HHS OIG Data Brief  August 2017  OEI-01-15-00300 
 
FDA Oversight of Tobacco Manufacturing Establishments  
 
Smoking is the leading cause of preventable 
 
RESULTS AT A GLANCE  disease and death in the United States, responsible 
  for more than 480,000 deaths annually.1  Until 
2009, tobacco products were largely exempt from 
   The Tobacco Control Act authorized 
Federal oversight.  That year, Congress passed the 
   FDA to regulate domestic tobacco 
   manufacturers beginning in 2009.  To    Family Smoking Prevention and Tobacco Control 
   monitor the Tobacco Control Acts  Act (Tobacco Control Act), which authorized the 
   implementation, OIG analyzed  
Food and Drug Administration (FDA) to begin 
   registration and inspection data for  
regulating tobacco products in the United States.2  
   tobacco manufacturing facilities from  
The Tobacco Control Act granted FDA 
   2010 to 2015.  We found: 
comprehensive authority over domestic tobacco 
  In the first 6 years that FDA was 
products and established the Center for Tobacco 
authorized to regulate tobacco, 
Products (CTP) at FDA to oversee the 
171 tobacco establishments 
registered with it.  manufacturing, distribution, and marketing of 
these products.3  User fees from tobacco 
  Cigarettes account for two-thirds 
of the consumer-use tobacco  manufacturers and importers are the sole source of 
products that registrants listed.  funding for FDA's regulation of tobacco products.     
  FDA largely met its requirement to  CTPs goal is to reduce harm from all regulated 
inspect tobacco establishments 
tobacco products by preventing people from 
biennially. 
starting to use tobacco products, encouraging 
  FDA concluded that no 
tobacco users to quit, and reducing the adverse 
enforcement action was needed 
health impacts for those who continue to use 
after its inspections of 
tobacco products.4  Toward this goal, CTP and 
manufacturing establishments.  
FDAs Office of Regulatory Affairs (ORA) 
  FDA issued 14 warning letters to 
collaborate in the oversight of tobacco 
manufacturersmostly for 
manufacturers.   
violations of advertising and 
labelingas a result of its 
FDA has a wide range of tools to meet its goals, 
surveillance of tobacco marketing. 
including the ability to set policy and issue 
 
guidance; to regulate the production and 
 
  distribution of tobacco products; to conduct research; and to educate the public on the effects of 
regulated tobacco products.5   
On August 8, 2016, FDAs jurisdiction expanded to include additional tobacco products such as 
electronic nicotine delivery systems (e.g., e-cigarettes and vape pens), cigars, hookah tobacco, 
and nicotine gels.6     
Our work focuses on FDAs efforts to regulate and oversee domestic tobacco manufacturing 
establishments in the early years of implementing the Tobacco Control Act (see Exhibit 1).  This 
data brief presents descriptive information about how tobacco establishments register and 
provide product listings, as well as FDAs inspections and enforcement actions related to tobacco 
manufacturing establishments, spanning 2010 to 2015.  During this timeframe, FDA required 
only manufacturers of cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette 
tobacco to register and list their products. 
Exhibit 1:  Focus Areas for FDAs CTP 
 
Source:  FDA, About CTP:  What CTP Does.  Accessed at http://www.fda.gov/TobaccoProducts/AboutCTP/ucm451269.htm on July 27, 2017. 
The blue box indicates the CTP focus area that is the subject of this data brief. 
Registration   
Domestic establishments involved in the manufacturing, preparation, compounding, or 
processing of tobacco products in the United States must register annually with FDA.7  Owners 
and operators of tobacco establishments (subsequently referred to as registrants; see the box with 
key terms below) may submit information to FDA using paper forms or FDAs online 
registration system, the FDA Unified Registration and Listing System.8  Registrants must submit 
their initial registration immediately upon engaging in the manufacturing of tobacco products 
and reregister annually no later than December 31 of that same year.9   
Registration must include the name and address of each establishment, as well as the name and 
places of business of the registrants.10  A single registrant may register multiple establishments.  
Though registrants are not required to do so, they can identify the type of work that the 
establishment does, such as relabeling and packaging. 
2   
 
 
 
 
 
 
 
 
Source:  Food, Drug, and Cosmetic Act  201(e) and FDA, Guidance for Industry:  Registration and Product Listing for Owners and Operators of 
 
Domestic Tobacco Product Establishments (Revised*), November 2016.
Product Listing 
Registrants must provide FDA with a list of tobacco products manufactured, prepared, 
compounded, or processed by an establishment for commercial distribution.11  The product 
listing must include all labeling andfor certain tobacco productsa representative sample of 
advertising for that product.12  Registrants must also report certain changes to their product lists 
twice a year.13  FDA uses product listing information to determine compliance with provisions of 
the law, such as requirements for packaging, labeling, and advertising.  Finally, registrants must 
clearly identify each product listing by the product name (e.g., Pall Mall Blue Box) and 
category (e.g., cigarettes, paper, filter, or smokeless tobacco).14  For purposes of submitting 
product listing information, FDA distinguishes tobacco products as either Consumer Use 
(ready for consumer markets) or For Further Manufacturing (generally, components of 
unfinished tobacco products), depending on the intended use of the product.  In November 2016, 
FDA announced its intent to enforce registration and listing requirements for finished tobacco 
products only.15 
Inspections 
FDA must inspect each registered establishment that manufactures, compounds, or processes 
tobacco products at least biennially from the date of registration.16, 17  FDA began inspecting 
tobacco establishments on October 1, 2011.  FDA investigators from ORA inspect tobacco 
establishments to ensure that they are in compliance with provisions of the Food, Drug, and 
Cosmetic Act and that products are not adulterated or misbranded.  Provisions include but are not 
limited to the following:  registration and product listing; ingredient listing; requirements for 
packaging, labeling, and advertising; and marketing authorization for certain tobacco products.18  
Although FDA has the authority to establish Good Manufacturing Practices for tobacco products, 
it has not yet done so.19  Good Manufacturing Practices assure proper design, monitoring, and 
3  control of manufacturing processes and facilities in order to protect public health.  Once FDA 
establishes Good Manufacturing Practices for tobacco products, its investigators will also inspect 
for compliance with those requirements.  
During these inspections, FDA reviews processes and 
Inspection findings of 
procedures; observes and evaluates manufacturing operations; 
significant, objectionable 
documents and collects information; identifies violations; 
conditions warrant 
communicates potential violations and objectionable conditions  regulatory actions and 
to the establishments management; and documents any proposed  receive a classification of 
corrective action plans.20  Following an inspection, FDA issues  Official Action Indicated. 
one of three classifications based on its findings:  No Action 
Indicated, when the inspectors find no objectionable conditions or practices; Voluntary Action 
Indicated, when findings are serious enough to record but do not require regulatory action; or 
Official Action Indicated, when inspectors find significant, objectionable conditions or 
practices and regulatory action is warranted.    
During the next routine inspection of an establishment, FDA follows up on the outcome of the 
actions it recommended.  If FDA finds that the establishment did not address its 
recommendations, it may take an advisory action, such as issuing a warning letter, or it may take 
an enforcement action, such as imposing a civil monetary penalty, making a seizure, issuing 
an injunction, or launching criminal prosecution.  
Surveillance 
In addition to inspections, FDA conducts routine surveillance of tobacco marketing activities to 
ensure compliance with aspects of the Food, Drug, and Cosmetic Act.  For example, a tobacco 
products labeling and advertising cannot use modified risk descriptors such as light, mild, 
or low without an FDA order.21  This surveillance of marketing activities includes monitoring 
and evaluating promotional and advertising materials.  FDA may examine websites, social 
media, newspapers, magazines, posters, and other promotional materials.  It identifies these 
materials through regulatory submissions made to FDA (e.g., the product labels and 
advertisements that manufacturers are required to submit upon registration); point-of-sale 
advertising and other promotional materials for tobacco products; the Internet; and complaints.22  
FDAs surveillance can result in advisory actions, such as warning letters, or enforcement 
actions.23 
 
METHODOLOGY  
 
We based this data brief on four data sources:  (1) FDA Unified Registration and Listing System 
data from calendar years (CYs) 2010 through 2015; (2) data on inspections of tobacco 
establishments from fiscal years (FYs) 2011 through 2015; (3) enforcement action data from 
inspections and surveillance of tobacco marketing activity from FYs 2011 through 2015; and 
4  (4) interviews with FDA officials.  We determined the number of tobacco establishments that 
registered annually from 2010 through 2015 with FDA, as well as the number of products they 
listed.   
Our analysis had some limitations.  We were unable to determine the extent to which registrants 
listed all products, as well as whether all tobacco establishments registered as required.  We did 
not assess the appropriateness of the enforcement actions that FDA took or did not take.  We 
were unable to determine whether FDA precisely met the biennial inspection requirement 
because the data that we received from FDA did not include the month of registration.  
Therefore, we could determine only whether FDA inspected a tobacco establishment within the 
year that the inspection was due, rather than within the specific month.   
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. 
   
5  RESULTS 
 
In the first 6 years of the Tobacco Control Acts 
implementation, 171 tobacco establishments registered with 
FDA 
Tobacco establishments started registering with FDA slowly, with 20 establishments registering 
in 2010.24  This slow start may have resulted from initial uncertainty about registration 
requirements.  For example, FDA acknowledged that the tobacco industry may have needed 
additional time to provide submissions.25   
Tobacco establishments annual registrations fluctuated between 2012 and 2015.  Some 
registrants did not register their establishments annually as required, while others registered their 
establishments unnecessarily, according to FDA.  For example, from CY 2011 through CY 2015, 
29 registrants missed their annual registration at least once, and 8 missed registration for 2 years.  
Furthermore, the opening and closing of tobacco establishments in this time period might have 
contributed to the fluctuation.   
Exhibit 2:  Registration of Tobacco Establishments, CYs 20102015 
 
Source:  OIG analysis of FDA registration data, 2017. 
FDA cannot determine the total number of establishments that should register each year, but 
FDA staff told us that they sometimes learn through other sourcessuch as FDA inspections and 
establishments competitorsabout establishments that fail to register.  FDA told us that in such 
cases, it would take appropriate action. 
6  Although they are not required to do so, registrants may provide information about the type of 
manufacturing activities that occur at each establishment.  Of the registrants that provided 
information since 2010, most identified their activities as manufacturing and/or storing: 
39 percent listed manufacturing and 30 percent listed storing.  Registrants may list more 
than one type of production activity for a single establishment.  For example, registrants may list 
different types of manufacturing such as blending, packaging, and labeling, indicating that the 
establishment is involved in many parts of the process.   
Cigarettes account for two-thirds of the consumer-use 
tobacco products that registrants listed 
As part of the registration process, registrants must submit 
FDA can use the product 
product lists.  From 2010 through 2015, registrants submitted 
lists when it inspects 
product lists for 7,191 unique products.  Product lists include 
establishments to 
components of tobacco products for further manufacturing use, 
determine whether 
such as paper and filters, as well as finished products that are for 
registrants submitted 
consumer use, such as cigarettes and chewing tobacco.26  For 
complete lists. 
example, a pack of cigarettes is a finished product, composed of 
multiple components (see Exhibit 3).   
Exhibit 3.  Example of Components of a Cigarette Pack 
 
 
7  About three-quarters of the tobacco products listed with FDA are for consumer use.  Cigarettes, 
moist snuff, and roll-your-own tobacco products make up 90 percent of the total number of 
consumer-use products.  Cigarettes compose 68 percent of the total, while moist snuff and 
roll-your-own products compose 13 and 9 percent, respectively (see Exhibit 4).   
Exhibit 4. Tobacco Products for Consumer Use According to Product Lists 
Provided to FDA, CYs 20102015  
 
 
 
Source:  OIG analysis of FDA product listing data, 2016.
 
The remaining one-quarter of tobacco products listed with the FDA are for components of 
tobacco for further manufacturing.  Tipping paper and paper account for over half of these 
products (see Exhibit 5).   
   
8  Exhibit 5. Tobacco Products for Further Manufacturing According to Product Lists 
Provided to FDA, CYs 20102015   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source:  OIG analysis of FDA product listing data, 2017.
FDA largely met its requirement to inspect tobacco 
manufacturing establishments biennially 
FDA inspected 103 of the 171 registered establishments at least once between FY 2012 and 
2015, meeting its inspection requirement.  Three of the 171 establishments merged with other 
registered establishments during the time period we examined, and FDA inspected them under 
their new ownership, resulting in a total of 168 unique establishments.  Of the 65 establishments 
that initially registered but were not inspected by FDA, 58 were not actively manufacturing 
FDA-regulated tobacco products, according to FDA, and did not require an inspection because 
they were not required to register.  In addition, some 
establishments had due dates for inspections that were after  The inspections included a review of 
registration and product listing; 
the time period examined in this review.  Finally, two 
ingredient listing; packaging, labeling 
establishments due for inspection were located on Tribal land.  
and advertising requirements; and 
See Exhibit 1 in Appendix A for the reasons FDA did not 
marketing authorization for certain 
inspect the 65 establishments. 
tobacco products. 
FDA told us that it needed additional time before starting 
inspections of establishments that are affiliated with Tribes and located on Tribal land.  These 
federally recognized Tribes are unique governments that required FDA to follow established 
government-to-government policies.27, 28  After FDA understood its obligations with regard to 
Tribal governments and determined how best to meet them, it began routine biennial inspections 
of Tribal establishments in FY 2014.  FDA split the initial Tribal inspections across 
9  2 FYs.  One of the establishments on Tribal land did not receive an inspection within those 
2 FYs (FYs 2014 and 2015).   
Between FY 2012 and 2015, FDA inspected 70 of the 103 establishments twice, meeting its 
inspection requirement.  Of the remaining 33 establishments, FDA did not inspect them twice for 
the following reasons:  the establishments were not actively manufacturing regulated tobacco 
products and therefore did not require an inspection; they were located on Tribal land; or they 
had inspection dates falling after the time period examined in this review.  See Exhibit 2 in 
Appendix A for the reasons FDA did not inspect these 33 establishments twice.  FDA conducted 
a total of 173 inspections. 
FDA concluded that no enforcement action was needed after 
its inspections of manufacturing establishments 
None of the 173 inspections of tobacco establishments resulted  No Action Indicated:  No 
in any official action.  FDA classified the results of almost all  objectionable conditions or practices 
(161 of 173) of its inspections as No Action Indicated.  FDA                                                                   
classified none as Official Action Indicated, which indicates that  Voluntary Action Indicated:  Findings 
it did not find any instances of noncompliance severe enough to  are serious enough to record but do 
necessitate enforcement actions, such as civil monetary  not require regulatory action   
penalties.                                                                     
Official Action Indicated:  Significant, 
FDA classified the results of 6 of the 173 inspections as 
objectionable conditions or practices 
Voluntary Action Indicated, meaning that it identified 
that warrant regulatory action 
objectionable conditions that did not meet the threshold for 
regulatory (advisory, administrative, or judicial) action.  FDA cited five of these six 
establishments for product labeling problems.  FDA also cited one of the five establishments for 
failure to register and failure to submit a list of harmful or potentially harmful constituents.  FDA 
cited the sixth establishment for failure to provide product and ingredient lists and for failure to 
pay user fees.  See Exhibit 6 for the number and type of classifications that FDA assigned to 
inspections. 
The remaining six inspections did not result in a classification.  In three cases, when inspectors 
went to the establishments, they found that the establishments were either no longer in business 
or not actively manufacturing tobacco products.  The other three inspections were still open at 
the time when FDA provided data to OIG. 
   
10  Exhibit 6:  Classifications for Tobacco Establishment Inspections, FYs 20122015 
 
 
Source:  OIG analysis of FDA inspection data, 2017. 
FDA issued 14 warning letters to manufacturersmostly for 
violations of advertising or labelingas a result of its 
surveillance of tobacco marketing 
In addition to conducting inspections, FDA conducts routine surveillance of marketing activities 
for tobacco products.  For example, FDA reviews manufacturers websites to determine whether 
tobacco product labeling and advertising are false or misleading.  FDA also reviews marketing 
activities to ensure that manufacturers, distributors, and retailers are not sponsoring or causing to 
be sponsored certain types of public events (e.g., musical or artistic events).  Through its 
surveillance activities from FYs 2011 through 2015, FDA identified 20 violations, related to 
advertising and labeling; sponsorships of public events; and the sale of flavored cigarettes, such 
as a mint blend.  In one case, it identified a failure to pay assessed user fees.  It issued 14 
warning letters in response to these violations.  
According to FDA, these warning letters serve as an opportunity for regulated entities to come 
into compliance voluntarily.  Although regulated entities have no legal obligation to respond to 
the letters, they must be in compliance with the Food, Drug, and Cosmetic Act.  Failure to do so 
may result in additional FDA actions, such as a civil monetary penalty, seizure, or injunction.  
See Exhibit 7 for the numbers and type of violations covered by these warning letters. 
   
11  Exhibit 7:  Surveillance Warning Letters, by Year and Type of Violation 
 
 
Source:  OIG analysis of FDA surveillance warning letters, 2016.
 
CONCLUSION 
 
Since the passage of the Tobacco Control Act, FDA has taken important steps in its oversight of 
tobacco products by implementing requirements for registration, listing, and inspection.  In the 
first 6 years of the Tobacco Control Acts implementation, 171 establishmentscovering more 
than 7,000 unique productsregistered with FDA.  FDA largely met its inspection requirement 
to inspect registered establishments biennially, although it initially delayed inspecting 
establishments on Tribal lands. 
Given establishments slow start in registration and missed annual renewals, it is important for 
FDA to ensure that all registrants update annually and provide full product list information.  
Complete and accurate information on registrants will aid FDA in fulfilling its oversight role, 
which has now broadened to include establishments with products such as vape pens,  
e-cigarettes, and cigars.   
12  APPENDIX A  
Exhibit 1:  Reasons FDA Did Not Inspect Tobacco Manufacturing Establishments 
at Least Once 
Reason FDA did not inspect establishment at least once  Number of establishments 
Establishment was not actively manufacturing  58 
FDA-regulated tobacco products 
Establishment was not due for inspection based on  6 
registration date 
Establishment was located on Tribal land  1 
Total  65 
Source:  OIG analysis of FDA registration and inspection data, 2017. 
 
Exhibit 2:  Reasons FDA Did Not Inspect Tobacco Manufacturing Establishments 
Twice 
Reason FDA did not inspect establishment twice  Number of establishments 
Establishment was not actively manufacturing tobacco  15 
products after first inspection 
Establishment was located on Tribal land  7 
FDA conducted second inspection outside of scope of this  6 
data brief 
Establishment went out of business  2 
Establishment was not due for inspection based on previous  3 
inspection date 
Total  33 
Source:  OIG analysis of FDA registration and inspection data, 2017. 
 
   
13  ACKNOWLEDGMENTS 
Ivan Troy served as the team leader for this study, and Elizabeth Havener served as the lead 
analyst.  Matt Blackburn, Office of Evaluation and Inspections, also contributed to this 
study.  Office of Evaluation and Inspections staff who provided support include Christine Moritz 
and Melicia Seay. 
We would also like to acknowledge the contributions of other Office of Inspector General staff, 
including Jessica Swanstrom. 
This data brief was prepared under the direction of Joyce Greenleaf, Regional Inspector General 
for Evaluation and Inspections in the Boston regional office, and Danielle Fletcher and Kenneth 
Price, Deputy Regional Inspectors General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, contact the Office of 
   
Public Affairs at Public.Affairs@oig.hhs.gov. 
14  ENDNOTES 
                                                           
1 Centers for Disease Control and Prevention, Smoking and Tobacco Use.  Accessed at 
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/ on June 21, 2017. 
2 Family Smoking Prevention and Tobacco Control Act, P.L. No. 111-31 (June 22, 2009), adding chapter IX to the 
Food, Drug, and Cosmetic Act. 
3 Food, Drug, and Cosmetic Act  901(e). 
4 FDA, Center for Tobacco Products Overview.  Accessed at 
http://www.fda.gov/TobaccoProducts/AboutCTP/ucm383225.htm on June 21, 2017. 
5 See, e.g., Food, Drug, and Cosmetic Act  906(d), (e), and (f). 
6 81 Fed. Reg. 28974 (May 10, 2016).   
7 Food, Drug, and Cosmetic Act  905. 
8 FDA Form 3741. 
9 Food, Drug, and Cosmetic Act  905(b), (c), and (d). 
10 Food, Drug, and Cosmetic Act  905(b), (c), and (d). 
11 Food, Drug, and Cosmetic Act  905(i)(1). 
12 Food, Drug, and Cosmetic Act  905(i)(1)(B). 
13 Food, Drug, and Cosmetic Act  905(i)(3). 
14 Food, Drug, and Cosmetic Act  905(i) and FDA, Guidance for Industry:  Registration and Product Listing for 
Owners and Operators of Domestic Tobacco Product Establishments (Revised*), November 2016.  Accessed at 
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf on 
June 21, 2017.   
15 FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco 
Product Establishments (Revised*), November 2016. Accessed at 
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf on 
June 21, 2017. 
16 Food, Drug, and Cosmetic Act  905(g). 
17 FDA also conducts preapproval inspections and for-cause inspections of tobacco establishments.  For-cause 
inspections can be triggered, for example, by complaints from consumers or industry.   
18 FDA, Letter to Tobacco Product Registered Establishments, August 16, 2011.  
19 Food, Drug, and Cosmetic Act  906(e). 
20 FDA, Inspections and Operations Manual, Chapter 5:  Establishment Inspections.  Accessed at 
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf on June 21, 2017. 
21 Food, Drug, and Cosmetic Act  911(a). 
22 FDA, Enforcement Action Plan for Promotion and Advertising Restrictions, October 2010.  Accessed at 
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM227882.pdf on June 21, 
2017.  
23 Ibid. 
24 74 Fed. Reg. 58298, 58299 (Nov. 12, 2009).  FDA originally required establishments to register by December 31, 
2009, but later stated that it would not enforce the registration requirement until February 28, 2010. 
25 74 Fed. Reg. 58298, 58299 (Nov. 12, 2009). 
26 From the data provided by the registrants, we cannot determine the extent to which registrants complied with 
requirements to submit product information initially or to report biannually any changes to their product lists, 
including the introduction or discontinuation of any products.  In fact, FDA can determine whether a registrant has 
submitted a complete list only when it inspects the tobacco establishment.   
27 U.S. Department Of Health And Human Services, Tribal Consultation Policy, 2010; Exec. Order No. 13,175, 
November 6, 2000.   
28 Before beginning inspections of Tribal establishments, FDA reached out to Tribal leaders and Tribal government 
officials to educate them about the Tobacco Control Act and discuss it with them. 
15