U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

MARKETING GRANTED ORDERS

Philip Morris Products S.A.

Attention: Laura Leigh Oyler, U.S. Agent for PMP S.A., Head of U.S. Regulatory Affairs

FDA Submission Tracking Numbers (STNs): PM0004337.PD1 - PM0004337.PD2

Dear Laura Oyler: 

 

We completed review of your sPMTAs1 and are issuing marketing granted orders for the tobacco 

products identified in Appendix A. Our finding that permitting the marketing of the new products is 

appropriate for the protection of the public health (APPH) does not mean FDA has “approved” the 

new tobacco products 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 products specified in Appendix A are approved by FDA (see Section 301(tt) of the FD&C Act). 

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

tobacco products, as described in your applications and specified in Appendix A, is APPH. The 

issuance of these marketing granted orders confirms that you have met the requirements of 

section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products. Under the 

provisions of section 910, you may introduce or deliver for introduction into interstate commerce 

the tobacco products, in accordance with the marketing order requirements outlined in these

orders, including all appendices.

The authority to market the new tobacco products under these orders are also contingent upon 

the conditions listed in these orders and subject to the requirements in the enclosed appendices. 

The requirements in these orders are intended to help ensure that the marketing of your products will 

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

factors, initiation among non-users, particularly youth. However, compliance with these requirements 

alone is not a guarantee that the marketing of the products 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 products. 

Based on our review of your sPMTAs, the marketing restrictions in Appendix D are necessary to our 

conclusion that permitting the marketing of the new tobacco products is appropriate for the 

1 Supplemental Premarket Tobacco Product Applications (sPMTAs) submitted under section 910 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). Applicants that have received a marketing granted order for a tobacco product may, as an alternative 

format of submitting an application that meets the content requirements of 21 CFR 1114.7, submit a supplemental PMTA to 

seek marketing authorization for modifications to such product, which result in a new tobacco product under section 910(a)(1)

of the FD&C Act. 

(b) (6)
PM0004337.PD1 - PM0004337.PD2 Page 2 of 17 

protection of public health. Absent these restrictions, a marketing granted order for these 

applications could not issue consistent with the requirements of section 910(c) of the FD&C Act. We 

also recommend that you take additional steps to limit youth exposure to your print and point-of-sale 

advertising, including, for example, limiting advertising to print publications where 85% or more of 

the readership is 21 years of age or older and/or selecting publications that do not over-index for 

youth, requiring advertising to be placed inside the store, and placing product displays near other 

age-restricted products and away from toys and candy. 

FDA is requiring that the products subject to this order adhere to the same marketing requirements 

that FDA found necessary for the products subject to marketing authorization on April 30, 2019; 

however, based on current experience we have updated the timelines for reporting. 

Additionally, these orders are conditioned upon the products conforming with any applicable current 

or future tobacco product standards, unless specifically exempted under these orders or the product 

standard(s). 

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

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

You may be eligible to submit an sPMTA, in accordance with 21 CFR 1114.15, 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 original tobacco products subject to this letter. Applicants 

that have questions about whether it would be appropriate to submit an sPMTA 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 products 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 products specified in Appendix A comply 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 these tobacco products and later decide to reintroduce the products 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.
PM0004337.PD1 - PM0004337.PD2 Page 3 of 17 

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 Elizabeth Do, Regulatory Health Project Manager, at 

(301) 796 - 5205 or Elizabeth.Do@fda.hhs.gov.

If you have any questions regarding postmarket activities for the tobacco products subject of these

orders, please contact Chad Burger, Director, Division of Product Compliance, at 

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

Sincerely, 

/S/ 

Benjamin Apelberg, Ph.D.

Director (Acting)

Office of Science

Center for Tobacco Products

Enclosures:

Appendix A – New Tobacco Products Subject of This Letter

Appendix B – Postmarket Recordkeeping and Retention 

Appendix C – Postmarket Reporting

Appendix D – Marketing Restrictions 

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





PM0004337.PD1 - PM0004337.PD2 Page 9 of 17 

Appendix C

Postmarket Reporting 

I. Annual Reporting

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

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

determine whether continued marketing of each new tobacco products are appropriate for the 

protection of public health or whether there is or may be other grounds for withdrawing or temporarily 

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

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

REPORT for PM0004337.PD1 - PM0004337.PD2. The cover letter should include the STN(s) and 

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

marketing status outside the United States; 

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

warnings) not previously submitted (e.g., if previously submitted under section 905(i) or 

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

date and manner of submission), including the date the labeling was first disseminated and the 

date when the labeling was discontinued, and a description of all changes to the labeling. The 

labeling must include all the panels and be presented in the actual size and color with legible 

text. The labeling must include labels, inserts/onserts, instructions, and any other accompanying 

information or materials for the products;

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

to consumers, or for use in engaging or communicating with consumers not previously 

submitted (e.g., if previously submitted under 905(i) or previously submitted at the last 

reporting period and no changes were made, please list the date and manner of submission), 

along with the original date such materials were first disseminated and the date they were 

discontinued, and a description of all changes to the materials. The materials must be legible, 

include all panels where applicable (e.g., print ads, point of sale signs) and reflect the actual size 

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

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

sufficient resolution to allow FDA to read lettering clearly. If resizing the advertisement does not 

allow for text to be read easily, the complete text must be provided separately and clearly 

referenced. Digital media, such as videos and animations must be submitted in a format that 

FDA is able to open and review;

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

the reporting period, including:

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

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

and

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

is outside the scope of the marketing granted order.
PM0004337.PD1 - PM0004337.PD2 Page 10 of 17 

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

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

6. A complete list of ongoing and completed studies about the tobacco products conducted by, or 

on your behalf, that have not been previously reported; 

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

you, concerning scientific investigations and literature about the tobacco products that have not 

been previously reported, as well as significant findings from publications not previously 

reported; 

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

tobacco products that have been reported to you or that you are aware of, accompanied by a 

statement of any changes to the overall risk associated with the tobacco products, and a 

summary of any changes in the health risks, including the nature and frequency of the adverse 

experience, and potential risk factors; 

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

extent that you collect or receive such data, including: 

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

region, major retail markets, and channels in which the products are sold; 

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

and

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

geographic region, and tobacco use status;

10. A summary of the implementation and effectiveness of your policies and procedures 

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

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

regarding restrictions on access to the products for individuals under the federal 

minimum age of sale of tobacco products; 

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

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

marketing, and/or promotional materials, not previously submitted, including qualitative and 

quantitative research studies used to determine message effectiveness, consumer knowledge, 

attitudes, beliefs, intentions and behaviors toward using the products, and including the findings 

or these studies and copies of the stimuli used in testing;

13. A summary of all consumer evaluation research studies conducted – whether by you, on your 

behalf, or at your direction - among any audiences, not previously submitted, to determine the 

effectiveness of labeling, advertising, marketing, and/or promotional materials and shifts in 

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

and including the findings of these studies and copies of the stimuli used in testing; 

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

and/or promotional materials – whether conducted by you, on your behalf, or at your direction 
PM0004337.PD1 - PM0004337.PD2 Page 11 of 17 

– including a list of all entities involved and a description of their involvement, including a 

description of contractual agreements with such entities; 

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

by you, on your behalf, or at your direction - not previously submitted, including strategic 

creative briefs and paid media plans by channel and by product, and the details, dollar 

amount(s) and flighting of such plans, by channel and by product, including a description of any: 

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

establish, maintain, and monitor highly targeted advertising and marketing plans and 

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

plans and media buys;

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

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

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

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

actions taken to restrict access to the products and limit exposure to the products’ 

labeling, advertising, marketing, and/or promotion;

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

and/or promote the products; 

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

advertise, market, and/or promote the products; 

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

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

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

products; or

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

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

were first used and the date they were discontinued, and a description of all changes to 

such plans since the last periodic report, by channel and by product;

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

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

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

impressions to individuals under the federal minimum age of sale of tobacco products, and 

including a summary of implementation of any corrective and preventive measures, not 

previously submitted;

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

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

breakout by age-group (i.e., adults, ages 25+; young adults, ages 18-24; and youth, ages 12-17 

and ages 11 and under), not previously submitted. This analysis must be verified against postlaunch delivery-verification reports submitted to you from an accredited source; and

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

appropriate for the protection of public health.

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

suspension as described in section 910(d) of the FD&C Act. Grounds that FDA will consider for 
PM0004337.PD1 - PM0004337.PD2 Page 12 of 17 

withdrawal under section 910(d) of the FD&C Act include scenarios in which FDA finds that the 

continued marketing of the product is no longer APPH. These scenarios may include, but are not limited 

to, certain changes in product use behaviors that were not expected in FDA’s assessment of the PMTA

(e.g., increases in the percentage or number of youth and young adults who report use of your products, 

fewer users of potentially more harmful products switching to your products than anticipated), changes 

in FDA’s understanding of the net effects of your products on the population as a whole, or new 

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

understood during the review process. 

II. Serious and Unexpected Adverse Experiences Reporting and Reporting of Certain Manufacturing 

Deviations

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

experiences that are both serious and unexpected and your analysis of the association between the 

adverse experience and each new tobacco product within 15 calendar days after the report is received 

by you. These experiences may become known to you through any source including a customer 

complaint, request, or suggestion made as a result of an adverse experience, a manufacturing deviation 

analysis, tobacco product defect, or failure reported to you; or identified in the literature or media. 

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

SERIOUS UNEXPECTED ADVERSE EXPERIENCE REPORT for PM0004337.P1 – PM0004337.PD2. 

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

that results in any of the following outcomes:

• Death;

• A life-threatening condition or illness; 

• Inpatient hospitalization or prolongation of existing hospitalization;

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

life functions;

• A congenital anomaly/birth defect; or

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

the health of a person and may require medical or surgical intervention to prevent one of the 

other outcomes listed in this definition.

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

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

experience is not consistent with:

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

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

as postmarket reports and studies;

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

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

for the adverse experience; or 

• The results of nonclinical laboratory studies.
PM0004337.PD1 - PM0004337.PD2 Page 13 of 17 

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

presents a reasonable probability that the tobacco product contains a manufacturing or other defect not 

ordinarily contained in tobacco products on the market that would cause serious, adverse health 

consequences or death you are required to report the deviation to FDA within 15 calendar days of 

identification. 

III. Notifications

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

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

marketing plans and materials to FDA. This requirement to submit the product’s labeling, advertising,

marketing, and promotional materials and plans in advance of their use is not for pre-approval – that is, 

FDA is not requiring that it review and approve such materials or plans before they may be used. Rather,

such advance notification will provide FDA timely access to such materials and plans and, if needed, 

allow FDA to provide advisory comments, including any concerns about their possible impact on youth

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

notification to FDA. 

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

not limited to the publication, dissemination to consumers, or use in engaging or communicating with

consumers of such materials. The duration of these notification requirements is as follows: 

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

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

Each 30-day notification must include:

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

NOTIFICATION for PM0004337.PD1 – PM0004337.PD2. The cover letter should include the 

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

planned dissemination date;

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

products. The materials must be legible, include all panels where applicable (e.g., print ads,

point of sale signs) and reflect the actual size and colors used. For any materials that would not

fit on an 8.5” x 11” piece of paper, you may resize and submit electronic versions of such

materials in a format that FDA can review and with sufficient resolution to allow FDA to read all 

lettering clearly. If resizing the advertisement does not allow for text to be read easily, the

complete text must be provided separately and clearly referenced; and 

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

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

and by product, including any plans to:

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

maintain, and monitor highly targeted advertising and marketing plans and media buys, 

including a list of all data sources used to target advertising and marketing plans and 

media buys; 
PM0004337.PD1 - PM0004337.PD2 Page 14 of 17 

b. Targeting specific group(s) by age-range(s), including young adults, ages 21-24, and 

other demographic or psychographic characteristics that reflect your intended audience, 

including the source(s) of such data; 

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

actions taken to restrict access and exposure to the products’ labeling, advertising, 

marketing, and/or promotion;

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

and/or promote the products; 

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

advertise, market, and/or promote the products; 

f. Conduct consumer engagements – whether by you, on your behalf, or at your direction 

– including events at which the products will be demonstrated and how access will be 

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

products; or 

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

market, and/or promote the products. 
PM0004337.PD1 - PM0004337.PD2 Page 15 of 17 

Appendix D

Marketing Restrictions14

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

Smoking Prevention and Tobacco Control Act, these orders require you to: 

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

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

HeatSticks packs as well as in all advertisements for such products and kits.15 Specifically, the 

warning statement must appear directly on the package and must be clearly visible underneath 

any cellophane or other clear wrapping as follows: 

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

the package and the warning area must comprise at least 30 percent of each of the 

principal display panels; 

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

greatest possible proportion of the warning area set aside for the required text; 

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

fonts) and in black text on a white background or white text on a black background in a 

manner that contrasts by typography, layout, or color, with all other printed material on 

the package; 

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

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

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

the principal display panel have the same orientation.

• For print advertisements and other advertisements with a visual component (including, for 

example, advertisements on signs, shelf-talkers, websites, mobile applications, and e-mail), the 

warning statement must appear in the upper portion of the area of the advertisement within 

the trim area as follows: 

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

o Appear in at least 12-point font size and the warning statement must occupy the 

greatest possible proportion of the warning area set aside for the required text; 

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

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

in a manner that contrasts by typography, layout, or color, with all other material on the 

advertisement; 

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

respect to warnings for the products subject to this order.

15 This warning must appear on each package and each advertisement, in addition to the rotating Surgeon General warnings 

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

warnings as described in this order).
PM0004337.PD1 - PM0004337.PD2 Page 16 of 17 

o Be capitalized and punctuated as indicated in this order; 

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

such that the text of the warning statement and the other textual information in the 

advertisement have the same orientation; and 

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

statement and that is not less than 3 millimeters (mm) or more than 4 mm. 

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

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

advertisements under the Federal Cigarette, Labeling and Advertising Act (FCLAA). 

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

United States Federal Trade Commission (FTC).

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

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

establish, maintain, and monitor use of independent age- and 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 products to individuals who are under the 

federal minimum age of sale of tobacco products. 

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

owned digital properties (e.g., your company-owned, 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, to restrict 

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

or above the federal minimum age of sale of tobacco products. 

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

shared digital properties (e.g., your product-branded social media accounts, pages and 

associated content; content promoting your products on your behalf disseminated through 

another entity’s social media accounts) – whether conducted by you, on your behalf, or at your 

direction – establish, maintain, and monitor use of the available site-, platform- and content- 

(e.g., post, video) specific age-restriction controls (e.g., age-restrict an entire product-branded 

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

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

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

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

the federal minimum age of sale of tobacco products. 

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

digital media (e.g., paid digital banner advertisements for the products running on another 
PM0004337.PD1 - PM0004337.PD2 Page 17 of 17 

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

of influencer content; paid advertising in streaming/Over-The-Top video programming; paid 

advertising in streaming/internet radio content) – whether conducted by you, on your behalf, or 

at your direction:

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

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

marketing, and/or promotion to only individuals who are or above the federal minimum age 

of sale of tobacco products. Such targeting must use only first- and/or second-party ageverified data, where: 

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

data collected via site traffic to your company-owned website; data you use in direct 

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

independent, competent, and reliable data sources; and

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

competent and reliable entity (e.g., another company’s 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 federal minimum age of sale of tobacco products. Such monitoring also 

requires post-launch delivery verification reports for other paid media be submitted to you or 

entities working on your behalf or at your direction from an accredited source. 

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

advertise, market, and/or promote the products – whether conducted by you, on your behalf, or 

at your direction – disclose to consumers or viewers, via the use of statements such as 

“sponsored by [firm name]” in such labeling, advertising, marketing, and/or promotional 

materials, any relationships between you and entities that create labeling for, advertise, market, 

and/or promote the products, on your behalf, or at your direction.