U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993 

www.fda.gov 

October 12, 2021 

MARKETING GRANTED ORDERS 

R.J. Reynolds Vapor Company 

Attention: Aaron P. Williams, Ph.D. 

Senior Vice President, Scientific & Regulatory Affairs 

RAI Services Company 

401 North Main Street 

Winston-Salem, NC 27101 

FDA Submission Tracking Numbers (STNs): PM0000551, PM0000553, PM0000560 

Dear Dr. Williams: 

We completed review of your above-referenced PMTAs1 and are issuing marketing granted orders for 

the tobacco products identified in Appendix A. 

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

tobacco products, as described in your applications and specified in Appendix A, is appropriate for 

the protection of the public health. It should be noted that our determination that the marketing of 

these products is APPH is based on the submitted microbial stability data2

. 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 is 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 

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

(FD&C Act) 

2 In your PMTAs, you stated that the shelf life of the subject products is 

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)

, but did not provide data that would allow 

FDA to evaluate whether the products are microbially stable over . The data provided support microbial stability of 

the products over . The stability data for is acceptable and there are no other stability concerns, so the 

lack of stability data fo does not preclude an APPH finding for the subject products. If you would like FDA to 

evaluate additional microbial stability data for a longer period, submit this information in a post-market report. 
 

 

PM0000551, PM0000553, PM0000560 Page 2 of 20 

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 PMTAs, the marketing restrictions in Appendix D are necessary to our 

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

of the 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. Relatedly, we support 

certain aspects of your marketing plan, as described in your PMTAs, that are intended to help address 

the potential for youth use of your products. Specifically, you stated you intend to use the following 

measures to help reduce youth appeal of your marketing materials: “No testimonials by sports figures 

or celebrities or any person with special appeal to persons under 21 years of age; No person appearing 

in any advertising materials shall be under age 25 or be styled to look under age 25; Content shall not 

include characters, images, or themes designed to target youth; Content shall not be related to youth 

or youth-oriented activities; Content shall not suggest that use of R.J. Reynolds Vapor Company's 

("RJRV") products is essential to social prominence, distinction, success or sexual attraction, nor shall 

any content picture a person using any RJRV products in an exaggerated manner; and Content shall not 

depict persons participating in, or obviously just having participated in, a physical activity requiring 

stamina or athletic conditioning beyond that of normal recreation.” We encourage you to implement 

these measures because they are likely to help further mitigate risks to youth. 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. 

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). 

Our finding that permitting the marketing of the new tobacco products is 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). 

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 a supplemental PMTA for modification(s)3

 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 a supplemental PMTA for modification(s) they are seeking 

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

Science for more information. 

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

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

3 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. 
 

 

PM0000551, PM0000553, PM0000560 Page 3 of 20 

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

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

labeling, and advertising requirements. 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. 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal4,5

 using 

eSubmitter.6 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 date7

; 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. 

4 https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal 

5 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal. 6 https://www.fda.gov/industry/fda-esubmitter 

7 https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp 
PM0000551, PM0000553, PM0000560 Page 4 of 20 

If you have any questions, please contact Barbara Banchero, Regulatory Health Project Manager, at 

(301) 796-1937 or Barbara.Banchero@fda.hhs.gov. 

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

orders, please contact Lillian Ortega, Director, Division of Enforcement and Manufacturing, at CTP-OCEPostmarket@fda.hhs.gov. 

Sincerely, 

Digitally signed by Matthew R. Holman -S 

Date: 2021.10.12 10:54:57 -04'00' 

Matthew R. Holman, Ph.D. 

Director 

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 
PM0000SSl, PM0000553, PM0000560 Page 5 of 20 

AppendixA8 

New Tobacco Products Subject of This Letter 

Common Attributes of PMTA 

Submission date October 10, 2019 

Receipt date October 17, 2019 

Applicant R.J. Reynolds Vapor Company 

Product manufacturer R.J. Reynolds Vapor Company 

Product category ENDS (Electronic Nicotine Delivery System) 

Attributes9 New Tobacco Product 

STN PM0000SSl 

Product name Vuse Solo Power Unit 

Product sub-category ENDS Component 

Package type Paperboard Carton 

Package quantity 1 Power Unit 

Characterizing flavor10 None 

Additional properties Length: 87 mm 

Diameter: 9.6 mm 

Battery capacit y: 2: 270 milliAmpere hours (mAh) 

Wattage: 3.00 W11 

Universal Serial Bus (USS) charger 

STN PM0000553 

Product name Vuse Replacement Cartridge Original 4.8% Gl 12 

Product sub- category Closed E-cigarette 

Package type Paperboard Carton/ Blister Pack 

Package quantity 2 Cartridges 

Characterizing flavor Original 

Nicotine 

57.4 mg/ ml 

concentration 

E-liquid volume 0.5 ml / cartridge 

PG/VG ratio 21/ 79 

Additional properties Length: 37.6 mm 

Diameter: 9.6 mm 

Gl Tube Material: Stainless Steel 

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

9 We interpret package type to mean container closure system and package quantity to mean product quantity w ithin the 

container closure system, unless otherwise identif ied. 

10 Provided as part of product labeling 

11 The initial target wattage for a puff is=l:5~~4~ % W forE'.j milliseconds, which then drops to a target of l:5 4 % W for 

the remainder of the puff duration 

12 The Vuse Solo "Original" e-liquid is a tobacco flavored e-liquid. 
PM0000SSl, PM0000553, PM0000560 Page 6 of 20 

STN PM0000560 

Product name Vuse Replacement Cartridge Original 4.8% G212 

Product sub-category Closed E- cigarette 

Package type Paperboard Carton/ Blister Pack 

Package quantit y 2 Cartridges 

Characterizing flavor Original 

Nicotine 

57.4 mg/ ml 

concentration 

E-liquid volume 0.5 ml / cartridge 

PG/VG ratio 21/ 79 

Addit ional properties Length: 37.6 mm 

Diameter: 9.6 mm 

G2 Tube Material:[(t>r(4) I 
PM0000SSl, PM0000553, PM0000560 Page 7 of 20 

Appendix B 

Postmarket Recordkeeping and Retention 

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

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

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

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

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

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

duly designated by the Secretary, upon request. 

Record Description Retention Period 

Prior PMTAs Each PMTA submitted prior to marketing orders 4 years from the date 

that FDA issues the 

marketing order 

Postmarket reports Postmarket reports, including periodic and adverse 4 years from the date the 

experience reports as described in this order report was submitted to 

FDA or until FDA inspects 

the records, whichever 

occurs sooner 

Correspondence with FDA Correspondence with FDA pertaining to each 4 years from the date of 

authorized product distribution of the last 

batch of each product 

subject to this order 

Study data Nonclinical or clinical study documentation including: 4 years from the date of 

• Source data; t he order or 4 years 

• Study protocols (including statistical analysis from t he conclusion of 

plan) and amendments showing t he dates t he study, whichever 

and reasons for each protocol revision; occurs later 

• Institutional Review Board {IRB) or 

Independent Ethics Committee {IEC) 

approvals; 

• Informed consent forms; 

• Correspondence with study 

monitors/investigators/contract research 

organizations/sponsors/I RB/I EC; 

• Investigator financial disclosure statements; 

• Progress reports; 

• Monitoring reports; 

• Adverse experience reports; 

• Case report forms/subject diaries/medical 

records/laboratory reports; 

• Subject data line listings/observations 

records; 

• Test article accountability records; 

• Study results/protocol summaries/study 

reports; and 

• Certifications and amendments to 

certifications 
PM0000SSl, PM0000553, PM0000560 Page 8 of 20 

Record Description Retention Period 

Manufacturing records Records pertaining to the manufacture, in process 4 years from t he date of 

and release testing, production process (including any distribution of each 

changes to the process, facility, or controls), batch of each product 

packaging, storage, and stability monitoring and subject to this order 

testing (including protocol and results) 

Records a nd reports of all manufacturing deviations, 

investigations, and corrective and preventive actions 

including, but not limited to, those deviations 

associated with processing, testing, packing, labeling, 

storage, holding and distribution; and any deviation 

that may affect the characteristics of each final 

product 

Sales and/or distribution A list of distributors and retailers of the products, 4 years from the date of 

records including brick-and-mortar and digital13 (including distribution of each 

internet/online and mobile) batch of each product 

subject to this order 

Any available information (not to include personally 

identifiable information) about product purchasers, 

such as purchasers' demographics (e.g., age, gender, 

race/ethnicity, geographic region) and previous or 

current use of other tobacco products (i.e., dual use) 

With respect to individuals under the federal 

minimum age of sale of tobacco products, policies 

and procedures regarding restrictions on access to 

the products, including purchaser age and identity 

verification processes 

Complaints Records pertaining to any and all complaints 4 years from the date of 

associated with the tobacco product that is the distribution of each 

subject of this order; such records may also include batch of each product 

your a nalysis of those complaints subject to this order 

Health hazard analysis Health hazard analyses, if performed voluntarily or 4 years from the date of 

directed by FDA distribution of each 

batch of each product 

subject to this order 

Labeling Specimens of all labeling (including all labeling 4 years from the date of 

variations, such as those reflecting different required initial dissemination to 

warnings), labels, inserts/onserts, instructions, and the public 

other accompanying information 

Advertising, marketing and Copies of all advertising, marketing, and/or 4 years from the date of 

promotional materials and promotional materials published, disseminated to initial dissemination to 

plans consumers, or for use in engaging or communicating the public or 

with consumers implementation 

13 For the purposes of this order, here and throughout the document, "digital" includes internet/online and mobile. 
PM0000SSl, PM0000553, PM0000560 Page 9 of 20 

Record Description Retention Period 

Copies of 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: 

• Use of competent and reliable data sources, 

methodologies, and technologies to 

establish, maintain, and monitor highly 

targeted advertising and marketing plans 

and media buys, including a list of all data 

sources used to target advertising and 

marketing plans and media buys; 

• Targeting of specific group(s) by agerange(s), including young adults, ages 21-24, 

and other demographic or psychographic 

characteristics that reflect your intended 

audience(s), including the source(s) of such 

data; 

• 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; 

• Use of owned, earned, shared, or paid media 

to create labeling for, advertise, market, 

and/or promote the products; 

• Use of broadcast, satellite, or cable TV 

media, or broadcast or satellite radio media, 

including copies of media buy schedules prelaunch, program lists, projected percent 

audience compositions by age breakouts 

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

program, projected audience indices by age 

breakouts (i.e., 2-11, 12-17, 18-24, 25-54, 

55+) by program, reach and frequency goals, 

and any other targeting or purchasing 

parameters; 

• Use of partners, influencers, bloggers, 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 will be demonstrated and how 

access will be restricted to individuals at or 

above the federal minimum age of sale of 

tobacco products; or 
PM0000SSl, PM0000553, PM0000560 Page 10 of 20 

Record Description Retention Period 

• Use of public relations or other 

communications outreach to create labeling 

for, advertise, market, and/or promote the 

products 

Copies of all records pertaining to the actual delivery 

of advertising impressions, including media tracking 

and optimization, by channel, by product (if 

applicable), by program (where applicable), and by 

audience demographics (e.g., age, gender, 

race/ethnicity, geographic region), media buy 

summaries, program lists, number of units by 

program, impressions by program, percent audience 

compositions by age breakouts (i.e., 21+, 2-11, 12-17, 

18-24, 25-54, 55+) by program, audience indices by 

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

program, reach and frequency, any other parameters 

purchased against the buying demographics, postlogs that verify TV /radio ads ran within the approved 

parameters, and post-launch delivery-verification 

reports for other paid media submitted to you or 

entities working on your behalf or at your direction 

from an accredited source 

Policies and procedures for real-time digital media 

monitoring to identify, correct, and prevent delivery 

of advertising impressions to individuals under the 

federal minimum age of sale of tobacco products, 

including documentation of such monitoring activities 

and implementation of corrective and preventive 

measures 

Formative consumer Copies of any formative research studies conducted 4 years after the studies 

research among any audiences, in the formation of the are completed 

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 

Consumer evaluation Copies of any consumer evaluation research studies 4 years after the studies 

research conducted among any audiences to determine the are completed 

effectiveness of the labeling, advertising, marketing, 

and/or promotional materials and any shifts in 

consumer knowledge, attitudes, beliefs, intentions, 

and behaviors toward using the products, and 

including copies of the stimuli used in testing 
PM0000SSl, PM0000553, PM0000560 Page 11 of 20 

Record Description Retention Period 

Contractual agreements Copies of any contractual agreements regarding the 4 years from the date of 

creation or dissemination of the products' labeling, the contract or until the 

advertising, marketing, and/or promotional materials, contract expires, 

including, for example, in print media, online or whichever is later 

through digital platforms (e.g., social media and 

mobile applications), such as influencers, bloggers, 

and ambassadors, on your behalf, or at your direction 
PM0000551, PM0000553, PM0000560 Page 12 of 20 

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 

report to FDA on an annual basis, beginning twelve months from the date of the orders, to help FDA 

determine whether continued marketing of each new tobacco products product/products is 

appropriate for the protection of public health or whether there are or may be other grounds for 

withdrawing or temporarily suspending such orders. 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 PM0000551, PM0000553, PM0000560. The cover letter should include the STN(s) 

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

period; 

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; 
PM0000551, PM0000553, PM0000560 Page 13 of 20 

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; A separate summary of all adverse experiences related to 

liver abnormalities, seizures or neurological symptoms, and respiratory symptoms characteristic 

of EVALI; 

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; 
PM0000551, PM0000553, PM0000560 Page 14 of 20 

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 

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 broadcast, satellite, or cable TV media, or broadcast or satellite radio media, 

including media buy summaries, program lists, number of units by program, program 

and network TRPs, impressions by program, percent audience compositions by age 

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

breakouts (i.e., 2-11, 12-17, 18-24, 25-54, 55+) by program, reach and frequency, any 

other parameters purchased against the buying demographics; 

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

advertise, market, and/or promote the products; 

g. 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 

h. 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 (if 

applicable), by program (where applicable), and by audience demographics, (e.g., age, gender, 
PM0000551, PM0000553, PM0000560 Page 15 of 20 

race/ethnicity, geographic region), not previously submitted, and verified against post-logs (for 

TV/radio) and post-launch delivery-verification reports for other paid media submitted to you or 

entities working on your behalf or at your direction 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 

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 PM0000551, PM0000553, PM0000560. 

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 adverse event 

Inpatient hospitalization or prolongation of existing hospitalization 

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

normal life functions 

A congenital anomaly/birth defect 

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 any of the following: 

•

•

•

•

•

•
 

 

PM0000551, PM0000553, PM0000560 Page 16 of 20 

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

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

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 

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. 

These notifications 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:

On an ongoing basis, please provide notification of any labeling, advertising, marketing or 

promotion in broadcast, satellite, or cable TV media or broadcast or satellite radio media; 

and 

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

notification of all other 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 PM0000551, PM0000553, PM0000560. 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

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PM0000551, PM0000553, PM0000560 Page 17 of 20 

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

demographic or psychographic characteristics that reflect your intended audience(s), 

including the source(s) of such data; 

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

take actions to restrict access to the products and limit 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 broadcast, satellite, or cable TV media, or broadcast or satellite radio media, 

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

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

program, projected audience indices by age breakouts (i.e., 21+, 2-11, 12-17, 18-24, 25-

54, 55+) by program, reach and frequency goals, and any other targeting or purchasing 

parameters; 

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

advertise, market, and/or promote the products; 

g. 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 

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

market, and/or promote the products. 
PM0000551, PM0000553, PM0000560 Page 18 of 20 

Appendix D 

Marketing Restrictions 

Under section 910(c)(1)(B) of the FD&C Act, these orders require 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 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 

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 at 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:

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▪ “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
 

 

PM0000551, PM0000553, PM0000560 Page 19 of 20 

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.

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

broadcast, satellite, or cable TV media, and/or broadcast or satellite radio media (e.g., video 

advertisements for the products airing during broadcast cable television programming; audio 

advertisements for the products airing through radio media channels; ads airing via 

multichannel video programming distributors; ads airing during Video on Demand/Full Episode 

Player extensions to network buys; addressable TV ads) – whether conducted by you, on your 

behalf, or at your direction: 

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-logs that verify TV/radio ads ran within the approved parameters and 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. 

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▪

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

methodologies, and technologies to target delivery of such labeling, advertising, marketing, and/

or promotion to individuals who are at or above the federal minimum age of sale of tobacco 

products. Such targeting must adhere to the following requirements, at a minimum:

▪ All TV and radio programs must have reported audience compositions of 85% or more

adults who are at or above the federal minimum age of sale of tobacco products;

All TV and radio programs must have reported audience indices of 99 or lower for youth

aged 2-11; and

All TV and radio programs must have reported audience indices of 99 or lower for youth

aged 12-17..

▪

▪
PM0000551, PM0000553, PM0000560 Page 20 of 20 

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. 

The marketing restrictions in these orders were determined based on review of the information 

submitted in your PMTAs, including information about how you intend to advertise and market the 

products, and in consideration of other marketing restrictions that currently apply to and/or affect the 

marketing of your products, including policies and practices of media entities (e.g., no broadcast TV 

network currently accepts tobacco advertising). Any change in the policies or practices of media entities 

that has the effect of expanding opportunities for manufacturers of tobacco products to reach youth 

and any subsequent changes in your use of such media entities may, in turn, affect the APPH analysis of 

your products, based on our obligation to consider how products are likely to be used, including by 

youth. 

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