U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993 

www.fda.gov

MODIFIED RISK GRANTED ORDER– 

EXPOSURE MODIFICATION

Philip Morris Products S.A.

Attention: Adam Susser, Esq., Senior Counsel, Regulatory Affairs, U.S. Agent for PMP S.A.

8800 Harness Trail

Potomac, MD 20854

FDA Submission Tracking Number (STN): MR0000192

Dear Adam Susser: 

We completed review of your MRTPA1,2 and are issuing a modified risk granted order (MRGO) for the 

tobacco product identified in Appendix A. 

Based on our review of your MRTPA, we determined that the proposed modified risk tobacco

product, as described in your application and specified in Appendix A, as actually used by 

consumers, has satisfied the requirements of section 911(g)(2)(A) and (B), including that it is

appropriate to promote the public health and is expected to benefit the health of the population as 

a whole, taking into account both users of tobacco products and persons who do not currently use 

tobacco products. Therefore, we authorize the marketing of the modified risk tobacco product with 

the following reduced exposure claim: 

“AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.

• This significantly reduces the production of harmful and potentially harmful chemicals.

• Scientific studies have shown that switching completely from conventional cigarettes to the

IQOS system significantly reduces your body’s exposure to harmful or potentially harmful

chemicals.”

Under the provisions of section 911, you may introduce or deliver for introduction into interstate 

commerce the modified risk tobacco product, in accordance with this exposure modification order. 

Under section 911(g)(2)(C)(ii), this order is conditioned on your agreement to conduct postmarket 

surveillance and studies (PMSS) in accordance with a protocol approved by FDA and to submit the 

results of such PMSS annually. See Appendix B for information on required PMSS. This order also 

includes requests related to other record retention and reporting, as outlined in all attached 

appendices. 

1 Modified Risk Tobacco Product Application (MRTPA) submitted under section 911(d) of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) 2 The IQOS 3 System has already received a marketing order for its premarket (PMTA) submission (PM0000634) and it 

represents an updated version of the IQOS 2.4 System, which can be legally marketed and has a modified risk granted order
MR0000192 Page 2 of 14 

This order for this MRTPA expires July 07, 2024 to align with the expiration of the MRTPA MRGO for 

the IQOS 2.4 System. If you wish to renew your order, we recommend a request for renewal is 

received by FDA at least 360 days prior to the expiration date. Your renewal may cross-reference 

your MRTPA for the IQOS 2.4 system and the MRTPA that is subject to this order. 

The requirements in this exposure modification order are intended to help ensure that your modified 

risk tobacco product will continue to satisfy the requirements of section 911(g)(2)(A) and (B). 

However, compliance with these requirements alone is not a guarantee that the modified risk

tobacco product will continue to be appropriate to promote public health and continue to be 

expected to benefit the health of the population as a whole, particularly if, despite these measures, 

there is a significant increase in youth initiation or initiation by non-users. FDA will continue to 

monitor the marketing of your product and its impact on the population. FDA will continue to 

monitor the marketing of your modified risk tobacco product and its impact on the population. 

This order authorizing the marketing of this modified risk product does not mean FDA “approved” the 

product specified in Appendix A; therefore, you may not make any express or implied statement or 

representation directed to consumers that conveys, promotes, or would mislead consumers into 

believing, among other things that the tobacco product specified in Appendix A, as being “approved” 

by FDA (see Section 301(tt) of the FD&C Act). Moreover, because these products have not been 

authorized under section 911(g)(1) (risk modification order), you may not market these products with 

reduced risk claims.

The modified risk tobacco product subject to this exposure modification order is subject to 

withdrawal as described in section 911(j) of the FD&C Act.

The modified risk tobacco product specified in Appendix A is subject to the requirements of the 

associated December 7, 2020, PMTA order and appendices, FD&C Act, and its impending regulations.

We remind you that all regulated tobacco products, including the tobacco product specified in 

Appendix A, are subject to the requirements of the FD&C Act and its implementing regulations. 

These requirements include, but are not limited to, annual registration, listing of products, listing 

of ingredients, reporting of harmful and potentially harmful constituents, packaging, labeling, 

and advertising requirements, and payment of user fees. It is your responsibility to ensure the 

tobacco product specified in Appendix A complies with all applicable statutory and regulatory 

requirements. FDA will monitor your compliance with all applicable statutes and regulations.

In accordance with 40 CFR 1506.6, we will make your Environmental Assessment (EA) publicly 

available.
MR0000192 Page 3 of 14 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal3,43,

4using 

eSubmitter.5,5 Alternatively, submissions may be mailed to:

Food and Drug Administration

Center for Tobacco Products

Document Control Center (DCC)

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

The CTP Portal and FDA’s Electronic Submission Gateway (ESG) are generally available 24 hours a day, 

seven days a week; if the upload is successful, submissions are considered received by DCC on the day of

upload. Submissions delivered to DCC by courier or physical mail will be considered timely if received 

during delivery hours on or before the due date6

; if the due date falls on a weekend or holiday, the 

delivery must be received on or before the preceding business day. We are unable to accept regulatory 

submissions by e-mail. 

If you have any questions regarding this order, please contact Barbara Banchero, Regulatory Health 

Project Manager, at (301) 796-1937 or Barbara.Banchero@fda.hhs.gov.

If you have any questions regarding postmarket activities for the tobacco products subject of this order, 

please contact Lillian Ortega, Director, Division of Enforcement and Manufacturing, at

CTP-OCE-Postmarket@fda.hhs.gov. 

Sincerely,

/S/

Matthew R. Holman, Ph.D.

Director

Office of Science

Center for Tobacco Products

Enclosures:

Appendix A – Tobacco Product Subject of This Letter

Appendix B – Required Postmarket Surveillance and Studies

Appendix C – Recordkeeping and Retention

Appendix D – Conditions of Marketing

3 https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal 4 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal.

5 https://www.fda.gov/industry/fda-esubmitter 6 https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp
MR0000192 Page 4 of 14 

Appendix A7

Tobacco Product Subject of This Letter 

Attributes of MRTPA

Submission date March 18, 2021

Receipt date March 18, 2021

Applicant Philip Morris Products S.A.

Product manufacturer Philip Morris Products S.A.

Product category Heated Tobacco Product (HTP)8,9

Product subcategory Open HTP

Order type Exposure Modification 911(g)(2) order

Proposed claims

AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.

• This significantly reduces the production of harmful and potentially

harmful chemicals.

• Scientific studies have shown that switching completely from

conventional cigarettes to the IQOS system significantly reduces

your body’s exposure to harmful or potentially harmful chemicals.

Attributes Tobacco Product

STN MR0000192

Product name IQOS 3 System Holder and Charger7,

Package type Box 

Product quantity 1 Holder, 1 Charger

Characterizing flavor None

Length 92.25 mm (Holder)

114. 80 mm (Charger)

Diameter 14.40 mm (Holder) (smallest)

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

Wattage Not provided

Battery Capacity > 110 milliAmpere hour (mAh) (Holder)

> 2600 mAh (Charger)

Additional property Ventilation: Not provided

Source of energy: Electric (rechargeable battery) 

Thickness: 23.00 mm (Charger) 

Width: 46.35 mm (Charger)

7 Brand/sub-brand or other commercial name used in commercial distribution. 8 Upon scientific review, the product category and product subcategory were revised.

9 The IQOS products are also regulated as cigarettes and cigarette components and parts. Cigarettes and their components and 

parts must be in compliance with the FD&C Act and applicable regulations.
MR0000192 Page 5 of 14 

Appendix B

Required Postmarket Surveillance and Studies (PMSS) 

Under section 911(g)(2)(C)(ii) of the FD&C Act, an order under 911(g)(2) is conditioned on the 

applicant’s agreement to conduct postmarket surveillance and studies in order to “determine the 

impact of the order on consumer perception, behavior, and health, and to enable the [FDA] to review 

the accuracy of the determinations upon which the order was based in accordance with a protocol 

approved by the [FDA].”

I. PMSS Content

MRTP Use Behavior and Consumer Understanding and Perception

After receiving authorization, the determination of whether the tobacco product that is the subject of 

this order continues to satisfy the requirements of section 911(g)(2)(A) and (B), is driven, in part, by use 

behavior. Therefore, monitoring use of the tobacco product that is the subject of this order in terms of 

uptake, dual use, and complete switching is required. In particular, your PMSS must assess the extent to 

which new MRTP users were never, former, or current smokers, or other tobacco product users before 

initiating the MRTP and the extent to which new users of the MRTP become exclusive IQOS users, dual 

users with combusted cigarettes or other tobacco products, or transition to combusted cigarette 

smoking over time. Relatedly, such surveillance must include an assessment of consumers’ 

understanding of the claim and perceptions of the product. These studies should be designed to observe 

behavior over a sufficient period of time to examine, for instance, the extent to which dual use of IQOS 

and combusted cigarettes is a transitional versus stable pattern of use.

Given the novelty of these products and the uncertainty related to the impact of modified risk 

information on youth, your studies must also be designed to monitor individuals under the age of 18 to 

assess: (a) youth awareness of IQOS, to evaluate how effectively your marketing is limiting unintended 

exposure to youth, and (b) youth use of the IQOS system, to help ensure that marketing of the MRTPs 

does not have unintended consequences for youth use. Your surveys must also monitor young adults 

below the legal age to purchase tobacco products (i.e., ages 18-20).

Your studies must also include an assessment of consumers’ understanding of the claim and perceptions 

of the products. In particular, your PMSS must assess the extent to which users of the product 

understand that reducing their exposure to harmful and potentially harmful chemicals is relative to 

smoking, as described in the modified risk information, and that current smokers must use the IQOS 

system exclusively and stop smoking. Thus, current smokers who take up IQOS, must understand that 

they should switch completely to IQOS and stop smoking and that cutting down on combusted 

cigarettes per day while using IQOS is not sufficient. Other tobacco users who switch to IQOS must 

understand that the reduction in harmful and potentially harmful chemicals is relative to combusted 

cigarette smoking and not to other types of tobacco use.

Your studies must have clear research objectives, including assessing whether the modified risk tobacco 

product leads to changes in product use behaviors that are expected to benefit population health. Your 

protocol must include a statistical analysis plan describing, among other things, how you plan to conduct 

inferential statistical analyses to address these objectives.
MR0000192 Page 6 of 14 

In addition, FDA has determined that assessing the impact of your MRTP order on uptake of the product 

requires surveillance of MRTP sales and distribution, which provide information to assess tobacco 

consumption at the population level. Your PMSS protocols must describe procedures for monitoring and 

reporting MRTP sales and distribution in the U.S. by product, major metropolitan areas, and channels 

where the product is sold (e.g., IQOS stores and kiosks, convenience stores, food and drug stores, 

internet and digital retailers, tobacco specialty shops). Your annual PMSS report must include: 

• U.S. sales and distribution of the tobacco product by quarter since the date of issuance of your 

modified risk granted order (for the initial reporting period) or the previous reporting period (for 

all reports that follow), including total U.S. sales and distribution reported in dollars and units, 

and broken down by major metropolitan areas, and channels where the products were 

distributed and sold during the reporting period (e.g., IQOS stores, convenience stores, food and 

drug stores, internet and digital retailers, tobacco specialty shops). 

• A brief synthesis and summary of the sales and distribution data for the initial reporting period 

or the previous reporting period (for all reports that follow), including annual and quarterly 

growth rate (percent change) in total U.S. sales and distribution of the tobacco product, postMRTP authorization. 

MRTP Use and Health Risk – Toxicology

Although your applications demonstrated that switching completely from combusted cigarettes to the 

IQOS system would, in general, significantly reduce exposure to harmful or potentially harmful 

chemicals, there were some chemicals that were higher in Heatstick aerosol than in combusted cigarette 

smoke. Additional research must be conducted to better characterize the potential impact of these 

exposures. In your applications, you reported computational toxicology predictions on chemicals found 

in higher levels in Heatstick aerosols than in reference combusted cigarette smoke. However, your 

applications lacked details of the quantitative structure-activity relationship (QSAR) modeling prediction 

results including, information to judge reliability of the modeling results, information on how you made 

interpretations of the model predictions, and a description of the training sets used in the models and 

why they are appropriate for tobacco constituents to predict adverse effects at the endpoints that were 

tested. An adequate computational toxicology assessment of Heatstick aerosols must be conducted in 

order to predict potential adverse effects in users before toxicity may be evident. 

Given that the chemicals analyzed by QSAR are found in higher levels in Heatstick aerosols than in 

reference combusted cigarette smoke and that Heatsticks are novel tobacco products for which long 

term health consequences have not been established, you must conduct a rigorous computational 

toxicology study using a battery of genotoxicity and carcinogenicity models (modeled endpoints: in vitro 

bacterial mutagenicity, mammalian cell mutagenicity, clastogenicity, rodent carcinogenicity) that have 

been validated in the published literature. A well-designed computational toxicology study must use 

both structure-activity-relationship (SAR), as well as QSAR models, and provide a full explanation of the 

computational basis for each prediction from the models. This includes probabilistic information of the 

prediction from a statistical model (i.e., probability of being positive), how the predictions were 

interpreted, model training set information including structurally similar compounds in the training set 

to the query compound, information on external validation testing and applicability domain of the 

models to understand reliability of the results for assessing the tobacco compounds.

MRTP Use and Health Risk – Serious and Unexpected Adverse Experiences
MR0000192 Page 7 of 14 

In order for FDA to determine whether the modified risk product that is the subject of this order, as 

actually used by consumers, continues to be appropriate to promote the public health and continues to 

be expected to benefit the health of the population as a whole taking into account both users of tobacco 

products and persons who do not currently use tobacco products (section 911(g)(2)(A-B)), your PMSS 

must include ongoing surveillance of all adverse experiences including those that are both serious and 

unexpected associated with the use of the MRTP. 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; or tobacco product defect, or failure, reported to you, or identified in the literature or 

media. Your PMSS protocols must include procedures for monitoring and analyzing adverse experiences 

and your annual PMSS report must include: 

• A summary of reported serious and unexpected adverse experiences for the tobacco product, 

which includes a listing of all serious and unexpected adverse experiences during the reporting 

period and a cumulative list, including all 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. 

In addition, the PMTA order for your tobacco product, issued on December 07, 2020, requires you to 

report to the FDA all adverse experiences that are both serious and unexpected and your analysis of the 

association between the adverse experience and the 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, tobacco product 

defect, or failure, reported to you, or identified in the literature or media. We request that when 

submitting such reports, you reference both your PMTAs and your MRTPAs for this product. Your 

information should be submitted with a cover letter that includes the following text in the subject line: 

SERIOUS UNEXPECTED ADVERSE EXPERIENCE REPORT FOR STNs PM0000424-PM0000426, PM0000419, 

PM0000634, MR0000059-MR0000061, MR0000133 and MR0000192.

For purposes of this reporting, 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 of 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 this reporting, 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 the tobacco product as 

described in the PMTA (including the results of human subject investigations) and other relevant 

sources of information, such as postmarket reports and studies; 
MR0000192 Page 8 of 14 

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

person(s) experiencing the adverse experience and the person’s predisposing risk factor profile 

for the adverse experience; or 

• The results of nonclinical laboratory studies. 

Surveillance of New Research Study Findings on the MRTP and Consumer Perception, Behavior, or

Health

In order for FDA to determine whether the tobacco product that is the subject of this order, as actually 

used by consumers, continues to be appropriate to promote the public health and continues to be 

expected to benefit the health of the population as a whole, your PMSS must include surveillance of 

new research study information about the MRTP and consumer perception, behavior, or health. In 

particular, your PMSS protocol must include procedures for monitoring and assessing previously 

unreported (new) findings both in published or unpublished studies conducted by you or on your behalf 

and in published or otherwise available studies regarding the MRTP and consumer perception, behavior, 

or health. Your annual PMSS report must include:

• A summary of significant findings about the tobacco product from research studies conducted 

by you or on your behalf, whether or not such studies were specifically required under this 

order. 

• 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 MRTP and 

consumer perception, behavior, or health.

Modeling the Impact of the MRTP on Population Health

In order for FDA to determine whether the tobacco products that are the subject of this order continue 

to be appropriate to promote the public health and continue to be expected to benefit the health of the 

population as a whole, your PMSS must include computational modeling of the impact of the MRTPs on 

population health. Such modeling must incorporate data and information collected through PMSS, 

including the percentage of former smokers who start using IQOS; the percentage of current smokers 

who start using IQOS and become dual users; the percentage of current smokers who switch completely 

to IQOS; the percentage of youth and young adults below the legal age of purchase who start using 

IQOS; and the percentage of individuals who start using IQOS and then initiate or re-initiate combusted 

cigarette smoking. Postmarket modeling must incorporate the latest information on acute and longterm health effects of using IQOS relative to combusted cigarette smoking in order to assess the short 

and long-term population health impacts of the marketing. Your annual PMSS report must include:

• A description of the methodological approach used in the model;

• A copy of the model or its underlying code, such that FDA can independently run and verify the 

model inputs and outputs;

• A description of all model inputs, including the justification for input values and how they were 

derived from postmarket data and information; and

• A summary of the modeling results and their implications for assessing whether the MRTPs 

continue to be appropriate to promote the public health and continue to be expected to benefit 

the health of the population as a whole.
MR0000192 Page 9 of 14 

II. Submitting PMSS Protocols and Reports

As required under section 911(g)(2)(C)(ii) of the FD&C Act, your modified risk order is conditioned on 

your agreement to conduct PMSS under an approved protocol, and to submit the results for FDA to 

determine the impact of the order and review the accuracy of determinations on which the order is 

based. Within 30 days of receiving this notice, you must submit your agreement to conduct PMSS and 

complete protocols for your PMSS. FDA expects that modifications of previously approved protocols 

for the original MRTPA (MR0000133) that incorporate the product subject of this order would be 

appropriate for the PMSS required under this order. Label your submission clearly as a “PMSS 

Protocol,” and reference your MRTPA Submission Tracking Numbers (STNs). If you have more than one 

protocol, submit each protocol as a separate submission. If applicable, each protocol should include the 

name(s) of the principal investigator(s) and materials that demonstrate the relevant professional 

credentials and training that qualify them to lead the study. Within 60 days of receipt of the protocol(s), 

FDA intends to review the protocol(s) and evaluate if the principal investigator proposed to be used in 

the surveillance has sufficient qualifications and experience to conduct the surveillance and if the 

protocol(s) will result in collection of data or other information that has the potential to enable FDA to 

accurately determine the impact of the order on consumer perception, behavior and health and to 

review of accuracy of the determinations upon which the order was based, pursuant to section 

911(g)(2)(C)(ii) of the FD&C Act. FDA will notify you of, and provide opportunities to address, any 

deficiency in the submission. If the PMSS protocol is amended subsequent to FDA approval, FDA must 

receive the amended protocol promptly. For protocol amendments that are administrative in nature 

(e.g., corrections in punctuation or titles), the amended protocol must be received by FDA within 30 

days of the update. For protocol amendments that seek to modify the study design (including endpoints, 

sites, questionnaires, methodology, etc.) or other scientific parameters, you may not initiate the change 

until you receive FDA approval.

As part of the requirement to conduct PMSS, you must initiate and conduct your PMSS per the 

timeframes established in your protocols and approved by FDA. Note that for PMSS that involve human 

subjects, the anticipated start date for each study must account for the time required for securing IRB 

approval, as needed. In addition to specifying the start date, your protocols must contain timelines for 

completion of major study milestones including, as applicable, the start and completion of participant 

recruitment, initiation of data collection (per wave, if applicable), completion of data collection, analysis, 

and report writing. If you deviate from these timelines, we request that you report the deviation within 

30 days to FDA.

Section 911(g)(2)(C)(iii) requires that the results of the PMSS be submitted on an annual basis. As this 

product will be modifying the previously approved protocol for MR0000133, it should be submitted 

when the PMSS report is submitted for MR0000133. These reports must be identified as “PMSS Report”, 

and the MRTPA STNs should be referenced for each report. The PMSS Report must indicate the 

beginning and ending date of the period covered by the report and must include accomplishments since 

the last reporting period. For quantitative updates on studies in progress (e.g., participant accrual), 

reports should describe both interim (since the last reporting period) as well as cumulative (since study 

initiation) accomplishments. The PMSS Report describing studies in progress must describe the status of 

PMSS, including, as applicable, the status of recruitment, data collection, and analysis; a summary of the 

study milestones achieved and any deviations from the approved timelines in the protocol; a summary 

of protocol amendments; and a summary of any preliminary analyses conducted. Once a study is 

completed, the PMSS Report should include the complete final study report.
MR0000192 Page 10 of 14 

Appendix C

Recordkeeping and Retention

The exposure modification order for your modified risk tobacco product is effective for a period to end

on July 07, 2024. If you wish to renew your order, we recommend you submit a request for renewal

360 days prior to the end of your effective timeframe. In order to help ensure that your exposure

modification order meets the standard for renewal and to help expedite the review of any renewal

applications, we request that you establish and maintain the records listed below. The records should be

retained for a period of not less than four years from the date of distribution of the last batch of the

tobacco products listed in your orders under section 911(g)(2). The records should be legible, written in

English, and upon request, available for inspection and copying by officers or employees duly designated

by the Secretary. Please note that Appendix B requires you to periodically submit some of these records

to FDA (e.g., in PMSS reports). Additionally, we remind you that the PMTA order for your tobacco

product issued on December 07, 2020, also requires you to establish and maintain records, some of

which overlap with the records listed below:

• The MRTPAs submitted prior to the orders

• Postmarket reports, as described in the Required PMSS Appendix, including adverse experience

reports and all relevant documentation associated with the experience

• Records of all nonclinical or clinical studies, including:

o Source data;

o Study protocols (including statistical analysis plan);

o Amendments showing the dates and reasons for any protocol revisions;

o Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approvals or nonapprovals;

o Informed consent forms;

o Correspondence with study monitors/investigators/contract research

organizations/sponsors/IRB/IEC; 

o Investigator financial disclosure statements;

o Progress reports;

o Monitoring reports;

o Adverse experience reports;

o Case report forms/subject diaries/medical records/laboratory reports;

o Subject data line listings/observation records;

o Test article accountability records;

o Study results/protocol summaries/study reports; and

o Certifications and amendments to certifications

• Records pertaining to the manufacture, in process and release testing, production process 

(including any changes to the process, facility, or controls), packaging, storage, and stability 

monitoring and testing (including protocol and results) of the products

• Records pertaining to the sale, distribution, or other disposition of the products, specifically:

o A list of distributors and retailers of the products, including brick-and-mortar and digital. For 

the purposes of this order, here and throughout the document, “digital” includes 

internet/online and mobile; 

o Any available information (not to include personally identifiable information) about product 

purchases, 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); 
MR0000192 Page 11 of 14 

o Policies and procedures regarding verification of the age and identity of purchasers of the 

products; and 

o Policies and procedures regarding restrictions on youth access to the products

• Health hazard analyses, if performed voluntarily or directed by FDA

• Records pertaining to any and all complaints associated with any of the products that you 

receive or of which you are aware

• Records pertaining to the products’ labeling, advertising, marketing, and/or promotion – 

whether conducted by you, on your behalf, or at your direction – including: 

o Specimens of all labeling (including all labeling variations, such as those reflecting different 

required warnings), labels, inserts/onserts, instructions, and other accompanying 

information;

o Copies of all advertising, marketing, and/or promotional materials published, disseminated 

to consumers, or for use in engaging or communicating with consumers;

o Copies of any formative research studies conducted among any audiences in the formation 

of the labeling, advertising, marketing, and/or promotional materials, including qualitative 

and quantitative research studies used to determine message effectiveness, consumer 

knowledge, attitudes, beliefs, intentions, and behaviors toward using the products, and 

including copies of the stimuli used in testing;

o Copies of any consumer evaluation research studies conducted among any audiences to 

determine the effectiveness of 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;

o Copies of any contractual agreements regarding the creation and/or dissemination of the 

products’ labeling, advertising, marketing, and/or promotional materials, including for 

example, in print media, online or through digital platforms (e.g., social media and mobile 

applications), such as influencers, bloggers, and ambassadors, on your behalf, or at your 

direction; 

o Copies of all advertising and marketing plans, including strategic creative briefs and paid 

media plans, by channel and by product, and the 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;

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

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

your intended target audience;

 With respect to individuals under the federal minimum age of sale of tobacco products, 

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 social media to create labeling for, advertise, 

market, and/or promote the product;

 Use of broadcast, satellite, or cable TV media, or broadcast or satellite radio media,

including copies of media buy schedules pre-launch, program lists, projected percent 

audience compositions by age breakouts (i.e., 21+, 2-11, 12-17, 18-24, 25-54, 55+) by 

program, audience indices by age breakouts (i.e., 2-11, 12-17, 18-24, 25-54, 55+) by

program, reach and frequency goals, and any targeting or purchasing parameters;

 Use of partners, influencers, bloggers, and/or brand ambassadors to create labeling for, 

advertise, market, and/or promote the product; 
MR0000192 Page 12 of 14 

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

direction – including events at which the products were demonstrated and how access 

will be restricted to individuals at or above the federal minimum age of sale of tobacco 

products; and/or

 Use of public-relations or other communications outreach to create labeling for, 

advertise, market, and/or promote the product; 

o Copies of all records pertaining to the actual delivery of advertising impressions, including 

media tracking and optimization, by channel, by product (if applicable), by program (where 

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

region), media buy summaries, program lists, number of units by program, percent audience 

compositions by age breakouts (i.e., 21+, 2-11, 12-17, 18-24, 25-54, 55+) by program, 

audience indices by age breakouts (i.e., 2-11, 12-17, 18-24, 25-54, 55+) by program, reach 

and frequency, any other parameters purchased against the buying demographics, post-logs 

that verify TV/radio ads ran within the approved parameters, and all post-launch deliveryverification reports for other paid media submitted to you or entities working on your behalf 

or at your direction from an accredited source; and 

o Policies and procedures for real-time digital media monitoring to identify, correct, and 

prevent delivery of advertising impressions to individuals under the federal minimum age of 

sale of tobacco products, including documentation of such monitoring activities and 

implementation of corrective and preventive measures.
MR0000192 Page 13 of 14 

Appendix D

Conditions of Marketing

The PMTA order for your tobacco product11, issued on December 07, 2020, requires you to report to the 

FDA manufacturing information. We request that when submitting such reports, you reference both 

your PMTA and your MRTPA for the product. When cross-referencing, please provide the date of 

submission and location in the submission where the information is covered.

For each twelve-month reporting period, the annual reports should include:

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

PM0000424-PM0000426, PM0000419, PM0000634, MR0000059-MR0000061, MR0000133 and 

MR0000192. The cover letter should include the STN(s), static product ID if applicable, and 

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

• 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 PMTA/MRTPA;

 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.12

• 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. For additional information on manufacturing deviations, see

below.

Manufacturing Deviations

You should promptly investigate all manufacturing deviations including, but not limited to, those 

associated with processing, testing, packing, labeling, storage, holding, and distribution. The PMTA order 

for your tobacco product, issued on December 07, 2020, requires that, 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. We request that when submitting such 

reports, you reference both your PMTA and your MRTPA for the product.

Discontinuation and Reintroduction

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

distribution of the modified risk tobacco product and later decide to reintroduce the modified risk 

11 PMP SA has requested a modification to the required Cigarette Health Warnings for the IQOS brand. This is still under 

discussion with FDA. What is listed within this order does not convey any decision from FDA on that topic. 12 We note that any modifications made to a tobacco product that render it a new tobacco product are subject to

the premarket review requirements under section 910 of the FD&C Act.
MR0000192 Page 14 of 14 

tobacco product into the market, please contact the Office of Compliance and Enforcement prior to 

reintroduction. Section 905(i)(3) of the FD&C Act requires you to update your product listing 

biannually to reflect any products that have been discontinued and/or reintroduced into interstate 

commerce.