U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993 

www.fda.gov 

MARKETING GRANTED ORDERS

Logic Technology Development LLC

Attention: Emil H. Weiss, Regulatory Affairs Manager

300 Frank W Burr Boulevard, Suite 70

Teaneck, NJ 07666

FDA Submission Tracking Numbers (STNs): Multiple STNs, see Appendix A

Dear Emil Weiss:

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 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 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) 2 The data provided support microbial stability of the products over 12 months for PM0000529.PD1 and PM0000531.PD1, and

over 15 months for PM0000535.PD1 – PM0000537.PD1, PM0000540.PD1, and PM0000541.PD1. The stability data for 12

months (for PM0000529.PD1 and PM0000531.PD1), and 15 months (for PM0000535.PD1 – PM0000537.PD1, PM0000540.PD1,

and PM0000541.PD1) is acceptable and there are no other stability concerns. If you would like FDA to evaluate additional

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

                                 

                           

                         

                             

                             

                                 

                               

                                 

                                 

                           

                               

                               

                         

                             

                               

                         

                                

                                 

                           

                                   

                   

                       

                         

  

                                 

                             

                             

                                

                               

                             

                          

                           

                   

                                 

                     

                             

Multiple STNs, see Appendix A Page 2 of 21

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 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

eliminated all social media accounts as of September 28, 2020; are not currently paying social media

or any other influencers to market or promote your products; do not employ social media bots to

market your products; only use models over the age of 30 in your consumer marketing materials; do

not use characterizing words such as sweet, fruity, candy, juicy, iced, soda, mouthwatering, sugary,

gummy, sour, tart, cool, or naturally flavored; do not use cartoon imagery or images of foods

marketed to youth; require adult consumers to confirm they are current tobacco or vapor users and

to participate in mandatory age verification before any in‐person interactions with Logic products;

provide your retail partners with the most advanced and up‐to‐date training to ensure only adult

consumers can access your products; and support the We Card program as a member of the

Manufacturers’ Advisory Council. Additionally, as of March 16, 2021, you have discontinued online

sales of all Logic products via your website. We encourage you to continue these measures because

they are likely to help further mitigate risks to youth. We also recommend that you take additional

steps to limit youth exposure to your print and point‐of‐sale advertising, including, for example,

limiting advertising to print publications where 85% or more of the readership is 21 years of age or

older and/or selecting publications that do not over‐index for youth.

Additionally, these orders are conditioned upon the products conforming with any applicable current

or future tobacco product standards, unless specifically exempted under these orders or the product

standard(s).

Our finding that permitting the marketing of the new 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). In addition, the issuance of marketing granted orders for your products

does not mean FDA has made a determination on whether the statements or representations3 on

your products’ labels, labeling or advertising, do or do not convey modified risk.4

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)5 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

3 For example, in STNs PM0000529‐PM0000531, the leaflet and user guide provide the following description for the new

products, “A unique combination of vapor technology and real tobacco provides satisfying taste and no smoke smell and no

ash.” Point‐of‐sale advertisement states “Real Tobacco. No Smoke Smell. No Ash.” Labeling for the cartridge and capsules states

“No Ash, No Smoke Smell.” 4 No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an

order issued pursuant to Section 911(g) in the FD&C Act is effective with respect to such product. 5 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 21

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, 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 Portal6,7 using

eSubmitter.8 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 date9

; 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.

6 https://www.fda.gov/tobacco‐products/manufacturing/submit‐documents‐ctp‐portal 7 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal. 8 https://www.fda.gov/industry/fda‐esubmitter 9 https://www.fda.gov/tobacco‐products/about‐center‐tobacco‐products‐ctp/contact‐ctp
                   

                             

     

                           

                       

       

     

              

     

Multiple STNs, see Appendix A Page 4 of 21

If you have any questions, please contact Carlos Suarez, MPH, Regulatory Health Project Manager, at

(301) 796 ‐ 5453 or Carlos.Suarez@fda.hhs.gov.

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

orders, please contact Lillian Ortega, Director, Division of Enforcement and Manufacturing, at

CTP‐OCE‐Postmarket@fda.hhs.gov.

Sincerely,

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 21

Appendix A10

New Tobacco Products Subject of This Letter

Common Attributes of PMTA

Submission date August 19, 2019

Receipt date August 19, 2019

Applicant Logic Technology Development LLC

Product manufacturer Logic Technology Development LLC

Product category ENDS (VAPES)

Attributes New Tobacco Product

STN PM0000529.PD1

Product Name Logic Vapeleaf Regular Cartridge/Capsule Package 11

Product Subcategory ENDS Other

Package Type Blister Pack

Package Quantity 5 Capsules

Characterizing Flavor None

Additional Properties Mass of flavored tobacco granules per capsule: 310 mg

Nicotine Content: < 39.8 mg‐dry base/g

STN PM0000530.PD1

Product Name Logic Vapeleaf Cartridge/Capsule Package11

Product Subcategory Closed E‐Liquid

Package Type Cartridge12

Package Quantity 1 Cartridge

Characterizing Flavor None

Nicotine Concentration 0 mg/mL

E‐liquid Volume 1.125 mL

PG/VG Ratio 50/50

Additional Properties Contains an atomizer

STN PM0000531.PD1

Product Name Logic Vapeleaf Tobacco Vapor System11

Product Subcategory Closed E‐Cigarette

Package Type Box

Package Quantity 1 Battery Unit

Characterizing Flavor Not Provided

Additional Properties Diameter: 9.2 mm, Length: 69.4 mm, Battery Capacity: >210

milliAmpere hours (mAh), Wattage: Ranges from 3.5 to 3.0 watts

over the course of approximately 300 puffs, Universal Serial Bus

(USB) Charger

10 Brand/sub‐brand or other commercial name used in commercial distribution. 11 This product contains properties of ENDS and Heated Tobacco Products (HTPs). As such, it may be considered an HTP in the

future.

12 Contains U‐plugs on either end of cartridge.
                   

     

             

     

       

       

  

     

       

   

             

     

   

         

      

               

             

     

   

         

      

                       

                     

         

             

     

       

       

  

     

       

   

           

     

   

         

      

                       

                     

         

Multiple STNs, see Appendix A Page 6 of 21

Attributes New Tobacco Product

STN PM0000535.PD1

Product Name Logic Pro Tobacco e‐Liquid Package

Product Subcategory Closed E‐Liquid

Package Type Blister Pack

Package Quantity 2 Cartridges

Characterizing Flavor Tobacco

Nicotine Concentration 20.0 mg/mL

E‐liquid Volume 1.5 mL

PG/VG Ratio 69/25

STN PM0000536.PD1

Product Name Logic Pro Capsule Tank System

Product Subcategory ENDS Other

Package Type Box

Package Quantity 1 Capsule Case

Characterizing Flavor Not Provided

Additional Properties Diameter: 14.1 mm, Length: 65.5 mm

STN PM0000537.PD1

Product Name Logic Pro Capsule Tank System

Product Subcategory Closed E‐Cigarette

Package Type Box

Package Quantity 1 Battery Unit

Characterizing Flavor Not Provided

Additional Properties Diameter: 14.1 mm, Length: 78.2 mm, Battery Capacity: 650 mAh,

Wattage: Ranges from 5 to 4.5 watts over the course of

approximately 520 puffs, USB Charger

STN PM0000540.PD1

Product Name Logic Power Tobacco e‐Liquid Package

Product Subcategory Closed E‐Liquid

Package Type Blister Pack

Package Quantity 2 Cartridges

Characterizing Flavor Tobacco

Nicotine Concentration 27.0 mg/mL

E‐liquid Volume 1.2 mL

PG/VG Ratio 68/25

STN PM0000541.PD1

Product Name Logic Power Rechargeable Kit

Product Subcategory Closed E‐Cigarette

Package Type Box

Package Quantity 1 Battery Unit

Characterizing Flavor Not Provided

Additional Properties Diameter: 9.2 mm, Length: 82.6 mm, Battery Capacity: 340 mAh,

Wattage: Ranges from 5.25 to 4 watts over the course of

approximately 300 puffs, USB Charger
                   

   

     

                                 

                                  

                                  

                         

                          

                               

               

   

                           

        

               

             

           

       

         

     

   

                 

   

           

       

       

       

               

  

  

  

  

  

  

  

  

  

  

  

           

         

       

     

   

Multiple STNs, see Appendix A Page 7 of 21

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;

 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
                   

   

  

   

             

           

             

           

             

               

           

     

       

       

     

   

  

             

               

             

             

   

           

     

       

       

                

             

               

           

           

     

       

       

                    

     

           

     

       

       

             

             

       

  

           

   

   

     

     

           

         

             

   

           

   

     

                                 

Multiple STNs, see Appendix A Page 8 of 21

Record Description Retention Period

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

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

4 years from the date of

initial dissemination to

the public or

implementation

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

   

             

             

                 

               

            

  

  

  

  

  

  

Multiple STNs, see Appendix A Page 9 of 21

Record Description Retention Period

Copies of all advertising and marketing plans

including strategic creative briefs and paid media

plans, by channel and by product, and the details,

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

channel and by product, including any:

 Use of competent and reliable data sources,

methodologies, and technologies to

establish, maintain, and monitor highly

targeted advertising and marketing plans

and media buys, including a list of all data

sources used to target advertising and

marketing plans and media buys;

 Targeting of specific group(s) by 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 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
                   

   

               

      

  

             

             

             

               

         

         

                 

               

       

         

           

       

             

                 

         

   

                 

             

           

           

         

             

               

         

  

Multiple STNs, see Appendix A Page 10 of 21

Record Description Retention Period

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

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
                   

   

                 

             

         

               

             

         

                

           

         

   

     

Multiple STNs, see Appendix A Page 11 of 21

Record Description Retention Period

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
                   

   

   

   

                               

                                     

                           

                                 

                    

                          

                  

                       

            

                         

                       

                             

                             

                               

                                 

                   

           

                 

                         

                         

                           

                             

                             

                                 

                                       

                                 

                             

                               

                             

             

                         

       

                        

                             

                               

                 

Multiple STNs, see Appendix A Page 12 of 21

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 product is appropriate for the protection

of public health or whether there is or may be other grounds for withdrawing or temporarily suspending

such order. For each 12‐month reporting period, the report must include:

1. A single submission with a cover letter that includes the following subject line: ANNUAL

REPORT for PM0000529.PD1 ‐ PM0000531.PD1, PM0000535.PD1 ‐ PM0000537.PD1,

PM000040.PD1 ‐ PM0000541.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.
                   

                             

             

                             

                  

                               

                         

                       

                           

                                 

                             

                               

                           

               

   

                             

  

                               

                  

                           

                        

                         

               

           

                       

                       

                       

                       

             

                           

                           

                   

                   

                         

                     

                             

                         

                     

Multiple STNs, see Appendix A Page 13 of 21

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

testing protocol(s) (including batch/lot sampling) and results;

6. A complete list of ongoing and completed studies about the tobacco products conducted by, or

on your behalf, that have not been previously reported;

7. Full reports of information published or known to you, or which should be reasonably known to

you, concerning scientific investigations and literature about the tobacco products that have not

been previously reported, as well as significant findings from publications not previously

reported;

8. A summary and analysis of all serious and unexpected adverse experiences associated with the

tobacco products that have been reported to you or that you are aware of, accompanied by a

statement of any changes to the overall risk associated with the tobacco products, and a

summary of any changes in the health risks, including the nature and frequency of the adverse

experience, and potential risk factors; a separate summary of all adverse experiences related to

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

of EVALI;

9. A summary, full reports, and analysis of all user complaints of Logic Pro (PM0000535) product

leakage;

10. 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;

11. A summary of the implementation and effectiveness of your policies and procedures

regarding verification of the age and identity of purchasers of the products;

12. 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;

13. 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;

14. 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
                   

                     

                              

                         

                           

                               

             

                           

                         

                             

                                

                     

                     

                             

       

                 

                   

               

                           

                           

         

                           

       

                           

                       

                     

                           

                         

              

                       

           

                       

                         

                             

   

                     

                       

                               

                       

                           

                     

                       

                           

Multiple STNs, see Appendix A Page 14 of 21

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;

15. 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;

16. 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;

17. 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
                   

                       

   

                           

                       

                     

                         

                           

                           

             

                         

                               

                               

                                 

                                 

                                    

                           

                                   

                             

          

                   

                                   

                             

                               

                            

                             

                                

                              

       

Multiple STNs, see Appendix A Page 15 of 21

including a summary of implementation of any corrective and preventive measures, not

previously submitted;

18. 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

19. 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 PM0000529.PD1 ‐ PM0000531.PD1,

PM0000535.PD1 ‐ PM0000537.PD1, PM000040.PD1 ‐ PM0000541.PD1.
                   

                           

               

       

         

                           

   

         

                       

                                 

           

                       

                               

         

                             

                             

         

                         

                     

          

           

                           

                             

                           

                                 

                                 

                           

                           

                                   

                                     

                               

                             

                             

      

Multiple STNs, see Appendix A Page 16 of 21

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.

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 requires 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.
                   

                                   

                             

                         

                           

                          

                             

                  

         

                          

   

                  

                     

   

                         

                           

                                    

                                   

                                   

                              

                    

                           

                               

             

                     

                       

                             

  

                     

               

           

                           

                       

     

                         

        

                     

                       

                       

                           

Multiple STNs, see Appendix A Page 17 of 21

This notification must be received by FDA at least 30 days prior to dissemination, which includes but is

not limited to the publication, dissemination to consumers, or use in engaging or communicating with

consumers of such materials. The duration of these notification requirements is as follows:

 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 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 PM0000529.PD1 ‐ PM0000531.PD1, PM0000535.PD1 ‐ PM0000537.PD1,

PM000040.PD1 ‐ PM0000541.PD1. The cover letter should include the STN(s) and

corresponding tobacco product name(s), applicant name, date of notification, and planned

dissemination date;

2. Full‐color copies of all such labeling, advertising, marketing, and promotional materials for the

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; 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;
                   

                     

            

                           

                             

                           

  

                   

          

   

Multiple STNs, see Appendix A Page 18 of 21

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 19 of 21

Appendix D

Marketing Restrictions

Under section 910(c)(1)(B) of the FD&C Act, these orders requires you to:

 For any digital sales – whether conducted by you, on your behalf, or at your direction –

establish, maintain, and monitor use of independent age‐ and identity‐verification service(s)

that compare customer information against independent, competent, and reliable data sources,

such as public records, to prevent the sale of the products to individuals who are under the

federal minimum age of sale of tobacco products.

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

owned digital properties (e.g., your company‐owned, consumer‐directed, product‐branded

website(s) and/or mobile applications) – whether conducted by you, on your behalf, or at your

direction – establish, maintain, and monitor use of independent age‐ and identity‐verification

service(s) that compare customer information against independent, competent, and reliable

data sources, such as public records, at the first point of access to such properties, to restrict

access to such labeling, advertising, marketing, and/or promotion to only individuals who are at

or above the federal minimum age of sale of tobacco products.

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

shared digital properties (e.g., your product‐branded social media accounts, pages and

associated content; content promoting your products on your behalf disseminated through

another entity’s social media accounts) – whether conducted by you, on your behalf, or at your

direction – establish, maintain, and monitor use of the available site‐, platform‐ and content‐

(e.g., post, video) specific age‐restriction controls (e.g., age‐restrict an entire product‐branded

account and all associated content disseminated through such account; ensure age‐restriction of

a specific video disseminated by an influencer promoting the products on your behalf through

the influencer’s account), at the first point of access to such properties, to restrict access to such

labeling, advertising, marketing, and/or such promotion to only individuals who are at or above

the federal minimum age of sale of tobacco products.

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

digital media (e.g., paid digital banner advertisements for the products running on another

company’s website; paid advertising for the products running in social media; paid distribution

of influencer content; paid advertising in streaming/Over‐The‐Top video programming; paid

advertising in streaming/internet radio content) – whether conducted by you, on your behalf, or

at your direction:

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

methodologies, and technologies to precisely target delivery of such labeling, advertising,

marketing, and/or promotion to only individuals who are or above the federal minimum age

of sale of tobacco products. Such targeting must use only first‐ and/or second‐party age‐

verified data, where:

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

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

                     

             

                     

                     

                            

                     

                   

                   

                     

                          

               

                     

                           

                     

                       

                     

                             

          

                       

                     

                               

                         

                           

                              

                               

     

                               

   

                     

                         

                                   

                         

                  

                     

                            

                         

                             

                    

Multiple STNs, see Appendix A Page 20 of 21

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 21 of 21

 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.