Form FDA 3779 FDA 3779 Potential Tobacco Product Violations Report

Potential Tobacco Product Violations Reporting Form

FDA-3779 5-2016 version

Potential Tobacco Product Violations Reporting

OMB: 0910-0716

Document [pdf]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No.: 0910-0716
Expiration Date: xx/xx/xxxx

Potential Tobacco Product Violations Report

(See page 3 for PRA Statement)

Directions:
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.
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, complete the form below:

Date and State Where Violation Occurred
I do not recall the date this
potential violation occurred

Date potential violation occurred (mm/dd/yyyy)

State in which potential violation occurred

Description of Product
Type

Potential violation type
(choose all that apply)

Tobacco Brand

Sales to minors

Free samples

Flavored cigarette sales

Self-service display/direct access to
cigarette or smokeless tobacco

Advertising/promotion/marketing
Vending machine/direct access to cigarette
or smokeless tobacco or covered tobacco
products

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

Sale of cigarettes in packs of less than 20
Unsure

Newspaper

Price signage

Magazine

Posters

Periodicals

Coupons

Billboard

Internet

Direct mail

Unsure

In-store advertisements

Who potentially violated?
(choose all that apply)

Retailer

Distributor

Manufacturer

Unsure

Importer
FORM FDA 3779 (4/16)

Page 1 of 3

PSC Publishing Services (301) 443-6740

EF

Potential Tobacco Product Violations Report
Description of potential violation

Name and physical address of the potential violator, if known
Retailer, manufacturer, importer, or distributor name

Street Address

Street Address Line 2

City

State/Province/Region

Postal/Zip Code

If report is about a website, insert website address:

All reports will remain private 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
May we contact you if we
No, I want my report to be anonymous. (Please note that if you submit this form by email,
need additional information?
FDA will receive your email address. However, if you choose “no” FDA will not contact you.)
Yes, FDA may contact me. (Please fill in contact information below.)
Name

Affiliation (such as company, school, or group)

Street Address

Street Address Line 2

(continued on next page)
FORM FDA 3779 (4/16)

Page 2 of 3

Potential Tobacco Product Violations Report
City

State/Province/Region

Postal/Zip Code

Phone Number

Email

Please email me to notify me
that FDA got my complaint

No
Yes

In order to receive a response, please configure your email spam/junk
filter 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 the following address:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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 By Email

Print Form

Reset Form

An email message automatically will be produced when you click the SUBMIT BY EMAIL button. In the resulting email
message, please don’t forget to click the “Send” button or its equivalent when you are ready to send the email.

OMB Paperwork Reduction Act Statement
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden for this collection of information is estimated to average 0.25 hour per response,
including the time to review instructions, search existing data sources, gather and maintain the data
needed and complete and review the collection of information. Send comments regarding this burden
estimate or any other aspect of this information collection, including suggestions for reducing this
burden, to the following address:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“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 number.”
FORM FDA 3779 (4/16)

Page 3 of 3


File Typeapplication/pdf
File TitleFORM FDA 3779 - layout file for OMB review
SubjectPotential Tobacco Product Violations Report
AuthorPSC Publishing Services
File Modified2016-05-05
File Created2016-04-27

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