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Guidance, Compliance & Regulatory Information (Tobacco)

Potential Tobacco Product Violations Reporting - Form FDA 3779

Form Approved: OMB No. XXXX-XXXX, Expires X month day, 20XX
See OMB statement at bottom.

Use this form to report potential tobacco related violations of the Federal Food Drug and Cosmetic Act and associated
regulations. These submissions are reviewed by FDA’s Center for Tobacco Products, Office of Compliance and Enforcement.
WHO can report? – Any member of the public.
Tell us:
WHEN did you see the potential violation?
WHERE did the potential violation occur?
WHAT is the potential violation?
WHY report? – Information we receive from the public is often very helpful in identifying problems with marketed products
and possible violations of the laws that we enforce.
To submit your report, use the form below or choose one of the following options (the alternative submission options below
will include links in the final version of this form):
| To submit your report by mail | To submit your report by phone | To submit your report by email |
| To submit report using web form |
__________________________________________________________________________________
(*Required field)

Date potential violation
occurred

1
MM

/ 1
DD

I do not recall the date this
potential violation occurred







State in which potential
violation occurred *

Alabama

/ 2011
YYYY

Description of Product
Type

*

Cigarette

Tobacco brand (character
limit 250)
Potential violation type
(choose all that apply)

 Sales to minors
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


 Flavored cigarette sales





 Advertising/promotion/marketing




 Free samples





 Vending machine/self-service display/direct access to




cigarette or smokeless tobacco
 Sale of cigarettes in packs less than 20





 Unsure





Type of potentially
violative promotional
materials (choose all that
apply)

 Newspaper





 Magazine





 Periodicals
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



 Billboard
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



 Direct Mail
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 In-store advertisements
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 Price signage
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



 Posters
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



 Coupons
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
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 Internet advertising





 Unsure





Who potentially violated?
(choose all that apply)

 Retailer





 Manufacturer




 Importer





 Distributor





Description of potential
violation (character limit
1000)

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Please provide name and physical address of the potentially violative party/location below by potential violator
types, if known.

Retailer, Manufacturer,
Importer, or Distributor
name (character limit 250)
Address
Street Address
Address Line 2
City

State / Province / Region

Postal / Zip Code
If report is about a
website, please provide
website address here:
Upload relevant files here
(maximum size is 8MB):

Browse...

All reports will remain confidential to the extent allowed by law. For more information about FDA’s internet policies, please
visit: http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm 1.

May we contact you if we
need additional
information?

 Yes, CTP may contact me. (Please fill in contact information below.)




 No, I want my report to be anonymous.





Name (character limit
250)
Affiliation (such as
company, school or group)
(character limit 250)
Address
Street Address
Address Line 2
City
Phone number
Email
I would like to receive an
email to let me know CTP
got my complaint

State / Province / Region

Postal / Zip Code
### ### ####
 Yes




 No





In order to receive a response, please configure your email spam/junk filer to allow messages from
ctpcompliance@fda.hhs.gov. In most cases, this is solved by adding our email address to your address book.
If you would rather submit your report to us in writing along with any attachments, please do so at the following address:
Tobacco Product Violation Report, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
9200 Corporate Boulevard
Rockville, MD 20850-3229
To reach us by telephone, please call 1-877-CTP-1373, and select option 3. You may also email us at
ctpcompliance@fda.hhs.gov.

Submit Form

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OMB Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 0.25 hours (15 minutes) per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed,
and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of the Chief Information Officer
1350 Piccard Drive, 420A
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.

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Links on this page:
1. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
2. /FDAgov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
3. /FDAgov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
4. /FDAgov/AboutFDA/ContactFDA/default.htm
5. /FDAgov/AboutFDA/WorkingatFDA/default.htm
6. /FDAgov/AboutFDA/Transparency/Basics/default.htm
7. /FDAgov/RegulatoryInformation/FOI/default.htm
8. /FDAgov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
9. /FDAgov/SiteMap/default.htm
10. /FDAgov/AboutFDA/Transparency/default.htm
11. /FDAgov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
12. http://www.fda.gov
13. /FDAgov/AboutFDA/ContactFDA/default.htm
14. http://www.usa.gov
15. /FDAgov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
16. /FDAgov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
17. /FDAgov/NewsEvents/InteractiveMedia/default.htm#micro
18. /FDAgov/NewsEvents/InteractiveMedia/default.htm#Facebook
19. /FDAgov/NewsEvents/InteractiveMedia/ucm200145.htm
20. /FDAgov/NewsEvents/InteractiveMedia/default.htm#flickr
21. /FDAgov/ForFederalStateandLocalOfficials/default.htm
22. /FDAgov/NewsEvents/default.htm
23. /FDAgov/CombinationProducts/default.htm
24. /FDAgov/AdvisoryCommittees/default.htm
25. /FDAgov/ScienceResearch/default.htm
26. /FDAgov/RegulatoryInformation/default.htm
27. /FDAgov/Safety/default.htm
28. /FDAgov/EmergencyPreparedness/default.htm
29. /FDAgov/InternationalPrograms/default.htm
30. /FDAgov/NewsEvents/default.htm
31. /FDAgov/Training/default.htm
32. /FDAgov/ICECI/default.htm
33. /FDAgov/ForFederalStateandLocalOfficials/default.htm
34. /FDAgov/ForConsumers/default.htm
35. /FDAgov/ForIndustry/default.htm
36. /FDAgov/ForHealthProfessionals/default.htm
37. http://www.hhs.gov

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Accessibility 3

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Contact FDA 4

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Careers 5

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FDA Basics 6



FOIA 7

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No Fear Act 8

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Site Map 9

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Transparency 10

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Website Policies 11
12

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA 13
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For Government 21

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For Press 22

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Combination Products 23

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Advisory Committees 24

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Science & Research 25

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Regulatory Information 26

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Safety 27

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Emergency Preparedness 28

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International Programs 29

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News & Events 30

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Training and Continuing Education 31



Inspections/Compliance 32

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State & Local Officials 33

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Consumers 34

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Industry 35

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Health Professionals 36
37

Links on this page:
1. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
2. /FDAgov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
3. /FDAgov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
4. /FDAgov/AboutFDA/ContactFDA/default.htm
5. /FDAgov/AboutFDA/WorkingatFDA/default.htm
6. /FDAgov/AboutFDA/Transparency/Basics/default.htm
7. /FDAgov/RegulatoryInformation/FOI/default.htm
8. /FDAgov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
9. /FDAgov/SiteMap/default.htm
10. /FDAgov/AboutFDA/Transparency/default.htm
11. /FDAgov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
12. http://www.fda.gov
13. /FDAgov/AboutFDA/ContactFDA/default.htm
14. http://www.usa.gov
15. /FDAgov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
16. /FDAgov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
17. /FDAgov/NewsEvents/InteractiveMedia/default.htm#micro
18. /FDAgov/NewsEvents/InteractiveMedia/default.htm#Facebook
19. /FDAgov/NewsEvents/InteractiveMedia/ucm200145.htm
20. /FDAgov/NewsEvents/InteractiveMedia/default.htm#flickr
21. /FDAgov/ForFederalStateandLocalOfficials/default.htm
22. /FDAgov/NewsEvents/default.htm
23. /FDAgov/CombinationProducts/default.htm
24. /FDAgov/AdvisoryCommittees/default.htm
25. /FDAgov/ScienceResearch/default.htm
26. /FDAgov/RegulatoryInformation/default.htm
27. /FDAgov/Safety/default.htm
28. /FDAgov/EmergencyPreparedness/default.htm
29. /FDAgov/InternationalPrograms/default.htm
30. /FDAgov/NewsEvents/default.htm
31. /FDAgov/Training/default.htm
32. /FDAgov/ICECI/default.htm
33. /FDAgov/ForFederalStateandLocalOfficials/default.htm
34. /FDAgov/ForConsumers/default.htm
35. /FDAgov/ForIndustry/default.htm
36. /FDAgov/ForHealthProfessionals/default.htm
37. http://www.hhs.gov

http://wcms.fda.gov/FDAgov/TobaccoProducts/GuidanceComplianceRegulatoryInformati...

2/14/2012