Ii U.S. FOOD & DRUG 

ADM I N ISTRATIO N 

Technical Project Lead (TPL} Review of PMTA 

New Tobacco Product[s] Subject of this Review 1 

STN PM0000634 

Common Attributes 

Submission date March 30, 2020 

Receipt date April 1, 2020 

Applicant Philip Morris Products S.A. 

Product manufacturer Philip Morris Products S.A. 

Application type Supplemental 

Product category Cigarette 

Product subcategory Non-combusted 

Cross-Referenced Submission[s] 

PM0000634 PM0000479J fi) (41 I 

Supporting FDA Memoranda Relied Upon in this Review 

PM0000634 None 

Recommendation 

Issue marketing granted order letter for t he new tobacco product subject of this review. 

Technical Project Lead (TPL): 

Priscilla Callahan-Lyon, M.D. 

Senior Science Advisor 

Office of the Director, Center for Tobacco Products 

Signatory Decision: D Concur with TPL recommendation and basis of recommendation 

D Concur with TPL recommendation wit h additional comments (see 

separate memo) 

D Do not concur with TPL recommendation (see separate memo) 

Matthew R. Holman, Ph.D. 

Director 

Office of Science 

1 Tobacco product details, amendments, and dat es provided in t he Appendix. PM TA means premarket tobacco product 

application(s). 

Priscilla Callahan-Lyon, M .D. 
 

TPL Review of PMTA: PM0000634 Page 2 of 24 

TABLE OF CONTENTS 

1. EXECUTIVE SUMMARY....................................................................................................................3 

2. BACKGROUND................................................................................................................................4 

2.1. NEW TOBACCO PRODUCT ............................................................................................................... 4 

2.2. REGULATORY ACTIVITY.................................................................................................................... 4 

2.3. SCOPE OF REVIEW ........................................................................................................................... 4 

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

3.1. COMPARISON PRODUCT ................................................................................................................. 5 

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

Synthesis.......................................................................................................................... 5 

3.2. PRODUCT CHARACTERIZATION ....................................................................................................... 5 

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

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

3.3. ABUSE LIABILITY............................................................................................................................... 7 

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

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

3.4. USER POPULATIONS ........................................................................................................................ 7 

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

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

3.5. TOXICANT EXPOSURE ...................................................................................................................... 8 

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

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

3.6. HEALTH EFFECTS.............................................................................................................................. 8 

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

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

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

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

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

3.8. STATUTORY REQUIREMENTS.........................................................................................................10 

Public health conclusion................................................................................................10 

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

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

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

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

4.2. ENVIRONMENTAL CONCLUSION ...................................................................................................11 

5. CONCLUSION AND RECOMMENDATION........................................................................................11 

6. APPENDIX ....................................................................................................................................12 

6.1. MARKETING GRANTED ORDER APPENDICES.................................................................................13 

Appendix A: Postmarket Recordkeeping and Retention...............................................13 

Appendix B: Postmarket Reporting...............................................................................17 

Appendix C: Marketing Requirements..........................................................................23 

LIST OF TABLES 

Table 1. Disciplines reviewed........................................................................................................................4 

Table 2. Consults...........................................................................................................................................4 

Table 3. New tobacco product....................................................................................................................12 

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TPL Review of PMTA: PM0000634 Page 3 of 24 

Table 4. Amendments.................................................................................................................................12 

1. EXECUTIVE SUMMARY 

On April 1, 2020, FDA received a PMTA for the IQOS 3 device, to be used with the previously authorized 

Marlboro Heatsticks (regular, Smooth Menthol, and Fresh Menthol, PM0000424 – PM0000426). The 

applicant referenced the PMTAs for the Marlboro Heatsticks as well as for the IQOS 2.4 Holder and 

Charger, PM0000479. The previous PMTAs were granted marketing authorization April 30, 2019. The 

IQOS 3 Holder and Charger is similar in design to IQOS 2.4 and uses the same tobacco source (Marlboro 

Heatsticks). 

Scientific review of the application found that the comparison between IQOS 2.4 and the proposed IQOS 

3 device is appropriate. The applicant has provided adequate information on the manufacturing process 

and product quality controls that will help ensure that the IQOS 3 device is manufactured consistently 

and will meet the applicant’s specifications. The aerosol from the IQOS 3 device has been evaluated and 

found to be comparable to that from use of the IQOS 2.4 device. No new exposures or risks for the new 

device were identified. 

The IQOS 3 device is not marketed in the U.S.; however, the applicant has provided user information 

from the international marketing experience with IQOS 3 as well as consumer reports, complaint, 

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

adverse experiences identified. The user information from international survey data found no evidence 

of increased uptake of IQOS by youth or young adults, and IQOS 3 seemed to be more accepted by 

consumers with a slightly decreased likelihood of dual use with cigarettes as compared to IQOS 2.4. 

There is no evidence the user population for IQOS 3 will be different from the population who use IQOS 

2.4. Although the marketing information provided is not U.S. data, use patterns available for IQOS 2.4 

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

the product similarities, there is no evidence of increased risk for youth initiation and use for IQOS 3 as 

compared to IQOS 2.4. 

There are no U.S. data for IQOS 3; however, the similarities in the product designs of IQOS 2.4 and IQOS 

3, as well as the fact that the same Heatsticks are used in both devices, make it unlikely there are new 

concerns related to health effects, product quality, human factors, or product misuse for IQOS 3 as 

compared to IQOS 2.4. As the two devices have similar operating procedures, use the same tobacco 

sources, and produce comparable aerosols, FDA has no reason to believe the IQOS 3 device will result in 

different nicotine exposure, use patterns, user populations, or abuse liability. 

The Agency determined that, given the modifications are mainly aesthetic, the projected market volume 

(Confidential Appendix 1) is similar to that of the original IQOS System, 

(b) (4)

the environmental impacts 

of the new tobacco product IQOS 3 are considered in the original PMTA Environmental Assessment for 

IQOS 2.4. Specifically, the Agency did not identify any significant environmental impacts 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, as 

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

described below); 

Priscilla Callahan-Lyon, M.D. 
TPL Review of PMTA: PM0000634 Page 4 of 24 

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;2 

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 IQOS 3, PM0000634. 

2. BACKGROUND 

2.1. NEW TOBACCO PRODUCT 

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

with more detail in the Appendix. 

2.2. REGULATORY ACTIVITY 

On April 1, 2020, FDA received one PMTA from Philip Morris Products S.A. FDA issued an 

Acceptance letter to the applicant on April 8, 2020. FDA issued a Filing letter to the applicant on 

April 20, 2020. 

FDA sent a Deficiency letter to Philip Morris Products S.A. on August 13, 2020, requesting 

addit ional information needed to complete the review. The applicant responded on August 27, 

2020. Information in this amendment, PM0000907, is considered in this review. 

Refer to the Appendix 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 tobacco 

product subject of this review. 6. 4. was reviewed by the chemistry review team; the 

information is sufficient for this PMTA. The information in[(l:>) (4) Iw as included in the 

PMTA; therefore, a separate w ritten review of[(I:>) (4) Iwas not needed.[(15) (4) 

I 

Table 1. Disciplines reviewed 

Discipline Reviewer(s) Review Date 

Engineering Pritesh Darji 8/ 11/ 2020 

Chemistry Yuan-Wei (David) Nei 8/ 13/ 2020 

Medical Lester Lacorte 8/ 12/ 2020 

Environmental Shannon Hanna 8/ 12/ 2020, 10/ 6/ 2020 

Table 2. Consults 

OCE-BIMO Tara Singh 7/ 9/ 2020 

OCE-DEM Abraham Agyapong 6/ 17/ 2020 

OCE- OPAL Melissa View 8/ 12/ 2020, 10/ 6/ 2020 

2 FDA has not yet promulgated any regulat ions under Section 906(e) of t he FD&C Act. 

Priscilla Callahan-Lyon, M .D. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TPL Review of PMTA: PM0000634 Page 5 of 24 

3. SCIENTIFIC REVIEW 

3.1. COMPARISON PRODUCT 

Discipline key findings 

• The applicant compared IQOS 3 with previously authorized IQOS 2.4. 

• The applicant compared 57 aerosol HPHC yields and four additional aerosol constituents 

generated from the monitor Heatsticks using the IQOS 3 system and the previously 

authorized IQOS 2.4 system.

 The applicant states the monitor Heatstick 

is equivalent to the regular Marlboro Heatsticks marketed in the U.S. The applicant also 

compared the IQOS aerosol yields to measured mainstream smoke HPHCs of Kentucky 

reference cigarettes 3R4F and 1R6F. 

(b) (4)

• The applicant compared the IQOS 3 System Holder and Charger to the authorized IQOS 

2.4 System in terms of the safety profile and Adverse Event (AE) proportion and 

distribution using post-market consumer reports, global AE data, and published 

literature. The applicant-submitted data indicates the IQOS 3 and IQOS 2.4 products are 

comparable and have similar characteristics with respect to their reported safety and 

health effects (AE) profile. 

Synthesis 

This supplemental PMTA for the IQOS 3 device appropriately compares the new proposed 

device to the previously authorized IQOS 2.4 device. The application includes data 

demonstrating that using the authorized Marlboro Heatsticks in the IQOS 3 device produces 

aerosol that is equivalent to that produced by the authorized IQOS 2.4 device. The IQOS 3 

device is not available in U.S. markets but is marketed internationally; the applicant has 

provided information from post-market consumer report databases, global AE data, and 

published literature that do not demonstrate new or unexpected AEs related to use of IQOS 

3 with the authorized Marlboro Heatsticks. The applicant has demonstrated that using the 

IQOS 3 device with the Marlboro Heatsticks is comparable to use of the authorized IQOS 2.4 

device with the same Heatsticks. 

3.2. PRODUCT CHARACTERIZATION 

Discipline key findings 

Product design and composition 

• The IQOS 3 system consists of a holder that heats tobacco sticks (Marlboro 

Heatsticks) and a charger that recharges the holder after each Heatstick use. The 

IQOS 3 system has the following changes from the previously authorized IQOS 2.4 

system: 

o New side-opening design on the charger (for insertion of the holder) 

o New magnetic charging connector on the holder 

o New LED indicator light design 

o New haptic feature 

o 

(b) (4)

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TPL Review of PMTA: PM0000634 Page 6 of 24 

• There were two reported AEs that initially appeared to have been re lated to product 

quality issues; however, after further review and analysis, it is unlikely that either of 

these events were associated w ith the IQOS 3 device. 

Manufacturing 

• The applicant described the manufacturing process for IQOS 3 including the 

assembly of the holder and charger printed circuit boards (PCBs), final assembly of 

the holder and charger, and packaging of the IQOS 3 device. Manufacturing of IQOS 

3 System is performed by two companies, both owned by {15) {4) 

(6) rt) 

Both companies are located i (b) (4) 

• Assembly of the IQOS 3 System consists of(b) (4) 

(b) (4) 0 ~ • The applicant has provided sufficient details of the assembly processes, in-process 

controls, and product release testing at each assembly process for the IQOS 3 

System. The described manufacturing processes and control strategies are 

appropriate for ensuring consistency in the product production. 

• No manufacturing inspections were conducted as part of this review. 

Product stability 

• There were no stability data included in the submission. As this supplemental PMTA 

is for a device, no stability data is necessary. 

Product test data 

• Test data provided by the applicant support the provided battery specifications and 

range limits and adequately characterize battery performance. In addition, the 

applicant submitted thermal cleaning profile specifications and data describing 

droplet size distribution. 

• The PMl-58 study showed that aerosol HPHC data from the new IQOS 3 System and 

the previously authorized IQOS 2.4 System using monitor Heatsticks were 

analytically equivalen 5 4 - Additionally, ... ae- r""o_.s._o... l H_P_H_C_y-ie_l_d_s_fo_r_t_h_e_n_e_w- lQ_O_S_3_S_y_s-te_m_ w_i-th_ m_o_n_i_tor 

Heatsticks were lower compared to mainstream smoke (MSS) HPHC yields from the 

3R4F reference cigarette. 

• The FDA-18 study showed that aerosol HPHC data generated from the new IQOS 3 

System using commercially available Heatsticks were lower than MSS HPHC data 

generated from the 1R6F reference cigarette. 

• The applicant provided data for four additional constituents: 3-chloro-1,2-

propondiol, furfural, 2-furanmethanol, and glycidol. Aerosol yields for these four 

constituents produced by the IQOS 3 System using monitor Heatsticks, generated 

from (15) (4) , were higher than those 

from the reference 1R6F cigarette. This is consistent w ith the resu lts observed w ith 

the previously authorized IQOS 2.4 system, PM0000479; the aerosol generated by 

the IQOS 3 System and the previously authorized IQOS 2.4 System were analytically 

equivalent for all four constituents. 

Priscilla Callahan-Lyon, M .D. 
 

 

 

 

 

 

 

 

 

 

 

 

 

TPL Review of PMTA: PM0000634 Page 7 of 24 

Synthesis 

As TPL, I agree with the engineering and chemistry conclusions that this PMTA contains 

sufficient information to characterize the product design and adequate processes and 

controls to help ensure that the product meets the manufacturer’s specifications. 

3.3. ABUSE LIABILITY 

Discipline key findings 

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

subjective effects included in this application. 

Synthesis 

There are no new data specifically related to abuse liability in this supplemental PMTA. The 

IQOS 3 device operates in a similar manner and uses the same Marlboro Heatsticks as the 

previously authorized IQOS 2.4 device. The aerosol from the IQOS 3 device has been 

evaluated and found to be comparable to that from use of the IQOS 2.4 device. As the two 

devices have similar operating procedures, use the same tobacco sources, and produce 

comparable aerosols, FDA has no reason to believe the IQOS 3 device will result in different 

nicotine exposure, use patterns, user populations, or abuse liability. 

3.4. USER POPULATIONS 

Discipline key findings 

This PMTA did not include new data related to product use or user populations for IQOS in 

the U.S. The applicant provided results of IQOS use behaviors based on surveys conducted 

among IQOS owners in 5 non-U.S. countries (Germany, Japan, Italy, South Korea, and 

Switzerland). The results include information on average daily consumption (measured as 

Heatsticks/day) and use patterns and are stratified by gender and age for each country. In 

each of these countries, multiple IQOS products are available for purchase including IQOS 

2.4, IQOS 2.4P (this version superseded IQOS 2.4 in international markets), and IQOS 3. In 

general, more survey participants owned only the IQOS 3 device than owned multiple 

devices; i.e., both IQOS 2.4/IQOS 2.4P and IQOS 3. In addition, of those surveyed, owners of 

IQOS 3 were more likely to predominantly or exclusively use this device as compared to 

using multiple IQOS types or dual use of IQOS and cigarettes. The self-reported data show 

that in September 2019, among IQOS owners who completed the survey, exclusive use of 

IQOS 3 across these five countries was ~60%. 

Labeling and advertising 

The initial supplemental PMTA did not include full copies of all the proposed product 

labeling, including color variations. Additional information was submitted by the 

applicant on August 27, 2020. The Division of Promotion, Advertising, and Labeling 

(DPAL) in the Office of Compliance and Enforcement (OCE) conducted a supplementary 

review of the label and labeling and had no concerns regarding the labeling submitted. 

Synthesis 

The marketing and use patterns for IQOS 3 in other countries does not necessarily reflect or 

predict initiation or user behavior in the U.S. It is helpful to note that IQOS 3 seems to be 

accepted by tobacco users in other countries and some of the users report switching 

completely to IQOS (as opposed to dual use with cigarettes). However, the data are quite 

limited. The survey only included those willing to provide information and who had 

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TPL Review of PMTA: PM0000634 Page 8 of 24 

purchased at least one IQOS system. In addition, panelists who owned IQOS devices other 

than IQOS 2.4, 2.4P or IQOS 3 (e.g., IQOS 3 Multi – another version available in some 

countries) or those who own other heated tobacco products were excluded. Youth and 

young adults < age 24 years were grouped together making it impossible to determine the 

rate of youth interest and initiation/product purchase; however, mean age of the IQOS 

users in all the countries was ~ 40 years. FDA has no reason to believe the marketing and 

use patterns in the U.S. for IQOS 3 will be significantly different from those for IQOS 2.4. The 

postmarket restrictions imposed on IQOS 2.4 would also be imposed on IQOS 3; these 

restrictions will prevent acquisition of IQOS 3 by consumers below legal age. These 

international data may not reflect the way IQOS 3 would be used in the U.S. Tobacco 

product regulations and product availability vary from country to country. Additionally, the 

advertising and marketing plans used by manufacturers varies depending on the local 

market conditions and regulations. All of these factors limit the usefulness of this 

information in supporting the PMTA. 

3.5. TOXICANT EXPOSURE 

Discipline key findings 

The nonclinical data provided in this application demonstrate that the aerosol generated 

with the IQOS 3 device when using Marlboro Heatsticks is comparable to that generated 

with the IQOS 2.4 device using the same Heatsticks. This supplemental PMTA relies on the 

nonclinical data submitted for the IQOS 2.4 (PM0000479) and the Marlboro Heatsticks 

(PM0000424 – PM0000426). 

Synthesis 

The IQOS 3 device operates in a similar manner and uses the same Marlboro Heatsticks as 

the authorized IQOS 2.4 device. The aerosol from the IQOS 3 device has been found to be 

comparable to that from use of the IQOS 2.4 device. As the two devices have similar 

operating procedures, use the same tobacco source, and produce comparable aerosols, 

there is no reason to believe the IQOS 3 device will result in different toxicant exposures. 

3.6. HEALTH EFFECTS 

Discipline key findings 

BIMO inspection findings 

• No inspections were conducted. 

Short and long-term health effects (clinical and observational) 

• No new health effects or different health risks were reported for the IQOS 3 System 

Holder and Charger to raise additional product concerns. 

Likelihood and effects of product misuse 

• The application provided Safety Warnings and Instructions for IQOS 3 to address 

human use factors, mitigate potential product malfunction, and reduce the risk of 

injury. 

• Accidental secondhand exposure data for IQOS 3 is limited in the applicantsubmitted published research. 

• The overall health risks appear to be similar for IQOS 2.4 and IQOS 3. 

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TPL Review of PMTA: PM0000634 Page 9 of 24 

• There were no product engineering and design features of concern for IQOS 3. 

• The likelihood of and effects from product misuse are expected to be comparable 

for the IQOS 2.4 and IQOS 3 Systems. 

• The user profile and characteristics and product use behaviors are expected to be 

similar across IQOS products. 

Adverse experiences 

• The AE profile appears similar for the IQOS 3 System compared with the authorized 

IQOS 2.4 System. The applicant provided non-U.S., spontaneous consumer-reported 

AE Reports from the PMI Global Safety Database. No human clinical studies were 

provided in this supplemental application. There are limited specific data on product 

use patterns; e.g., dual use, incomplete switching, complete switching, and the data 

provided are survey results from use of IQOS 3 in non-U.S. markets. This limits the 

analysis of AEs from real-world use of the IQOS 3 System with other concomitant 

tobacco product use. 

• Data from the PMI global safety database indicate that both versions of the IQOS 

System have similar proportions and numbers of AEs in the most frequently 

reported System Organ Class (SOC). Specific health effect data from U.S.-based 

product users is limited as the IQOS 3 System is not commercially available in the 

U.S. 

• A search of CTP’s Safety Reporting Portal (SRP) found three reports that contained 

the word “IQOS” submitted between 1/1/2014 and 6/24/2020. All of these were 

submitted from outside the U.S. and the specific IQOS device is not identified. There 

was one report on the PMI Tobacco Heating System 2.2 and one that named 

“heets.” None of the information found in the SRP indicates new or unexpected AEs 

associated with IQOS 3. 

Synthesis 

The applicant reports the total number of IQOS users worldwide is > 12.4 million and 

estimates that ~24% of current IQOS users use the IQOS 3 system. As described in Section 

3.4.1, the applicant included a user survey describing IQOS use behavioral data from IQOS 

owner panels in Germany, Japan, Italy, South Korea, and Switzerland. The applicant also 

provided information from their consumer product safety database and updates from 

published literature related to use of IQOS products. 

There are limited data specifically related to use of IQOS 3; however, the provided 

information does not indicate any new or unexpected AE signals in the literature, the global 

database, or the consumer reports. There are no U.S. data for IQOS 3; however, the 

similarities in the product designs of IQOS 2.4 and IQOS 3, as well as the fact that the same 

Heatsticks are used in both devices, make it unlikely there are new concerns related to 

health effects, product quality, human factors, or product misuse for IQOS 3 as compared to 

IQOS 2.4. 

3.7. POPULATION AND PUBLIC HEALTH 

Discipline key findings 

The population health information included in this supplemental PMTA is related to the 

survey data described in Section 3.4.1. 

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TPL Review of PMTA: PM0000634 Page 10 of 24 

Synthesis 

As noted above, the application does not include specific information on use of IQOS 3 in 

the U.S. The submitted product use information, including product initiation, use patterns, 

populations, dual use, switching behaviors, etc., are the survey results from non-U.S. 

countries and do not necessarily translate to behaviors in the U.S. where tobacco regulation 

and product availability is different. 

This application is for a new IQOS device which will be used with the same Heatsticks 

authorized for use in the IQOS 2.4 device. As the product design and characteristics are 

similar, the tobacco source (Marlboro Heatsticks) is unchanged, and the aerosol produced 

from using the Heatsticks in the two devices is comparable, there is no reason to believe the 

impact on population health will be different for IQOS 3 as compared to IQOS 2.4. In fact, 

the survey data (non-U.S.) submitted by the applicant indicates there may be an increased 

likelihood of complete switching for combusted cigarette users who purchase an IQOS 3 

device. Although the non-U.S. data may be of limited use for supporting the PMTA, this 

survey data supports the conclusion that combusted cigarette users who switch to IQOS 3 

should see health benefits similar to the benefits of switching to IQOS 2.4. 

There is no evidence the user population for IQOS 3 will be different from the population 

who use IQOS 2.4. The survey data also show no evidence of increased youth and young 

adult initiation of IQOS 3 use in international markets. This is not U.S. data, but use patterns 

available for IQOS 2.4 within the U.S. have not raised new concerns regarding product use in 

youth and young adults. Given the product similarities, there is no evidence of increased risk 

for youth initiation and use for IQOS 3 as compared to IQOS 2.4. 

3.8. STATUTORY REQUIREMENTS 

Public health conclusion 

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

the IQOS 3 device as described by the applicant for use with the authorized Marlboro 

Heatsticks is determined to be appropriate for the protection of the public health (APPH). 

The proposed product labeling is not false or misleading. 

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 PMTA contains sufficient information to characterize the product 

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

manufacturer’s specifications. 

Product standards 

There are no applicable product standards for this PMTA. 

4. ENVIRONMENTAL DECISION 

4.1. DISCIPLINE FINDINGS 

Potential impacts of the proposed action and no action, from product manufacturing, use, and 

disposal, are discussed in the Environmental Assessment (EA) for the original IQOS System PMTA 

(STNs PM0000424, PM0000425, PM0000426 and PM0000479). The tobacco product in this EA is 

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TPL Review of PMTA: PM0000634 Page 11 of 24 

slightly modified as compared to the tobacco product in the original PMTA with the abovementioned differences. The Agency determined that, given the modifications are mainly 

aesthetic, the projected market volume (Confidential Appendix 1) is similar to that of the 

original IQOS System, and that 

, the environmental impacts of the new tobacco product are 

considered in the original PMTA EA. Specifically, the Agency did not identify any significant 

environmental impacts from the proposed and alternative actions. 

(b) (4)

4.2. ENVIRONMENTAL CONCLUSION 

A finding of no significant impact (FONSI) was signed by Luis G. Valerio, Jr., on October 6, 2020. 

The FONSI was supported by an environmental assessment prepared by FDA on 

October 6, 2020. 

5. CONCLUSION AND RECOMMENDATION 

Based on our review of your PMTA, we determined that permitting marketing of the new tobacco 

product, as described in your application and specified in Appendix, Table 3, is appropriate for 

the protection of the public health. The issuance of this marketing granted order confirms that 

you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of 

your new tobacco product. Under the provisions of section 910, you may introduce or deliver for 

introduction into interstate commerce the tobacco product, in accordance with the marketing 

order requirements outlined in this order, including all appendices. Periodic reporting is required 

on a quarterly basis. See Appendix B for additional information on reporting requirements. 

FDA has examined the environmental effects of finding the new tobacco product appropriate for the 

protection of the public health and made a Finding of No Significant Impact (FONSI). 

A marketing granted order should be issued for the new tobacco product subject of this review, as 

identified on the cover page of this review. 

Priscilla Callahan-Lyon, M.D. 
TPL Review of PMTA: PM0000634 Page 12 of 24 

6. APPENDIX 

Table 3. New tobacco product 

Common Attributes 

Submission date March 30, 2020 

Receipt date April 1, 2020 

Applicant Philip Morris Product s S.A. 

Product manufact urer Philip Morris Product s S.A. 

Product category Cigarettes 

Product subcategory Non-Combusted 

Attributes3 New Tobacco Product 

STN PM0000634 

Product name IQOS 3 device4 

Package type Box 

Package quantity 1 Holder, 1 Charger 

Characterizing flavor None5 

92.25 mm (Holder)

114.90 mm (Charger) Length 

14.40 mm (Holder) (smallest ) 

14.90 mm (Holder) (largest area with protruding button) Diameter 

Ventilation Not Provided 

Source of energy Electric (rechargeable battery) 

Thickness: 23 mm (Charger) 

Width: 46.35 mm (Charger) Addit ional property Battery Capacity:(6) (~) I(Holder) 

Battery Capacity: (b) (4) I(Charger) 

Table 4. Amendments 

Submission 

Date 

Receipt 

Date 

Amendment Applications 

being 

amended 

Reviewed Status Brief 

Description 

August 27, 

2020 

August 27, 

2020 

PM0000907 All 6 Yes Act ive Response to 

August 13, 

2020 FDA 

Information 

Request 

3 We interpret package type to mean container closure system and package quantity to mean product quantity w ithin the 

container closure system, unless ot herwise identif ied. 

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

Provided as part of product labeling 

This amendment applies to all STN subj ect of this review. 6 

5 

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TPL Review of PMTA: PM0000634 Page 13 of 24 

6.1. MARKETING GRANTED ORDER APPENDICES 

Appendix A: 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. 

Record Description Retention Period 

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

that FDA issued 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 

or nonapprovals; 

• 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), 

4 years from the date of 

distribution of each 

batch of each product 

subject to this order 

Priscilla Callahan-Lyon, M.D. 
 

 

 

 

 

 

 

TPL Review of PMTA: PM0000634 Page 14 of 24 

Record Description Retention Period 

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 

product7 

For products that have been distributed, if a 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. 

Sales and/or distribution 

records 

A list of distributors and retailers of the products, 

including brick-and-mortar and digital8 (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 legal purchasing 

age, 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 

4 years from the date of 

initial dissemination to 

the public or 

implementation 

8 For the purposes of this order, here and throughout the document, “digital” includes internet/online and mobile. 

Priscilla Callahan-Lyon, M.D. 
 

 

 

 

TPL Review of PMTA: PM0000634 Page 15 of 24 

Record Description Retention Period 

Copies of all advertising and marketing plans 

including strategic creative briefs and paid media 

plans, by channel and by product, 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 age-range(s), 

including young adults, ages 21-24, and other 

demographic or psychographic characteristics 

that reflect your intended audience(s), 

including the source of such data; 

• With respect to individuals under the legal 

purchasing age, actions taken to restrict access 

to the product and limit exposure to the 

products’ labeling, advertising, marketing, and 

promotion, or other consumer directed 

activities; 

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

create labeling for, advertise, market, or 

promote the products; 

• Use of partners, influencers, bloggers, or brand 

ambassadors to create labeling for, advertise, 

market, or promote the products; 

• Consumer engagements – whether conducted 

by you, on your behalf, or at your directions -

including events at which the products were 

demonstrated and how access was restricted to 

individuals at or above the legal purchasing 

age; or 

• Use of public relations or other 

communications outreach to create labeling 

for, advertise, market, or promote the products 

Copies of all records pertaining to the actual delivery 

of advertising impressions, including 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 

minimum legal purchasing age, including 

documentation of such monitoring activities and 

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TPL Review of PMTA: PM0000634 Page 16 of 24 

Record Description Retention Period 

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, or promotional 

materials, including qualitative and quantitative 

research studies used to determine message 

effectiveness, 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 

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, 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 termination 

Priscilla Callahan-Lyon, M.D. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TPL Review of PMTA: PM0000634 Page 17 of 24 

Appendix B: Postmarket Reporting 

I. Periodic Reporting 

Under section 910(f) of the FD&C Act, this order requires that you submit the following periodic reports 

to FDA on a quarterly basis for a period of two years beginning six months from the date of this order or 

when the next report for PM0000479 is submitted, whichever is first. For each three-month reporting 

period, these periodic reports must include: 

• A single submission with a cover letter that includes the following subject line: PERIODIC 

REPORT for PM0000634. The cover letter should include the STN(s) and corresponding tobacco 

product name(s), applicant name, date of report, and reporting period. 

• A summary of U.S. sales and distribution of the tobacco products, including total U.S. sales 

reported in dollars, units, and volume, and broken down by U.S. census region, major retail 

markets, and channels where the products are sold (e.g., convenience stores, food and drug 

markets, big box retailers, digital platforms, tobacco specialty shops, company-owned stores). 

This summary must also be broken down by product (e.g., specific HeatStick flavor). 

• Data on product purchasers. Report any data collected about new purchasers, those who have 

switched tobacco products, and/or multiple product users. The results must be broken down by 

purchaser demographics (e.g., age, gender, race/ethnicity, geographic location) and must not 

include personally identifiable information. 

Under section 910(f) of the FD&C Act, this order also requires that you submit the periodic reports to 

FDA on a quarterly basis beginning six months from the date of this order or when the next report for 

PM0000479 is submitted, whichever is first. For each three-month reporting period, these periodic 

reports must include: 

• A cover letter that includes the following text in your subject line: PERIODIC REPORT for 

PM0000634. The cover letter should include the STN(s) and corresponding tobacco product 

name(s), firm name, date of report, reporting period. 

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

reports submitted to you from an accredited source. 

• A summary of media tracking and optimization, by channel, by product, and by audience 

demographics (e.g., age, gender, race/ethnicity, geographic location), including a summary of 

real-time digital media monitoring to identify, correct, and prevent delivery of advertising 

impressions to youth, ages 17 and under, and including a summary of implementation of any 

corrective and preventive measures. 

Under section 910(f) of the FD&C Act, this order require that you submit the following postmarket 

reports to FDA on an annual basis, beginning twelve months from the date of the order9 to help FDA 

determine whether continued marketing of each new tobacco product is appropriate for the protection 

of the public health or whether there is or may be grounds for withdrawing or temporarily suspending 

such order. For the 12-month reporting period, the report must include: 

• A single submission with a cover letter that includes the following subject line: PERIODIC 

REPORT for PM0000634. 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; 

9 The Annual Report for PM0000634 can be submitted with the Annual Report for PM0000479 beginning April 2021. 

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TPL Review of PMTA: PM0000634 Page 18 of 24 

• A summary of how the marketing of the tobacco products continues to be appropriate for the 

protection of public health, which includes: 

o A status report of ongoing studies and a summary of completed studies about the 

tobacco products conducted by you, or on your behalf. 

o A summary of significant findings in publications not previously reported and full copies 

of the articles. This must include any new scientific data (published or otherwise) on the 

likelihood of product use by current users of tobacco products within the same tobacco 

product category, current users of tobacco products in other tobacco product 

categories, former users of any tobacco product, and youth and young adults. 

o A summary of reported adverse experiences for the tobacco products, which includes a 

listing of all adverse experiences, including the serious and unexpected adverse 

experiences previously reported. The summary must be accompanied by an analysis of 

the reports and a statement of any changes to risk information related to the products 

including nature, frequency, and potential aggravating factors. 

o A summary of U.S. sales and distribution of the tobacco products, not previously 

submitted, including total U.S. sales reported in dollars, units, and volume, and broken 

down by U.S. census region, major retail markets, and channels where the products are 

sold (e.g., convenience stores, food and drug markets, big box retailers, digital 

platforms, tobacco specialty shops, company-owned stores). This summary must also 

be broken down by product. 

o Data on product purchasers not previously submitted. Report any data collected about 

new purchasers, those who have switched tobacco products, and/or multiple product 

users. The results must be broken down by purchaser demographics (e.g., age, gender, 

race/ethnicity, geographic location) and must not include personally identifiable 

information. 

o A summary of the implementation and effectiveness of your policies and procedures 

regarding verification of the age and identity of purchasers of the products. 

o A summary of the implementation and effectiveness of your policies and procedures 

regarding restrictions on youth access to the products. 

o A description of each change made to the manufacturing process, facilities, or controls 

during the reporting period including: 

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

 The rationale for making each change; and 

 A certification that the reported change did not result in any modification (including 

a change in design, any component, any part, or any constituent, including a smoke 

or aerosol constituent, or in the content, delivery, or form of nicotine, or any other 

additive or ingredient) of the tobacco products and the basis for concluding that 

each manufacturing change did not result in any modification to the products. 

o A summary 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 indicate any 

deviation(s) that may affect the characteristics of the products. 

o All final printed labeling, including all labeling variations not previously submitted, 

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. 

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TPL Review of PMTA: PM0000634 Page 19 of 24 

o 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, 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 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 text may be provided separately and referenced. 

o 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, 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 of these studies and copies of the stimuli used in testing. 

o A summary of all consumer evaluation research studies conducted – whether by you, on 

your behalf, or at your direction – among any audiences, to determine the effectiveness 

if labeling, advertising, marketing and/or promotional materials and any 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. 

o 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 – not previously submitted, including a list of all entities involved 

and a description of their involvement, including a description of contractual 

agreements with such entities. 

o A description of the implementation of all advertising and marketing plans, including 

strategic creative briefs and paid media plans – whether conducted by you, on your 

behalf, or at your direction – by channel and by product, and the dollar amount(s) and 

flighting of such plans, by channel and by product, including a description of 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; 

 Targeting of specific adult audiences by age-range(s), including young adults, 

ages 18-24, and other demographic and/or psychographic characteristics that 

reflect the intended target audience, including a list of all data sources used to 

target advertising and marketing plans and media buys; 

 Actions taken to restrict youth-access and limit youth-exposure to the products’ 

labeling, advertising, marketing, and/or promotion; 

 Use of owned, earned, shared, and/or paid media to create labeling for, advertise, 

market, and/or promote the products; 

 Use of partners, influencers, bloggers, and/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 were demonstrated; and/or 

 Use of earned media and/or public-relations outreach to create labeling for, 

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

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TPL Review of PMTA: PM0000634 Page 20 of 24 

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. 

 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. 

 A summary of media tracking and optimization, by channel, by product, and by 

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

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

prevent delivery of advertising impressions to youth, ages 17 and under, and 

including a summary of implementation of any corrective and preventive measures, 

not previously submitted. 

II. Serious and Unexpected Adverse Experiences Reporting 

Under section 910(f) of the FD&C Act, this order requires 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 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 PM0000634. 

For purposes of reporting under this order, serious adverse experience means an adverse experience 

that results in any of the following outcomes: 

• Death; 

• A life-threatening adverse event; 

• 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 this order, 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 associated with the use or exposure to each tobacco 

product as described in the PMTA and other relevant sources of information, such as 

product labeling and postmarket reports; 

• 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 

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TPL Review of PMTA: PM0000634 Page 21 of 24 

• The results of nonclinical laboratory studies. 

III. Notifications 

Under sections 910(c)(1)(B) and 910(f) of the FD&C Act, this order also requires that for the first six 

months after the date of your marketing granted order you provide FDA a notification of all labeling, 

advertising, marketing, and/or promotional materials for which you plan on disseminating to the public 

or using to engage or communicate with consumers. These notifications are not for pre-approval but 

are required so that FDA can have timely access to your marketing plans and materials, and if needed, 

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

and tobacco use initiation and, on the finding that continued marketing of your product is appropriate 

for the protection of the public health. Failure to comment on your 30-day notifications does not mean 

that FDA determined that your materials are compliant. 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. 

Each 30-day notification must include: 

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

NOTIFICATION for PM0000634. 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/or promotional materials for 

the product. 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. 

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

channel and by product, 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 a list of all data sources used to target advertising and marketing plans and 

media buys; 

c. With respect to individuals below the minimum purchasing age, actions taken to restrict 

access and exposure to the products’ labeling, advertising, marketing, or promotion; 

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

promote the product; 

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

advertise, market, or promote the product; 

Priscilla Callahan-Lyon, M.D. 
 

 

TPL Review of PMTA: PM0000634 Page 22 of 24 

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 legal purchasing age; or 

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

market, or promote the product. 

Priscilla Callahan-Lyon, M.D. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

TPL Review of PMTA: PM0000634 Page 23 of 24 

Appendix C: Marketing Requirements 

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

• For any digital sales – 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, to prevent the sale of the product to individuals who are under the 

federal minimum legal age to purchase tobacco products. 

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

owned digital properties (e.g., your company-owned, consumer-directed, 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 in order to 

restrict access to product promotion, through labeling, advertising, marketing, and to restrict 

such product promotion to only individuals who are at least of federal minimum legal age to 

purchase 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 through 

the influencer’s account), at the first point of access to such properties in order to restrict access 

to such product promotion through labeling, advertising, marketing, and to restrict such 

promotion to only individuals who are at least of federal minimum legal age to purchase 

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 product running on another 

company’s website; paid advertising for the product running in social media; paid distribution 

of influencer 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 at least of federal minimum legal 

age to purchase 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 

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TPL Review of PMTA: PM0000634 Page 24 of 24 

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 first-party 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 minimum legal purchasing age. Such monitoring also requires post-launch 

delivery verification reports be submitted to you 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 product – 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 product, on your behalf, or at your direction. 

At any time, FDA may request that you provide any of the documents described in Appendix D. In 

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

inspect any record(s) described in Appendix D. 

If you discontinue the manufacture, preparation, compounding or processing for commercial 

distribution of this tobacco product and later decide to reintroduce the products into the market, please 

contact the Office of Science prior to reintroduction. Also, every person who owns or operates any 

domestic establishment engaged in the manufacture, preparation, compounding, or processing of a 

tobacco product or tobacco products shall update their product listing biannually to reflect certain 

changes, including any products that have been discontinued and/or reintroduced into interstate 

commerce. 

Priscilla Callahan-Lyon, M.D.