U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

www.fda.gov

MODIFIED RISK GRANTED ORDER– RISK MODIFICATION

U.S. Smokeless Tobacco Company LLC

Attention: Rebecca A. Rivas, Senior Director, Regulatory Submissions

Altria Client Services LLC

601 East Jackson Street

Richmond, VA 23219

FDA Submission Tracking Number (STN): MR0000108

Dear Rebecca A. Rivas: 

We completed review of your MRTPA1 and are issuing a modified risk granted order for the tobacco 

product identified in Appendix A. This order authorizing the marketing of this modified risk product

does not mean FDA “approved” the modified risk product specified in Appendix A; therefore, you may 

not make any express or implied statement or representation directed to consumers that conveys, 

misleads, or would mislead consumers into believing, among other things, that the modified risk tobacco 

product specified in Appendix A is “approved” by FDA (see Section 301(tt) of the FD&C Act). The risk 

modification order is subject to withdrawal as described in section 911(j) of the FD&C Act.

Based on our review of your MRTPA, we determined that the proposed modified risk tobacco

product, Copenhagen Classic Snuff, as described in your application and specified in Appendix A, as 

actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease 

to individual tobacco users and benefit the health of the population as a whole, taking into account 

both users of tobacco products and persons who do not currently use tobacco products. Therefore,

we authorize the marketing of the modified risk tobacco product with the following modified risk 

claim: 

“IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes 

reduces risk of lung cancer.”

Under the provisions of section 911 of the FD&C Act, you may introduce or deliver for introduction 

into interstate commerce the modified risk tobacco product specified in Appendix A, in accordance 

with this risk modification order. This risk modification order includes requirements related to 

conditions for marketing under section 911(h) of the FD&C Act and postmarket surveillance and 

studies (PMSS) under section 911(i) as well as requests related to other record retention and 

reporting, as outlined in all attached appendices. 

1 Modified Risk Tobacco Product Application (MRTPA) submitted under section 911(d) of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act)
MR0000108 Page 2 of 20 

This order expires five years from the issue date of this letter. If you wish to renew your order, we 

recommend that a request for renewal be received by FDA 360 days prior to the expiration date. Your 

renewal may cross-reference your MRTPA that is subject to this order. 

The requirements in this risk modification order are intended to help ensure that your modified risk 

tobacco product, as actually used by consumers, will continue to significantly reduce harm and the 

risk of tobacco-related disease to individual tobacco users and benefit the health of the population as 

a whole, taking into account both users of tobacco products and persons who do not currently use 

tobacco products. However, compliance with these requirements alone is not a guarantee that the 

modified risk tobacco product, as actually used by consumers, will continue to significantly reduce 

harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the 

population as a whole, particularly if, despite these measures, there is a significant increase in use of 

your modified risk tobacco product by youth or non-users of tobacco products. FDA will continue to 

monitor the marketing of your modified risk tobacco product and its impact on the population. 

Based on our review of your MRTPA, the marketing requirements in Appendix D are necessary to our 

conclusion that permitting the marketing of the modified risk tobacco product will benefit the 

population as a whole. Absent these requirements, a modified risk granted order for this application 

could not issue consistent with the requirements of section 911 of the FD&C Act. Relatedly, we support 

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

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

measures to help reduce youth appeal of your marketing materials, restrict youth access to your 

products, and limit youth exposure to your labeling, advertising, marketing, and promotion: 

• Limit direct mail and email to only adult tobacco consumers who have agreed to receive 

communications through the Altria Client Services Tobacco Consumer Database. 

• Limit consumer engagement programs and marketing interactions at retail locations to only 

adults who confirm they are current tobacco consumers.

• Implement a retailer trade program aimed at preventing underage sales by training store 

personnel who sell tobacco products (using We Card® or equivalent training); displaying We 

Card® or equivalent signage; requiring age verification; displaying retail signage that conveys to 

adults not to purchase tobacco products for underage use; and adhering to the Smokeless 

Tobacco Master Settlement Agreement.

• Limit signage at retail locations and require signs in stores be placed within 48” of tobacco 

products. 

We encourage you to implement these measures because they are likely to help further mitigate risks to

youth. We also recommend that you take additional steps to limit youth exposure to product marketing

at points-of-sale (e.g., requiring advertising to be placed only inside the store) and in print media (e.g.,

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

of age or older and/or selecting publications that do not over-index for youth).

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

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

and it is your responsibility to ensure the tobacco product specified in Appendix A complies with 

all applicable statutory and regulatory requirements. 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 
MR0000108 Page 3 of 20 

payment of user fees. 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. 

We encourage you to submit all regulatory correspondence electronically via the CTP Portal2,3 using 

eSubmitter.4 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 date;

5 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. 

2 https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal 3 FDA’s Electronic Submission Gateway (ESG) is still available as an alternative to the CTP Portal. 4 https://www.fda.gov/industry/fda-esubmitter 5 https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp
MR0000108 Page 4 of 20 

If you have any questions, please contact Annie Seaman, MS, Regulatory Health Project Manager, at 

(301) 796-6103 or Annie.Seaman@fda.hhs.gov.

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

please contact Chad Burger, Director, Division of Enforcement and Manufacturing, at CTP

OCE-Postmarket@fda.hhs.gov.

Sincerely, 

S 

Todd L. Cecil, Ph.D.

Acting Director

Office of Science

Center for Tobacco Products

Enclosures: 

Appendix A – Tobacco Product Subject of This Letter

Appendix B – Amendments Received for This Application 

Appendix C – Required Postmarket Surveillance and Studies (PMSS)

Appendix D – Advertising and Promotion Requirements 

Appendix E – Recordkeeping and Retention 
MR0000108 Page 5 of 20 

Appendix A6,7,8678

68

Tobacco Product Subject of This Letter

68 

Attributes of MRTPA

Applicant U.S. Smokeless Tobacco Company LLC

Product manufacturer U.S. Smokeless Tobacco Company LLC

Product category Smokeless Tobacco

Product subcategory Loose Moist Snuff

Order type 911(g)(1) Risk Modification Order

Modified Risk Claim: “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from 

cigarettes reduces risk of lung cancer.”

Attributes Tobacco Product

STN MR0000108

Product name Copenhagen Classic Snuff

Submission date March 19, 2018

Receipt date March 20, 2018

Package type Fiberboard Can/Metal Lid

Package quantity 34.02 grams

Characterizing flavor Tobacco

Nicotine source Tobacco

Additional Properties Tobacco cut size: Cuts Per Inch (CPI)

6 Effective April 14, 2022, FDA’s authority to regulate tobacco products was extended to include tobacco products containing 

nicotine from any source. https://www.congress.gov/bill/117th-congress/house-bill/2471 

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

8 The characterizing flavor previously identified as “None” has been updated in FDA records to “Tobacco” to accurately reflect

that the product provides a tobacco characterizing flavor from the filler. As such, this product does not have any change in

characterizing flavor.

(b) (4)
MR0000108 Page 6 of 20 

Appendix B

Amendments Received for This Application 

Submission Date Receipt 

Date

Applications 

being 

amended

Reviewed Brief Description

April 10, 2018 April 10, 

2018

All Yes Correction to Appendix 7.3.2 15 

Claim Comprehension and 

Intentions (CCI) Study SSAP Syntax 

Code.

July 11, 2018 July 11, 

2018

All Yes Tabulated master bibliography 

index.

July 18, 2018 July 18, 

2018

All Yes Applicant submitted updated 

version of Table 7.1-17, summary of 

individual lot results.

August 8, 2018 August 8, 

2018

All Yes Response to FDA’s July 10, 2018, 

Advice/Information Request letter.

August 27, 2018 August 27, 

2018

All Yes Response to FDA’s August 23, 2018,

Clarification Request

February 1, 2019 February 1, 

2019

All Yes Response to FDA’s January 24, 2019,

Clarification Request

April 8, 2021 April 8, 2021 All Yes Notification for when a complete 

response to FDA’s Deficiency letter 

will be submitted

September 29, 2021 September 

29, 2021

All Yes Response to the Deficiency letter 

issued on March 26, 2021

March 9, 2022 March 9, 

2022

All Yes Response to FDA’s March 7, 2022, 

request for information regarding 

labeling and manufacturing 

information.
MR0000108 Page 7 of 20 

Appendix C 

Required Postmarket Surveillance and Studies (PMSS) 

Under Section 911(i)(1) of the FD&C Act, FDA must require postmarket surveillance and studies for any 

product for which an applicant received an order under 911(g)(1) in order to: “...determine the impact of 

the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the 

accuracy of the determinations upon which the order was based, and to provide information that the 

Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco 

product.” 

I. PMSS Content

MRTP Use Behavior and Consumer Understanding and Perception

After receiving authorization, the determination of whether the tobacco product that is the subject of

this order (hereinafter, the MRTP), as actually used by consumers, continues to benefit the health of the 

population as a whole is likely to be driven by use behavior. Therefore, monitoring use of the MRTP in 

terms of uptake, dual use, and complete switching is required. In particular, your PMSS must assess the 

extent to which new users of the MRTP were non-users of tobacco products, smokers, or other tobacco 

product users before initiating the MRTP, and the extent to which such new users of the MRTP become 

exclusive users or dual users with cigarettes or other tobacco products, including other smokeless 

tobacco (ST) products, over time. Relatedly, such surveillance must include an ongoing assessment of 

consumers’ understanding of the claim and perceptions of the MRTP. In particular, PMSS must assess 

the extent to which users of the MRTP understand that, to reduce their risk of lung cancer as described 

in the modified risk claim, they must switch from smoking cigarettes to using the MRTP exclusively. To 

adequately assess these impacts, you must conduct PMSS that include assessing users’ behavior and 

consumer understanding at multiple time points. 

In addition, FDA has determined that assessing the impact of your MRTP order on uptake of the product 

requires surveillance of MRTP sales and distribution, which provide information to assess tobacco 

consumption at the population level. Your PMSS protocols must describe procedures for monitoring and 

reporting MRTP sales and distribution in the U.S. by major metropolitan areas and channels where the 

MRTP is sold (e.g., convenience stores, food and drug stores, internet and digital retailers, tobacco 

specialty shops). Your annual PMSS report must include: 

• U.S. sales and distribution of the MRTP by quarter since the granting of your modified risk 

granted order (for the initial reporting period) or the previous reporting period (for all reports 

that follow), including, total U.S. sales and distribution reported in dollars and units, and broken 

down by major metropolitan areas and channels where the product was distributed and sold 

during the reporting period (e.g., convenience stores, food and drug stores, internet and digital 

retailers, tobacco specialty shops). 

• A brief synthesis and summary of the sales and distribution data for the initial reporting period 

or the previous reporting period (for all reports that follow), including annual and quarterly 

growth rate (percent change) in total U.S. sales and distribution of the MRTP since this Order 

was issued. 

• All Universal Product Codes (UPCs) used for the MRTP when selling or distributing it in the U.S.
MR0000108 Page 8 of 20 

MRTP Use and Health Risk – Adverse Experiences

In order for FDA to determine whether the MRTP, as actually used by consumers, continues to benefit 

the health of the population as a whole, your PMSS must include ongoing surveillance of all adverse 

experiences associated with the use of the MRTP. 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, tobacco product defect, or failure, reported to you, or identified in the literature or 

media. Your PMSS protocols must include procedures for monitoring and analyzing adverse experiences 

and your annual PMSS report must include: 

• A summary of reported adverse experiences for the tobacco product, which includes a listing of 

all adverse experiences during the reporting period and a cumulative list, including all serious 

and unexpected adverse experiences previously reported. The summary must be accompanied 

by an analysis of the reports and a statement of any changes to risk information related to the 

product including nature, frequency, and potential aggravating factors. 

For purposes of this reporting under this order, 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 of 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 this 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 the tobacco product as 

described in the MRTPA (including the results of human subject investigations) 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 

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

for the adverse experience; or 

• The results of nonclinical laboratory studies. 

Surveillance of New Research Study Findings on the MRTP and Consumer Perception, Behavior, or Health

In order for FDA to determine whether the MRTP, as actually used by consumers, continues to benefit 

the health of the population as a whole, your PMSS must include surveillance of new research study 

information about the MRTP and consumer perception, behavior, or health. In particular, your PMSS 

protocol must include procedures for monitoring and assessing findings both in your own studies (i.e., 

studies conducted by you or on your behalf) and in publications including any new scientific data 
MR0000108 Page 9 of 20 

(published or otherwise) regarding the MRTP and consumer perception, behavior, or health. Your 

annual PMSS report must include: 

• A summary of significant findings about the tobacco product from research studies conducted 

by you or on your behalf, whether or not such studies were specifically required under this 

order. 

• A summary of significant findings in publications not previously reported and full copies of the 

articles. This must include any new scientific data (published or otherwise) on the MRTP and 

consumer perception, behavior, or health. 

Modeling the Impact of the MRTP on Population Health 

In order for FDA to determine whether the MRTP continues to benefit the health of the population as a 

whole, your PMSS must include computational modeling of the impact of the MRTP on population 

health. Such modeling must incorporate data and information collected through PMSS, including the 

percentage of former smokers who start using the MRTP; the percentage of current smokers who start 

using the MRTP and become dual users; the percentage of current smokers who switch completely to 

the MRTP; the percentage of youth and young adults below the federal minimum age of sale who start 

using the MRTP; the percentage of individuals who start using the MRTP and then initiate or re-initiate 

combusted cigarette smoking; the percentage of other tobacco product users, including a specific 

breakout for other ST products, who start using the MRTP and become dual users; and the percentage 

of other tobacco product users, including a specific breakout for other ST products, who switch 

completely to the MRTP. Postmarket modeling must incorporate the latest information on acute and 

long-term health effects of using the MRTP relative to combusted cigarette smoking in order to assess 

the short and long-term population health impacts of the marketing. Your annual PMSS report must 

include: 

• A description of the methodological approach used in the model; 

• A copy of the model or its underlying code, such that FDA can independently run and verify 

the model inputs and outputs; 

• A description of all model inputs, including the justification for input values and how they 

were derived from postmarket data and information; and 

• A summary of the modeling results and their implications for assessing whether the MRTP 

continues to benefit the health of the population as a whole.

II. Submitting PMSS Protocols and Reports 

Within 30 days of receiving this notice, you must submit complete protocols for your PMSS as required 

under section 911(i)(2) of the FD&C Act. Label your submission clearly as a “PMSS Protocol,” and 

reference your MRTPA Submission Tracking Number (STN). If you have more than one protocol, each 

protocol should be a separate submission. If applicable, each protocol should include the name(s) of the 

principal investigator(s) and materials that demonstrate the relevant professional credentials and 

training that qualify them to lead the study. Within 60 days of receipt of the protocol(s), FDA will 

determine if the principal investigator proposed to be used in the surveillance has sufficient 

qualifications and experience to conduct the surveillance and if the protocol(s) will result in collection of 

the data or other information that FDA designates as necessary to protect public health, pursuant to 

section 911(i)(2) of the FD&C Act. FDA will notify you of and provide opportunities to address, any 

deficiency in the submission. If the PMSS protocol is amended subsequent to FDA approval, FDA must 
MR0000108 Page 10 of 20 

receive the amended protocol promptly. For protocol amendments that are administrative in nature 

(e.g., corrections in punctuation or titles), the amended protocol must be received by FDA within 30 

days of the update. For protocol amendments that seek to modify the study design (including endpoints, 

sites, questionnaires, methodology, etc.) or other scientific parameters, you may not initiate the change 

until you receive FDA approval. 

As part of the requirement to conduct PMSS, you must initiate and conduct your PMSS per timeframes 

established in your protocols and approved by FDA. Note that for PMSS that involve human subjects, the 

anticipated start date for each study must account for the time required for securing IRB approval, as 

needed. In addition to specifying the start date, your protocols must contain timelines for completion of 

major study milestones including, as applicable, the start and completion of participant recruitment, 

initiation of data collection (per wave, if applicable), completion of data collection, analysis, and report 

writing. If you deviate from these timelines, we request that you report the deviation within 30 days to 

FDA. 

Section 911(i) of the FD&C Act requires that the results of PMSS be submitted on an annual basis. These 

reports must be identified as “PMSS Report” and reference the MRTPA STN for each report. The PMSS 

Report must indicate the beginning and ending date of the period covered by the report and must 

include accomplishments since the last reporting period. For quantitative updates on studies in progress 

(e.g., participant accrual), reports should describe both interim (since the last reporting period) as well 

as cumulative (since study initiation) accomplishments. The PMSS Report describing studies in progress 

must describe the status of PMSS, including, as applicable the status of recruitment, data collection, and 

analysis; a summary of the study milestones achieved and any deviations from the agreed upon 

timelines in the protocol; a summary of protocol amendments; and a summary of any preliminary 

analyses conducted. Once a study is completed, the PMSS Report should include the complete final 

study report.
MR0000108 Page 11 of 20 

Appendix D 

Advertising and Promotion Requirements 

I. Recordkeeping and Retention

Under section 911(h)(5) of the FD&C Act, these risk modification orders require you to establish and 

maintain the following records:

• Records pertaining to the product’s labeling, advertising, marketing, and/or promotion – 

whether conducted by you, on your behalf, or at your direction – including: 

o Specimens of all labeling (including all labeling variations, such as those reflecting different 

required warnings), labels, inserts/onserts, instructions, and other accompanying 

information;

o Copies of all advertising, marketing, and/or promotional materials published, disseminated 

to consumers, or for use in engaging or communicating with consumers;

o 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 product, and 

including copies of the stimuli used in testing;

o Copies of any consumer evaluation research studies conducted among any audiences to 

determine the effectiveness of labeling, advertising, marketing, and/or promotional 

materials and any shifts in consumer knowledge, attitudes, beliefs, intentions, and behaviors 

toward using the product, and including copies of the stimuli used in testing;

o Copies of any contractual agreements regarding the creation and/or dissemination of the 

product’s 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; 

o Copies of all advertising and marketing plans, including strategic creative briefs and paid 

media plans, by channel and by product, and the 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;

 Targeting of specific adult audiences by age-range(s), including young adult audiences, 

ages 21-24, and other demographic and/or psychographic characteristics that reflect 

your intended target audience;

 With respect to individuals under the federal minimum age of sale of tobacco products, 

actions taken to restrict youth-access and limit youth-exposure to the product’s

labeling, advertising, marketing, and/or promotion; 

 Use of owned, shared, and/or paid social 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 product; 

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

direction – including events at which the product was demonstrated and how access will 
MR0000108 Page 12 of 20 

be restricted to individuals at or above the federal minimum age of sale of tobacco 

products; or

 Use of public-relations or other communications outreach to create labeling for, 

advertise, market, and/or promote the product;

o 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 delivery-verification reports submitted to you from an accredited source, by 

channel, by product, and by audience demographics; and 

o 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. 

II. Annual Reporting

Under section 911(h)(5) of the FD&C Act, this order requires that you submit the following reports to 

FDA on an annual basis, beginning twelve months from the date of this order. For each twelve-month 

reporting period, these annual reports must include:

• A cover letter that includes the following text in your subject line: ANNUAL REPORT for

MR0000108. The cover letter should include the STN, static product ID if applicable, and

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

• Records pertaining to the product’s labeling, advertising, marketing, and/or promotion – 

whether conducted by you, on your behalf, or at your direction – including: 

o A summary of all formative research studies conducted 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 product, and including the findings of these studies and copies 

of the stimuli used in testing; 

o A summary of all consumer evaluation research studies conducted 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 product, and including the findings of these 

studies and copies of the stimuli used in testing; and 

o A summary of the creation and dissemination of the product’s labeling, advertising, 

marketing, and/or promotional materials including a list of all entities involved and a 

description of their involvement, including a description of contractual agreements with 

such entities. 

• 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 the details, dollar amount(s) and flighting 

of such plans, by channel, including a description of any:

o 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;
MR0000108 Page 13 of 20 

o 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; 

o With respect to individuals under the federal minimum age of sale of tobacco products, 

actions taken to restrict access to the product and limit exposure to the product’s labeling, 

advertising, marketing, and/or promotion; 

o Use of owned, earned, shared, or paid media to create labeling for, advertise, market, 

and/or promote the product;

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

advertise, market, and/or promote the product; 

o Consumer engagements – whether conducted by you, on your behalf, or at your direction – 

including events at which the product was demonstrated and how access was restricted to 

individuals at or above the federal minimum age of sale of tobacco products; or

o Use of public-relations or other communications outreach to create labeling for, advertise, 

market, and/or promote the product; 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; 

• An analysis of the actual delivery of advertising impressions, by channel, and by audience 

demographics (e.g., age, gender, race/ethnicity, geographic region), not previously submitted. 

This analysis must be verified against post-launch delivery-verification reports for paid media 

submitted to you or entities working on your behalf or at your direction from an accredited 

source; 

• A summary of media tracking and optimization, by channel and by audience demographics (e.g.,

age, gender, race/ethnicity, geographic region), including a summary of real-time digital media

monitoring to identify, correct, and prevent delivery of advertising impressions to individuals 

under the federal minimum age of sale of tobacco products, and including a summary of

implementation of any corrective and preventive measures, not previously submitted; 

• 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 product; and 

• 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. 
MR0000108 Page 14 of 20 

III. Notifications

Under section 911(h)(5) of the FD&C Act, this order requires that as of the authorization date of your

modified risk order, and for a period of six months starting with the initial dissemination of the

marketing materials for the MRTP, you submit the following notifications of your marketing plans and

materials to FDA and all other labeling, advertising, marketing, and promotion. 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. 

This 30-day notification requirement to submit the product’s labeling, advertising, marketing, and/or

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 and on the finding that continued marketing of your product will benefit the

health of the population as a whole. You may begin disseminating the materials 30 days after the

notification is received by FDA. 

Each 30-day notification must include:

• A single submission with a cover letter that includes the following subject line: 30-DAY 

NOTIFICATION for MR0000108. The cover letter should include the STN and corresponding 

tobacco product name, applicant name, date of notification, and planned dissemination date;

• Full-color copies of all such labeling, advertising, marketing, and/or promotional materials for 

the product, Copenhagen Classic Snuff. The materials must 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 material does not allow for text to be read easily, the text 

may be provided separately and referenced. Digital media, such as videos, must be submitted in 

a format that FDA is able to open and review.

• 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 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 sources of such data; 

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

actions taken to restrict access to the product and limit exposure to the product’s labeling, 

advertising, marketing, and/or promotion; 

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

promote the product;
MR0000108 Page 15 of 20 

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

market, and/or promote the product; 

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

including events at which the product will be demonstrated and how access will be 

restricted to individuals at or above the federal minimum age of sale of tobacco products; 

and/or

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

market, and/or promote the product.
MR0000108 Page 16 of 20 

IV. Additional Conditions for Marketing

Under section 911(h)(5) of the FD&C Act, this order requires you to: 

• For any of the product’s 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 product’s 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 product 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 product on your behalf through 

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

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

federal minimum age of sale of tobacco products. 

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

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

company’s website; paid advertising for the product 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:

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

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

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

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

 “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.
MR0000108 Page 17 of 20 

• 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-launch delivery verification reports for paid media be submitted to you or entities 

working on your behalf or at your direction from an accredited source. 

• For any use of partners, influencers, bloggers, and/or brand ambassadors to create labeling for, 

advertise, market, and/or promote the product – 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 product, on your behalf, or at your direction.

The requirements above are intended to help ensure that the MRTP, as actually used by consumers, will 

continue to benefit the health of the population as a whole. Limiting youth initiation of the product and, 

relatedly, youth exposure to advertising and marketing materials for the product are important factors 

in the population health benefit analysis. Accordingly, FDA also recommends limiting youth exposure to 

any of the tobacco product’s labeling, advertising, marketing, and/or promotion appearing in print 

media publications.

 

After receiving authorization, the determination of whether the MRTP, as actually used by consumers, 

continues to benefit the health of the population as a whole is likely to be driven by use behavior. An 

uptake in youth initiation and use of the product would have a significant negative impact on the 

population health benefit analysis. To help ensure that your product, as actually used by consumers, 

continues to benefit the health of the population as a whole, we strongly recommend that you take 

measures to limit youth initiation and use of the product, beyond limiting advertising and promotion as 

required in this order. For example, we strongly recommend you adopt the following measures related 

to all digital sales of your product: 

• 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 product to individuals who are under the 

federal minimum age of sale of tobacco products. 

Relatedly, we request that you submit the following information to CTP on an annual basis: 

• A summary of the implementation and effectiveness of any policies and procedures regarding 

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

• A summary of the implementation and effectiveness of any policies and procedures regarding 

restrictions on youth access to the product. 

We remind you that if FDA can no longer make the determination that your product, as actually used by 

consumers, will benefit the health of the population as a whole, FDA must withdraw the modified risk 

order, after an opportunity for an informal hearing. See under section 911(j)(1) of the FD&C Act. 
MR0000108 Page 18 of 20 

Although adopting the measures above is not in itself a guarantee that the product will continue to 

benefit the health of the population as a whole, it is an important step in helping to ensure that there 

are no grounds for withdrawal of your order. 
MR0000108 Page 19 of 20 

Appendix E 

Recordkeeping and Retention

The risk modification order for your MRTP is effective for 5 years from the issue date of the order. If you

wish to renew your order, we recommend you submit a request for renewal 360 days prior to the end of

your effective timeframe. In order to help ensure that your risk modification order meets the standard

for renewal and to help expedite the review of any renewal application(s), we request that you establish 

and maintain the records listed below. The records should be retained for a period of not less than four

years from the date of distribution of the last batch of the tobacco product listed in your order under

section 911(g)(1) of the FD&C Act. The records should be legible, written in English, and upon request,

available for inspection and copying by officers or employees duly designated by the Secretary. Please

note that Appendices C and D require you to periodically submit some of these records to FDA (e.g., in

PMSS reports and/or advertising and promotion-related reports). 

• The MRTPA and amendments submitted prior to the orders

• Postmarket reports, as described in Appendix C, including adverse experience reports and all 

relevant documentation associated with the experience

• Records of all nonclinical or clinical studies, including:

o Source data;

o Study protocols (including statistical analysis plan);

o Amendments showing the dates and reasons for any protocol revisions;

o Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approvals or nonapprovals;

o Informed consent forms;

o Correspondence with study monitors/investigators/contract research 

organizations/sponsors/IRB/IEC;

o Investigator financial disclosure statements;

o Progress reports;

o Monitoring reports;

o Adverse experience reports;

o Case report forms/subject diaries/medical records/laboratory reports;

o Subject data line listings/observation records;

o Test article accountability records;

o Study results/protocol summaries/study reports; and

o Certifications and amendments to certifications 

• 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) of the product

• Records pertaining to the sale, distribution, or other disposition of the product, specifically:

o A list of distributors and retailers of the product, including brick-and-mortar and digital. For 

the purposes of this order, here and throughout the document, “digital” includes 

internet/online and mobile; 

o Any available information (not to include personally identifiable information) about product 

purchases, 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); and

o With respect to individuals under the federal minimum age of sale of tobacco products, 

policies and procedures regarding restrictions on access to the product, including purchaser 

age and identity verification processes. 
MR0000108 Page 20 of 20 

• Health hazard analyses, if performed voluntarily or directed by FDA

• Records pertaining to any and all complaints associated with the product that you receive or of 

which you are aware.