U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov 

MARKETING GRANTED ORDER 

22nd Century Group, Inc. 

ATTENTION: Karen Delaney, Program Manager 

8560 Main Street, Suite 4 

Williamsville, NY 14221 

FDA Submission Tracking Numbers (STNs): PM0000491 and PM0000492 

Dear Ms. Delany: 

We completed review of your PMTAs1 

1 Premarket Tobacco Product Application (PMTA) submitted under section 910(b) of the Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

and are issuing marketing granted orders for the tobacco 

products identified in Appendix A. 

Based on our review of your PMTAs, we find that the new tobacco products, as described in your 

applications and specified in Appendix A, are appropriate for the protection of public health. The 

issuance of these marketing granted orders confirms that you have met the requirements of 

section 910(c) of the FD&C Act and permits marketing of your new tobacco products. Therefore, you 

may introduce or deliver for introduction into interstate commerce the new tobacco products listed 

in Appendix A. 

Our finding does not mean that FDA has “approved” the new tobacco products specified in Appendix 

A; therefore, you may not make any express or implied statement or representation directed to 

consumers that conveys, or misleads or would mislead consumers into believing, among other things, 

that the new tobacco products specified in Appendix A are “approved” by FDA (see section 301(tt) of 

the FD&C Act). 

The authority to market the new tobacco products under these orders is also contingent upon the 

conditions listed in this order and subject to the requirements in the enclosed appendices. 

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). 

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 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. 

The products subject to these marketing granted orders are subject to withdrawal or temporary 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 2 of 15 

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

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, and payment of user fees. Labeling and/or advertising that represents 

explicitly or implicitly that a tobacco product contains a reduced level of a substance or presents a 

reduced exposure to a substance (e.g. nicotine) would render that product a Modified Risk Tobacco 

Product (“MRTP”) (sec. 911(b)(2)(A)(i)(II)). Additionally, tobacco product labeling and/or advertising that 

uses the descriptors “light”, “low”, or “mild” or similar descriptors would render that product an MRTP 

(sec. 911(b)(2)(A)(i)). A product may not be marketed as modified risk tobacco product (MRTP) without 

an order from FDA under 911(g) of the FD&C Act. 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. 

As a reminder, you must comply with applicable requirements under section 4 of Federal Cigarette 

Labeling and Advertising Ac t (15 U.S.C. 1333), e.g., you must submit a warning plan to the United States 

Federal Trade Commission (FTC). 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal2,

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

3 

3 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal. 

using eSubmitter.

4 

4 https://www.fda.gov/industry/fda-esubmitter 

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 date5

5 https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp 

; 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. 
 

 

 

 

PM0000491 and PM0000492 Page 3 of 15 

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

(301) 348 - 3032 or kristopher.vanamburg@fda.hhs.gov. 

If you have any questions regarding postmarket activities for the products within this order, please 

contact Rose Bianchi, at (301) 796 – 2382 or Rose.Bianchi@fda.hhs.gov. 

Sincerely, 

/S/ 

Matthew R. Holman, Ph.D. 

Director 

Office of Science 

Center for Tobacco Products 

Enclosures: 

Appendix A - List of Tobacco Products That Are Subject of This Letter 

Appendix B - Postmarket Record Keeping and Retention 

Appendix C - Postmarket Reporting 

Appendix D - Marketing Requirements 
PM0000491 and PM0000492 Page 4 of 15 

Appendix A 

List of Tobacco Products That Are Subject of This Letter 

Common Attributes of PMTAs 

Date of Submission: December 4, 2018 

Date of Receipt: December 4, 2018 

Product Manufacturer: 22nd Century Group, Inc. 

Product Category: Cigarettes 

Product Sub-Category: Combusted, Filtered 

PM0000491 

Product Name:6 

6Brand/sub-brand or other commercial name used in commercial distribution. 

Moon ® light

Package Type: Hard Pack 

Package Quantity: 20 Per Pack 

Characterizing Flavor: None 

Length: 83mm 

Diameter: 7.9mm 

Ventilation: 13% 

PM0000492 

Product Name:6 Moon ® light Menthol 

Package Type: Hard Pack 

Package Quantity: 20 Per Pack 

Characterizing Flavor: Menthol 

Length: 83mm 

Diameter: 7.9mm 

Ventilation: 13% 
 

 

 

 

 

 

PM0000491 and PM0000492 Page 5 of 15 

Appendix B 

Postmarket Recordkeeping and Retention 

Under section 910(f) of the FD&C Act, these orders require 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 cumulatively, that is, for a period of not less than four years 

from the date of distribution of the last batch of each product subject to this order, as 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. 

Type of Record Description Retention Period 

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

distribution of the last 

batch of each product 

subject to this order 

Postmarket reports Postmarket periodic reports submitted to FDA, 

including documents such as: status report of 

ongoing studies conducted by, or on behalf of, the 

applicant; adverse experience reports and all 

relevant documentation associated with the 

experience; summary of how the new product 

continues to be appropriate for the protection of the 

public health 

4 years from the date of 

distribution of the last 

batch of each product 

subject to this order 

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); 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 

distribution of the last 

batch of each product 

subject to this order 
 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 6 of 15 

The following records must be retained on a rolling basis, that is, for a period of not less than four years 

from the date of distribution of each batch of each product subject to this order or four years from the 

date of initial dissemination of materials to the public, as specified 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. 

Type of 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.7 

7 For products that have been distributed, if a deviation occurs that you determine presents a reasonable probability that the 

tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that 

would cause serious, adverse health consequences or death you are required to report the deviation to FDA within 15 calendar 

days of identification. 

4 years from the date of distribution 

of each batch of each product 

subject to this order 

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

distribution records products, including brick-and-mortar, and 

digital (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); 

Policies and procedures regarding restrictions 

on youth-access to the products, including 

purchaser age and identity verification 

processes. 

of each batch of each product 

subject to this order 

Complaints Records pertaining to any and all complaints 

associated with the tobacco product(s) that 

is/are the subject of this order(s). 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 
 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 7 of 15 

Health hazard analyses 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 

dissemination to the public 

Advertising marketing 

and promotional 

materials and plans 

Copies of all advertising, marketing and/or 

promotional materials, published, 

disseminated to consumers, or for use in 

engaging or communicating with consumers 

Copies of all advertising and marketing plans 

including strategic creative briefs and paid 

media plans, by channel and by product, and 

the details, dollar amount(s) and flighting of 

such plans, by channel and by product, 

including any: 

 Use of competent and reliable data 

sources, methodologies, and 

technologies to establish, maintain, 

and monitor highly targeted advertising 

and marketing plans and media buys, 

including a list of all data sources used 

to target advertising and marketing 

plans and media buys; 

 Targeting of specific adult audiences by 

age-range(s), including young adult 

audiences, ages 18-24, and other 

demographic and psychographic 

characteristics that reflect your 

intended target audience(s), how the 

target audience(s) were defined and 

the insights used to develop the target 

audience profiles(s) and the source of 

such insights; 

 Actions taken to restrict youth-access 

and limit youth-exposure to the 

products’ labeling, advertising, 

marketing, and promotion; 

 Use of owned, earned, shared/social, 

and/or paid media to create labeling 

for, advertise, market, and/or promote 

the products; 

 Use of partners, influencers, bloggers, 

and/or brand ambassadors to create 

labeling for, advertise, market, and/or 

promote the products; 

 Consumer engagements – whether 

conducted by you, on your behalf, or at 

your directions - including events at 

4 years from the date of 

dissemination to the public 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 8 of 15 

which the products will be 

demonstrated and/or; 

 Use of public relations outreach to 

create labeling for, advertise, market, 

and/or promote the products. 

Copies of all records pertaining to media 

tracking and optimization, by channel, by 

product, and by audience demographics (e.g., 

age, gender, race/ethnicity, geographic 

region), and all post-launch deliveryverification reports submitted to you from an 

accredited source, by channel, by product, 

and by audience demographics. 

Policies and procedures for real-time digital 

media monitoring to identify, correct, and 

prevent any delivery of advertising 

impressions to youth, ages 17 years and 

under, including documentation of such 

monitoring activities and implementation of 

corrective and preventive measures. 

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 from the date of 

dissemination to the public 

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 from the date of 

dissemination to the public 

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

agreements regarding the creation and/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. 

dissemination to the public 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 9 of 15 

Appendix C 

Postmarket Reporting 

I. Periodic Reporting 

Per section 910(f) of the FD&C Act, these orders require that you submit periodic reports every 6 

months to FDA once during the month of June of each year and once during the month of December of 

each year, beginning June 2020, 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 grounds 

for withdrawing or temporarily suspending such order. For the six-month reporting period, the report 

must include: 

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

REPORT for STN PM0000491 and PM0000492. The cover letter should include the STN(s) and 

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

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

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

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

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

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

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

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

information or materials for the products. 

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

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

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

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

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

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

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

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

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

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

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

referenced. Digital media, such as videos must be submitted in a format that FDA is able to open 

and review. 

Per 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 November 2020, 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 grounds for withdrawing or temporarily suspending such order. For the 12-

month reporting period, the report must include: 

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

REPORT for STN PM0000491 and PM0000492. 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. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 10 of 15 

2. A summary of how the new product continues to be appropriate for the protection of 

the public health, including: 

a. A status report of ongoing studies and a summary of completed studies about 

the product conducted by, or on behalf of, the applicant; 

b. A summary of significant findings on publications not previously reported, with copies of 

the full articles included. Any new scientific data (published or otherwise) on the 

likelihood of product use by current users of tobacco products within the same tobacco 

product category, current users of tobacco products in other tobacco product 

categories, former users of any tobacco product, and use by youth and young adults 

must also be reported; 

c. All serious or unexpected adverse experiences reported to you, including a listing and 

analysis (accompanied by a statement of any changes to the reference risk information 

and a summary of important risks, including the nature, frequency, and potential risk 

factors) 

d. A summary of sales and distribution of the new product, including 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 product is sold (e.g., convenience stores, food 

and drug markets, big box retailers, digital platforms, tobacco specialty shops); and 

e. Data on product purchasers. Report any data collected about new purchasers, those 

who have switched tobacco products, and/or multiple product users. The results must 

be broken down by purchaser demographics (e.g., age, gender, and race/ethnicity, 

geographic location) and must not include personally identifiable information. Also, any 

change in the intended target market for the product should be reported. The data 

described above may include sales data and post-marketing analyses. 

3. A summary of the implementation and effectiveness of your policies and procedures regarding 

verification of the age and identity of purchasers of the products. 

4. A summary of the implementation and effectiveness of your policies and procedures regarding 

restrictions on youth access to the products. 

5. 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 

c. A certification that the reported change did not result in any modification (including a 

change in design, any component, any part, or any constituent, including a smoke 

constituent, or in the content, delivery or form of nicotine, or any other additive or 

ingredient) of the tobacco product; and the basis for concluding that each change did 

not result in any modification to the final product. Modifications to any component or 

part of the previously authorized tobacco product would render the modified tobacco 

product a new product, for which premarket authorization is required. These 

modifications should not be provided in a periodic report. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 11 of 15 

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

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

7. 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.. 

8. 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. 

9. 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. 

10. A description of the implementation of all advertising and marketing plans not previously 

submitted, including strategic creative briefs and paid media plans– whether conducted by you, 

on your behalf, or at your direction - by channel and by product, and the dollar amount(s) and 

flighting of such plans, by channel and by product, including a description of any: 

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 adult audiences by age-range(s), including young adults, 

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

intended target audience, including how the target audience(s) are defined and the 

insights used to develop the target audience profiles(s), including the source of such 

insights; 

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

labeling, advertising, marketing, and/or promotion; 

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

advertise, market, and/or promote the products; 

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

advertise, market, and/or promote the products; 

f. Consumer engagements – whether conducted by you, on your behalf, or at your 

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

g. Use of public-relations 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. 

11. An analysis of the actual delivery of advertising impressions, by channel, by product, and by 

audience demographics (e.g., age, gender, race/ethnicity, geographic location), including a 

breakout by age-group (i.e., adults, ages 25+; young adults, ages 18-24; and youth, ages 12-17 
 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 12 of 15 

and ages 11 and under), not previously submitted. This analysis must be verified against postlaunch delivery-verification reports submitted to you from an accredited source. 

12. A summary of media tracking and optimization, by channel, by product, and by audience 

demographics (e.g., age, gender, race/ethnicity, geographic location), including a summary of 

real-time digital media monitoring to identify, correct, and prevent delivery of advertising 

impressions to youth, ages 17 and under, and including a summary of implementation of any 

corrective and preventive measures, not previously submitted. 

II. Serious Adverse Experiences Reporting 

Under section 910(f) of the FD&C Act, these orders require that you report to the FDA all adverse 

experiences that are serious, whether expected or 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 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 

ADVERSE EXPERIENCE REPORT for STN PM0000491 and PM0000492. 

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

that results in any of the following outcomes: 

• Death; 

• A life-threatening adverse event; 

• Inpatient hospitalization or prolongation of existing hospitalization; 

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

normal life functions; 

• A congenital anomaly/birth defect; 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 this order, unexpected adverse experience means an adverse 

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

experience is not consistent with: 

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

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

postmarket reports and studies; 

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

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

factor profile for the adverse experience; or 

• The results of nonclinical laboratory studies. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 13 of 15 

III. Notifications 

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

months after the date of your marketing granted orders you provide FDA a 30-day notification for all 

labeling, advertising, marketing, and/or promotional materials for which you plan on disseminating to 

the public. These notifications are not for pre-approval but are required so that FDA can have timely 

access to your marketing plans and materials, and if needed, provide you advisory comments, including 

any concerns about their possible impact on youth appeal and tobacco use initiation and, on the finding, 

that continued marketing of your products is appropriate for the protection of the public health. You 

may begin disseminating the materials 30 days after providing notification to FDA. 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. 

• 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 may be provided separately and clearly referenced. 

• 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: 

o 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; 

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

other demographic and psychographic characteristics that reflect your intended target 

audience, including how the target audience(s) are defined and the insights used to 

develop the target audience profile(s); 

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

marketing, and/or promotion; 

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

market, and/or promote the products; 

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

advertise, market, and/or promote the products; 

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

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

o Use public-relations 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 
 

 

 

 

 

 

PM0000491 and PM0000492 Page 14 of 15 

Appendix D 

Marketing Requirements 

Under section 910(c)(1)(B) of the FD&C Act, this order requires: 

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

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

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

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

federal minimum legal age to purchase tobacco products. 

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

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

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

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

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

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

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

least of federal minimum legal age to purchase tobacco products. 

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

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

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

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

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

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

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

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

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

labeling, advertising, marketing, and/or promotion to only individuals who are at least of federal 

minimum legal age to purchase tobacco products. 

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

digital media (e.g., paid digital banner advertisements for the product(s) running on another 

company’s website; paid advertising for the product(s) running in social media; paid distribution 

of influencer content) – whether conducted by you, on your behalf, or at your direction: 

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

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

marketing, and/or promotion to only individuals who are at least of federal minimum legal 

age to purchase tobacco products. Such targeting must use only first- and/or second-party 

age-verified data, where: 

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

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

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

independent, competent, and reliable data sources; and 
 

 

 

 

 

 

 

 

 

 

 

 

 

PM0000491 and PM0000492 Page 15 of 15 

 “Second-party” age-verified data is first-party data owned and age-verified by another 

competent and reliable entity (e.g., another company’s first-party user registration data) 

to which you have access. Such data must be age-verified by the second party. 

 “First-party” and “second-party” data does not include data obtained from data 

aggregators who categorize consumers based on trackable activities and inferred 

interests (e.g., internet search terms, video interactions, browsing history, purchasing 

behaviors) to create demographic and psychographic profiles marketers may use to 

enhance audience targeting. Such data is not considered age-verified and can only be 

used in combination with first- and/or second-party age-verified data. 

• Establish, maintain, and monitor use of competent and reliable data sources, methodologies, 

and technologies (e.g., using an embedded tracking pixel in all digital advertising) – whether 

conducted by you, on your behalf, or at your direction – to track and measure actual delivery of 

all advertising impressions, by channel, by product, and by audience demographics (e.g., age, 

gender, race/ethnicity, geographic location), including a breakout by age-group (i.e., adults, ages 

25+; young adults, ages 18-24; and youth, ages 12-17 and ages 11 and under). Such monitoring 

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

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

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

• 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. 

At any time, FDA may request that you provide any of the documents described in Appendix D. In 

addition, under section 704 of the FD&C Act, FDA may inspect your establishment(s) and request to 

inspect any record(s) described in Appendix D. 

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. 

You may be eligible to submit a supplemental PMTA for modification(s) 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 of 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.