Part 1 – Introduction to Civil Money Penalty and No-Tobacco-Sale Order Complaints


What do you need to know
if you receive a Civil
Money Penalty or a
No-Tobacco Sale Order
Complaint?We’ll tell you in this
special five-part edition
of FDA’s Tobacco
Compliance Webinars.
Welcome to this edition
of FDA Tobacco Compliance
Webinars – education and
Information for retailers
and small businesses,
sponsored by the US Food
and Drug Administration,
and its Center for Tobacco
Products.I’m David Racine.Thanks for joining us!The FDA has created this
multipart webinar, called
“CMP and NTSO Complaints,”
to assist you, retailers
and small businesses,
who have received a Civil
Money Penalty or a
No-Tobacco-Sale Order
Complaint, which we also
refer to as CMPs and
NTSOs.We’ll cover this
topic in five parts.
This episode is part 1,
Introduction to CMP and
NTSO Complaints.In part two, we cover How
to Pay a CMP using the
Online Payment Portal.Part three covers How to
File an Answer and the
Consequences for Not
Filing an Answer.
Part four reviews the
Settlement Process.
And Part five will go
over the Hearing Process,
including what happens
before the hearing is
conducted, during the
hearing itself, and after
the hearing.All five webinars are
available on the FDA
Tobacco Compliance
Webinars page.
To access the webinars,
visit www.fda.gov and type
“FDA Tobacco Compliance
Webinars” in the search
bar.Follow the FDA Tobacco
Compliance Webinars link
in the search results
to find all available
webinars.The webinars are
organized by year.
You can watch all five
webinars in order, or skip
ahead to a webinar
topic of your choice.
Now, let’s start
the first webinar.
I’m joined by Lieutenant
Brian Thomas from the
Office of Compliance
and Enforcement.
Lt.Thomas will present the
Introduction to CMP and
NTSO Complaints.Lt.Thomas …Thanks Captain Racine.This webinar, the first in
our series of five, will
focus on CMP and
NTSO Complaints.
Specifically, we will
discuss: — What is a
Civil Money Penalty (also
known as a CMP) — What is
a No-Tobacco-Sale Order
(also known as an NTSO),
and — What is
a Complaint.
Included in this
discussion will be: — a
description of what is
in a Complaint, — a
description of the
documents that accompany
the Complaint, — and
an explanation of what
happens after you
receive a Complaint.
A Civil Money Penalty, or
CMP, is simply a monetary
sum assessed for
violations of the law.
The Federal Food, Drug,
and Cosmetic Act (known as
the FD&C Act) gives FDA
the authority to assess a
CMP for violations of
certain requirements of
the Act.The monetary sum
assessed is based on a
published penalty
schedule, and the amount
varies depending upon how
many violations of the
tobacco regulations occur
during a specified period.
Because FDA’s Center for
Tobacco Products counts
violations of the
regulations when
determining the CMP
amount, an inspection
could result in more
than one violation.
If a retailer is found
to have violated certain
requirements of the FD&C
Act as listed in the
Complaint, they may be
liable for the amount of
the CMP sought.A No-Tobacco-Sale Order,
or NTSO, is an order
prohibiting the sale of
tobacco products at a
retail establishment.A retailer who has
repeated violations of the
tobacco regulations may be
subject to an NTSO order.
Repeated violations are
defined as five violations
of certain tobacco
regulations within a
thirty-six month period
that constitute a repeated
violation.The maximum NTSO period
that CTP intends to seek
are 30 days for the first
NTSO, 6 months for the
second NTSO, and an
indefinite period for the
third or subsequent NTSO.FDA has compiled a
glossary of common terms
that you will encounter
when dealing with CMPs and
NTSOs.Please feel free to use
this glossary when viewing
this webinar series, or
when reading your CMP or
NTSO Complaint.The glossary is available
as a download at the
Tobacco Compliance
Webinars page on the FDA
website.We’ll remind you how to
find that website at the
end of this webinar.Now we’ll discuss what a
CMP or an NTSO Complaint
is, what you’ll receive
with your Complaint, and
what happens after the
Complaint is delivered to
you.Retailers receive CMP or
NTSO Complaints when the
FDA’s Center for Tobacco
Products has evidence that
indicates an establishment
violated the Tobacco
Control Act.The FDA’s Center for
Tobacco Products initiates
a CMP or NTSO action by
serving a Complaint upon
the retailer or
its representative.
Serving the Complaint
simply means that the
Complaint has been
delivered to you.
In most cases, you will
receive your Complaint at
your retail establishment
through a mailing service,
such as UPS or the
US Postal Service.
Now let’s turn our
attention to the Complaint
itself.A Complaint is the legal
document that identifies
the statutory or
regulatory violations that
are the basis for
seeking a CMP or NTSO.
In other words, the
Complaint tells you the
information that FDA’s
Center for Tobacco
Products is using to
seek the CMP or the NTSO.
The Complaint also
identifies the amount of
the CMP or the duration of
the NTSO that FDA’s Center
for Tobacco
Products is seeking.
The Complaint has several
sections that provide
important specific
information.
The first section is
called the Introduction.
The Introduction
identifies the parties to
the Complaint.In a CMP or an NTSO
action, the parties are
the FDA’s Center for
Tobacco Products and the
retailer.The Introduction also sets
forth the amount of the
CMP sought or the duration
of the NTSO sought.
The next section of the
Complaint is called the
Legal Authority section.The Legal Authority
section sets forth the
laws governing the sale
and distribution of
tobacco products and the
authority for a CMP and/or
NTSO.This is the first page of
a sample CMP Complaint.
On the far-right side it
is titled: “Administrative
Complaint for Civil
Money Penalty.” An NTSO
Complaint looks just like
a CMP Complaint, except it
is titled: “Administrative
Complaint for
No-Tobacco-Sale Order.” As
you can see, the heading
or the caption, identifies
you, the retailer, as the
Respondent for
this Complaint.
Throughout the CMP or
NTSO process, you will be
referred to as the
Respondent and the Center
for Tobacco Products at
FDA will be referred to as
the Complainant.The caption also lists
the docket numbers for the
Complaint.We will discuss docket
numbers in more detail
later in this
presentation.
The first page of the
Complaint contains the
Introduction section and
begins the Legal Authority
section.The Current Allegations
section of the Complaint,
among other things,
provides the most recent
facts and circumstances
forming the basis for the
action.It sets forth the name
and address of your
establishment.In CMP Complaints, this
section also provides the
brand names of the
tobacco products that were
involved in the violation,
the dates and times of the
most recent violations,
and the specific laws that
you allegedly violated.The Previous Case
History section provides
information about the
retailer’s previous CMP
and NTSO history,
including the dates and
specific regulatory
violations alleged in
previous Complaints,
and the outcome of those
actions.If this is your first
CMP, there will not be a
Previous Case
History section.
The Complaint will also
have a section titled
Responding to
the Complaint.
This section provides you
with specific information
on how and when to
respond to the Complaint.
If you choose to contest
the matter, you must take
action within 30 days of
receiving the Complaint by
filing an Answer or
successfully requesting an
extension.If you take no action, you
could be issued a default
judgment.Answers, extensions, and
default judgments will be
explained in detail in our
third webinar: How to File
an Answer and Consequences
for not Filing an Answer.
The Complaint also informs
you that you have the
right, but are not
required, to obtain an
attorney to represent
you in this case.
Your Complaint will be
accompanied by several
documents.One of them is
the cover letter.
The cover letter is
addressed to your retail
establishment.The subject line of the
cover letter will state
whether a CMP or NTSO
Complaint is included, and
will include your
establishment name and
street address, case
docket numbers, and the
retailer case number.Docket numbers and the
retailer case number are
used to identify your case
and are used in filing
documents, when paying
CMPs online, during the
settlement process,
and during the hearing
process.We will address when and
how you will use docket
numbers and retailer
case numbers during each
relevant webinar in this
series of five webinars.
The cover letter also sets
forth the amount of the
CMP or duration of the
NTSO sought, and provides
contact information for
the FDA’s Center for
Tobacco Products.The cover letter also
outlines the various
options for responding
to the Complaint.
These options are: Option
1: Acknowledge that the
violations occurred and
pay the full penalty
amount.This option exists
only for CMP cases.
Please view the second
webinar in this series
“How to Pay a CMP Using
the Online Payment Portal”
to learn more about the
acknowledgment and payment
process.Option 2: Settlement.Please view the fourth
webinar, “The Settlement
Process” to learn more.Option 3: Request
a hearing.
We cover that in the fifth
webinar, “The Hearing
Process.” And Option 4:
Request an extension of
time to file an Answer.Watch the third webinar,
“How to File an Answer and
Consequences for Not
Filing an Answer” to learn
more.Finally, you will find
information on how to
submit documents.In addition to the cover
letter, FDA’s Center for
Tobacco Products encloses
with the Complaint:
inspection documents and
photos related to the most
recent inspection that led
to the CMP or NTSO action.
For example, you may see
a report by the inspector,
photos of the evidence
collected during the
inspection, or a photo of
your retail establishment
from the outside.Once the Complaint has
been delivered to you, the
FDA’s Center for Tobacco
Products files the
Complaint with the US
Department of Health and
Human Services,
Departmental Appeals
Board, also
known as the DAB.
“Filing” means submitting
a copy of the Complaint to
the DAB.The filing of a Complaint
for a CMP or an NTSO
officially opens an
administrative enforcement
action.The DAB employs several
Administrative Law Judges
(also known as ALJs)
in its Civil Remedies
Division, or CRD.The CRD ALJs provide
impartial, independent
review of administrative
actions such as CMP and
NTSO cases.The ALJs are qualified
under the Federal
Administrative Procedure
Act to conduct hearings on
the record.For more information
regarding the DAB, visit
the DAB website at the
link provided in the
slide.A CRD ALJ will be assigned
to each Complaint filed
with the DAB.The ALJ determines the
procedures and outcomes of
the Complaint based on
submissions from both
sides.Once the DAB has a copy of
the Complaint and the ALJ
is assigned, the ALJ will
send information about the
procedures to be followed
for each specific case to
you and the FDA’s Center
for Tobacco Products.
The roles and
responsibilities of the
ALJs are discussed in more
detail in the webinar on
the Hearing Process.This concludes our
introduction to CMP and
NTSO Complaints.To summarize the material
we have covered in this
webinar: – We have
defined a CMP.
– We have defined a NTSO.– We have discussed what
a Complaint is and what
information is included
in a Complaint.
– We reviewed what is
included in the cover
letter and the other
documents that accompany a
Complaint.– We have discussed the
entity that conducts CMP
and NTSO hearings.And finally, we provided
you a glossary of terms
that may be helpful as you
watch the other webinars
in this series, or as you
read through the CMP or
NTSO Complaint that
was delivered to you.
Now that we’ve covered the
basics of a CMP and NTSO
Complaint, we encourage
you to view the other
webinars in the series to
help you understand the
CMP and NTSO
Complaint processes.
The remaining webinars
are: – Part 2: How to pay
a CMP using the online
payment portal; – Part 3:
How to File an Answer
and consequences for not
filing an Answer; – Part
4: The Settlement Process;
and – Part 5: The Hearing
Process We have additional
webinars available to
provide more detailed
background information
regarding CMPs and NTSOs,
such as how violations are
counted and what amount of
CMP or duration of
NTSO may be assessed.
In particular, please
watch: – Retail Compliance
Check Inspections: An
Overview for Tobacco
Retailers from 2016; and
Guidance for Industry:
Determination of the
Period Covered by a
No-Tobacco-Sale Order and
Compliance With an Order
from 2015.You can find these
webinars on the same
Tobacco Compliance
Webinars page as this
webinar.As a reminder, you can
find all of our webinars
by typing “FDA Tobacco
Compliance Webinars” in
the search bar on the
main FDA homepage.
Thank you for watching
part 1 of our webinar on
CMP and NTSO Complaints,
brought to you by the
FDA’s Center for Tobacco
Products, whose mission is
to protect our kids and
the nation’s health from
the dangers of tobacco.