U.S. Food & Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov 

December 07, 2020 

MARKETING GRANTED ORDER 

Philip Morris Products S.A. 

Attention: Dr. Jeffrey Walker, CEO 

Teton Regulatory Sciences 

1441 E South Temple 

Salt Lake City, UT 84102-1844 

FDA Submission Tracking Number (STN): PM0000634 

Dear Dr. Walker: 

We completed review of your PMTA1 and are issuing a marketing granted order for the tobacco product 

identified in Appendix A. 

Based on our review of your PMTA, we determined that the new tobacco product, as described in 

your application and specified in Appendix A, 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. 

Our finding does not mean FDA has “approved” the new tobacco product specified in Appendix A; 

therefore, you may not make any express or implied statement or representation in a label, labeling, 

or through the media or advertising, that the new tobacco product specified in Appendix A is 

approved by FDA (see Section 301(tt) of the FD&C Act). 

The authority to market the new tobacco product under this order is also contingent upon the 

conditions listed in this order and subject to the requirements in the enclosed appendices. 

Additionally, this order is conditioned upon the product conforming with any applicable current or 

future tobacco product standards, unless specifically exempted under this order or the product 

standard(s). 

The requirements in this order are intended to help ensure that the marketing of your product will 

continue to be appropriate for the protection of the public health, taking into account initiation among 

non-users, particularly youth. However, compliance with these requirements alone is not a guarantee 

that the marketing of the product will remain appropriate for the protection of the public health, 

particularly if, despite these measures, there is a significant uptake in youth initiation, for example. 

FDA will continue to monitor the marketing of your product. This order does not constitute a finding 

that any of the products outside the scope of this authorization are in compliance with the FD&C Act 

1 Premarket Tobacco Product Application (PMTA) submitted under section 910 of the Federal Food, Drug, and Cosmetic Act 

(FD&C Act) 
 

 

 

 

 

 

 

PM0000634 Page 2 of 15 

and its implementing regulations. FDA has not evaluated other components or parts, or accessories 

that you may choose to market with the iQOS system, such as A/C power adapters, USB cables, 

charging docks, cleaners, disposal units, and pouches. To the extent that any premarket authorization 

requirements of section 910 of the FD&C Act apply, FDA does not intend to enforce them with respect 

to such products. However, it is your responsibility to ensure that these products comply with all other 

applicable laws and regulations. For example, if you choose to include the brand name “IQOS” on items 

other than the products authorized in these orders, you need to evaluate whether that would comply 

with 21 CFR 1140.34(a). In addition, we recommend you evaluate whether any of the branded 

accessories you plan to market would constitute advertising that requires the applicable warnings. 

The product subject to this marketing granted order is subject to withdrawal or temporary suspension 

as described in section 910(d) of the FD&C Act. 

You may be eligible to submit a supplemental PMTA for modification(s)2

 made to tobacco products 

that received marketing granted orders, by cross-referencing content in the PMTA and postmarket 

reports for the tobacco product subject of this letter. Applicants that have questions about whether it 

would be appropriate to submit a supplemental PMTA for modification(s) they are seeking to 

implement should contact their Regulatory Health Project Manager (RHPM) within the Office of 

Science for more information. 

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. 

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

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

contact the Office of Science prior to reintroduction. 

2 We note that any modifications made to a tobacco product would render it a new tobacco product that would be subject to 

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

 

 

 

PM0000634 Page 3 of 15 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal3,4

 using 

eSubmitter.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, please contact Donna Cheung, Regulatory Health Project Manager, at 

(240) 402-5340 or Donna.Cheung@fda.hhs.gov. 

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

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

OCE-Postmarket@fda.hhs.gov. 

Sincerely, 

Digitally signed by Matthew R. Holman -S 

Date: 2020.12.07 12:22:25 -05'00' 

Matthew R. Holman, Ph.D. 

Director 

Office of Science 

Center for Tobacco Products 

Enclosures: 

Appendix A – New Tobacco Product Subject of This Letter 

Appendix B – Postmarket Recordkeeping and Retention 

Appendix C – Postmarket Reporting 

Appendix D – Marketing Requirements 

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 
 

 

 

 

 

 

 

 

 

PM0000634 Page 4 of 15 

Appendix A 

New Tobacco Product Subject of This Letter 

Attributes of PMTA 

Submission date March 30, 2020 

Receipt date April 1, 2020 

Applicant Philip Morris Products S.A. 

Product manufacturer Philip Morris Products S.A. 

Product category Cigarettes 

Product subcategory Non-Combusted 

STN PM0000634 

Product name IQOS 3 System Holder and Charger7 

Package type Box 

Package quantity 1 Holder, 1 Charger 

Characterizing flavor None8 

Length 92.25 mm (Holder) 

114.90 mm (Charger) 

Diameter 14.40 mm (Holder) (smallest) 

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

Ventilation Not provided 

Source of energy Electric (rechargeable battery) 

Additional property Thickness: 23 mm (Charger) 

Width: 46.35 mm (Charger) 

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

Battery Capacity: > 2600 mAh (Charger) 

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

8 Provided as part of product labeling. 
 

 

 

 

 

 

 

 

 

PM0000634 Page 5 of 15 

Appendix B 

Postmarket Recordkeeping and Retention 

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

listed below. At any time during the retention period described in this order, FDA may request that you 

provide any of the documents described below. In addition, under section 704 of the FD&C Act, FDA 

may inspect your establishment(s) and request to inspect any record(s) described below. 

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

records must be legible, in English, and available for inspection and copying by officers or employees 

duly designated by the Secretary, upon request. 

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), 

packaging, storage, and stability monitoring and 

testing (including protocol and results) 

4 years from the date of 

distribution of each 

batch of each product 

subject to this order 
 

 

 

 

 

 

 

 

PM0000634 Page 6 of 15 

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 

product9 

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 digital10 (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 

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: 

4 years from the date of 

initial dissemination to 

the public or 

implementation 

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

 

 

 

 

 

PM0000634 Page 7 of 15 

• 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 

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 

4 years after the studies 

are completed 
 

 

PM0000634 Page 8 of 15 

effectiveness, consumer knowledge, attitudes, 

beliefs, intentions, and behaviors toward using the 

products, and including copies of the stimuli used in 

testing 

Consumer evaluation 

research 

Copies of any consumer evaluation research studies 

conducted among any audiences to determine the 

effectiveness of the labeling, advertising, marketing, 

and/or promotional materials and any shifts in 

consumer knowledge, attitudes, beliefs, intentions, 

and behaviors toward using the products, and 

including copies of the stimuli used in testing 

4 years after the studies 

are completed 

Contractual agreements Copies of any contractual agreements regarding the 

creation or dissemination of the products’ labeling, 

advertising, marketing, 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 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000634 Page 9 of 15 

Appendix C 

Postmarket Reporting 

1. 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 order 11 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: 

1. 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 

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

 

 

•

PM0000634 Page 10 of 15 

product name(s), applicant name, date of report, reporting period, and marketing status outside 

the United States; 

 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. 
 

 

 

 

 

 

 

 

 

 

PM0000634 Page 11 of 15 

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 

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. 
 

 

 

 

 

 

 

 

PM0000634 Page 12 of 15 

 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. 

2. 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 

• The results of nonclinical laboratory studies. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000634 Page 13 of 15 

3. 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; 

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. 
 

 

 

 

 

 

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Appendix D 

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 

marketing to your adult smoking customers) that you have age-verified through 

independent, competent, and reliable data sources; and 
 

 

 

 

 

 

 

 

 

 

PM0000634 Page 15 of 15 

 “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.