U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov

MARKETING GRANTED ORDERS 

NJOY LLC 

Attention: David Graham, Chief Impact Officer and Executive Vice President of Regulatory Affairs 

635 15th Street, Suite 100 

Baraboo, WI 53913 

FDA Submission Tracking Numbers (STNs): PM0000613.PD1 – PM0000615.PD1 and PM0000622.PD1, 

see Appendix A 

Dear David Graham: 

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, is appropriate for 

the protection of 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 data.2 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 

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) 

(b) (4)

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

(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 for (b) 

(PM0000622.PD1) and (PM0000614.PD1 and PM0000615.PD1). FDA determined this timeframe is acceptable 

and there are no other stability concerns. 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 postmarket report. 
 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 2 of 19 

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 public health. Absent these restrictions, a marketing granted order for these applications could not be 

issued consistent with the requirements of section 910(c) of the FD&C Act. 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, restrict youth access to your products, and limit youth 

exposure to your labeling, advertising, marketing, and promotion: 

• Not utilizing the following marketing practices: 

o Broadcast or digital radio advertising, 

o Television advertising, 

o Outdoor advertising, 

o Print advertising, 

o Direct mail advertising, 

o Search engine advertising, 

o Online display advertising, 

o Paid or unpaid product placements, 

o Public relations or earned media, 

o In-person engagements or activations, 

o Social media promotion, 

o Partners, sponsors, influencers, bloggers, or brand ambassadors, 

o Referral or affiliate programs, or 

o Product sampling; 

• Prohibiting the use of cartoon images or characters, fruit or food-related images, or imagery 

of any kind that is intended, designed, or otherwise likely to appeal to minors; 

• Limiting human portrayals to only depictions of models who are or appear to be over age 

45; 

• Limiting the use of NJOY-owned social media properties to the sole purpose of receiving 

inbound customer service communications and utilizing all available platform-native agegating functionality to restrict access to adults; 

• Maintaining Distributor and Retailer Policies that govern the selection and oversight of 

tobacco retailers that carry NJOY ACE products; 

• Prohibiting the sale of NJOY ACE products on third-party websites; 

• Limiting the number of products that can be purchased in a given time period or 

transaction; 

• Using competent and reliable third-party sources to verify the age and identity of users 

against public records before granting access the product website or conducting online 

sales; 

• Requiring retailers to only place NJOY ACE products in non-self-service areas of the store; 

and 

• Conducting quarterly audits of point-of-sale signage located in retail chains that carry NJOY 

to determine whether only NJOY-approved trade marketing materials are being utilized. 
 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 3 of 19 

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 point-ofsale advertising (e.g., requiring advertising to be placed inside the store, placing displays near other 

age-restricted products and away from 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 crossreferencing 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. 

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. 

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. 
 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 4 of 19 

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. 

If you have any questions, please contact Kristopher VanAmburg, Regulatory Health Project Manager, at 

(301) 348-3032 or Kristopher.VanAmburg@fda.hhs.gov.

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

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

Sincerely, 

/S/ 

Matthew R. Holman, Ph.D. 

Director 

Office of Science 

Center for Tobacco Products 

Enclosures (if provided electronically, the Appendix is not included in physical mail): 

Appendix A – New Tobacco Products Subject to This Letter 

Appendix B – Required Postmarket Recordkeeping and Retention 

Appendix C – Postmarket Reporting 

Appendix D – Marketing Requirements 

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 
PM 0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 5 of 19 

Appendix A 

New Tobacco Products Subject to This Letter 

Common Attributes of PMTAs 

Submission date March 10, 2020 

Receipt date March 10, 2020 

Applicant NJOY LLC 

Product manufacturer NJOY LLC 

Product category ENDS (Electronic Nicotine Delivery System) 

Attributes New Tobacco Product 

STN PM0000613 

Static Product ID PDl 

Product name NJOY ACEDevice8 

Product subcategory Closed E-Cigarette 

Package t ype Box 

Package quantit y 1 E-Cigarette 

Characterizing flavor None 

Length 74.12 mm 

Diameter 29.8mm 

Wattage 6.5 W 

Battery Capacit y 400 mAh 

E-liquid volume Not applicable 

Nicotine 

concentration 

Not applicable 

PG/VG Ratio Not applicable 

Additional Properties Thickness: 13.5 mm 

Universal Serial Bus (USB) 

STN PM0000614 

Static Product ID PDl 

Product name NJOY ACEPOD Classic Tobacco 2.4%8 

Product subcategory Closed E-Liquid 

Package t ype Cart ridge 

Package quantit y 2 Cart ridge 

Characterizing flavor Tobacco 

E-Liquid Volume 1.9 ml 

Nicotine 

Concentration 

2.4%w/w 

PG/VG Ratio 0.839 

Additional Properties Length: 34.75 mm 

Thickness: 11.57 mm 

Width: 29.59 mm 

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

9 Applicant provided value. Addit ionally, applicant provided PG and VG values as percentages of ingredient formula for each 

product . 
PM 0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 6 of 19 

Attributes New Tobacco Product 

STN PM0000615 

Static Product ID PDl 

Product name NJOY ACEPOD Classic Tobacco 5%8 

Product subcategory Closed E-Liquid 

Package t ype Cart ridge 

Package quantit y 2 Cart ridge 

Characterizing flavor Tobacco 

E-Liquid Volume: 1.9 ml 

Nicotine 

Concentration: 

5%w/w 

PG/VG Ratio: 0.759 

Additional Properties Length: 34.75 mm 

Thickness: 11.57 mm 

Width: 29.59 mm 

STN PM0000622 

Static Product ID PDl 

Product name NJOY ACEPOD Rich Tobacco 5%8 

Product subcategory Closed E-Liquid 

Package t ype Cart ridge 

Package quantit y 2 Cart ridge 

Characterizing flavor Tobacco 

E-Liquid Volume: 1.9 ml 

Nicotine 

Concentration: 

5%w/w 

PG/VG Ratio: 0.779 

Additional Properties Length: 34.75 mm 

Thickness: 11.57 mm 

Width: 29.59 mm 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 7 of 19 

Appendix B 

Required 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 issued 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; 

• 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 

4 years from the date of 

the order or 4 years 

from the conclusion of 

the study, whichever 

occurs later 

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) 

4 years from the date of 

distribution of each 

batch of each product 

subject to this order 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 8 of 19 

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 

Sales and/or distribution 

records 

A list of distributors and retailers of the products, 

including brick-and-mortar and digital10 (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 

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; 

4 years from the date of 

initial dissemination to 

the public or 

implementation 

10 For the purposes of this order, here and throughout the document, “digital” includes internet/online and mobile. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 9 of 19 

• 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 of such data; 

• With respect to individuals under the federal 

minimum age of sale of tobacco products, 

actions taken to restrict access to the product 

and limit exposure to the products’ labeling, 

advertising, marketing, and/or promotion; 

• 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 directions -

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 

• 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, 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 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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 as influencers, bloggers, and 

ambassadors, on your behalf, or at your direction 

4 years from the date of 

the contract or until the 

contract expires, 

whichever is later 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Appendix C 

Postmarket Reporting 

I. Annual Reporting 

Under section 910(f) of the FD&C Act, this order requires that you submit the following periodic reports 

to FDA on an annual basis, beginning twelve months from the date of these orders 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 PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1. The cover letter should 

include the STN(s) and corresponding tobacco product name(s), applicant name, date of report, 

reporting period, and marketing status outside the United States; 

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

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

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

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

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

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

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

information or materials for the products; 

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

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

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

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

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

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

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

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

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

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

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

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

FDA is able to open and review; 

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

the reporting period, including: 

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

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

and 

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

is outside the scope of the marketing granted order. 

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; 
 

 

 

 

 

 

 

 

 

 

 

 

 

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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; 

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; 
 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 13 of 19 

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, 

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. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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 PM0000613.PD1 – PM0000615.PD1 and 

PM0000622.PD1. 

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

that results in any of the following outcomes: 

• Death; 

• A life-threatening condition or illness; 

• Inpatient hospitalization or prolongation of existing hospitalization; 

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

normal life functions; 

• A congenital anomaly/birth defect; or 

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

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

prevent one of the other outcomes listed in this definition. 

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

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

experience is not consistent with: 

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

exposure to each tobacco product as described in the PMTA and other relevant sources 

of information, such as postmarket reports and studies; 

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

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

factor profile for the adverse experience; or 

• The results of nonclinical laboratory studies. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 15 of 19 

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, 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 PM0000613.PD1 – PM0000615.PD1 and PM0000622.PD1. The cover 

letter should include the STN(s), static product ID if applicable, 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/or promotional materials 

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

print ads, point of sale signs) and reflect the actual size and colors used. For any materials 

that would not fit on an 8.5” x 11” piece of paper, you may resize and submit electronic 

versions of such materials in a format that FDA can review and with sufficient resolution to 

allow FDA to read all lettering clearly. If resizing the advertisement does not allow for text 

to be read easily, the complete text must be provided separately and clearly referenced. 

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; 
 

 

PM0000613.PD1 - PM0000615.PD1 and PM0000622.PD1, see Appendix A Page 16 of 19 

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

plans and media buys; 

c. With respect to individuals below the minimum purchasing age, 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. 
 

 

 

 

 

 

 

 

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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: 

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

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

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

independent, competent, and reliable data sources; and 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 “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 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. 

• 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. 
 

 

 

 

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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.