U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov

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): Multiple STNs, see Appendix A

Dear Dr. Williams: 

We completed review of your 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, are appropriate 

for the protection of the public health (APPH). It should be noted that our determination that the 

marketing of these products is APPH is based in part 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 are also contingent upon 

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

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

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

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

alone is not a guarantee that the marketing of the products will remain appropriate for the protection 

of the public health, particularly if, despite these measures, there is a significant uptake in youth 

initiation, for example. FDA will continue to monitor the marketing of your products. 

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

(FD&C Act)

2 For PM0000636 and PM0000712, you stated that the shelf life of the subject products is 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 for 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. 

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)
Multiple STNs, see Appendix A Page 2 of 22 

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 practices, 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: “Not use any social 

media platforms (e.g., Facebook, Instagram, Twitter) or social media influencers for marketing and 

promotional purposes; 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 also support your proposed efforts to ensure responsible 

retailing practices intended to prevent underage sales to minors, plans to age‐verify tobacco 

consumers opting‐in to receive direct mail/e‐mail marketing, and plans to conduct age‐ and identity‐

verification of consumers participating in engagement events. 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 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 products appealing to youth like toys and candy. 

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 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, in accordance with 21 C.F.R. § 1114.15, 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.

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.
Multiple STNs, see Appendix A Page 3 of 22 

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

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

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

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

and advertising requirements. 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
Multiple STNs, see Appendix A Page 4 of 22 

If you have any questions, please contact Sequoia Bacon, Regulatory Health Project Manager, at (301) 

796‐0736 or Sequoia.Bacon@fda.hhs.gov. 

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

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

Postmarket@fda.hhs.gov. 

Sincerely, 

/S/ 

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
Multiple STNs, see Appendix A Page 5 of 22 

Appendix A8

New Tobacco Products Subject of This Letter 

Common Attributes of PMTAs

Applicant R.J. Reynolds Vapor Company

Product manufacturer R.J. Reynolds Vapor Company

Product category ENDS (VAPES)

Attributes New Tobacco Product

STN PM0000635

Submission date April 2, 2020 

Receipt date April 2, 2020

Product name Vuse Vibe Power Unit

Product subcategory Closed E‐Cigarette

Package type Paperboard Carton

Package quantity 1 Power Unit

Characterizing flavor 9 Unflavored 

Additional properties Length: 82.5 mm

Diameter: 13.0 mm

Wattage:10 W

Battery capacity: milliAmpere hour (mAh)

Universal Serial Bus (USB) Charger

Battery Manufacturer: 

STN PM0000636

Submission date April 2, 2020 

Receipt date April 2, 2020

Product name Vuse Vibe Tank Original 3.0%

Product subcategory Closed E‐Liquid 

Package type Paperboard Carton/Blister Pack

Package quantity 2 Cartridges

Characterizing flavor Tobacco11

E‐liquid volume 1.9 mL per cartridge

Nicotine concentration 36.0 mg/mL

PG/VG ratio 20/80

Additional properties Length: 59.0 mm

Diameter: 13.0 mm

Nicotine content: 3.0% w/w

8 Brand/sub‐brand or other commercial name used in commercial distribution. 9 Provided as part of product label.

10 The applicant states the wattage listed represents the nominal operating range; the upper and lower wattages have a 

variation of %. 11 Labels may contain descriptive term such as “Original.”

(b) (4)(b) (4)(b) (4) (b) (4)
Multiple STNs, see Appendix A Page 6 of 22 

Attributes New Tobacco Product

STN PM0000646

Submission date April 15, 2020 

Receipt date April 15, 2020

Product name Vuse Ciro Power Unit

Product subcategory Closed E‐Cigarette 

Package type Paperboard Carton

Package quantity 1 Power Unit

Characterizing flavor9 Unflavored 

Additional properties Length: 83.5 mm

Diameter: 9.2 mm

Battery Capacity: milliAmpere hour (mAh)

Wattage:12 Expected High: W

Expected Low: W

Universal Serial Bus (USB) Charger

Battery Manufacturer: 

STN PM0000712

Submission date April 15, 2020 

Receipt date April 15, 2020

Product name Vuse Ciro Cartridge Original 1.5%

Product subcategory Closed E‐Liquid 

Package type Paperboard Carton/Blister Pack

Package quantity 3 Cartridges

Characterizing flavor Tobacco11

Nicotine concentration 17.7 mg/ml

PG/VG ratio 29/71

E‐liquid volume 0.9 ml per cartridge

Additional properties Length: 50.0 mm

Diameter: 9.2 mm

Nicotine Content: 1.5% 

STN PM0004287

Submission date April 2, 2020 

Receipt date April 2, 2020

Product name Vuse Vibe Power Unit

Product subcategory Closed E‐Cigarette 

Package type Paperboard Carton

Package quantity 1 Power Unit

Characterizing flavor9 Unflavored 

Additional property Length: 82.5 mm

Diameter: 13.0 mm

Wattage:10 W

Battery capacity: milliAmpere hour (mAh)

Universal Serial Bus (USB) Charger

Battery Manufacturer:

12 The wattages listed represent the average of 15 samples ± 95% confidence interval.

(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4)(b) (4)
Multiple STNs, see Appendix A Page 7 of 22 

Attributes New Tobacco Product

STN PM0004293

Submission date April 15, 2020 

Receipt date April 15, 2020

Product name Vuse Ciro Power Unit

Product subcategory Closed E‐Cigarette 

Package type Paperboard Carton

Package quantity 1 Power Unit

Characterizing flavor9 Unflavored 

Additional property Length: 83.5 mm

Diameter: 9.2 mm 

Wattage:12 Expected High: W

 Expected Low: W

Battery capacity: milliAmpere hour (mAh)

Universal Serial Bus (USB) Charger

Battery Manufacturer:

(b) (4) (b) (4) (b) (4)(b) (4)
Multiple STNs, see Appendix A Page 8 of 22 

Appendix B

Postmarket Recordkeeping and Retention

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

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

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

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

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

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

duly designated by the Secretary, upon request. 

Record Description Retention Period

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

that FDA issues the 

marketing order 

Postmarket reports Postmarket reports, including periodic and 

adverse experience reports as described in this 

order

4 years from the date 

the report was 

submitted to FDA or 

until FDA inspects the 

records, whichever 

occurs sooner

Correspondence with 

FDA 

Correspondence with FDA pertaining to each 

authorized product

4 years from the date 

of distribution of the 

last batch of each 

product subject to 

this order

Study data Nonclinical or clinical study documentation 

including: 

• Source data; 

• Study protocols (including statistical 

analysis plan) and amendments showing 

the dates and reasons for each protocol 

revision; 

• Institutional Review Board (IRB) or 

Independent Ethics Committee (IEC) 

approvals; 

• Informed consent forms; 

• Correspondence with study 

monitors/investigators/contract 

research organizations/

sponsors/IRB/IEC; 

• Investigator financial disclosure 

statements; 

• Progress reports; 

• Monitoring reports; 

• Adverse experience reports; 

4 years from the date 

of the order or 4 years 

from the conclusion 

of the study, 

whichever occurs 

later 
Multiple STNs, see Appendix A Page 9 of 22 

Record Description Retention Period

• 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

Manufacturing records Records pertaining to the manufacture, in 

process and release testing, production process 

(including any changes to the process, facility, or 

controls), packaging, storage, and stability 

monitoring and testing (including protocol and 

results) 

Records and reports of all manufacturing 

deviations, investigations, and corrective and 

preventive actions including, but not limited to, 

those deviations associated with processing, 

testing, packing, labeling, storage, holding and 

distribution; and any deviation that may affect 

the characteristics of each final product

4 years from the date 

of distribution of each 

batch of each product 

subject to this order

Sales and/or distribution 

records 

A list of distributors and retailers of the 

products, including brick‐and‐mortar and 

digital13 (including internet/online and mobile)

Any available information (not to include 

personally identifiable information) about 

product purchasers, such as purchasers’ 

demographics (e.g., age, gender, race/ethnicity, 

geographic region) and previous or current use 

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

With respect to individuals under the 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 

4 years from the date 

of distribution of each 

batch of each product 

subject to this order

13 For the purposes of this order, here and throughout the document, “digital” includes internet/online and mobile.
Multiple STNs, see Appendix A Page 10 of 22 

Record Description Retention Period

Complaints Records pertaining to any and all complaints 

associated with the tobacco product that is the 

subject of this order; such records may also 

include your analysis of those complaints 

4 years from the date 

of distribution of each 

batch of each product 

subject to this order

Health hazard analysis Health hazard analyses, if performed voluntarily 

or directed by FDA

4 years from the date 

of distribution of each 

batch of each product 

subject to this order

Labeling Specimens of all labeling (including all labeling 

variations, such as those reflecting different 

required warnings), labels, inserts/onserts, 

instructions, and other accompanying 

information 

4 years from the date 

of initial 

dissemination to the 

public

Advertising, marketing 

and promotional 

materials and plans

Copies of all advertising, marketing, and/or

promotional materials published, disseminated

to consumers, or for use in engaging or

communicating with consumers

Copies of all advertising and marketing plans 

including strategic creative briefs and paid media 

plans, by channel and by product, 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 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; 

• 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 

4 years from the date 

of initial 

dissemination to the 

public or 

implementation
Multiple STNs, see Appendix A Page 11 of 22 

Record Description Retention Period

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 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., 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 

• 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 
Multiple STNs, see Appendix A Page 12 of 22 

Record Description Retention Period

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, 

post‐logs that verify TV/radio ads ran within the 

approved parameters, and all 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 

research 

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

4 years after the 

studies are completed

Consumer evaluation 

research 

Copies of any consumer evaluation research

studies conducted among any audiences to

determine the effectiveness of the labeling,

advertising, marketing, and/or promotional

materials and any shifts in consumer knowledge,

attitudes, beliefs, intentions, and behaviors 

toward using the products, and including copies

of the stimuli used in testing 

4 years after the 

studies are completed 

Contractual agreements Copies of any contractual agreements regarding

the creation or dissemination of the products’

labeling, advertising, marketing, and/or

promotional materials, including, for example, in 

print media, online or through digital platforms

(e.g., social media and mobile applications), such

4 years from the date 

of the contract or 

until the contract 

expires, whichever is 

later 
Multiple STNs, see Appendix A Page 13 of 22 

Record Description Retention Period

as influencers, bloggers, and ambassadors, on

your behalf, or at your direction 
Multiple STNs, see Appendix A Page 14 of 22 

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 is appropriate for the protection 

of public health or whether there are 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 PM0000635, PM0000636, PM0000646, PM0000712, PM0004287, PM0004293. 

The cover letter should include the STN(s) and corresponding tobacco product name(s), 

applicant name, date of report, and 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. 
Multiple STNs, see Appendix A Page 15 of 22 

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

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; 
Multiple STNs, see Appendix A Page 16 of 22 

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, and/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, 
Multiple STNs, see Appendix A Page 17 of 22 

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 PM0000635, PM0000636, PM0000646, PM0000712, 

PM0004287, PM0004293. 

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

that results in any of the following outcomes:

• Death;

• A life‐threatening condition or illness; 

• Inpatient hospitalization or prolongation of existing hospitalization;

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

normal life functions;

• A congenital anomaly/birth defect; or

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

jeopardize the health of a person, and may require medical or surgical intervention to 

prevent one of the other outcomes listed in this definition.

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

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

experience is not consistent with:
Multiple STNs, see Appendix A Page 18 of 22 

• 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 

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/or 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 PM0000635, PM0000636, PM0000646, PM0000712, PM0004287, 

PM0004293. 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 
Multiple STNs, see Appendix A Page 19 of 22 

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;

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 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. 
Multiple STNs, see Appendix A Page 20 of 22 

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 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 

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:

 “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 
Multiple STNs, see Appendix A Page 21 of 22 

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: 

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.

• 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 fan 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. 
Multiple STNs, see Appendix A Page 22 of 22 

• 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.