The applicant named them the FDA 18+6 and the PMl-58. 

They claim that the FDA 18+6 study included the HPHCs t ypically found in heated 

tobacco products and the PMl-58 captured 58 constituents that include the FDA 

HPHCs and other aerosol constituents. The applicant also provided the results of a 

non-targeted screening that they claim is intended to identify any additional 

constituents not currently included in the FDA HPHC list. 
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• Aerosol HPHC data from the PMI-58 study indicated that aerosol HPHC yields for the 

new products were generally lower or similar to HPHC yields in the authorized 

products. 

• Aerosol HPHC data from the FDA 18+6 study indicated that aerosol HPHC yields for 

the new products were lower than the mainstream smoke HPHC yields for the 1R6F 

reference cigarette. 

• Non-Targeted Differential Screening: The applicant stated that the NTDS identified 

12 aerosol constituents in the new products that were not in the authorized 

products or in the HPHC list. Of these 5 were probable or possible carcinogens. Of 

these 5 constituents, only one, , was indicated to increase relative to the 

authorized product. The levels of and other constituents in the aerosol 

were low and are unlikely to contribute to exposure concerns. 

Synthesis 

As TPL, I agree with the engineering, chemistry, and toxicology conclusions that these 

sPMTAs contain 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 

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

3.3.1.1. Toxicity (Tox) 

• Evaluation of NTDS study indicates that the new product aerosols contain 5 

probable or possible carcinogenic chemicals that are present in higher levels than 

the authorized product or 1R6F3 cigarette comparison products. Of these 5 

constituents, only one, , was indicated to increase relative to the 

authorized product. These probable or possible carcinogenic chemicals are present 

at low levels in the new products. When balanced against the significant decreases 

in the total number of HPHCs and total HPHC yields found in combusted cigarettes 

the increase in coumarone is small and does not represent a significantly increased 

risk when considered in the totality of constituent changes. 

• The new products’ aerosol contains an increased amount of a few HPHCs relative to 

the authorized product using a modified Canadian Intense smoking regimen. 

However, these HPHCs are markedly decreased in comparison to the 3R4F reference 

cigarette under the same smoking regimen. Glycerol is increased in the new 

products’ aerosols compared to the 3R4F reference cigarette, but this increase is 

also offset by decreases in several known carcinogens and respiratory toxicants (i.e., 

acetaldehyde; ammonia, benzene, benzo[a]pyrene, 1,3-butadiene, formaldehyde, 

3 The reference cigarette products 3R4F and 1R6F are both representative of typical marketed products. The 3R4F reference 

cigarette is no longer available (beginning in 2018). The HPHC yields of these two products are not the same, but are similar 

enough for the comparison of the new and authorized tobacco products. The application includes several studies, each 

collected alongside a reference product. Some constituent values are compared to 1R6F and others against 3R4F and are 

appropriately noted herein reported. While not interchangeable, the results of both reference products are suitable for the 

evaluation of chemical and toxicological risks. 

(b) (4)

(b) (4)

(b) (4)

3.2.2. 

3.3.1. 

-
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isoprene, mercury, toluene, TSNAs, and other constituents) when compared to the 

3R4F reference cigarette. 

• Given the magnitude and statistical significance of the decreases in HPHC number 

and HPHC yields in the new products’ aerosols compared to 3R4F reference 

cigarette, the data on HPHCs and their associated yields for new products are 

acceptable. 

Synthesis 

The sPMTAs contain sufficient information to characterize the toxicant exposure. The 

applicant provided measurements of tested HPHCs and a screen of constituents in the 

product aerosol for new products, authorized products, and in the smoke for combusted 

reference cigarettes. Some HPHCs increased in the new products, when compared to the 

1R6F combusted cigarettes. When these constituents were compared to the authorized 

product, only one increased relative to the authorized products. The absolute increase in 

this one constituent was small and does not represent an exposure risk when considered in 

the totality of constituent changes. Further, the toxicant exposure of the new products is 

low relative to combusted cigarettes. In consideration of a similar level of toxicant exposure 

compared to the authorized products and when comparing the new products to combusted 

cigarettes, the significant decreases in the total number of HPHCs observed and total yields 

of HPHCs observed in the new products, the changes described by the applicant do not 

demonstrate a different toxicant exposure risk than the authorized products. 

3.4. ABUSE LIABILITY 

Discipline key findings 

No new clinical data regarding abuse liability of the new products was submitted; however, 

the applicant submitted nicotine yield data to bridge the new products and cross-referenced 

clinical data submitted with the authorized products. Cross-referenced clinical data 

suggested that in current adult smokers, nicotine exposure and reduction in craving or 

withdrawal of the authorized products was similar to combusted cigarettes. Data from the 

authorized products can be bridged to the new products, thus the abuse liability profile of 

the new products is expected to be similar to combusted cigarettes. 

 

Synthesis 

There are no new data specifically related to abuse liability in these sPMTAs. However, the 

applicant submitted nicotine yield data to bridge the new products and cross-referenced 

clinical data submitted with the authorized products. The bridging data is sufficient to allow 

the application of the findings of the authorized products to the new products. Further, the 

applicant stated that the new products have a similar flavor profile, operating procedures, 

use similar tobacco sources, and produce comparable aerosols. Based on the bridging data 

and underlying clinical data from the authorized product, FDA has no reason to believe the 

new products will result in different nicotine exposure, use patterns, user populations, or 

abuse liability. 
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3.5. USER POPULATIONS 

Discipline key findings 

The target population of the new products is current adult smokers. The applicant provided 

bridging data between the new and authorized products that is sufficient to allow the 

application of the clinical studies submitted for the authorized products to the new 

products. These studies provide sufficient evidence to inform use behavior of the new 

products in current adult smokers. Dual use of the new products with combusted cigarettes 

is likely to occur based on use behavior associated with the authorized products. 

Observational data suggest that dual use of the new products with combusted cigarettes 

may occur less frequently than with the authorized products. The nicotine exposure of the 

new products is predicted to be similar to combusted cigarettes; therefore, current adult 

smokers who initiate use of the new products may completely switch to the new products. 

The rate of complete switching to the new products from combusted cigarettes is unknown; 

however, observational data indicate a similar or higher rate compared to the authorized 

products. The authorized products were associated with higher nicotine exposures than 

nicotine nasal spray (NNS)/nicotine replacement therapy (NRT) gum, and these findings can 

be bridged to the new products. These findings suggest there is a higher likelihood of use of 

the new products compared to NNS/NRT gum in smokers who are interested in quitting 

tobacco products. Based on the abuse liability of the authorized products, the new products 

are predicted to have a similar risk of progression to regular use in non-tobacco users 

(including youth) as combusted cigarettes. No clinical studies were provided in this 

supplemental PMTA, nor with the authorized products addressing use of the new products 

among vulnerable populations. The impact of the new products on abuse liability and 

product use behavior in vulnerable populations other than youth is unknown. 

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 sufficient bridging data to allow the application of 

appropriate data from the authorized product to the new products. Further, 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. 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 
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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 pointof-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 age-restricted 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. 

3.6. HEALTH EFFECTS 

Discipline key findings 

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

applicant references the clinical and observational studies provided for the authorized 

product. There were no specific data related to addiction, short- and long-term health 

effects, or likelihood and effects of product misuse included in the applications. Because 

these products are line extensions 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. Toxicology 

The applicant provided neutral red uptake (NRU) cytotoxicity assay data comparing 

the new products and authorized product. The cytotoxicity of the new products and 

authorized product were statistically equivalent. Therefore, NRU data from the new 

products are acceptable. 

3.6.1.2. BIMO inspection findings 

No inspections were recommended or conducted. 

3.6.1.3. 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 products. 

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 
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product misuse for the new products. 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 these 

sPMTAs. Because these products are line extensions of an authorized product it is 

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

these new products. 

Synthesis 

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

produced from the new products are comparable to that produced from the authorized 

product and substantially lower than combusted cigarettes, there is no reason to believe the 

impact on population health will be different for the new products compared to the 

authorized product. Similarly, there is no evidence the user population for new products 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 products as compared to 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 Sienna and Bronze HeatSticks (PM0004337.PD1 and PM0004337.PD2, 

respectively) as described by the applicant for use with 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 sPMTAs contain 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 these sPMTAs. 

4. ENVIRONMENTAL DECISION 

4.1. DISCIPLINE FINDINGS 

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

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

April 25, 2022. The FONSI was supported by an environmental assessment prepared by FDA on 

April 25, 2022. 

5. CONCLUSION AND RECOMMENDATION

Based on our review of the sPMTAs, I find that permitting the marketing of the new products is

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

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

marketing restrictions applied to PM0000424 will also be applied to these products, with an 

update in frequency to annual reporting (see Appendix D). 

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

of No Significant Impact (FONSI). 

Marketing granted orders should be issued for the new products subject to 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 December 11, 2020 

Receipt date December 14, 2020 

Applicant Philip Morris Products S.A. 

Product manufacturer Philip Morris Products S.A. 

Product category Heated Tobacco Product (HTP) 4 

Product subcategory HTP Consumable 

Attributes5

'

6 New Product 

STN PM0004337 

Static Product ID PDl 

Product name Marlboro Sienna HeatSticks

7 

Package type Box 

Package quantity 20 HeatSticks 

Characterizing flavor Tobacco8 

Nicotine Source Tobacco 

Diameter 7.42 mm 

Length 45mm 

Ventilation Not Applicable 

Additional property Source of energy: Electric (rechargeable battery) 

STN PM0004337 

Static Product ID PD2 

Product name Marlboro Bronze HeatSticks7 

Package type Box 

Package quantity 20 HeatSticks 

Characterizing flavor Tobacco8 

Nicotine Source Tobacco 

Diameter 7.42 mm 

Length 45mm 

Ventilation Not Applicable 

Additional property Source of energy: Electric (rechargeable battery) 

4 The IQOS products meet the definitions 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. 

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

container closure system, unless otherwise identified. 

6 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/bi ll/117th-congress/house-bi 11/2 4 71

7 Brand/sub-brand or other commercial name used in commercial distribution. 

8 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. 
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Table 3. Amendment received 

Submission Receipt Date Amendment Applications Reviewed Brief Description 

Date being 

amended 

Oct 13, 2021 Oct 13, 2021 PM0005102 All9 Yes Response to Aug 19, 

2021 Deficiency Letter 

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 t he IQOS brand, I recommend updates to requirements under sections 

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

and applied to all lQOS products t hat have received marketing authorization. 

6.1.1. 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 t he retention period described in t his order, 

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

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 . 

Record Description Retention Period 

Prior PMTAs Each PMTA submitted prior to market ing orders 4 years from t he date 

t hat FDA issues t he 

marketing order 

Postmarket reports Post market reports, including periodic and adverse 4 years from t he date t he 

experience reports as described in t his order report was submitted to 

FDA or unt il FDA inspects 

t he records, whichever 

occurs sooner 

Correspondence with FDA Correspondence wit h FDA pertaining to each 4 years from t he date of 

authorized product dist ribution of the last 

batch of each product 

subject to this order 

Study data Nonclinical or clinical study documentation including: 4 years from t he date of 

• Source data; t he order or 4 years 

• Study protocols (including statistical analysis from the conclusion of 

plan) and amendments showing the dates the study, whichever 

and reasons for each protocol revision; occurs later 

• Inst it utional Review Board (IRB) or 

Independent Ethics Committee (IEC) 

approvals; 

9 This amendment applies to all STNs subject to t his review. 
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Record Description Retention Period 

• Informed consent forms; 

• Correspondence with study 

monitors/investigators/contract research 

organizations/sponsors/lRB/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 

Manufacturing records Records pertaining to the manufacture, in process 4 years from t he date of 

and release testing, production process (including any distribution of each 

changes to t he process, facility, or controls), batch of each product 

packaging, storage, and stability monitoring and subject to this order 

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 t he characteristics of each final 

product 

Sales and/or distribution A list of distributors and retailers of the products, 4 years from t he date of 

records including brick-and-mortar and digital10 (including distribution of each 

internet/online and mobile) batch of each product 

subject to this order 

Any available information (not to include personally 

ident ifiable 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 

Complaints Records pertaining to any and all complaints 4 years from t he date of 

associated with the tobacco product t hat is the distribution of each 

1

° For the purposes of this order, here and throughout the document, "digital" includes internet/on line and mobile. 
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Record Description Retention Period 

subject of t his order; such records may also include batch of each product 

your analysis of those complaints subject to this order 

Health hazard analysis Healt h hazard analyses, if performed voluntarily or 4 years from t he date of 

directed by FDA distribution of each 

batch of each product 

subject to this order 

Labeling Specimens of all labeling (including all labeling 4 years from t he date of 

variations, such as those reflecting different required initial dissemination to 

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

other accompanying information 

Advertising, marketing and Copies of all advertising, marketing, and/or 4 years from t he date of 

promotional materials and promotional materials published, disseminated to initial dissemination to 

plans consumers, or for use in engaging or communicating the public or 

with consumers implementation 

Copies of all advertising and marketing plans 

including strategic creative briefs and paid media 

plans, by channel and by product, and t he 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 

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 t he 

products; 

• Consumer engagements - whether 

conducted by you, on your behalf, or at your 

direction -including events at which the 
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Record Description Retention Period 

products will be demonstrated and how 

access will be rest ricted to individuals at or 

above the federal minimum age of sale of 

t obacco products; or 

• Use of public relations or other 

communicat ions outreach to create labeling 

for, advertise, market, and/or promote the 

products 

Copies of all records pertaining to media t racking and 

optimization, by channel, by product, and by 

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

race/ethnicit y, 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-t ime digital media 

monitoring to identify, correct, and prevent delivery 

of advertising impressions t o individuals under the 

federal minimum age of sale of tobacco products, 

including documentat ion of such monitoring act ivities 

and implementation of correct ive and preventive 

measures 

Formative consumer Copies of any formative research studies conducted 4 years after the studies 

research among any audiences, in the formation of the are complet ed 

labeling, advertising, marketing, and/or promot ional 

materials, including qualitative and quantitative 

research studies used to determine message 

effectiveness, consumer knowledge, att itudes, 

beliefs, intentions, and behaviors toward using t he 

products, and including copies of t he st imuli used in 

t esting 

Consumer evaluation Copies of any consumer evaluat ion research studies 4 years after the studies 

research conducted among any audiences to determine the are complet ed 

effectiveness of t he labeling, advertising, marketing, 

and/or promot ional materials and any shifts in 

consumer knowledge, attitudes, beliefs, intent ions, 

and behaviors toward using t he products, and 

including copies of t he stimuli used in t esting 

Contract ual agreements Copies of any contract ual agreements regarding t he 4 years from t he date of 

creation or dissemination of the products' labeling, the cont ract or until t he 

advertising, market ing, and/or promotional mat erials, contract expires, 

including, for example, in print media, online or whichever is later 

t hrough digital platforms (e.g., social media and 

mobile applications), such as influencers, bloggers, 

and ambassadors, on your behalf, or at your direction 
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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 PM0004337.PD1 - PM0004337.PD2. 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 

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. 
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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; 

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, 
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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 

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 
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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. 

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 PM0004337.PD1 – PM0004337.PD2. 
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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 

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 
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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 PM0004337.PD1 - PM0004337.PD2. 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; 

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. 
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Appendix D: Marketing Requirements11 

Under section 910(c)(1)(B) of the FD&C Act, and in accordance with section 202(a) of the 

Family Smoking Prevention and Tobacco Control 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 

kits.12 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; 

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 

11 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. 

12 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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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 

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 
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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 

monitoring also requires post-launch delivery verification reports for other paid 
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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.