U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

MARKETING GRANTED ORDER

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 Number (STN): PM0004691.PD1

Dear Laura Oyler:

  

We completed review of your sPMTA1 and are issuing a marketing granted order for the tobacco

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

appropriate for the protection of the public health (APPH) 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).  

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

tobacco product, as described in your application and specified in Appendix A, is APPH. 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.

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.  

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, among other

factors, 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.  

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

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

1 Supplemental Premarket Tobacco Product Application (sPMTA) 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)
PM0004691.PD1    Page 2 of 17

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

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 product subject to this order adhere to the same marketing requirements that

FDA found necessary for the product subject to marketing authorization on April 30, 2019; however,

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

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 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 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 product 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 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 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 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.
PM0004691.PD1    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 Product 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





PM0004691.PD1    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 PM0004691.PD1.  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.
PM0004691.PD1    Page 10 of 17

5. A summary of any stability monitoring, and testing of the product, 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 product 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 product 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 product 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 product, 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 product 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 product are sold;  

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

c. Demographic characteristics of product 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 product;

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 product, 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 product,

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

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

and/or promotional materials – whether conducted by you, on your behalf, or at your direction

– including a list of all entities involved and a description of their involvement, including a
PM0004691.PD1    Page 11 of 17

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 product 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 product;

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

advertise, market, and/or promote the product;

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 product; 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 post‐

launch delivery‐verification reports submitted to you from an accredited source;  and

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

for the protection of public health.

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. Grounds that FDA will consider for withdrawal under

section 910(d) of the FD&C Act include scenarios in which FDA finds that the continued marketing of the
PM0004691.PD1    Page 12 of 17

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 product,  fewer users of

potentially more harmful products switching to your product than anticipated), changes in FDA’s

understanding of the net effects of your product 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, 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 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 PM0004691.PD1.

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 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 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 of adverse experiences associated with the use or exposure to

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

as postmarket reports and studies;

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

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

for the adverse experience; or  

 The results of nonclinical laboratory studies.

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

presents a reasonable probability that the tobacco product contains a manufacturing or other defect not
PM0004691.PD1    Page 13 of 17

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, this order 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 PM0004691.PD1.  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

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; and  

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

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

and by product, including any plans to:

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

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

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

media buys;  

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

other demographic or psychographic characteristics that reflect your intended audience,

including the source(s) of such data;
PM0004691.PD1    Page 14 of 17

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.  

   
PM0004691.PD1    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 kits15. 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 product 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).
PM0004691.PD1    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
PM0004691.PD1    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 age‐

verified data, where:

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

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

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

independent, competent, and reliable data sources; and

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

competent and reliable entity (e.g., another company’s 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.