U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

 

 

MARKETING ORDER 

Philip Morris Products S.A. 

ATTENTION: Dr. Jeffrey Walker, CEO Teton Regulatory Sciences 

1125 E. Glacier Road 

Jackson, Wyoming 83001-4876 

FDA Submission Tracking Numbers (STNs): PM0000424-PM0000426, PM0000479

Dear Dr. Walker: 

The Food and Drug Administration (FDA) completed the review of your Premarket Tobacco Product 

Applications (PMTAs) submitted under section 910(b) of the Federal Food, Drug, and Cosmetic Act 

(FD&C Act), specified in Appendix A.

Based on our review of your PMTAs, we find that the marketing of the new tobacco products 

specified in Appendix A is appropriate for the protection of public health, and that you have met the 

other requirements of section 910(c) of the FD&C Act. This marketing order is subject to marketing 

requirements under section 910(c)(1)(B) of the FD&C Act and record retention and reporting 

requirements under section 910(f) of the FD&C Act, as outlined in Appendix B. Additionally, this 

order is conditioned upon the products conforming with any applicable current or future tobacco 

product standards, unless specifically exempted under this order or the product standard(s). Under 

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

the new tobacco products, in accordance with the order requirements outlined in Appendix B. 

The requirements in this order 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 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. 

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 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. 

April 30, 2019
PM0000424-PM0000426, PM0000479 Page 2 of 15

We note that, in your September 5, 2018 and March 25, 2019 amendments to your PMTAs, you include 

representations about your marketing plan for your products in the United States and indicate that you 

intend to focus marketing on adult cigarette smokers while limiting reach to unintended audiences. FDA 

encourages you to consider measures to limit youth-exposure to any of the products’ labeling, 

advertising, marketing, and/or promotion appearing in print media publications. Limiting youth 

exposure and initiation and use of the products as you have indicated in your PMTAs (i.e., complete 

switching to IQOS by adult cigarette smokers) are important components of consideration for the 

marketing of these products to continue to be appropriate for protection of the public health. 

Also, in accordance with 40 CFR 1506.6, we will make your environmental assessments publicly 

available. 

This order authorizing the marketing of these new tobacco products does not mean FDA “approved” the 

new tobacco products specified in Appendix A; therefore, you may not make any express or implied 

statement or representation directed to consumers that conveys, or misleads or would mislead 

consumers into believing, among other things, that the new tobacco products specified in Appendix A 

are “approved” by FDA.1 The products subject to this marketing order are subject to withdrawal or 

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

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

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

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

ingredients, reporting of harmful and potentially harmful constituents, and payment of user fees. There 

are also packaging, labeling, and advertising requirements with which you must comply. 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. 

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. 

For more information on your responsibilities under the FD&C Act, we encourage you to visit our 

website at http://www.fda.gov/TobaccoProducts. You may also obtain information by contacting us at 

1-877-CTP-1373, AskCTP@fda.hhs.gov, or SmallBiz.Tobacco@fda.hhs.gov. 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal 

(http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufacturing/uc

 

1 See Section 301(tt) of the FD&C Act. 
PM0000424-PM0000426, PM0000479 Page 3 of 15

m515047.htm)2 using eSubmitter (http://www.fda.gov/ForIndustry/FDAeSubmitter). 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 the FDA 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 date3

; 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, you may contact Donna Cheung, Regulatory Health Project Manager, at 

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

 Sincerely, 

Matthew R. Holman, Ph.D. 

Director 

Office of Science 

Center for Tobacco Products 

 

 

2 The FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal. 3 See http://www.fda.gov/tobaccoproducts/aboutctp/contactus/default.htm

Digitally signed by Matthew R. Holman -S 

Date: 2019.04.30 08:29:11 -04'00'


Appendices A and B Page 6 of 15

Appendix B 

Postmarket Recordkeeping, Retention, Reporting, and Marketing Requirements 

I. Record Retention 

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

listed below. The records must be retained for a period of not less than four years from the date of 

distribution of the last batch of the new tobacco products listed in your marketing authorization. The 

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

employees duly designated by the Secretary upon request: 

x The PMTA submitted prior to product order 

x Periodic postmarket reports, as described below, and adverse experience reports, including all 

relevant documentation associated with the experience 

x Records of all nonclinical or clinical studies, including: 

o Source data; 

o Study protocols (including statistical analysis plan); 

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

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

o Informed consent forms; 

o Correspondence with study monitors/investigators/contract research 

organizations/sponsors/IRB/IEC; 

o Investigator financial disclosure statements; 

o Progress reports; 

o Monitoring reports; 

o Adverse experience reports; 

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

o Subject data line listings/observation records; 

o Test article accountability records; 

o Study results/protocol summaries/study reports; and 

o Certifications and amendments to certifications 

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

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

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

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

o A list of distributors and retailers of the products, including brick-and-mortar and digital8

; 

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

purchases, such as purchasers’ demographics (e.g., age, gender, race/ethnicity, geographic 

region) and previous or current use of other tobacco products (i.e., dual use); 

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

products; and 

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

 

8 For the purposes of this order, here and throughout the document, “digital” includes internet/online and mobile. 
Appendices A and B Page 7 of 15

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

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

o Specimens of all labeling, labels, inserts/onserts, instructions, and other accompanying 

information; 

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

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

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

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

and quantitative research studies used to determine message effectiveness, consumer 

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

including copies of the stimuli used in testing; 

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

determine the effectiveness of labeling, advertising, marketing, and/or promotional 

materials and any shifts in consumer knowledge, attitudes, beliefs, intentions, and behaviors 

toward using the products, and including copies of the stimuli used in testing; 

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

products’ labeling, advertising, marketing, and/or promotional materials; 

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

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

plans, by channel and by product, including any: 

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

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

media buys; 

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

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

your intended target audience; 

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

labeling, advertising, marketing, and/or promotion; 

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

market, and/or promote the 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 

o Copies of all records pertaining to media tracking and optimization, by channel, by product, 

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

post-launch delivery-verification reports submitted to you from an accredited source, by 

channel, by product, and by audience demographics; and 

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

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

documentation of such monitoring activities and implementation of corrective and 

preventive measures 

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

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

receive or of which you are aware 
Appendices A and B Page 8 of 15

II. Serious and Unexpected Adverse Experiences Reporting 

Under section 910(f) of the FD&C Act, this order requires that you report to the FDA all adverse 

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

adverse experience and the tobacco product(s) within 15 calendar days after the report is received by 

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

request, or suggestion made as a result of an adverse experience, tobacco product defect, or failure, 

reported to you, or identified in the literature or media. Your information should be submitted with a 

cover letter that includes the following text in the subject line: SERIOUS UNEXPECTED ADVERSE 

EXPERIENCE REPORT FOR STN(s) XXX. 

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

that results in any of the following outcomes: 

x Death; 

x A life-threatening condition or illness; 

x Inpatient hospitalization or prolongation of existing hospitalization; 

x A persistent or significant incapacity or substantial disruption of the ability to conduct normal 

life functions; 

x A congenital anomaly/birth defect; or 

x 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: 

x The known or foreseeable risks associated with the use or exposure to the tobacco product as 

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

sources of information, such as product labeling and postmarket reports; 

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

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

for the adverse experience; or 

x The results of nonclinical laboratory studies. 

III. Manufacturing Deviations 

Under section 910(f) of the FD&C Act, this order requires that you establish and maintain 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. 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. 
Appendices A and B Page 9 of 15

IV. Periodic Reporting 

The information in the following postmarket periodic reports will help FDA determine whether 

continued marketing of your tobacco products is appropriate for the protection of public health and/or 

there are or may be other grounds for withdrawing or temporarily suspending the marketing 

authorization order. 

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 three months from the date of this 

order. For each three-month reporting period, these periodic reports must include: 

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

PM0000424-PM0000426, PM0000479. The cover letter should include the STN(s) and 

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

x 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). 

x 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 also submit periodic reports to 

FDA on a quarterly basis, beginning three months from the date of this letter. For each three-month 

reporting period, these periodic reports must include: 

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

PM0000424-PM0000426, PM0000479. The cover letter should include the STN(s) and 

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

x 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. 

x 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 also requires that you submit the following periodic 

reports to FDA on an annual basis, beginning twelve months from the date of this order. For each 

twelve-month reporting period, these periodic reports must include: 

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

PM0000424-PM0000426, PM0000479. The cover letter should include the STN(s) and 

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

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

protection of public health, which includes: 
Appendices A and B Page 10 of 15

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 (e.g., specific HeatStick flavor). 

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

monitoring and testing protocol (including batch/lot sampling) and results. 

o All final printed labeling (including all labeling variations, such as those reflecting different 

required warnings) 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. 
Appendices A and B 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 – 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 social 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; 
Appendices A and B Page 12 of 15

 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. 

o 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. 

o 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. 

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

following notifications to FDA. 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 products is appropriate for the protection 

of the public health. You may begin disseminating the materials 30 days after providing notification to 

FDA. 

x Provide FDA notification of all labeling, advertising, marketing, and/or promotional materials for 

which you have not previously provided notification, at least 30 days prior to the initial 

publication, dissemination to consumers, or use in engaging or communicating with consumers 

of such materials, and include in your notification: 

o Full-color copies of all such labeling, advertising, marketing, and/or promotional materials 

for the products. 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 All advertising and marketing plans, including strategic creative briefs and paid media plans, 

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

and by product, including any plans to: 

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

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

 Target specific adult audiences by age-range(s), including young adults, ages 18-24, and 

other demographic and/or psychographic characteristics that reflect your intended 

target audience, including a list of all data sources used to target advertising and 

marketing plans and media buys; 

 Restrict youth-access and limit youth-exposure to the products’ labeling, advertising, 

marketing, and/or promotion; 

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

market, and/or promote the products; 

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

advertise, market, and/or promote the products; 
Appendices A and B Page 13 of 15

 Conduct any consumer engagements – whether by you, on your behalf, or at your 

direction – including events at which the products will be demonstrated; and/or 

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

market, and/or promote the products. 

V. Marketing Requirements 

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, this order requires: 

x Inclusion of 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.9

 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. 

x 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; 

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 

 

9 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). When FDA promulgates a final rule with respect to health warnings for cigarettes, FDA will 

reevaluate the conditions of marketing with respect to warnings for the products subject to this order. 
Appendices A and B Page 14 of 15

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. 

x 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). 

x 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 requires you to: 

x 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 legal age to purchase tobacco products. 

x 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 consumer 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 

least of federal minimum legal age to purchase tobacco products. 

x 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 promotion to only individuals who are at least of federal 

minimum legal age to purchase tobacco products. 

x 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(s) running on another 

company’s website; paid advertising for the product(s) 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 
Appendices A and B 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. 

x 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 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). Such monitoring 

requires real-time digital media tracking, and identifying, correcting, and preventing delivery of 

advertising impressions to youth, ages 17 and under. Such monitoring also requires post-launch 

delivery verification reports be submitted to you from an accredited source. 

x 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.