U.S.  Department  of Health and  Human Services  
Office of Inspector General  
FDAs  Approach to Overseeing 
Online Tobacco Retailers  
Needs Improvement  
 
Ann Maxwell  
Deputy  Inspector  General  for  Evaluation  and  Inspections  
 
December 2022, OEI-01-20-00241  
  U.S.  Department of Health and Human Services  
 
Office of Inspector General  
Report  in Brief  
December  2022, OEI-01-20-00241  
Why OIG  Did This Review   FDAs  Approach  to  Overseeing  Online 
Youth tobacco use  in the United  
Tobacco  Retailers  Needs  Improvement   
States remains of  high concern.  
Because online tobacco sales 
What  OIG Found  
happen without buyers  interacting  
with  sellers  face  to  face, these  Key Takeaway   From  2010  through  2020,  for  the  
sales  present  a potentially easy   16,000 online  tobacco  websites  that  
This  review  raises questions 
way  for minors to buy tobacco  FDAs  contractor  flagged for  review,  
about  the  effectiveness  of 
products without having their ages  FDA  issued  warning  letters  to  
FDAs  efforts  to  prevent  youth 
verified.   The Food and Drug  899  websites  but  took  no  
access to tobacco products 
Administration (FDA) regulates  the   enforcement  actions.  Although  FDA  
online.  In  the  first  10  years  of  
manufacturing, distribution,  and   can  verify  compliance  immediately  
its  oversight,  FDA's  actions  
marketing of tobacco products.  As   following  warning  letters,  it  is  
toward  online  tobacco  retailers  
part of  multiple efforts to this end,  
unclear  to  what  extent  FDA  
were limited to  warning letters  
FDA  conducts investigations of  
conducted  additional  oversight  of  
and  its  oversight  has  had  poor  
online tobacco retailers to 
these  online  tobacco  retailers  at  
transparency.  
determine whether they  are  in 
later  dates  and found subsequent  
violation of the Family Smoking  
violations  that  could  result  in FDA  taking  enforcement  actions.  
Prevention and Tobacco Control  
Act (Tobacco Control Act).  If a  
FDA  faces  challengesmany  unique  to  the  online  environmentto  
retailer violates the Tobacco  
taking  action  against  online  tobacco  retailers  that  violate  the  Tobacco  
Control Act, FDA may  impose an  
Control  Act.  For  example,  websites  may  correct  violations  or  disappear 
advisory  actionsuch as a  warning  
before FDA  can  issue an  enforcement  action.  Adding to  these challenges  
letteror  an enforcement action.  
is  the  fact  that  FDA  has  not  taken certain  steps  that  could  help  it  address  
This study  assesses FDAs  efforts to 
gaps in  its ability to  oversee  online  tobacco  retailers.  For example, FDA  
oversee online tobacco retailers  
has  not  completed  rulemaking  on non-face-to-face  (e.g., online)  tobacco  
compliance  with the Tobacco 
sales,  nor  has  it  worked  with  the  Bureau  of  Alcohol, Tobacco, Firearms  
Control Act.  
and  Explosives  (ATF)part  of the Department  of Justiceto potentially  
How OIG Did This Review   obtain information on  online  tobacco  retailers,  beyond  that  which  is  
We analyzed annual summary data  already  obtained by  FDA.  Finally,  FDA  provides  limited  transparency  into  
from FDA from 2010 through  2020  its  oversight,  limiting  the  publics  ability  to  hold  it  accountable  for  
to determine the extent of FDAs   preventing  youth access  to  tobacco  online.  
advisory and enforcement actions  
and to identify  trends in FDAs  What OIG  Recommends  
oversight of online retailers.   We  We recommend that  FDA (1) collaborate  with  ATF  on oversight  of  online  
also  interviewed FDA officials and  tobacco  retailers;  (2)  complete  its  rulemaking  on non-face-to-face sales  
collected written responses from  of  tobacco  products, as  required  by  the  Tobacco  Control  Act;  (3)  collect  
FDA  to understand the following:   data  to support  process and  outcome  measures for  its oversight  of  
how  the online investigations   online  tobacco  retailers;  and  (4)  publish information and  performance 
program operates, FDAs  data  on its  oversight  of  online  tobacco  retailers.  FDA  concurred  with  our  
challenges  in implementing  the  
first  and  fourth recommendations  and  neither  concurred  nor  
program, and  FDAs  actions  to 
nonconcurred  with our  second  and  third  recommendations.   
address these  challenges.  Finally, 
we reviewed  FDAs public website   
to gather information on  FDAs  
oversight of online tobacco  
retailers.  
   
TABLE OF  CONTENTS  
 
 
BACKGROUND ................................................................................................................................................  1  
FINDINGS ......................................................................................................................................................... 8  
From 2010 through 2020, FDA  issued warning letters to online tobacco retailers but  did not take any  
enforcement actions  ................................................................................................................................................................  8  
FDA has not taken certain steps that could help it address gaps in its ability to oversee online  tobacco 
retailers  ....................................................................................................................................................................................... 12  
Finally, FDA  provides limited transparency into its oversight, limiting the publics ability to hold it  
accountable for preventing youth access to tobacco online  ................................................................................. 14  
CONCLUSION AND RECOMMENDATIONS ...........................................................................................  16  
Collaborate with ATF on oversight of  online tobacco retailers ............................................................................. 16  
Complete its rulemaking  on non-face-to-face sales of tobacco products, as required by the Tobacco  
Control Act  ................................................................................................................................................................................ 16  
Collect data  to support process and outcome measures for its oversight of  online tobacco retailers . 17  
Publish information and  performance data on its oversight of online tobacco retailers ............................ 17  
AGENCY COMMENTS AND OIG RESPONSE  .........................................................................................  18  
APPENDIX .....................................................................................................................................................  20  
Appendix A: Agency Comments ........................................................................................................................................ 20  
ACKNOWLEDGMENTS AND CONTACT  ................................................................................................  25  
Acknowledgments  .................................................................................................................................................................. 25  
Contact ........................................................................................................................................................................................ 25  
ABOUT THE OFFICE OF INSPECTOR GENERAL ....................................................................................  26  
ENDNOTES  .................................................................................................................................................... 27  
 
 
   
 
 
OBJECTIVE  
To assess the Food and  Drug Administration's (FDAs)  oversight of online tobacco  
retailers.  
 
Youth tobacco use in the United  States  remains of high concern.1   In particular, e-
cigarettes, a type of electronic nicotine delivery system (ENDS), have eclipsed other 
forms of  tobacco to become the most  commonly used tobacco product among  
youth.2   In 2020, close to  20 percent of high schoolers, or over 3 million students, 
reported that they currently use e-cigarettes.3   Since then, e-cigarette use among  
youth may have declined, although a  substantial  proportion of youth still use these 
products.4, 5   
Preventing youth access to tobacco  is one of three focus areas of FDAs Youth  
Tobacco Prevention Plan, which is a component of FDAs Comprehensive Plan for 
Tobacco and Nicotine  Regulation.  Curbing marketing of tobacco products aimed at  
youth and educating youth on the dangers of tobacco use are the two  other focus 
areas of  FDAs Youth Tobacco Prevention Plan.6  
Unlike in-person sales, online sales of tobacco products do not include a  face-to-face  
interaction between the buyer and the retailer.  Without this interaction, online sales 
represent a potentially easy way for  minors to buy tobacco products without having  
their ages verified.  In addition, research has shown that 95 percent of youth ages 13 
to 17 report having smartphones or access to one, and close to half of youth report  
using the internet on a near-constant  basis, which risks exposing them to marketing  
and sales of  tobacco products.7   This underscores the importance of FDAs oversight  
of online tobacco retailers within its efforts to limit youth access to tobacco products.  
The Tobacco  Control Act  
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act  
(Tobacco Control Act), which authorized the FDA to regulate tobacco products in the 
United States.8   Specifically, the Tobacco Control  Act amended the Federal Food,  
Drug, and Cosmetic Act  and granted FDA authority to regulate the manufacturing, 
distribution, and marketing of cigarettes  and  smokeless and  roll-your-own tobacco 
products.9   User fees from manufacturers and importers of certain classes of tobacco  
products are the sole source of funding for FDAs regulation of tobacco products.10   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Background |  1     
The Tobacco Control Act authorized FDA to inspect and investigate the activities of  
manufacturers, importers,  and retailers to assess their compliance with age and  
marketing restrictions on tobacco sales.11  
Among other things, the Tobacco Control Act also required FDA to issue rules on the 
sale and marketing of tobacco products that do not occur through a face-to-face  
transaction at a retailer based at a physical location.12   Specifically, the Tobacco 
Control Act  required FDA to  issue rules on the non-face-to-face sale and distribution  
of tobacco products and the advertising and promotion of tobacco products sold  
non-face-to-face by 18 months and 2 years after the enactment of the  Tobacco 
Control  Act, respectively.13   The Tobacco Control Act required these rules specifically 
to prevent non-face-to-face sales to  minors and to protect them from the associated  
promotion and marketing.14   In 2011, FDA issued an advanced notice of  proposed  
rulemaking to this end, but never completed its rulemaking.15  
The Prevent  All Cigarette Trafficking  Act  
In addition to the Tobacco Control Act, the Prevent All  Cigarette Trafficking Act  
(PACT)  Act of 2009 limits the sale of tobacco products.16   The PACT Act, which came 
into effect in 2010, prohibits retailers from using  the United States Postal  Service to  
deliver cigarettes and smokeless tobacco products directly to consumers.17   The 
Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) within the Department of  
Justice enforces the PACT Act.  Among other requirements, the PACT Act requires all  
online retailers that enter tobacco products into interstate commerce for delivery 
using a common carrier or private delivery service, including online retailers, to  
register with ATF.18   In 2021, Congress amended the PACT Act to cover online retailers 
of ENDS products in addition to cigarettes and smokeless tobacco products.19   
Although the PACT Act  does not apply to private delivery companies, these  
companies may have policies restricting or prohibiting the shipment of  tobacco  
products.20  
Additional Legislative and  Administrative Action to  Enhance 
FDAs  Oversight of  Tobacco  
Since the passage of the Tobacco Control Act, additional legislative and  
administrative actions have enhanced and added clarity to  FDAs oversight of tobacco  
products.  See Exhibit 1 for a timeline of these and other selected actions that have 
enhanced FDAs oversight over tobacco products.21  
   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Background |  2     
Exhibit 1: Timeline of selected actions that have enhanced FDAs oversight 
over tobacco products  
 
Source:  OIG analysis, 2022.  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
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FDA  Oversight  of  Online Tobacco  Retailers  
FDAs approach to overseeing  
tobacco includes an array of  
FDA oversight of  advertising  
effortsaimed at  
and promotion of tobacco  
manufacturers, importers, and  
In addition to its surveillance of websites 
retailersthat work in concert.  
selling tobacco, FDA monitors tobacco  
Its oversight of  online retailers 
advertising and labeling in social media, 
is one of those efforts.  
print media, and other venues.  In June 
To monitor compliance with the  2019, FDA and the Federal Trade 
Tobacco Control Act, FDA   Commission sent warning letters to four 
conducts surveillance of  the  e-liquid manufacturers whose social  
promoting, advertising, and   media posts violated the Tobacco  
labeling of tobacco products.   Control Act.22   In a September 2019 
Its surveillance includes online  letter to ENDS manufacturer JUUL Labs, 
media and  websites that   Inc., FDA expressed concerns about its 
advertise or sell tobacco   social media marketing.   Also, in 
products to consumers in the   September 2019, FDA issued a warning  
United  States.  To identify  letter to  JUUL Labs, Inc. after learning  
websites for surveillance, FDA   that it had  improperly marketed ENDS  
uses information from multiple  as modified  risk tobacco products in 
sources, mostly its contractor  talks to students in high schools.  
that uses technology to  flag  
specified criteria.  It also  uses its 
public complaint portal,  which may receive tips about potential  violations.23  
FDA may investigate an online  retailer when its  surveillance identifies a potential  
violation  of  the Tobacco Control Act.  FDA generally conducts two types of online 
investigations.  The first assesses an online retailers compliance with advertising and  
labeling requirements such as displaying the proper warning labels; compliance with 
the ban on flavored cigarettes; and compliance with other Federal restrictions on 
tobacco sales, marketing, and advertising.  The second is an undercover buy,  in which 
an underage purchaser, supervised in  person by a contractor and an  FDA staff  
member, attempts to buy a tobacco  product from an online retailer.  
When FDAs investigation identifies a potential violation of  the Tobacco Control Act, 
FDA must establish additional  information to support an action against a retailer.  
FDA must confirm  that  there is a violation;  confirm FDAs jurisdiction over the product 
in question;  identify the online retailers owner or most responsible party;  and  
determine whether the product was entered into interstate commerce.  
FDA uses contractors to  assist in certain aspects of its online surveillance activities.  
See Exhibit  2 for detail  on the surveillance and  investigation process.  
   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Background |  4     
Exhibit 2: FDAs investigations process for online retailers  
 
Source:  OIG interview with FDA officials, 2021.  
   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
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FDA Actions  When Retailers  Violate the Tobacco  Control  Act  
FDA has the authority to  take advisory and enforcement actions when it  determines 
that a retailer has violated the Tobacco Control Act.  Advisory actions include warning  
letters.  A warning letter represents FDAs attempt to bring a retailer into compliance 
and establish prior notice.  Enforcement actions include civil  money penalties (CMPs)  
and no-tobacco-sale orders (NTSOs).  A CMP is a  fine that  FDA assesses for violating  
the Tobacco Control Act.  An NTSO is an order that prohibits a retailer from selling  
tobacco products indefinitely or for a specified period of time.   In certain cases, FDA  
may pursue other enforcement actions including criminal prosecution, seizing  
tobacco products, or an injunction.24    
The penalties for violating the Tobacco Control Act increase with subsequent  
violations.  Generally, FDA issues a  warning letter the first time it finds a retailer in 
violation.  If  FDA finds the retailer in violation during subsequent investigations, it may 
issue CMPs that increase with each subsequent violation.  When FDA  finds that a  
retailer has committed repeated violations of the same FDA requirements, it may 
pursue an NTSO.  See Exhibit 3 below for a schedule of  FDAs  progressive actions.  
Exhibit 3: FDAs schedule of  penalties for  violating  restrictions on the sale  
and  distribution of  tobacco products as of March 17,  202225  
 
Source: 87 Fed. Reg. 15100 (Mar. 17, 2022).   FDA  updates  CMP amounts annually  in accordance with the Federal  Civil  
Penalties  Inflation Adjustment Act Improvements Act of 2015.  
   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Background |  6     
Related  Office of  Inspector General (OIG) work  
OIG previously issued a data brief evaluating  FDAs oversight of tobacco  
manufacturing establishments.   The data brief examined tobacco manufacturing  
establishment registration and product listing as well as FDAs inspection and  
enforcement actions from 2010 to 2015. We found that FDA  largely met its 
requirement to inspect  manufacturing facilities biennially, and that it concluded  that 
no enforcement action was needed after the inspections.26   The data brief did not  
include any recommendations for FDA.  OIG also has work  underway to examine 
FDAs tobacco compliance check inspection(s) program for retailers that  operate from 
a physical location.27   Finally, OIG is auditing FDAs premarket tobacco product  
application process for ENDS.28  
Methodology  
The scope of this review  is limited to  FDAs investigations of online retailers, which are 
part  of  its overall efforts to limit youth tobacco use.   We based this study on annual  
summaries of investigation activity from FDA;  an interview with FDA officials 
responsible for oversight of  online retailers;  written questions and answers with FDA;  
and materials on FDAs website.  
We requested annual summary data  of investigation activity for calendar years 2010 
through 2020 from FDA.  We requested the counts of  online retailers FDA  identified, 
investigations it completed, violations it observed, and advisory or enforcement  
actions it  issued.  FDA provided these data with the exception of counts of online 
investigations it completed,  which it did not have available.  We analyzed these data  
to determine the extent of  FDA advisory and enforcement actions and to  identify the 
trends and patterns in FDAs oversight of  online retailers.  
In addition, we interviewed FDA officials to understand  how the online investigations 
program operates, FDAs challenges in implementing the program, and FDAs actions 
to address those challenges.  We followed up with FDA  with sets of written questions 
and used FDAs responses to further our understanding of  its oversight.  
Lastly, we reviewed FDAs public website to gather information on relevant law, 
regulation, and guidance;  FDAs oversight of  online retailers;  priorities in enforcing the 
Tobacco Control Act;  and strategies to reduce youth access to tobacco.  
We did not  independently verify the data and information FDA provided.  
Standards  
We conducted this study in accordance with the Quality Standards for Inspection  and  
Evaluation  issued by the Council  of the Inspectors General on Integrity and Efficiency.  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Background |  7     
FINDINGS  
From  2010  through  2020,  FDA  issued  warning  letters  to  online 
tobacco  retailers  but  did  not  take any enforcement  actions  
FDA told us that it views success as impeding violative activities and changing  
industry practices.  A warning letter is an advisory action that FDA regards  as  a first  
step toward  taking an enforcement action such as a  CMP or an NTSO for violating the 
Tobacco Control Act.  To take an enforcement action, FDA  must prove that a violative 
retailer had  a subsequent violation during a later investigation.  
FDA issued 899 warning letters  to online tobacco retailers  that 
violated  the Tobacco Control Act  
Among the 16,511 websites flagged  for meeting  certain criteria, FDA  issued warning  
letters to 899 of them.  FDAs contractor flagged the websites as meeting criteria such 
as using the words light, mild,  or grape.   For flagged  websites, FDA conducts 
additional analysis to determine which websites have potential violations, support  
FDAs enforcement priorities, and are appropriate for  an FDA online investigation.   
FDA told us that, after issuing warning letters to online retailers, it provides feedback  
on corrective actions proposed by firms.  FDA also told us that it can instantly verify 
whether online retailers have taken corrective actionsa key difference from physical  
retailers that would require a revisit by an inspector.  See Exhibit  4 below for the 
number of warning letters FDA  issued to online tobacco retailers by year.  
Exhibit 4:  The number of warning letters issued  by FDA  to online tobacco 
retailers  grew steadily through 2016 before tapering off.  
 
Note: COVID-19  affected 2020 enforcement activities.  
Source:  OIG analysis  of FDA online tobacco retailer enforcement data, 2022.  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  8     
Y222222222222e000000000000a011111111112r901234567890              To111t358787153a660452058524l              
Although FDA has taken enforcement actions against retailers operating in physical  
locations, it  told us that  a CMP or NTSO is generally not the next step for violative  
online retailers after issuing a warning letter.29   FDAs Center for Tobacco  Products 
told us that  it refers some cases that require additional followup to other parts of  
FDA, such as its Office of Criminal Investigations or Office of  Regulatory Affairs.  Yet,  
beyond verifying compliance immediately following warning letters, it is unclear to 
what extent  FDA investigated these online retailers at later dates and found  
subsequent violations that could result in FDA  issuing CMPs and NTSOs.  This is 
important because, although FDA has the ability to instantly verify compliance 
following a warning letter, FDA can be certain of sustained compliance only  by  
following up with the retailer later.  
The violations  that FDA cited in warning letters reflected its  
evolving  oversight of tobacco products  
As FDAs authorities over tobacco evolved, its enforcement followed suit.  For  
example, after the Tobacco Control Act came into effect in 2009, FDA  focused on 
violations of the ban on flavored cigarettes and sales, marketing, and advertising.  By  
2013, FDA had additional guidance on the sale of tobacco to  minors, and its 
enforcement to prevent underage sales increased up to the onset of the COVID-19 
pandemic, when it was not possible for minors to sit at  a computer together with FDA  
staff to attempt undercover buys.  In 2020, new FDA guidance prioritized ENDS that  
lacked marketing authorizations.  
Within the 899 warning letters it issued, FDA cited 1,320 unique violations among  
online retailers since 2010.  The warning letters most frequently cited online tobacco  
retailers for advertising and labeling violations.   See Exhibit  5 for the numbers and  
types of violations FDA cited as a result of online retailer investigations.  
   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  9     
Exhibit 5: The numbers and types of violations that FDA cited shifted with 
changes in law, regulation, and guidance.  
 
Note: COVID-19 affected enforcement activities in 2020. 
Source: OIG analysis of FDA enforcement data for online tobacco retailers, 2022. 
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FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement   
OEI-01-20-00241  Findings | 10    
FDA  faces challenges  to taking action against  online tobacco  
retailers  that violate the Tobacco Control  Act  
Challenges around the volume, volatility, and transparency of online retailers make it  
difficult for FDA to  initiate an advisory or enforcement action against retailers that  
violate the  Tobacco Control Act.  One FDA official  described online tobacco sales as a 
wild West  environment where retailers can evade FDAs oversight.  
The limitless capacity of  the internet to host retailers means that the sheer volume of  
websites that FDA must  surveil is likely in the tens of thousands.  This surveillance is  
further  complicated by the evolving ways in which youth access the internet, such as 
through social media and by technology-driven changes in retailing, such as home 
delivery apps.  To address the large volume of retailers, FDA supplies its contractor 
with risk-based criteria to conduct keyword searches, algorithmic web searches, and  
searches of e-commerce websites such as eBay or Facebook  Marketplace to identify 
websites for potential investigation.   Although this approach helps FDA narrow the 
number of online retailers, it still leaves FDA  with  7,0008,000  potential targets for 
investigation every quarter.  FDA  then works with its contractor to  further narrow the 
list of potential  targets per criteria it  provides.  
Once FDA begins an investigation, it faces 
challenges with transparency and volatility 
that may prevent it from establishing the  
investigative facts it needs to take action 
against a violative retailer.   For example, it  
can be difficult to determine the owner or 
most  responsible party for an online retailer.  
Also, the retailer may go offline entirely,  
thereby undermining FDAs investigation.  
Furthermore, retailers may alter or shift the 
content of their websites, which could  
undermine FDAs efforts  to address a  
violation.  Finally, changes to  content could  
mean that a  retailer has become compliant  
with the lawnegating the need to continue 
with the investigation.  
Even if FDA issues a warning letter to  an online retailer, the nature of the online 
marketplace can make it challenging for FDA  to  work with the retailer to  obtain 
compliance or take progressive enforcement actions for subsequent violations.  To 
issue a CMP, subsequent CMPs, and  eventually an NTSO, FDA must establish a pattern 
of violations with the same owner and same website over time.30   However, it is not  
only unclear to what  extent FDA conducted additional oversight of these online 
retailers and found subsequent violations, but also, websites can come and go much 
more easily than a store at a physical location, making it harder to establish a pattern 
of violations.  For example, a retailer who receives a warning letter could easily hide its 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  11     
identity or launch new websites where it commits the same violations, thereby skirting  
progressive enforcement  action.  Furthermore, the online retailer may choose not to  
work with FDA to become compliant or, as an FDA official  told us, it may just  
disappear.  
FDA officials offered an example of  a special oversight effort that highlighted the 
challenges of compliance and enforcement in online tobacco sales.  See Exhibit 6 
below  for details of this example.  
Exhibit 6: FDA did not issue warning letters to 11 of 30 high-volume online 
domestic retailers selling prohibited ENDS products.  
 
Source:  FDA written response to OIG request for information, 2022.   
FDA  has  not  taken certain steps  that  could  help  it  address  gaps  
in its  ability to  oversee online tobacco  retailers  
FDA has taken actions to mitigate the challenges associated with overseeing online  
tobacco retailers, but it could do more.  For example, shortly after starting the 
program, FDA engaged contractors to help it sift  through the volume of  online  
retailers and to conduct  undercover buys. It has worked with e-commerce websites 
that host online tobacco retailers, payment processors, and social  media  platforms to  
leverage their internal oversight and governance to help FDA  enforce compliance with 
the Tobacco Control Act.  FDA told us that it has also called upon internal resources, 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  12     
such as its Office of Criminal Investigations, and  other government resources, such as  
the U.S. Customs and Border Protection and the Federal Trade Commission, to  
identify and  hold online  retailers accountable.  Still, FDAs approach to overseeing  
online tobacco retailers has gaps.  
FDA  does not obtain detailed information on  online tobacco  
retailers from ATF  
FDA lacks the kind of detailed  information from online retailers that ATF  collects 
under the PACT Act.  That information includes ownership and contact information, 
among other things.31   The Food, Drug, and Cosmetic  Act, as amended by the 
Tobacco Control Act,  does not  require tobacco retailers to register with FDA.  FDA  
told us that  it does not  work with ATF to regulate the sale of tobacco products by 
online retailers but does share information on investigations.32   However, because 
FDA does not draw  on ATFs information about  online retailers, FDA is left without  
information that could be key to its investigations.  For example, ATFs information 
could help FDA identify an online retailers  owner or  most responsible partya vital 
step in holding an online retailer that violates the Tobacco Control Act  accountable.  
FDA has  yet to issue a final rule to  strengthen its approach to  
overseeing  online tobacco retailers  
FDA has not fulfilled the Tobacco Control Acts requirement  to issue rules on the sale  
and marketing of tobacco products in non-face-to-face settings.  FDAs rulemaking  
process offers opportunities for the public to offer feedback and suggestions on 
proposed regulations, including those intended to enhance oversight of online 
tobacco retailers.  Although FDA solicited public feedback on non-face-to-face  
tobacco sales in its 2011 advanced notice of proposed rulemaking, FDA  withdrew the 
notice in 2017.  Since then, changes in internet technology  and in the tobacco  
marketplace make it  important for FDA to complete its rulemaking.  Doing so will 
provide additional, up-to-date  public input  and the opportunity for FDA to improve 
and strengthen its oversight of  online tobacco sales.  
FDA lacks data as  well as process and outcome measures for its 
oversight of online tobacco  retailers  
FDA was unable to tell us how many investigations of online  retailers it has conducted  
and does not set targets for the numbers of investigations it  will conduct.  For this  
review, FDA  was able to  provide us with data only about investigations that resulted  
in its taking  action against online retailers that violated the Tobacco Control Act.  
Accordingly, it is also unclear how often FDA conducted additional oversight of  
retailers to determine sustained compliance.  FDA told us that online investigations 
are difficult to quantify because they may cover multiple websites  and  various online 
media, and  even include inspection of a physical establishment such as a  
manufacturer, vape shop,  and/or retailer.  Also, FDA considers its investigations to be 
one tool within an array of efforts to  control youth access to tobacco.  Nonetheless, a  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  13     
lack of process measures reflecting the extent and results of investigations and  
outcomes measures tied to the programs goals hampers FDAs accountability to  
stakeholders and its ability to monitor and improve oversight.  
Finally,  FDA  provides  limited  transparency into  its  oversight,  
limiting  the publics  ability to  hold  it  accountable for preventing  
youth  access  to  tobacco  online  
Information  and data on  FDAs  
oversight of  online retailers are  FDAs Electronic  
important for holding FDA accountable  Reading Room  
to parents and other stakeholders, but   A page on FDAs website has 
FDA makes little of either available.   warning letters it issued to tobacco  
This makes it difficult to  know what   and nontobacco entities including  
FDAs oversight of online retailers is  food  and pharmaceutical  
accomplishing.   companies.  Users can filter the list  
for tobacco  entities, but the 
FDA does not publish information on 
filtering still  leaves letters to  
the purpose or goals of its oversight of  
retailers, manufacturers, and  
online retailers, which limits 
importers all grouped together, 
transparency into how it attempts to  
requiring the user to click through 
prevent youth access to tobacco on 
and open each letter to  determine 
the internet.  Some content on FDAs 
which type(s) of entity it  relates to.  
website mentions its surveillance of  
Warning letters issued prior to  
websites and publications, but FDA  
2017, which account for about half  
does not dedicate a page to describing  
of the warning  letters FDA issued,  
the surveillance, its purpose, and its 
are only available on a third-party 
goalsin general or with respect to  
archive site that is not  linked to the 
online retailers.  This means that FDA is 
reading room.  
missing the opportunity to inform the 
public and stakeholders about its 
efforts to curb youth access to tobacco online and how it measures the success of  
those efforts.  
Likewise, FDA publishes little data  on its investigations of online retailers, which limits 
the publics ability to hold it accountable.  Along with transparency about the purpose  
and goals of FDAs oversight of  online retailers, data on the extent and results of its 
investigations are key to accountability.  Publicly accessible data are limited to  
isolated statistics in a few reports or press releases on FDAs website.  This contrasts 
with FDAs Tobacco Retailer Compliance Inspection Program for retailers that sell  
tobacco from a physical location.  For that program, FDA makes all of its inspections 
data available in both searchable and downloadable formats.  We understand that  
FDA aims to safeguard its enforcement strategy so as not  to compromise the integrity 
of its investigations of online retailers.  However, its experience with tobacco retailers 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  14     
at physical locations demonstrates room for increased transparency in its oversight of  
online retailers.  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Findings |  15     
CONCLUSION AND  RECOMMENDATIONS  
Preventing youth access to tobacco  on the internet remains a challenging public 
health goal.  Youth tobacco use remains high.  The way youth purchase tobacco and  
the way tobacco is marketed continue to evolve (e.g., through social media).  Our 
findings raise questions about the effectiveness of  FDAs oversight of online tobacco  
retailers, which is  one prong in FDAs multipronged approach to preventing youth 
access to tobacco.  Although the fluid nature of  online retail  may make it difficult, 
especially to impose financial penalties against violative retailers, our analysis 
highlights opportunities FDA missed to improve its oversight of  online retailers.  
Leveraging those opportunities can advance FDAs efforts toward preventing youth 
access to tobacco.  Furthermore, the lack of transparency into FDAs oversight, 
including data showing the extent and  outcomes of its investigations, obscures FDAs 
track record beyond  knowledge  that  in 10 years, it has issued 899 warning letters.  
Therefore, we recommend that, at a  minimum, FDA:  
Collaborate with  ATF  on  oversight  of  online tobacco  retailers  
Given their shared interests in overseeing tobacco products, FDA should  work toward  
a more robust exchange of information with ATF.  According to FDA, they already 
share some information informally.  As the agency responsible for enforcing the PACT  
Act, ATF maintains a database that would be helpful to FDA.  That database includes 
information on online retailers that have registered with ATF  and their owners  
identities.  This information may be useful  for FDA to establish investigative facts.  To 
collaborate, FDA could work with ATF to establish a  Memorandum of  Understanding.  
The two agencies have done so before on their enforcement responsibilities with 
respect to adulterated alcoholic beverages.  
Complete its  rulemaking  on non-face-to-face  sales of tobacco  
products,  as  required  by  the Tobacco  Control Act  
This rulemaking could offer FDA insight for revising its oversight of online tobacco  
retailers that incorporates input  from a wide range of public stakeholders.  In its 2011 
advance notice of proposed rulemaking  on non-face-to-face sales of tobacco 
products, FDA asked for information on a number of topics including how the PACT  
Act (passed in 2009) would affect  online sales;  how retailers use communication 
technology to market tobacco products;  and which forms of  technology, advertising  
themes, and techniques are appealing to minors.  Ten years later,  these questions 
remain relevant given changes in technology and the tobacco marketplace, as well  as 
expansion of the PACT Act in 2021.  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Conclusions and Recommendations | 16     
Collect  data  to  support  process  and  outcome measures  for its  
oversight  of  online tobacco  retailers  
Given that FDAs investigations of online retailers are an important toolthough not  
the sole toolfor  reaching FDAs goals of impeding violative activities and changing  
industry practice, ensuring appropriate internal  oversight of  these activities is critical.  
Toward this end, collecting data on each investigation, its outcome, and any resulting  
FDA actions is foundational to understanding investigations  role, in light  of  FDA's 
array of  oversight activities.  In addition to collecting the oversight data, FDA should  
establish process measures that would use this data to describe the extent and results 
of investigations.   Outcome measures should also be established that, at  a minimum,  
include the extent to which violative retailers attain and sustain compliance.  The 
oversight data and process and outcome measures should help FDA determine 
whether its oversight is achieving its goals.  
Publish  information and  performance data  on its  oversight  of  
online tobacco retailers  
FDA should  ensure that information and performance data are easy to find on its 
website and  user-friendly.  FDA should establish procedures to ensure that the 
performance data are updated on a routine basis.  
By taking  these steps, FDA significantly increases its public accountability for 
preventing youth access to tobacco  on the internet.  Publishing information about the 
purpose and goals of  FDAs oversight of  online retailers will raise public awareness of  
its efforts.  Similarly, publishing performance data from process and outcomes 
measures  for completed  investigations  will help parents, industry, and other 
stakeholders understand  what FDA  is doing to  oversee online tobacco retailers and  
whether its oversight is making a difference.  
Beyond promoting transparency and accountability, raising the profile of FDAs 
oversight of  online tobacco retailers can have other benefits.  For example, it may 
raise awareness about the publics ability to alert  FDA to possible violations of the 
Tobacco Control Act among online tobacco retailers.  Also,  making more information 
available to  parents and promoting parental engagement could help prevent youth 
access to tobacco on the internet.  Not least, as FDA told us, its oversight activities 
can shine a public spotlight on violative behavior and motivate public health and  
trade groups to take action.  
We believe  that  the benefits merit an effort to strike a balance between greater 
transparency and safeguarding details of  FDAs enforcement  strategy.  
 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Conclusions and Recommendations | 17     
AGENCY  COMMENTS  AND  OIG  RESPONSE  
FDA concurred with two of  our recommendation and  neither  concurred  nor  
nonconcurred  with the remaining two, as detailed  below.   
First, FDA concurred with our recommendation that it collaborate with ATF on 
oversight of  online tobacco retailers.  FDA  stated  that it planned to explore 
developing a Memorandum of Understanding with ATF.  FDA  also described how it  
would  work  with ATF to  determine what information ATF collects that may be useful  
to FDAs online tobacco  retailer surveillance efforts.   In its Final  Management Decision,  
FDA should  detail  its efforts to collaborate with ATF and any progress toward a  
Memorandum of Understanding.  
FDA neither concurred nor nonconcurred with our second recommendation that it  
complete its rulemaking  on non-face-to-face sales of tobacco products, as required  
by the Tobacco Control  Act.  Instead, FDA  affirmed its commitment to  issuing rules to  
implement the Tobacco Control Act  and  stated that other laws and requirements 
including those enforced by States or other jurisdictionsmay achieve the same ends 
as a rule on non-face-to-face tobacco sales.  We maintain that completing this 
rulemaking is an important step toward FDAs goal of preventing youth access to  
tobacco products.  Through the rulemaking process, FDA has an opportunity to  
gather and make use of valuable insight from public stakeholders to strengthen FDAs  
oversight of  online tobacco retailers.  We ask that, in its Final  Management Decision,  
FDA  clarify  how  and when  it intends  to complete its rulemaking on non-face-to-face  
tobacco sales.   
FDA also neither concurred nor nonconcurred with our third recommendation that  it  
collect data  to support process and outcome measures for its oversight of  online  
tobacco retailers.  In its response, FDA expressed concerns that sharing information 
about ongoing investigations of online tobacco retailers may jeopardize 
investigations, thus enabling bad actors to evade FDA oversight.  Furthermore, FDA  
stated that some aspects of  its oversight may not be easily quantified, such as the  
extent to which  posting  warning  letters  deters retailers  from violating  FDA  
requirements.  We maintain that  collecting data,  as  our recommendation calls for,  will 
help FDA understand the extent to  which online retailer investigations achieve 
intended goals.  Online retailer investigations are just one aspect of FDAs array of  
online tobacco oversight, which makes it critical to understand the performance of  
this activity  specifically.  Additionally,  we  clarified  that our expectations around public 
reporting are for completed investigations.   In its Final Management Decision, FDA  
should explain its rationale for whether it intends to collect data to support process 
and outcome measures for its oversight of online retailers.   
Finally, FDA  concurred with our fourth  recommendation that it  publish information 
and  performance data on its oversight of  online tobacco retailers.  FDA stated that it  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Agency Comments and OIG Response | 18     
would create a webpage dedicated to online  tobacco retailer surveillance, including  
information about compliance and enforcement efforts.  FDA also expressed  concerns 
about publishing information that may disclose its enforcement strategy.  OIG  
acknowledges the  importance of preserving the integrity of FDAs enforcement  
strategy.   We  also maintain that  more  transparency around FDAs online surveillance 
efforts  will increase public accountability for these efforts.   FDA should provide an 
update on, and when available, a link  to its new webpage in its Final Management  
Decision.   
For the full text of  FDAs comments, see Appendix A.  
 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Agency Comments and OIG Response | 19     
APPENDIX  
Appendix A:  Agency Comments  
Following this page are the official comments from FDA.   
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Appendix A | 20    DATE:  October 3, 2022 
TO:  Suzanne Murrin 
Deputy Inspector General 
Office of Evaluation and Inspections  
FROM:  Beethika Khan, Ph.D. 
Digitally signed
Beethika 
Associate Commissioner for Economics and Analysis   by Beethika Khan
-S
Director, Office of Economics and Analysis  Khan -S 
Date: 2022.10.03 
Office of Policy, Legislation, and International Affairs  14:19:32 -04'00'
SUBJECT:   Draft Report, OEI-01-20-00241  
Attached are the Food and Drug Administrations general and technical comments to the 
Office of Inspector Generals September 1, 2022 draft report  entitled FDAs Approach to 
Overseeing Online Tobacco Retailers Needs Improvement. Thank you for the opportunity to 
provide feedback.  
Attachments  
U.S. Food and Drug Administration 
10903 New Hampshire Avenue 
Silver Spring, MD 20993  
www.fda.gov 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement 
OEI-01-20-00241  Appendix A | 21  FDAs General Comments  
OIG Draft Report: FDAs Approach to Overseeing Online Tobacco Retailers Needs 
Improvement, OEI-01-20-00241 
Thank you for the opportunity to review and comment on OIGs draft report.  
FDAs online tobacco surveillance program uses  a multi-pronged approach to comprehensively 
monitor all aspects of online activity related to tobacco products, including  sales, distribution, 
marketing, and advertising. Routine  surveillance  helps identify potential violations of the law  
and regulations. FDA then  conducts an investigation  of potential violations, including 
determining  whether a violation occurred, if FDA has jurisdiction over  the  product, whether the 
product entered into interstate commerce, and ownership  information. If supported by the  
evidence, FDA will take action. Depending on the nature of  the violation and the  retailers past  
compliance  history, FDA may issue a warning letter.  FDA may also pursue enforcement actions  
such as a civil money penalty or fine, injunction,  seizure, or criminal prosecution.  
FDAs online  tobacco surveillance program  is  flexible, allowing the Agency to shift focus with  
relative ease,  as informed  by the Center for Tobacco Products  enforcement priorities,  reports of  
violations received by the  public, and if an  emergent  public health issue arises.  
FDAs online tobacco surveillance program has played a  major role  in supporting FDAs highest  
tobacco enforcement priorities, which include  electronic nicotine delivery  systems (ENDS)  
products  that lack the required FDA marketing authorization.  
This year, FDA began enforcing the  new federal  law for Non-Tobacco Nicotine  (NTN) products, 
which took effect on April 14, 2022. After July 13, 2022, any NTN product that has not received 
premarket  authorization from FDA cannot be legally marketed. FDAs online  tobacco 
surveillance program  plays an important role in  its work to enforce  the new law. To date, FDA  
has sent warning letters to more  than 25 manufacturers  that had not submitted premarket 
applications  to FDA and were continuing to sell  or distribute  unauthorized NTN e-liquid online. 
FDA has also issued  3 warning  letters to online retailers for illegally selling NTN products to  
underage purchasers.   
The Agency appreciates  OIGs consideration of  the information we provided from our review of  
the preliminary draft report. We  are separately providing technical  comments  to the  draft 
intended to provide  clarity and accuracy. For example: 1)  a more accurate  description of the  
steps in  FDAs investigations process for online tobacco  retailers regarding the contractors 
roles, steps of the process, and reporting inspection data in  fiscal years for consistency  with  
Congressional reporting and contracting, and; 2)  reflection of the fact that most companies  
comply after receipt of a  warning letter and therefore enforcement action  is not necessary.  
FDAs comments on OIGs specific recommendations are below.  
Collaborate with ATF  on oversight of online  tobacco retailers.  
FDA concurs with the  recommendation that there may be additional opportunities to collaborate  
with ATF. FDA has  previously collaborated with ATF on other issues and will explore  
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement 
OEI-01-20-00241  Appendix A  | 22   developing a Memorandum of Understanding (MOU), if appropriate.  By the end of October  
2022, FDA  will communicate with  ATF to determine the appropriate ATF contacts  to obtain  
relevant PACT Act data. Subsequently, we will work with ATF to determine: 1) the  type of 
information ATF has regarding websites selling and marketing tobacco products online; 2)  
whether the information  can assist FDAs efforts related to online compliance and enforcement  
activities, and; 3) whether ATF is able to share the non-public information with FDA. We  
recognize that there may be information that ATF cannot share even under an MOU.   
Complete its rulemaking on non-face-to-face sales of  tobacco products, as required by the 
Tobacco Control Act.  
FDA remains committed to issuing rules to  implement the Tobacco Control Act. We  note that 
many of  the benefits of such a rule are also realized in other restrictions and requirements such as 
those under  the PACT Act, imposed by states and other  jurisdictions, and those placed on 
tobacco product manufacturers upon receiving a  Marketing  Granted Order from FDA for their 
premarket tobacco product application.  
Collect data to support process and outcome measures for its oversight of online retailers.  
FDA understands the potential benefit of this recommendation and will explore ways to  
maximize  transparency  without jeopardizing investigations. The Agency has  investigative  
processes in  place related to online investigations of websites selling or  marketing tobacco  
products, but limits information publicized about  ongoing online investigations to avoid 
disclosing enforcement  strategy, which could help retailers  evade compliance and enforcement. 
We post warning letters  on the public Warning Letter webpage used by all  FDA Centers. We 
also publicize cases  that  are important for  the public  to know about. For example, FDA  recently  
issued  a press statement  about a warning letter  on  the day it issued, August 18, 2022, to alert  the  
public of a firm marketing illegal flavored nicotine gummies. This was the first warning letter for 
this type of  product, which is of particular public  health concern because of  its  resemblance to  
kid-friendly food or candy products and the potential  to cause severe nicotine toxicity or even  
death among young children. We have observed  that since the issuance of the warning letter,  the 
companys website shows the product subject  to the warning letter as discontinued. This is just  
the first step in continued monitoring and surveillance to verify continued compliance. 
The Agencys goal  remains industry compliance  with the Federal Food, Drug and Cosmetic  Act. 
Compliance may be achieved in a number of ways, including ways that cant be  measured. For  
example, we know that the issuance  of warning letters, and publicizing such letters, can serve  as  
an important deterrent to  prevent violations.  
FDA understands the value of process measures for its oversight of online retailers. The Agency 
is evaluating our internal processes to determine  if they need to be updated and better  
documented.  
Publish information on the purpose and performance of  its oversight of online  tobacco 
retailers.  
FDA concurs with OIGs recommendation. While FDA posts all  warning letters and  related  
press statements to  the FDA website, we must balance not disclosing  enforcement strategy that  
could help retailers evade compliance and enforcement. As a result of OIGs recommendation,  
by March 2023, FDA will create a dedicated webpage on our  website  to provide  the public with 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement 
OEI-01-20-00241  Appendix A  | 23   information specific to FDAs tobacco online surveillance program. We  will include  information 
about the online surveillance program and additional  related undercover compliance and 
enforcement efforts that may be helpful and informative to the public, including purpose and 
performance. 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement 
OEI-01-20-00241  Appendix A  | 24    
ACKNOWLEDGMENTS  AND  CONTACT  
Acknowledgments  
Matt Blackburn  served as the team leader for this study.  Others in the Office of  
Evaluation and Inspections who conducted the study include  Jac Carreiro, Caitlin  
Foster, and  Rachel Pavia.  Office of Evaluation and Inspections headquarters staff who  
provided support include Althea Hosein, Michael Novello, Christine Moritz, and  Sarah  
Swisher.  
This report was prepared under the direction of  Joyce Greenleaf, Regional Inspector 
General for Evaluation and Inspections in the Boston  Regional Office, and  Kenneth 
Price, Deputy Regional Inspector General.  
Contact  
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found  
on the OIG website at  oig.hhs.gov.  
Office of Inspector General  
U.S. Department of Health and Human Services  
330 Independence Avenue, SW  
Washington, DC 20201  
 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Acknowledgments and Contact | 25     
ABOUT THE OFFICE OF INSPECTOR GENERAL  
The mission of the Office of Inspector General (OIG), as mandated by Public Law  
95-452, as amended, is to protect the integrity of the Department of Health and  
Human Services (HHS) programs, as well  as the health and welfare of beneficiaries 
served by those programs.  This statutory mission is carried out through a nationwide 
network of audits, investigations, and inspections conducted by the following  
operating components:  
The Office of  Audit Services (OAS)  provides auditing services for HHS, 
either by conducting audits with its own audit resources or by overseeing audit work  
done by others.  Audits examine the performance of HHS programs and/or its 
grantees and contractors in carrying out their respective responsibilities and are 
intended to  provide independent assessments of HHS programs and operations.  
These audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS.  
The Office of Evaluation and Inspections  (OEI)  conducts national  
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable  
information on significant issues.  These evaluations focus on preventing fraud, waste, 
or abuse and promoting economy, efficiency, and effectiveness of departmental  
programs.  To promote impact, OEI reports also  present practical recommendations 
for improving program operations.  
The Office of Investigations  (OI)  conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, operations, and  
beneficiaries.   With investigators working in all 50 States and the District  of  Columbia, 
OI utilizes its resources by actively coordinating  with the Department of  Justice and  
other Federal, State, and local law enforcement authorities.  The investigative efforts 
of OI  often lead to criminal convictions, administrative sanctions, and/or civil  
monetary penalties.  
The Office of Counsel to the Inspector General (OCIG)  provides 
general legal services to  OIG, rendering advice and opinions on HHS programs and  
operations and providing all  legal support for OIGs internal operations.  OCIG  
represents OIG in all civil and administrative fraud and abuse cases involving HHS  
programs, including False Claims Act, program exclusion, and civil monetary penalty 
cases.  In connection with these cases, OCIG also  negotiates and monitors corporate 
integrity agreements.  OCIG renders advisory opinions, issues compliance program 
guidance, publishes fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities. 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   About the Office of Inspector  General | 26     
ENDNOTES  
 
 
1  HHS.  Surgeon General releases advisory on E-cigarette epidemic among youth.   December 18,  2018.  Retrieved  from:  
https://web.archive.org/web/20181218205806/https://www.hhs.gov/about/news/2018/12/18/surgeon-general-releases-
advisory-e-cigarette-epidemic-among-youth.html  
2  CDC.  Estimates of Current Tobacco Use Among Youth.   2020.  Retrieved  from:  
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm#anchor_1549569386405  
3  CDC.  E-cigarette Use Among Middle and  High School Students   United States, 2020.  September 18, 2020.  Retrieved  
from:  
https://www.cdc.gov/mmwr/volumes/69/wr/mm6937e1.htm#:~:text=In%202020%2C%2019.6%25%20of%20high%20school% 
20students%20%283.02,middle%20school%20students%20%28550%2C000%29%20reported%20current%20e-
cigarette%20use.  
4  FDA.  Youth E-cigarette Use  Remains Serious Public Health  Concern Amid COVID-19 Pandemic.  September 30, 2021.   
Retrieved from:  https://www.fda.gov/news-events/press-announcements/youth-e-cigarette-use-remains-serious-public-
health-concern-amid-covid-19-pandemic  
5  FDA notes that the 2021 National Youth Tobacco Survey (NYTS) was fully conducted amid the global COVID-19 pandemic,  
during which time eligible students could participate in the  survey in classrooms, at home, or at some other place.  Thus,  
estimates from the 2021 NYTS should not be  compared with previous NYTS survey waves that were primarily conducted on 
school campuses.  (FDA.  Results from the Annual National  Youth Tobacco Survey.  November  10, 2022.  Retrieved from:  
https://www.fda.gov/tobacco-products/youth-and-tobacco/results-annual-national-youth-tobacco-survey)  
6  FDA.  Youth Tobacco Prevention Plan. September 14, 2020.  Retrieved from:  https://www.fda.gov/tobacco-products/youth-
and-tobacco/fdas-youth-tobacco-prevention-plan  
7  Monica Anderson and Jingjing Jiang. Teens, Social Media and Technology 2018. Pew Research Center. May 31, 2018.  
Retrieved from https://www.pewresearch.org/internet/2018/05/31/teens-social-media-technology-2018/   
8  Family Smoking Prevention and Tobacco Control and Federal Retirement Reform, P.L. No.   111-31 (enacted July 22, 2009).  
9  Tobacco Control Act, Div. A.,  Sec. 101 (enacted July 22, 2009), amending and adding Chapter IX to the FD&C Act.  
10  FD&C Act  919.  FDA.   FY 2021 Justification of Estimates for Appropriations Committees.  P. 268.  2020.  Retrieved from:  
https://www.fda.gov/media/135078/download  
11  Family Smoking Prevention and Tobacco Control and Federal Retirement Reform, Div. A.,  Sec. 103 (enacted July 22, 2009),  
amending section 702 of the FD&C Act.  
12  Family Smoking Prevention  and Tobacco Control and Federal Retirement Reform, Div. A.,  Sec. 101, amending and adding 
section 906 to the FD&C Act.  
13  Section 906(d)(4)(A)(i)-(ii) of the Tobacco Control Act.  
14  Section 906(d)(4)(A)(ii) of the  FD&C Act.  
15  76 Fed. Reg. 55835 (Sept.  9,  2011).  
16  Prevent All Cigarette Trafficking Act of 2009,  P.L. No. 111-154 (enacted Mar. 10, 2010).  
17  Prevent All Cigarette Trafficking Act of 2009,  P.L. No. 111-154 (enacted Mar. 10, 2010).   Sec. 3,  amending and adding 
section 1716E to Title 18 of the U.S. Code.  
 
FDAs Approach to Overseeing Online Tobacco Retailers Needs Improvement    
OEI-01-20-00241   Endnotes | 27     
 
18  15 U.S.C.  376.  
19  2021 Law: Consolidated Appropriations Act, 2021., P.L. 116-260, Division FF, Title VI, Section 602 (enacted Dec.  27, 2020),  
amending 15 U.S.C. 375 et seq.  
20  UPS.  How To  Ship Tobacco.  Retrieved from:  https://www.ups.com/us/en/support/shipping-support/shipping-special-
care-regulated-items/prohibited-items/tobacco.page, April  19, 2022.  
FedEx.  Tobacco shipping is  prohibited.  Retrieved from:  https://www.fedex.com/en-us/shipping/guidelines-for-shipping-
tobacco.html#:~:text=We%20prohibit%20the%20shipping%20of,Cigarettes  on April 19, 2022.  
DHL.   Dangerous Goods & Prohibited Items.  Retrieved from:  https://www.dhl.com/global-en/home/our-
divisions/freight/customer-service/dangerous-goods-and-prohibited-items.html  on April 19, 2022.  
21  2009 Law: Family Smoking Prevention and Tobacco Control  and Federal Retirement Reform, P. L.  111-31 (enacted July 22,  
2009).  
2009 Guidance: General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 
2), 74 Fed. Reg. 48974 (Sept. 22, 2009).  
2010 Guidance: Enforcement Policy Concerning Certain Regulations Restricting the Sale  and Distribution of Cigarettes and  
Smokeless Tobacco, 75 Fed. Reg. 25271 (May 7, 2010), and  Use of Light,  Mild, Low,  or Similar Descriptors in the Label,  
Labeling,  or Advertising of Tobacco Products, 75 Fed. Reg. 32953 (June 10,  2010).  
2011 Guidance: Civil Money Penalties and  No-Tobacco-Sale  Orders for Tobacco Retailers,  76 Fed. Reg. 22905 (Apr.  25, 2011).  
2011 Advanced Notice of Proposed Rulemaking:  Non-Face-to-Face Sale and Distribution  of Tobacco Products and 
Advertising, Promotion, and Marketing of Tobacco Products, 76 Fed. Reg. 55835 (Sept. 9, 2011).  
2013 Guidance: Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and  
Smokeless Tobacco To Protect Children and  Adolescents, 78 Fed. Reg. 52203 (Aug.  22, 2013).  
2016 Regulation: Deeming Tobacco Products To Be Subject  to the Federal Food, Drug, and Cosmetic Act, as Amended by the  
Family Smoking Prevention and Tobacco Control Act,  81  Fed.  Reg.  28973  (May  10,  2016).  
2019 Law: Further Consolidated Appropriations Act, 2020,  P.L. No. 116-94, Division N, Sec. 603 (enacted Dec.  20, 2019).  
2019 Guidance: Premarket Tobacco Product Applications for Electronic  Nicotine Delivery Systems (ENDS), 84 Fed. Reg. 27200 
(June 12, 2019).  
2020 Guidance: Enforcement Priorities for Electronic Nicotine  Delivery Systems and Other  Deemed Products on the Market 
Without Premarket Authorization (Revised),  85  Fed.  Reg.  23973  (Apr.  30,  2020).  
22  FDA. FDA, FTC take action to protect kids  by citing four firms that make, sell flavored e-liquids for violations related to 
online posts by social media influencers on their behalf. June 7, 2019. Retrieved from  https://www.fda.gov/news-
events/press-announcements/fda-ftc-take-action-protect-kids-citing-four-firms-make-sell-flavored-e-liquids-violations-
related   
23  FDA.  Report Potential Tobacco Product Violation.  April  29, 2020.  Retrieved from:  https://www.fda.gov/tobacco-
products/compliance-enforcement-training/report-potential-tobacco-product-violation  
24  FDA Ensuring Compliance with the Tobacco Control Act and Enforcing the Law.  October  4, 2021.   Retrieved from:  
https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/ensuring-compliance-tobacco-control-act-and-
enforcing-law  
25  87 Fed. Reg. 15100 (Mar. 17,  2022).  
26  OIG.   FDA Oversight of Tobacco Manufacturing Establishments.   August 2017.  Retrieved from:  
https://oig.hhs.gov/oei/reports/oei-01-15-00300.pdf  
27  OIG.  FDA's  Tobacco Retailer Compliance Check Inspection Program.  Retrieved from:  https://oig.hhs.gov/reports-and-
publications/workplan/summary/wp-summary-0000441.asp  
 
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OEI-01-20-00241   Endnotes | 28     
 
28  OIG.  Audit of the Food and  Drug Administration's Premarket Tobacco Product Application Process for Electronic Nicotine  
Delivery System Products.  Retrieved from:  https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-
0000632.asp  
29  FDA Center for Tobacco Products.  Compliance and Enforcement Report.  Retrieved from:  
https://www.fda.gov/media/131943/download.  FDA Center for Tobacco Products report covered  October 1, 2013December 
31, 2018.  
30  Section 103(q)(2)(A)   of   the   Tobacco Control   Act (codified   at   21 U.S.C.      333).  
31  ATF.  Bureau of Alcohol, Tobacco, Firearms and Explosives.  Prevent All Cigarette Trafficking (PACT) Act Registration Form.   
October 2020.  Retrieved from:  https://www.atf.gov/alcohol-tobacco/docs/form/prevent-all-cigarette-trafficking-pact-act-
registration-form-atf-form/download  
32  FDA.  Memorandum of Understanding Between the  Food and Drug Administration  
and The Bureau of Alcohol, Tobacco and Firearms, MOU 225-88-2000.   November 20, 1987.  Retrieved  from:  
https://www.fda.gov/about-fda/domestic-mous/mou-225-88-2000  
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